MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Anxiety (2328); Discomfort (2330); Sleep Dysfunction (2517); Dysuria (2684); Constipation (3274); Paresthesia (4421); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019, mesh removal procedure date, as no event date was reported.The complainant was unable to provide the suspect device's upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2009.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient underwent mesh removal.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient underwent mesh removal.Boston scientific received an additional information on july 13, 2022, as follows: on (b)(6) 2020, the patient had a telemedicine consultation for evaluation of chronic pelvic pain.Reportedly, the patient had chronic pelvic pain during the menstrual period and was diagnosed with endometriosis and urinary incontinence.As a result, the patient needed a hysterectomy and mesh placement in (b)(6) 2020.Following the surgery, the patient developed constant groin pain and underwent a revision, but she reports her groin pain got worse.She stated that her pain is persistent, intensity is 7-8/10 with some breakthrough pain (intensity 10/10), described as sharp and throbbing, and gets better with nothing, but gets worse with prolonged walking, standing, or sitting.The patient reports that she had more pain during intercourse and sat down for a while.She noticed that both of her legs were weaker than previously, especially her hip flexion, and that her thighs were tingling.Additionally, she claims that the skin around her groin is painful and sensitive when touched, occasionally radiating to her rectum.The patient also states that it took her around two weeks to feel better following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on (b)(6) 2020.She felt better and could move more easily.She did, however, start to have bilateral pelvic pain two weeks before her telemedicine session on (b)(6) 2020, and it spread to her bilateral legs and ankles.The patient experiences some tingling in her bilateral feet and a small swelling in her legs.Additionally, she had pressure in both legs.The woman took ibuprofen and tylenol, which helped but did not completely alleviate her pain.She also utilized a pillow-elevated leg and a transcutaneous electrical nerve stimulation (tens) system, which helped.Additionally, the pain during her consultation on (b)(6) 2020, was around 6/10.The patient was instructed to start lyrica for 5 days in addition to continuing pelvic floor exercises, transcutaneous electrical nerve stimulation (tens) when necessary, tylenol, and ibuprofen.The patient's back discomfort and calf pain have reportedly subsided since her most recent appointment and the time she began taking lyrica.She still experiences lower back pain, which originates in the vagina.Either sharp, acute, and short-lived pain was reported, or it was dull.The patient stops what she was doing when a searing pain strikes, but she denies falling or losing her balance even though she feels her hips give way.More so than tylenol or ibuprofen, the patient tried taking naproxen and saw a significant improvement.She keeps going to physical therapy for her lower back; she feels better while she's there, but the pain becomes worse afterward.Bending, walking, and sitting are reportedly the most pain- aggravating activities for the patient.According to the patient's telemedicine visit note on (b)(6) 2021.The patient has continued to suffer low back and pelvic pain that radiates to her legs since their last appointment.She believes that pudendal pulse radiofrequency ablation (rfa) or blocks have not provided her with enough comfort, and she is looking for a more permanent solution.She also finds that medications are only marginally beneficial.Since she was last seen, she reportedly started taking naproxen and her lyrica dosage was increased to 50 mg twice daily, which she finds beneficial and denies having any negative side effects.On (b)(6) 2020, the patient visited a doctor, who determined that the patient's pain "appears to come from the free ends of the transobturator mesh, which can be palpated on exam." in order to find the mesh and hydrodissect the nerves and tissue away from the mesh, the doctor intended to perform ultrasound-guided trigger point injections (tpi).Another doctor who treated the patient suggested that she have the transobturator mesh removed.On (b)(6) 2021, the patient states that her pelvic pain has gotten worse over the past three months on (b)(6) 2021.The left groin is where the pain is the worst.She experiences everyday groin pain on both sides and muscular spasms (particularly the left).Back and leg spasms are radiated.It is difficult for her to sit, stand, or lie down comfortably due to her agony.The patient claims that two weeks ago, he or she had a trigger point injection, but since then, the discomfort has gotten worse.She is aware of the surgical mesh's discomfort.She also mentioned having bladder pain.The patient additionally claims that recent relief from jaw pain.She also reports that she has occasionally clenched her jaw.The patient received 5 mg of flexeril for jaw pain and only took three times since it was too disabling.She noted that her spasm was somewhat relieved by the medication.She reports to her urogyn doctor who wants to remove her mesh, but she wants to wait before getting another operation once she receives further information about a potential surgery from urogyn, the patient indicates she is open to having repeat radiofrequency ablation (rfa) of the pudendal nerve.The patient connects with a physician via telephone for continued evaluation of her pelvic pain on (b)(6) 2021.She claims that because her pain is frequently up and down, it is difficult to discern whether she has improved since having the pudendal radiofrequency ablation (rfa).On (b)(6) 2021, the patient had her mesh resection, but she is unsure if it helped, and she claims that after the surgery, she is experiencing new pain that is distinct from her previous pain.The discomfort occurs in the hip, buttock, and back of the leg.The patient claims that her knees are a little swollen.She also mentions having some weakness in her legs and hips, which shows up as tightness and soreness after strenuous walking and a lack of strength.The patient adds that when the pain is severe, she feels it in her pelvic bones.The patient claims that at her 6-week follow-up, the doctor released her from pelvic rest and said she was recovering well and could resume her normal activities.Seven weeks after the surgery, she resumed her job.Considering that only a portion of the mesh was removed, the procedure was not entirely effective.The doctor does not believe that all the mesh was taken out.The patient also claims that her symptoms have gotten worse and that she is experiencing a different kind of discomfort.Her leg pain has gotten worse.She still feels stiff in her legs and hips.She experiences increasing back discomfort as the day goes on.The area of her left groin where incisions were made is also causing her severe discomfort and muscle spasms.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.The patient's use of a transcutaneous electrical nerve stimulation (tens) unit on her lower back, bio freeze, and hot showers all help.She had imaging of her hip and back and was sent to physical therapy.She underwent physical therapy for her pelvis and low back.This has also only slightly helped.Reportedly, flexeril is no longer covered if it is not authorized beforehand.The patient is being referred to a specialist because she also has jaw problems.The patient had a follow-up imaging on august 9, 2021.The patient was informed that a computed tomography (ct) scan of her abdomen revealed an expanding hemangioma that required repeat imaging in six months.She said that her primary care physician (pcp) had not told her about this while crying.She hasn't followed up on this discovery in any way.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She complains of generalized body ache, which can sometimes be made worse by stress and other times for no apparent reason.The patient's neck, trapezius areas, arms, thoracic back, lumbar spine, sacral area, and circumferentially down both of her lower extremities (ble) are all painful.Even after sleeping more than eight hours, she has poor sleep quality and doesn't feel rested when she wakes up.She mentions headaches, bloating, and abdominal discomfort.She is undergoing physical therapy, which she finds beneficial.She is also learning breathing exercises and stretching from them.The patient visited the clinic on (b)(6) 2021, for a follow-up regarding her persistent pelvic pain.According to reports, the patient's lyrica dosage was upped from 50 mg twice day to 100 mg twice daily.She was also reportedly recommended to an occupational therapist and a pain psychologist and talked about starting cymbalta.Following a morning dose of 100mg of lyrica, the patient is feeling drowsy.The patient still experiences 7/10 pain with intermittent pain on this visit.On other days, she feels almost pain-free, with just a little hip and groin stiffness, but as soon as she starts moving around or working, her pain flares up.The patient still occasionally has neck pain, and she is seeing physical therapy for her jaw, which is helping her.She did experience a flare-up of 10/10 left flank pain, and she subsequently went to the er for her pain 1 week ago.She received labs and extended release, was diagnosed with lumbar spine sprain, was given 10mg cyclobenzaprine, and was discharged.The patient's back pain is better now compared to before, and she takes cyclobenzaprine 5 mg every night at bedtime as needed (qhs).Moreover, the patient otherwise denies any new numbness, weakness, bowel or bladder incontinence.On (b)(6) 2021, the patient visited the clinic due to flu.She reports continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period tends to worsen her pain.The patient has appropriate follow up set up with her surgeon.Patient is stable on current pain medication regiment.Opioids help manage her pain and improve functional status.She also denies any adverse side effects to current regiment.On (b)(6) 2022, the patient reports worsening of pain.She states that obgyn must schedule surgery to remove mesh.Reportedly, the mesh has been found and will be removed.For now, the patient will continue with the same regiment.

Manufacturer Narrative

Block h2: additional information block b5 narrative updated h6 patient code e1405, e2326, e2330, e0123 added to capture the reportable events of dyspareunia, inflammation, pain and nerve damage.H6 impact code f1905, f2303, f2203, f18 captures the reported event of device revision, medication required, imaging required and rehabilitation.Correction: block b3 (date of event) updated.Block b3 date of event: event date discrepancies between the initial information received and the additional information received on july 13, 2022 could not be reconciled.The event date of (b)(6) 2009 has been selected based on the most recent information.Blocks d4, h4: the complainant was unable to provide the suspect device's upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e1405, e2326, e2330, e0123 added to capture the reportable events of dyspareunia, inflammation, pain and nerve damage.Impact code f1905, f2303, f2203, f18 captures the reported event of device revision, medication required, imaging required and rehabilitation.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h2: block b5 narrative has been updated based on the additional information received on november 8, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2019, implant procedure date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block b5 continuation: boston scientific received an additional information on october 13, 2022, as follows: on (b)(6) 2020, the patient went to the clinic with pain that predates either surgery.Her periods were quite painful, and she also had pain in between periods.The patient did experience some dyspareunia prior to the initial surgery with deep penetration; nevertheless, intercourse remained unbearable following hysterectomy and did not improve after mesh excision.She claims that the pain is so bad that it causes her chills at times, and that even the touch of her underwear on her vulva is painful.During a pelvic examination, there is an increase in tone bilaterally of the superficial perineal muscles at the posterior fourchette, but no point tenderness.According to reports, the patient has bilateral thrombotic thrombocytopenic purpura of the levator ani and obturators.The patient's relaxation was delayed and impaired.The patient also had significant pain while flexing the obturators (adducting knee).There is also pain with knee and hip flexion.There is no evidence of sciatica.Tenderness along the path of the transobturator tape at the superior aspect of the pubic rami was elicited bilaterally, though it was difficult to distinguish from tenderness at the obturator foramen.There was no palpable mesh or indication of mesh exposure.The patient reported chronic pelvic pain throughout her menstrual period on (b)(6) 2020 and was diagnosed with endometriosis and urinary incontinence.The patient also had constant groin pain.Her pain was described as radiating to her inner thigh, hip, and back, with an intensity of 7-8 to 10, with some breakthrough pain (intensity 10/10), sharp/throbbing, and increasing by walking/standing/sitting for a time.She stated that she felt more pain during intercourse and sat down for a bit.She noticed her legs were weaker (particularly hip flexion) than previously, and she felt a tingling feeling within her thigh.She claims that when she touches her skin around her groin, it becomes extremely sensitive and painful, sometimes radiating all the way to her rectum.The patient was called for a follow-up physical therapy appointment on (b)(6) 2020.The patient only received one session and is complaining of increasing pain.She said that she could feel the mesh moving while doing all of her household chores.During her follow-up, she reported a pain level of 7 out of 10 on the pain scale.Because of the bleeding, the patient was encouraged to see her doctor.She was still unable to sleep for more than a few hours and was unable to have intercourse.The patient mentioned that she will be having a pudendal nerve block.This will be when she has completed her physical therapy program.Transcutaneous electrical nerve stimulation (tens) and an ice pack were also recommended to the patient.Transcutaneous electrical nerve stimulation (tens) can be used to target the origin of the pudendal nerve at level s 2.3.4 for 25 minutes while applying an ice pack to the pelvis and hips.A tens unit for home use can assist patients gain some pain relief after 5 sessions if it decreases the pain, although activities such as kegel are prohibited until the mesh placement is changed.On (b)(6) 2020, the patient evaluated her pain as an 8 on a scale of 10.She further reported that the pain became worse when she got in swimming pool and that no other activities were out of the normal to her.According to reports, the patient did not respond well to her therapy during her visit, and the internal tissue of her vaginal canal has increased inflammation and pain in the groin area.The patient continued to complain about the mesh's hypermobility.The patient was told to keep using ice for pain relief and to hold soft tissue mobilization of the internal cavities and vaginal walls.When the pain decreases, the physical therapist will proceed with transcutaneous electrical nerve stimulation (tens) in the sacral area for 20 minutes, followed by soft tissue mobilization (stm) of the vaginal canal and exercises.Despite two instances of increasing pain due to external factors, the patient was improving with physical treatment, and the physical therapist had high expectations for further treatment when the patient received a pudendal nerve injection.On (b)(6) 2020, the patient says that it took around two weeks for her to experience relief following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on (b)(6) 2020.She was feeling better and moving more freely.She started having bilateral pelvic pain that extended down both legs to her ankles around two weeks ago.Her legs felt somewhat swollen, and she experienced tingling in both of her feet.She also felt pressure on both of her legs.She took tylenol 500 mg and ibuprofen 800 mg, which relieved her pain but did not completely alleviate it.Transcutaneous electrical nerve stimulation (tens) is also used, and the leg is elevated with a pillow to provide some relief.During her appointment, she notes that her pain is a 6 out of 10 and worse than normal, and that no specific movement has made it worse.The patient had telemedicine visit on september 23, 2020 and stated that she still experienced pelvic pain that radiated from inside the vagina to the lower back.The pain is either sharp and acute and usually goes away quickly, or it is dull.When the sharp pain is felt, the patient stops what she is doing and feels her hips give out.The patient denies falling or losing balance.She continues taking tylenol and motrin.The patient tried naproxen 500 mg with significant improvement, more than tylenol or ibuprofen.The patient continues to go for physical therapy for her lower back, with improvement when she goes, but she has increased pain afterwards.The patient went to pelvic physical therapy three weeks ago, which she felt was beneficial.Reported aggravating factors are: bending over, walking, and sitting.On january 19, 2021, the patient had a telemedicine visit and reported new complaints of pain in the inner left inner thigh along the saphenous distribution.She has pending imaging by her neurologist, which they will review once done.They may also consider saphenous nerve block.On january 25, 2021, the patient still reports pain.It is located in her pelvis and low back that radiates to her legs.She feels that she has not gotten adequate relief with pudendal pulsed radiofrequency ablation or blocks and is looking for more definitive treatment.The patient finds medicines minimally helpful.Reportedly, lyrica was increased to 50 mg twice daily which she finds helpful and denies any adverse side effects to and she was started on naproxen.On february 3, 2021, the patient reports that for the past three months, her pelvic pain has been progressively getting worse.Pain is worse in left groin.Experiences daily muscle spasms and sharp pain in bilateral groin (especially left).Spasm radiates to leg and back.Pain makes it difficult to sit, stand, or get into comfortable sleeping position.Patient reports getting trigger point injection two weeks ago but pain seems to have worsened since then.The patient says that her urogyn wants to remove her mesh but she wants to get a second opinion first before going for repeat surgery.Patient reports she is amenable to getting repeat pulsed radiofrequency of pudendal nerve once she gets more info about potential surgery from urogyn.On may 12, 2021, the patient connects with her physician via telephone for continued evaluation for her pelvic pain.She reports it's difficult to tell whether she had improvement with the pudendal radiofrequency because her pain tends to be up and down regularly.She had resection of her mesh on april 7, 2021 but is also unsure whether this helped.She reports having new pain since this surgery that is different than her prior pain.This new pain is in the hip, buttock, and posterior thigh.She reports having some swelling in her knees.She does report some weakness in her hip and legs, which manifests as tightness and pain after walking for long periods with loss of strength.She also says when the pain is severe she feels it in her pelvic bones.On june 23, 2021, the patient continues to have stiffness in her hips and legs.As the day goes by she has worsening back pain.She also has sharp pain and muscle spasms on her left groin which is where incisions were made.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.She uses transcutaneous electrical nerve stimulation (tens) unit on her lower back which helps, bio freeze, hot showers.She had imaging of her hip and back and was sent to physical therapy.She did physical therapy for her low back and pelvis.This has also been minimally helpful.On (b)(6) 2021, the patient was made aware of her computerized tomography (ct scan) result that shows an abdominal hemangioma which is growing and needs 6 months repeat imaging.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She reports all over body pain which is exacerbated at times due to stress and at times not associated with any factors she can think of.She has pain along her neck, trapezius regions, along her arms, in thoracic back, lumbar spine, radiating to sacral area and along bilateral lower extremities in circumferential manner.Sleep quality is poor and she wakes up not feeling refreshed even if she sleeps over 8 hours.She reports bloating and abdominal discomfort as well as headaches.She is currently in physical therapy, which she finds helpful.They are teaching her stretches and breathing techniques.On (b)(6) 2021, the patient still feels the same, in 7 out of 10 pain scale, which she described as an intermittent pain.She has days where she feels like almost no pain, with a little groin and hip stiffness, but once she starts performing activity, working, she experiences flare-ups of her pain.Sometimes, she has difficulty sleeping because of her pain.She still occasionally has neck pain, and she is seeing physical therapy for her jaw, and this is helping her.She did experience a flare-up of 10 out of 10 left flank pain, and she subsequently went to the emergency room.In the emergency room, she received labs and x-ray, and she was diagnosed with lumbar spine sprain, was given 10 mg cyclobenzaprine, and was discharged.Her back pain is better now compared to before, and she takes cyclobenzaprine 5 mg as needed.On october 13, 2021, the patient had a follow-up consultation.She reports continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period of time tends to worsen her pain.She has appropriate follow up set up with her surgeon.Patient is stable on current pain medication regiment.Reportedly, opioids help manage her pain and improve functional status.Denies any adverse side effects to current regimen.After a hiatus of several months, the patient returned to the care of a pelvic physical therapist in november 2021.The physical therapist told the patient that her pelvic floor has gotten worse, with weaker bladder control.The patient has been working with pelvic physical therapist but did not think her therapist was focused on the specifics of her reason for physical therapy and had her doing exercised that were too hard for her which flared her symptoms (she describes being instructed to squeeze a ball between her legs, which resulted in worse pain for several days).As recommended by her physician, the patient went for a session with a new physical therapy, and she was told by the facility that they didn't think they would be able to help her pain as long as the mesh remained in place.Moreover, the patient also has clinic notes from her local neurologist, and he described to her that she has nerve damage that is likely permanent impacting her bilateral genitofemoral nerves, pudendal nerves, inferior cluneal nerves and has recommended an electromyography study for evaluation of bilateral lumbosacral plexopathy.They have also suggested that she could increase her dose of lyrica.On july 11, 2022, the patient underwent a removal of foreign body bilateral groins to address chronic pelvic pain, pain due to genitourinary prosthetic devices, spastic pelvic syndrome and groin pain.During the surgery, a palpable subcutaneous irregularity of right lateral vulva at spot previously identified as likely site of previous incision from mesh placement, corresponding to location palpated while patient awake and marked.Possible some mucosal nodule on the right lateral vaginal wall corresponding to medial aspect of suspected retained mesh.No palpable subcutaneous irregularities on the left lateral vaginal wall.Palpable subcutaneous irregularity of left lateral vulva, symmetric to the right sided lesion, at location identified and marked in triage while patient awake as site of pain and placed that patient occasionally palpates a subcutaneous irregularity.Both sites located at level of clitoral hood and slightly medial to groin crease.Left site noted to be located 2+ centimeters anterior to and slightly medial to previous incision from 2021 surgery.During dissection, blue mesh identified subcutaneously bilaterally and followed to the level of the obturator foramen: on right groin this was removed in 3 segments due to tearing of mesh during dissection, measuring approximately 6 cm in total length.From left groin, similar blue mesh removed in single segment measuring 5 cm.No mesh palpable on either side after removal of mesh segments.After mesh removal, no submucosal irregularities palpated on either vaginal lateral wall corresponding to internal aspect of inferior pubic ramus, estimated to be about 1 cm medial to deepest aspect of groin dissections.Surgical pathology findings were skeletal muscle and fibrous tissues with foreign body type giant cells.On (b)(6) 2022, the patient had a telemedicine visit for a surgical follow-up.She was treated with keflex for suspected left groin incision first week post-operative.She had reports having a strong smell to her urine prior to taking the antibiotic, as well as vaginal odor for which she was treated with vaginal metrogel antibiotic.The vaginal odor improved, but she still noted urine odor.She had urine and std/vaginitis testing and would have an appointment upcoming next week for results.During this visit, she reported that her groin incisions looked good and were healing well.She still has pain, but it has improved since her surgery.She can tolerate more physical activity, but increased activity is associated with pain.She reported some pain with sitting, and sharp pain in her abdomen medial to the asis (anterior superior iliac spine), present bilaterally.She recently started physical therapy, tolerated short period of stretching but had significant pain afterwards.She returned to work over the past two weeks, working a few days per week with increased pain associated with work.She previously reported decreased clitoral sensation on the left.She reported being able to achieve orgasm with her new boyfriend, which is still the case.During the visit, the patient requested for replacement prescription for her previously prescribed tens unit as it was partly broken.Assessments at that time included chronic pelvic pain in female, spastic pelvic floor syndrome and vaginal discharge.She was advised to continue pelvic pt.Pain improvement is expected by 3 months from this visit.For a full recovery, she will likely need to continue with her physical therapy longer.Work may prolong the patient's recovery, but she does not have an option to not work.She was recommended to follow-up with pain management for lyrica renewal.Lyrica physiologic dependence and the risks of withdrawal vs the risks of addiction from lyrica was discussed.Valium was encouraged to continue with judicious usage, and the need for gradual taper was explained as opposed to abrupt discontinuation to prevent physiologic withdrawal.She was also advised to start vaginal estradiol twice a week to reduce risk for recurrent bv (bacterial vaginosis).It was also discussed the option to use otc boric acid suppository at first sign of vaginal odor or after sex to counteract ph shift caused by semen.Furthermore, it was planned to readdress sexual dysfunction persists despite improvement in pelvic pain over time.The patient was scheduled for a follow-up via telemedicine visit within three months.Boston scientific received an additional information on november 8, 2022, as follows: the patient was sent to physical therapy for pelvic pain on february 7, 2020.She is also incontinent.According to reports, the patient was born with two uteri and had three children by caesarian section.She claims she has been in pain since giving birth to her first child, and that the pain is on her left side, near the introitus.The patient claims to have constant pain and a weak pelvic floor.Primary symptoms are hypersensitivity, numbness, weakness.Related symptoms: sleeping difficulty, unsteadiness.Prior to this injury/episode, patient already had some difficulty with her pelvic area, and she states that she had painful periods.Prior to this injury/episode, patient already had some difficulty ascending or descending stairs.She is now unable to ascend stairs without assistance and has to lead with affected extremity when descending stairs.The patient's plan of care is pelvic therapeutic exercises once weekly for six weeks for treatment of pelvic pain.On (b)(6) 2021, the patient presents at the clinic with an 8 on a 10-point pain scale in the lumbar area with radiation to her groin and pelvis.According to the patient, pain usually feels better after physical therapy and the following day.Per the patient's request, she wants to continue skilled physical therapy as recommended twice a week for four weeks as physical therapy currently provided pain relief, but it this only short term.On (b)(6) 2022, the patient presents at the clinic with a 6 on a 10-point pain scale in the groin, vagina and pelvic floor.Reportedly, the patient only received four therapy sessions since (b)(6) 2021.Activities or events that aggravate symptoms include sitting, walking, changing positions, coughing, sneezing, and straining.She reports urine loss with active exercise, sneezing, laughing, coughing.Daytime frequency is 1 to 4 times per day.She has periodic trouble initiating urination.Nighttime frequency is 2 times per night.Patient is not sexually active; she reports that sex is painful.Current medications: pain medication, tylenol 500, muscle relaxers.Patient is unable to have sex, is unable to laugh or cough.Pt has difficulty with everyday activities that cause pain.Patient also reports lumbar sacral pain.The plan of care is four weeks of twice weekly abdominal strengthening exercises.Block e1: this event was reported by the patient's legal representation.The implant surgeon: (b)(6) ca united states 93306-4018 the explant surgeon: (b)(6) ca (b)(6) block h6: patient codes e020201, e1301, e1715, e1906, e1309, e0123, e2326, e1401, e2338, e2330, e2006, e1405, e2401 capture the reported events of anxiety, dysuria, scar tissue, infection, urinary retention, nerve damage, inflammation, abnormal vaginal discharge, swelling/edema, pain, erosion, dyspareunia, possible mucosal nodule on the right lateral vaginal wall and subcutaneous irregularity.Impact code f23, f2303, f1905, f18 capture the reportable events of unexpected medical intervention, medication required, mesh resection and rehabilitation.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient underwent mesh removal.Boston scientific received an additional information on july 13, 2022, as follows: on (b)(6) 2020, the patient had a telemedicine consultation for evaluation of chronic pelvic pain.Reportedly, the patient had chronic pelvic pain during the menstrual period and was diagnosed with endometriosis and urinary incontinence.As a result, the patient underwent a hysterectomy and mesh placement in (b)(6) 2019 (date is per the medical records provided).Following the surgery, the patient developed constant groin pain and underwent a revision (reported in the same records as an "excision of vaginal mesh exposure x 2 and resection of vaginal septum" in (b)(6) 2019), but she reports her groin pain got worse.She stated that her pain is located at the groin and radiates to her inner thigh, hip and back, is persistent, intensity is 7-8/10 with some breakthrough pain (intensity 10/10), described as sharp and throbbing, and gets better with nothing, but gets worse with prolonged walking, standing, or sitting.The patient reports that she had more pain during intercourse and sat down for a while.She noticed that both of her legs were weaker than previously, especially her hip flexion, and that her thighs were tingling.Additionally, she claims that the skin around her groin is painful and sensitive when touched, occasionally radiating to her rectum.Review of systems noted constipation in the past and anxiety (onset dates not provided).The patient also states that it took her around two weeks to feel better following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on (b)(6) 2020.She felt better and could move more easily.She did, however, start to have bilateral pelvic pain two weeks before her telemedicine session on (b)(6) 2020, and it spread to her bilateral legs and ankles.The patient experiences some tingling in her bilateral feet and a small swelling in her legs.Additionally, she had pressure in both legs.The patient took ibuprofen and tylenol, which helped but did not completely alleviate her pain.She also utilized a transcutaneous electrical nerve stimulation (tens) system, and elevated her leg with a pillow which helped.Additionally, the pain during her consultation on (b)(6) 2020, was around 6/10.The patient reported she had restarted her job as a housekeeper 2 weeks prior to her telemedicine appointment.The patient was instructed to start lyrica for 5 days in addition to continuing pelvic floor exercises, transcutaneous electrical nerve stimulation (tens) when necessary, tylenol, and ibuprofen.During a telemedicine visit on (b)(6) 2020, the patient reported that her back discomfort and calf pain have are portedly subsided since her most recent appointment and the time she began taking lyrica.She still experiences pelvic pain, which originates in the vagina.Either sharp, acute, and short-lived pain was reported, or it was dull.The patient stops what she was doing when a searing pain strikes, but she denies falling or losing her balance even though she feels her hips give way.More so than tylenol or ibuprofen, the patient tried taking naproxen and saw a significant improvement.She keeps going to physical therapy for her lower back; she feels better while she's there, but the pain becomes worse afterward.Bending, walking, and sitting are reportedly the most pain- aggravating activities for the patient.The plan was to start naproxen 500 mg twice daily and stop ibuprofen; increase lyrica to 25 mg qam and 50 mg qhs for 5 days, then continue at 50 mg twice daily; continue tylenol, tens, pt, and home pelvic floor physical exercise.According to the patient's telemedicine visit note on (b)(6) 2021.The patient has continued to suffer low back and pelvic pain that radiates to her legs since her last appointment.She believes that pudendal pulse radiofrequency ablation (rfa) or blocks have not provided her with enough comfort, and she is looking for a more permanent solution.She also finds that medications are only marginally beneficial.Since she was last seen, she reportedly started taking naproxen and her lyrica dosage was increased to 50 mg twice daily, which she finds beneficial and denies having any negative side effects.On (b)(6) 2020, the patient visited a doctor, who determined that the patient's pain "appears to come from the free ends of the transobturator mesh, which can be palpated on exam." in order to find the mesh and hydrodissect the nerves and tissue away from the mesh, the doctor intended to perform ultrasound-guided trigger point injections (tpi).Another doctor who treated the patient suggested that she have the transobturator mesh removed.On (b)(6) 2021, the patient states that her pelvic pain has gotten worse over the past three months on (b)(6) 2021.The left groin is where the pain is the worst.She experiences everyday groin pain on both sides and muscular spasms (particularly the left).Back and leg spasms are radiated.It is difficult for her to sit, stand, or lie down comfortably due to her agony.The patient claims that two weeks ago, she had a trigger point injection, but since then, the discomfort has gotten worse.She is aware of the surgical mesh's discomfort.She also mentioned having bladder pain.The patient additionally claims that recent relief from jaw pain.She also reports that she has occasionally clenched her jaw.The patient received 5 mg of flexeril for jaw pain and only took three times since it was too disabling.She noted that her spasm was somewhat relieved by the medication.She reports to her urogyn doctor who wants to remove her mesh, but she wants to wait before getting another operation once she receives further information about a potential surgery from urogyn, the patient indicates she is open to having repeat radiofrequency ablation (rfa) of the pudendal nerve.The patient connected with a physician via telephone for continued evaluation of her pelvic pain on (b)(6) 2021.She claims that because her pain is frequently up and down, it is difficult to discern whether she has improved since having the pudendal radiofrequency ablation (rfa).On (b)(6) 2021, the patient had her mesh resection, but she is unsure if it helped, and she claims that after the surgery, she is experiencing new pain that is distinct from her previous pain.The discomfort occurs in the hip, buttock, and back of the leg.The patient claims that her knees are a little swollen.She also mentions having some weakness in her legs and hips, which shows up as tightness and soreness after strenuous walking and a lack of strength.The patient adds that when the pain is severe, she feels it in her pelvic bones.The patient's problem list/past medical history at this time included chronic female pelvic pain, groin pain, neuralgia of both pudendal nerves, pelvic pain, spastic pelvic floor syndrome, and pain due to genitourinary devices/implants/grafts.On (b)(6) 2021, the patient reported that at her 6-week follow-up, the doctor released her from pelvic rest and said she was recovering well and could resume her normal activities.Seven weeks after the surgery, she resumed her job.Considering that only a portion of the mesh was removed, the procedure was not entirely effective.The doctor does not believe that all the mesh was taken out.The patient also claims that her symptoms have gotten worse and that she is experiencing a different kind of discomfort.Her leg pain has gotten worse.She still feels stiff in her legs and hips.She experiences increasing back discomfort as the day goes on.The area of her left groin where incisions were made is also causing her severe discomfort and muscle spasms.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.The patient's use of a transcutaneous electrical nerve stimulation (tens) unit on her lower back, bio freeze, and hot showers all help.She had imaging of her hip and back and was sent to physical therapy.She underwent physical therapy for her pelvis and low back.This has also only slightly helped.Reportedly, flexeril is no longer covered if it is not authorized beforehand.The patient is being referred to a specialist because she also has jaw problems.A ct of the lumbar spine was performed, but results were not reported in the medical records provided.The patient was asked to come to the clinic with the ct scan results so a physical exam could be performed, and it could be determined if facet arthropathy or si joint injections could help with her pain.The patient had a follow-up for imaging on (b)(6) 2021.The patient reported that no one had followed up with her on imaging which had been ordered 8 months ago.The patient was informed that a computed tomography (ct) scan of her abdomen revealed an expanding hemangioma that required repeat imaging in six months.She said that her primary care physician (pcp) had not told her about this.She hasn't followed up on this discovery in any way.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She complains of generalized body ache, which can sometimes be made worse by stress and other times for no apparent reason.The patient's neck, trapezius areas, arms, thoracic back, lumbar spine, sacral area, and circumferentially down both of her lower extremities (ble) are all painful.Even after sleeping more than eight hours, she has poor sleep quality and doesn't feel rested when she wakes up.She mentions headaches, bloating, and abdominal discomfort.She is undergoing physical therapy, which she finds beneficial.She is also learning breathing exercises and stretching from them.On exam, the patient had total body pain, reported head-to-toe pain associated with poor sleep quality.The patient was diagnosed with fibromyalgia and was given information about the diagnosis and treatment options.Changes to the treatment included increasing lyrica to 100 mg twice daily and consider cymbalta.The patient was also signed up for occupational therapy and pain psych and was referred to hepatology to follow up on ct scan findings.The patient had a telemedicine visit on (b)(6) 2021, for a follow-up regarding her persistent pelvic pain.Following a morning dose of 100mg of lyrica, the patient was feeling drowsy, so she was taking 50 mg in the morning and 100mg at night.The patient still experiences 7/10 pain with intermittent pain on this visit.On other days, she feels almost pain-free, with just a little hip and groin stiffness, but as soon as she starts moving around or working, her pain flares up.The patient still occasionally has neck pain, and she is seeing physical therapy for her jaw, which is helping her.She did experience a flare-up of 10/10 left flank pain, and she subsequently went to the er for her pain 1 week ago.She received labs and x-rays, was diagnosed with lumbar spine sprain, was given 10mg cyclobenzaprine, and was discharged.The patient's back pain is better now compared to before, and she takes cyclobenzaprine 5 mg every night at bedtime as needed (qhs).Moreover, the patient otherwise denies any new numbness, weakness, bowel or bladder incontinence.Changes to the plan included starting robaxin during the day and using flexeril 5mg as needed at night for insomnia from pain.On (b)(6) 2021, the patient had a follow-up telemedicine visit.She reported continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period worsened her pain.The patient had appropriate follow up set up with her surgeon.Patient was stable on current pain medication regiment.Opioids help manage her pain and improve functional status.She also denies any adverse side effects to current regiment.On (b)(6) 2022, the patient had a telemedicine visit and reported worsening groin pain.She states that obgyn must schedule surgery to remove mesh.Reportedly, additional mesh has been found and will be removed.For now, the patient will continue with the same regiment.Boston scientific received an additional information on september 13, 2022, as follows: on (b)(6) 2019, a robotic-assisted hysterectomy, bilateral salpingectomy, obtryx sling implantation, and cystoscopy were performed on the patient to treat abnormal uterine bleeding, pelvic pain, dysmenorrhea, dyspareunia, uterine didelphys, and stress urine incontinence.The following are the results of the surgery: upon entry into the abdomen, there was no sign of vascular or visceral harm.The irregular contour of the uterus suggests fibroids.Normal-appearing bilateral fallopian tubes with scarring consistent with tubal ligation history; normal-appearing left and right ovaries, each with a small hemorrhagic cyst.The anterior uterus has a moderate amount of adhesions.Cystoscopy revealed no signs of bladder injury or bilateral ureteral jets.Reportedly, the patient tolerated the procedure well and will have a voiding trial prior to discharge from the hospital with appropriate follow-up and a prescription for pain medication.On (b)(6) 2019, the patient came at the clinic for a check-up concerning pelvic pain.Her dyspareunia has also gotten much worse since her surgery, as stated by the patient.She claims she can't tolerate even a minute of intercourse.During her visit, the patient become emotional and claimed that she and her husband had recently married and that she could not even enjoy their honeymoon because of her pain.She says the pain is near the introitus and that she experiences a sharp clenching sensation that travels up into her bladder.She also complains of vaginal bleeding that is deeper and worse on the left side.The patient desperately wants to find a solution.She was encouraged to make an appointment for physical therapy and she states she has an appointment coming up on august 1, 2019.A gynecologic examination also identified a 1 cm region of mesh erosion just below the mid urethra.When the midurethral sling is palpated, blue mesh can be seen.In the midline, a remnant of the membranous septum can be seen.The vaginal cuff has fully healed.When the speculum was inserted, the patient experienced discomfort, although it was more severe in the left vaginal cuff than the right.During the bimanual exam, the left vaginal cuff looked to be tighter than the right.Additionally, the patient was prescribed with premarin cream after a mesh exposure was noted.The patient presented at the clinic on july 31, 2019, complaining of worsening pelvic pain.The patient claims that her pain has gotten worse in the last two weeks, and that her bilateral groin and back pain are now a 10/10, affecting her ability to walk, sit for long periods of time, and even sleep.During her visit, the patient was hunched over the exam table, rocking side to side in pain, and was emotional and easily moved to tears.The patient claims that the pain became unbearable and that she was at a loss for what to do.She was also asked if she had ever experienced back pain, and her husband, who was also there, stated that she had experienced back pain prior to the surgery, as well as a history of sciatica.The patient was asked if she was using the premarin cream as prescribed for the mesh exposure, and she responded that she was.Physical exam revealed pain with mild/moderate palpation of the external and internal oblique muscles bilaterally, patrick test and thomas test performed bilaterally also caused extreme pain.The mesh exposure was still present and caused the patient a great deal of pain when palpated.Levator ani muscles were extremely tender to palpation and patient asked to stop exam at that point.The assessment was lumbar back pain/sacroiliac joint pain; pelvic pain; dyspareunia; mesh exposure.The patient was advised that the patient's pain seemed to be musculoskeletal, and that while the groin pain could be from the sling, it did not have the classic physical findings.The physician was concerned about a possible herniated disc and advised the patient to consult her primary care physician right away.The patient was to continue premarin for the mesh exposure.On (b(6) 2019, the patient presented to the emergency department (ed) for vaginal pain.She had seen her primary care physician on august 7 where a ct of the abdomen and pelvis were not significant for any abnormalities.The patient reported that applying the premarin cream as prescribed has not assisted her symptoms.The patient was given norco and zofran with improvement in her symptoms.Moreover, the patient was prescribed with norco 10/325 mg for moderate to severe pain management.The patient states she would like to seek a second opinion regarding exposure of the urethral mesh.On (b)(6) 2019, the patient came to the clinic for a check-up regarding vaginal mesh exposure.The patient's lower back pain has also improved, but she still has vaginal and bilateral groin pain.According to reports, the doctor intends to bring the patient to the operating room for revision of the vaginal mesh, injection of local steroids, cystoscopy, and possible vaginal septum resection because she has been using premarin cream for 8 weeks and the vaginal mesh exposure remains symptomatic.The doctor informed the patient that removing the mesh could result in a recurrence of urinary incontinence.Furthermore, the patient claims that she occasionally leaks urine with a cough or sneeze, but that this has improved since surgery, and that she has recently felt unable to void entirely.They also considered the possibility of narrowing her vagina or causing further scarring by adjusting the mesh exposure and bringing that tissue together.The patient was informed that she would need to reduce her activities and not work for two weeks, as well as refrain from bathing and be on pelvic rest for six weeks.The patient agrees to the surgery because she is so upset with the pain and complication from the robotic hysterectomy.On october 10, 2019, the patient underwent pelvic exam under anesthesia, removal of vaginal mesh, vaginal septoplasty, and cystoscopy for vaginal mesh exposure, pelvic pain, dyspareunia, and lower back pain.Findings were noted as two areas of exposure, one midline just below the urethra and the other off to the left of the other area of exposure.Both were 0.5 -1cm in size.The vaginal septum was then palpated, and the left vagina was much tighter and shorter than the right vagina.The vaginal cuff was palpated in both vaginal pouches.No defect was palpated in the vaginal cuff or septum.Cystoscopy was performed and no vaginal mesh or bladder injury was seen.The mesh of the area of exposure was grasped with an allis clamps and the area beneath the mesh of the midurethral sling was undermined with a hemostat.There was an area between the two mesh exposures which the mesh went beneath, this area was undermined as well and traveled to the midline exposure which was also undermined with a hemostat.Then the mesh was grasped and the remaining attachment scar formation beneath the mesh was cut with metzenbaum scissors to free the mesh from the vagina.The mesh was then cut on the lateral portions of the mesh where the mesh was not exposed.Once the mesh was released, it was removed with traction and sent to pathology.The patient arrived at the clinic for a postoperative visit on (b)(6) 2019.She has pain where the mesh was exposed, as well as bilateral groin pain and lower back pain.The patient claims that the pain was better the next day after surgery, but that it has now significantly worsened six days later.She has difficulty sitting and walking.She denies having a fever, chills, nausea/vomiting, or experiencing vaginal bleeding.She also says she has dysuria and a slow urinary stream.The patient was once again quite frustrated that she was still in pain, and she was encouraged to continue her recuperation and limit her activity.On october 30, 2019, the patient reported that she still has groin pain and points to the retropubic areas, where she did not have pain despite having abundant old scar tissue from previous cesarean sections.Given this history, it's likely that her pain is being exacerbated by existing surgical scarring that has been crossed by the otherwise proper placement of the sling arms.Moreover, a well-estrogenized vaginal epithelium and good repair/closure in the areas underlying the urethra were observed during the examination, as well as good healing after septoplasty with good access for the medium-sized speculum along the full depth of the vaginal vault.There is a tighter right side of the vaginal canal with less elasticity, and it is likely the less developed or less used compartment during coital activity in the past.The doctor indicated that the side of vaginal didelphys that was more stiff and brittle may have resulted in postoperative mesh exposure as it rubbed against a more rigid underlying floor with her increased movement and transfer of greater intra-abdominal pressure.On december 4, 2019, the patient underwent a physical exam and it was observed that the patient has bilateral thigh tenderness to touch in the area of the transobturator sling.Vaginal exam shows no mesh exposure.The patient has a small vaginal caliber consistent with previous surgery for removal of the vaginal septum with some scarring.According to the reports, the patient may need to undergo thigh dissection with removal of the mesh in the thigh.Patient may need an autologous fascial sling for her incontinence.Patient may need vaginal dilations for her dyspareunia.On october 28, 2020, the patient reported that she had recently received 14 days of antibiotics that complicated a vaginal candidiasis characterized by itching and clumps of cottage cheese-thick dried discharge.The patient was given 1 tablet of 300 mg econazole and was counseled about the necessity for prophylactic antifungal medication for future antibiotic courses.Furthermore, during her clinic appointment, the patient's main complaint was that she experienced very foul discharge and severe pain during coital activity.The exam observed that the patient had an odorous vaginal discharge without any signs of the posterior compartment having been surgically addressed for the patient having any grossly detectable signs and symptoms of fistula during her visit.The following were observed during the pelvic exam: 1.The patient has a distinct locus of acute severe pain reproducible with every palpation and only gentle upward pressure on the left periurethral at the level of the subpubic ramus.The doctor believes it is related to the sling's remaining left arm, which is still low enough that any stretch during penile penetration for any straining lowering the abdominal contents and compressing them against the vaginal paravaginal tissues leads to impingement/thinking by the sharp ends of the embedded, in this case likely in scar tissue sling, the arm retained piece.2.The speculum exam was unremarkable but somewhat inadequate due to vaginal folds and associated tenderness with stretch and guarding from the patient, even after gradual removal of the dry, thick clumped secretions at the cuff.There was some redness in the right paramedian near the cuff, but no indication of a fistula or visible separation.3.Bimanual exam revealed very severe acute pain in the same area as the very limited redness, implying that the pain was caused by a looser cuff closure with an area of only scarred superficial epithelium layer without strong, full-thickness vaginal epithelium and rectovaginal septum tissue to support it against penile thrust or during straining and torque movements as part of her daily activities.The patient arrived at the clinic on (b)(6) 2021, for trigger point injections.The patient reported pain that starts in her groin area and radiates to her hips as well as her low back.She reported chronic muscle tightness as well.She reported that she experiences pain with walking, bending, any other movements.She is a housekeeper and stated that this was affecting her job and at times she doubles over in pain and cries during work.She also reported pain with wearing tight pants.Additionally, the patient also claims to be undergoing pelvic floor physiotherapy and intravaginal trigger point therapy.She claims to be in constant pain.She has also seen a pain management specialist and is currently taking gabapentin and naproxen to relieve her pain.She has also attempted injection of the pudendal nerve, which provided her with two weeks of relief.She has also been evaluated and claims that she was advised to have the remaining mesh removed.The patient reports continued stress urinary incontinence, especially with sneezing or coughing, that has not improved since the surgery.She also reports discomfort when voiding, especially the urge to urinate and a sensation of straining with urination.The nature of the pain appeared to be primarily from the bilateral free ends of the transobturator mesh, which could be palpated on exam and reproduced her pain upon manipulation.There did not seem to be any significant pelvic floor or obturator myofascial pain, nor any point tenderness along the suburethral profile of the sling.The patient agreed to proceed with localized injections.During the procedure, the ends of mesh palpated in medial to the ischio pubic ramus.Palpation of the overlying skin reproduced the pain.17 ml of a 50/50 solution of 1 % lidocaine with sodium bicarb with 1 ml of kenalog with injected on the medial side of the mesh and infiltrated around the skin overlying the mesh.The tissue was then manually manipulated and elevated in an attempt to free the mesh from surrounding tissues.The patient reports numbness and resolution of her pain upon completion of the procedure.The patient also reports chronic migraines with normal magnetic resonance imaging on (b)(6) 2021, seasonal allergies, a hepatic cyst with a hemangioma observed on (b)(6) 2020, and the need to repeat liver ultrasonography in six to twelve months to ensure stability, as well as hyperlipidemia.The following conditions require further testing: atherosclerotic cardiovascular disease (ascvd), gastroesophageal reflux disease (gerd), chronic pelvic pain following pudendal nerve block, allergic rash requiring triamcinolone and loratadine, and constipation.On april 7, 2021, the patient had a suburethral sling mesh resection, cystoscopy, and pelvic ultrasound.An incision was made in the midline anterior vaginal epithelium from the mid-urethra to within 3-4 cm of the vaginal cuff during the surgery.Laterally under the vaginal epithelium, the dissection was extended to expose the periurethral and vesicovaginal connective tissue to the level of the descending pubic rami bilaterally.No mesh was found after palpating the full length of the descending pubic ramus bilaterally.There were fibers of subepithelial foreign material on the left, consistent with mesh versus semi-permanent suture, and this was submitted to pathology.The same examination was carried out on the right vaginal dissection, and no palpable mesh was found.The subepithelial area was also observed with the non-bsc lighted retractor, which revealed the foreign material fibers, thought to be mesh, but no other mesh could be identified other than a 2 cm length of blue foreign material.After two hours of thorough dissection in the paravaginal and periurethral regions, no additional mesh was located, and the groin approach was chosen.With the ultrasound technician present, no mesh was found in the muscle bellies of the adductor brevis or gracillis, or in the adductor longus tendon.The obturator foramen was seen on its medial aspect to the descending pubic ramus, but no mesh was found.After that, an incision was made just inferior to the adductor longus tendon, just lateral to the descending pubic ramus.The subcutaneous adipose tissue was dissected away to the fascia level.The incision was palpated down the length of the left descending pubic ramus, lateral to the bone, and no perceptible mesh was found.Given the negative ultrasound findings and the lack of palpable discernible mesh, it was decided to postpone any dissection into the muscle.The incision was closed in two layers subcutaneously with 2-0 vicryl and then with a series of mattress sutures to relieve stress on the incision with 4-0 monocryl.The skin was subsequently closed in a subcuticular fashion with 4-0 monocryl.Hemostasis was found to be adequate.The vaginal epithelial incision was closed with a continuous 2-0 vicryl suture.A vaginal pack was put and will be withdrawn later in the evening.On april 8, 2021, the patient is doing very well.Her pain is well controlled with intravenous and prn oral medications.She is tolerating a regular diet.She denies nausea and vomiting.She is voiding spontaneously.She does report some urgency/frequency.She has not passed flatus.She has ambulated.She feels tired and was dizzy with ambulation.On (b)(6) 2021, the patient complains of bilateral temporomandibular joint (tmj) pain, stiffness, difficulty in eating/chewing since 1 year without any injury.She also complains of daily headaches, occasional eat pain and feels like her head is in a "bubble".She also complains of occasional light-headedness but denies any falls, chronic low back and severe pelvic pain following multiple mesh surgeries for stress incontinence since 2019.She also reports limited improvement with pain management and physical therapy at another clinic.Reportedly, the patient shows a high score on patient health questionnaire (phq-9) for depression screening, recommend further evaluation.The patient was referred to physical therapy on (b)(6)2022, due to stress incontinence following hysterectomy and bladder prolapse surgery.The patient claims that she tried physical therapy but that it was ineffective.Instead, the pain worsened over time.She tried physical therapy for two years without success.She further claims that the lack of reduction in pain intensity drove her to have another operation to remove the mesh in (b)(6) 2021, which was unsuccessful.The patient claims that the mesh insertion failed, causing her ongoing issues.The pain is still severe, and she is suffering from stress incontinence.The patient claims that she does not have to wear pads all of the time, but she does have to wear one when she is among family and friends or working.She can tolerate intercourse, but she experiences pain after orgasm, which can persist for more than 24 hours.The patient was given valium, which she introduces into her vagina to relieve pain.She does not want to go through physical therapy again because she did it for two years and saw no difference.She is currently enrolled in a gym and has attempted to walk at a slow speed for 20 minutes before experiencing pain in the groin to the low back.The patient plans to see her doctor next week to discuss various options for pain relief and removal of the mesh in her left groin.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient underwent mesh removal.Boston scientific received an additional information on july 13, 2022, as follows: on (b)(6) 2020, the patient had a telemedicine consultation for evaluation of chronic pelvic pain.Reportedly, the patient had chronic pelvic pain during the menstrual period and was diagnosed with endometriosis and urinary incontinence.As a result, the patient underwent a hysterectomy and mesh placement in (b)(6) 2019 (date is per the medical records provided).Following the surgery, the patient developed constant groin pain and underwent a revision (reported in the same records as an "excision of vaginal mesh exposure x 2 and resection of vaginal septum" in october 2019), but she reports her groin pain got worse.She stated that her pain is located at the groin and radiates to her inner thigh, hip and back, is persistent, intensity is 7-8/10 with some breakthrough pain (intensity 10/10), described as sharp and throbbing, and gets better with nothing, but gets worse with prolonged walking, standing, or sitting.The patient reports that she had more pain during intercourse and sat down for a while.She noticed that both of her legs were weaker than previously, especially her hip flexion, and that her thighs were tingling.Additionally, she claims that the skin around her groin is painful and sensitive when touched, occasionally radiating to her rectum.Review of systems noted constipation in the past and anxiety (onset dates not provided).The patient also states that it took her around two weeks to feel better following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on (b)(6) 2020.She felt better and could move more easily.She did, however, start to have bilateral pelvic pain two weeks before her telemedicine session on (b)(6) 2020, and it spread to her bilateral legs and ankles.The patient experiences some tingling in her bilateral feet and a small swelling in her legs.Additionally, she had pressure in both legs.The patient took ibuprofen and tylenol, which helped but did not completely alleviate her pain.She also utilized a transcutaneous electrical nerve stimulation (tens) system, and elevated her leg with a pillow which helped.Additionally, the pain during her consultation on (b)(6) 2020, was around 6/10.The patient reported she had restarted her job as a housekeeper 2 weeks prior to her telemedicine appointment.The patient was instructed to start lyrica for 5 days in addition to continuing pelvic floor exercises, transcutaneous electrical nerve stimulation (tens) when necessary, tylenol, and ibuprofen.During a telemedicine visit on (b)(6) 2020, the patient reported that her back discomfort and calf pain have reportedly subsided since her most recent appointment and the time she began taking lyrica.She still experiences pelvic pain, which originates in the vagina.Either sharp, acute, and short-lived pain was reported, or it was dull.The patient stops what she was doing when a searing pain strikes, but she denies falling or losing her balance even though she feels her hips give way.More so than tylenol or ibuprofen, the patient tried taking naproxen and saw a significant improvement.She keeps going to physical therapy for her lower back; she feels better while she's there, but the pain becomes worse afterward.Bending, walking, and sitting are reportedly the most pain- aggravating activities for the patient.The plan was to start naproxen 500 mg twice daily and stop ibuprofen; increase lyrica to 25 mg qam and 50 mg qhs for 5 days, then continue at 50 mg twice daily; continue tylenol, tens, pt, and home pelvic floor physical exercise.According to the patient's telemedicine visit note on (b)(6) 2021.The patient has continued to suffer low back and pelvic pain that radiates to her legs since her last appointment.She believes that pudendal pulse radiofrequency ablation (rfa) or blocks have not provided her with enough comfort, and she is looking for a more permanent solution.She also finds that medications are only marginally beneficial.Since she was last seen, she reportedly started taking naproxen and her lyrica dosage was increased to 50 mg twice daily, which she finds beneficial and denies having any negative side effects.On (b)(6) 2020, the patient visited a doctor, who determined that the patient's pain "appears to come from the free ends of the transobturator mesh, which can be palpated on exam." in order to find the mesh and hydrodissect the nerves and tissue away from the mesh, the doctor intended to perform ultrasound-guided trigger point injections (tpi).Another doctor who treated the patient suggested that she have the transobturator mesh removed.On (b)(6) 2021, the patient states that her pelvic pain has gotten worse over the past three months on (b)(6) 2021.The left groin is where the pain is the worst.She experiences everyday groin pain on both sides and muscular spasms (particularly the left).Back and leg spasms are radiated.It is difficult for her to sit, stand, or lie down comfortably due to her agony.The patient claims that two weeks ago, she had a trigger point injection, but since then, the discomfort has gotten worse.She is aware of the surgical mesh's discomfort.She also mentioned having bladder pain.The patient additionally claims that recent relief from jaw pain.She also reports that she has occasionally clenched her jaw.The patient received 5 mg of flexeril for jaw pain and only took three times since it was too disabling.She noted that her spasm was somewhat relieved by the medication.She reports to her urogyn doctor who wants to remove her mesh, but she wants to wait before getting another operation once she receives further information about a potential surgery from urogyn, the patient indicates she is open to having repeat radiofrequency ablation (rfa) of the pudendal nerve.The patient connected with a physician via telephone for continued evaluation of her pelvic pain onmay 12, 2021.She claims that because her pain is frequently up and down, it is difficult to discern whether she has improved since having the pudendal radiofrequency ablation (rfa).On (b)(6) 2021, the patient had her mesh resection, but she is unsure if it helped, and she claims that after the surgery, she is experiencing new pain that is distinct from her previous pain.The discomfort occurs in the hip, buttock, and back of the leg.The patient claims that her knees are a little swollen.She also mentions having some weakness in her legs and hips, which shows up as tightness and soreness after strenuous walking and a lack of strength.The patient adds that when the pain is severe, she feels it in her pelvic bones.The patient's problem list/past medical history at this time included chronic female pelvic pain, groin pain, neuralgia of both pudendal nerves, pelvic pain, spastic pelvic floor syndrome, and pain due to genitourinary devices/implants/grafts.On (b)(6) 2021, the patient reported that at her 6-week follow-up, the doctor released her from pelvic rest and said she was recovering well and could resume her normal activities.Seven weeks after the surgery, she resumed her job.Considering that only a portion of the mesh was removed, the procedure was not entirely effective.The doctor does not believe that all the mesh was taken out.The patient also claims that her symptoms have gotten worse and that she is experiencing a different kind of discomfort.Her leg pain has gotten worse.She still feels stiff in her legs and hips.She experiences increasing back discomfort as the day goes on.The area of her left groin where incisions were made is also causing her severe discomfort and muscle spasms.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.The patient's use of a transcutaneous electrical nerve stimulation (tens) unit on her lower back, bio freeze, and hot showers all help.She had imaging of her hip and back and was sent to physical therapy.She underwent physical therapy for her pelvis and low back.This has also only slightly helped.Reportedly, flexeril is no longer covered if it is not authorized beforehand.The patient is being referred to a specialist because she also has jaw problems.A ct of the lumbar spine was performed, but results were not reported in the medical records provided.The patient was asked to come to the clinic with the ct scan results so a physical exam could be performed and it could be determined if facet arthropathy or si joint injections could help with her pain.The patient had a follow-up for imaging on (b)(6) 2021.The patient reported that no one had followed up with her on imaging which had been ordered 8 months ago.The patient was informed that a computed tomography (ct) scan of her abdomen revealed an expanding hemangioma that required repeat imaging in six months.She said that her primary care physician (pcp) had not told her about this.She hasn't followed up on this discovery in any way.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She complains of generalized body ache, which can sometimes be made worse by stress and other times for no apparent reason.The patient's neck, trapezius areas, arms, thoracic back, lumbar spine, sacral area, and circumferentially down both of her lower extremities (ble) are all painful.Even after sleeping more than eight hours, she has poor sleep quality and doesn't feel rested when she wakes up.She mentions headaches, bloating, and abdominal discomfort.She is undergoing physical therapy, which she finds beneficial.She is also learning breathing exercises and stretching from them.On exam, the patient had total body pain, reported head-to-toe pain associated with poor sleep quality.The patient was diagnosed with fibromyalgia and was given information about the diagnosis and treatment options.Changes to the treatment included increasing lyrica to 100 mg twice daily and consider cymbalta.The patient was also signed up for occupational therapy and pain psych and was referred to hepatology to follow up on ct scan findings.The patient had a telemedicine visit on (b)(6) 2021, for a follow-up regarding her persistent pelvic pain.Following a morning dose of 100mg of lyrica, the patient was feeling drowsy, so she was taking 50 mg in the morning and 100mg at night.The patient still experiences 7/10 pain with intermittent pain on this visit.On other days, she feels almost pain-free, with just a little hip and groin stiffness, but as soon as she starts moving around or working, her pain flares up.The patient still occasionally has neck pain, and she is seeing physical therapy for her jaw, which is helping her.She did experience a flare-up of 10/10 left flank pain, and she subsequently went to the er for her pain 1 week ago.She received labs and x-rays, was diagnosed with lumbar spine sprain, was given 10mg cyclobenzaprine, and was discharged.The patient's back pain is better now compared to before, and she takes cyclobenzaprine 5 mg every night at bedtime as needed (qhs).Moreover, the patient otherwise denies any new numbness, weakness, bowel or bladder incontinence.Changes to the plan included starting robaxin during the day and using flexeril 5mg as needed at night for insomnia from pain.On (b)(6) 2021, the patient had a follow-up telemedicine visit.She reported continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period worsened her pain.The patient had appropriate follow up set up with her surgeon.Patient was stable on current pain medication regiment.Opioids help manage her pain and improve functional status.She also denies any adverse side effects to current regiment.On (b)(6) 2022, the patient had a telemedicine visit and reported worsening groin pain.She states that obgyn must schedule surgery to remove mesh.Reportedly, additional mesh has been found and will be removed.For now, the patient will continue with the same regiment.

Manufacturer Narrative

Block b3 date of event: event date discrepancies between the initial information received and the additional information received on july 13, 2022 could not be reconciled.The event date of november 9, 2009 has been selected based on the most recent information.Blocks d4, h4: the complainant was unable to provide the suspect device's upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e1405, e020201, e0123, e2326, e2338, e2330, e2006 capture the reportable events of dyspareunia, anxiety, nerve damage, inflammation, swelling, pain and erosion.Impact code f1905, f2303, f2203, f18 captures the reported event of device revision, medication required, imaging required and rehabilitation.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6 patient codes e1301, e1715, e232402, e1309, e1401, e0506, e1906 has been added.Block h6 impact code f23 unexpected medical intervention have been added.Block b3 date of event: date of event was approximated to (b)(6) 2019, implant procedure date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon: dr.(b)(6).The explant surgeon: dr.(b)(6).Block h6: patient codes e020201, e1301, e1715, e1906, e1309, e0123, e2326, e1401, e2338, e2330, e2006, e1405, capture the reported events of anxiety, dysuria, scar tissue, infection, urinary retention, nerve damage, inflammation, abnormal vaginal discharge, swelling/edema, pain, erosion and dyspareunia.Impact code f23, f2303, f1905, f18 capture the reportable events of unexpected medical intervention, medication required, mesh resection and rehabilitation.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient underwent mesh removal.Boston scientific received an additional information on july 13, 2022, as follows: on (b)(6) 2020, the patient had a telemedicine consultation for evaluation of chronic pelvic pain.Reportedly, the patient had chronic pelvic pain during the menstrual period and was diagnosed with endometriosis and urinary incontinence.As a result, the patient underwent a hysterectomy and mesh placement in (b)(6) 2019 (date is per the medical records provided).Following the surgery, the patient developed constant groin pain and underwent a revision (reported in the same records as an "excision of vaginal mesh exposure x 2 and resection of vaginal septum" in (b)(6) 2019), but she reports her groin pain got worse.She stated that her pain is located at the groin and radiates to her inner thigh, hip and back, is persistent, intensity is 7-8/10 with some breakthrough pain (intensity 10/10), described as sharp and throbbing, and gets better with nothing, but gets worse with prolonged walking, standing, or sitting.The patient reports that she had more pain during intercourse and sat down for a while.She noticed that both of her legs were weaker than previously, especially her hip flexion, and that her thighs were tingling.Additionally, she claims that the skin around her groin is painful and sensitive when touched, occasionally radiating to her rectum.Review of systems noted constipation in the past and anxiety (onset dates not provided).The patient also states that it took her around two weeks to feel better following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on (b)(6) 2020.She felt better and could move more easily.She did, however, start to have bilateral pelvic pain two weeks before her telemedicine session on (b)(6) 2020, and it spread to her bilateral legs and ankles.The patient experiences some tingling in her bilateral feet and a small swelling in her legs.Additionally, she had pressure in both legs.The patient took ibuprofen and tylenol, which helped but did not completely alleviate her pain.She also utilized a transcutaneous electrical nerve stimulation (tens) system, and elevated her leg with a pillow which helped.Additionally, the pain during her consultation on (b)(6) 2020, was around 6/10.The patient reported she had restarted her job as a housekeeper 2 weeks prior to her telemedicine appointment.The patient was instructed to start lyrica for 5 days in addition to continuing pelvic floor exercises, transcutaneous electrical nerve stimulation (tens) when necessary, tylenol, and ibuprofen.During a telemedicine visit on (b)(6) 2020, the patient reported that her back discomfort and calf pain have reportedly subsided since her most recent appointment and the time she began taking lyrica.She still experiences pelvic pain, which originates in the vagina.Either sharp, acute, and short-lived pain was reported, or it was dull.The patient stops what she was doing when a searing pain strikes, but she denies falling or losing her balance even though she feels her hips give way.More so than tylenol or ibuprofen, the patient tried taking naproxen and saw a significant improvement.She keeps going to physical therapy for her lower back; she feels better while she's there, but the pain becomes worse afterward.Bending, walking, and sitting are reportedly the most pain- aggravating activities for the patient.The plan was to start naproxen 500 mg twice daily and stop ibuprofen; increase lyrica to 25 mg qam and 50 mg qhs for 5 days, then continue at 50 mg twice daily; continue tylenol, tens, pt, and home pelvic floor physical exercise.According to the patient's telemedicine visit note on (b)(6) 2021.The patient has continued to suffer low back and pelvic pain that radiates to her legs since her last appointment.She believes that pudendal pulse radiofrequency ablation (rfa) or blocks have not provided her with enough comfort, and she is looking for a more permanent solution.She also finds that medications are only marginally beneficial.Since she was last seen, she reportedly started taking naproxen and her lyrica dosage was increased to 50 mg twice daily, which she finds beneficial and denies having any negative side effects.On (b)(6) 2020, the patient visited a doctor, who determined that the patient's pain "appears to come from the free ends of the transobturator mesh, which can be palpated on exam." in order to find the mesh and hydrodissect the nerves and tissue away from the mesh, the doctor intended to perform ultrasound-guided trigger point injections (tpi).Another doctor who treated the patient suggested that she have the transobturator mesh removed.On (b)(6) 2021, the patient states that her pelvic pain has gotten worse over the past three months on (b)(6) 2021.The left groin is where the pain is the worst.She experiences everyday groin pain on both sides and muscular spasms (particularly the left).Back and leg spasms are radiated.It is difficult for her to sit, stand, or lie down comfortably due to her agony.The patient claims that two weeks ago, she had a trigger point injection, but since then, the discomfort has gotten worse.She is aware of the surgical mesh's discomfort.She also mentioned having bladder pain.The patient additionally claims that recent relief from jaw pain.She also reports that she has occasionally clenched her jaw.The patient received 5 mg of flexeril for jaw pain and only took three times since it was too disabling.She noted that her spasm was somewhat relieved by the medication.She reports to her urogyn doctor who wants to remove her mesh, but she wants to wait before getting another operation once she receives further information about a potential surgery from urogyn, the patient indicates she is open to having repeat radiofrequency ablation (rfa) of the pudendal nerve.The patient connected with a physician via telephone for continued evaluation of her pelvic pain on (b)(6) 2021.She claims that because her pain is frequently up and down, it is difficult to discern whether she has improved since having the pudendal radiofrequency ablation (rfa).On (b)(6) 2021, the patient had her mesh resection, but she is unsure if it helped, and she claims that after the surgery, she is experiencing new pain that is distinct from her previous pain.The discomfort occurs in the hip, buttock, and back of the leg.The patient claims that her knees are a little swollen.She also mentions having some weakness in her legs and hips, which shows up as tightness and soreness after strenuous walking and a lack of strength.The patient adds that when the pain is severe, she feels it in her pelvic bones.The patient's problem list/past medical history at this time included chronic female pelvic pain, groin pain, neuralgia of both pudendal nerves, pelvic pain, spastic pelvic floor syndrome, and pain due to genitourinary devices/implants/grafts.On (b)(6) 2021, the patient reported that at her 6-week follow-up, the doctor released her from pelvic rest and said she was recovering well and could resume her normal activities.Seven weeks after the surgery, she resumed her job.Considering that only a portion of the mesh was removed, the procedure was not entirely effective.The doctor does not believe that all the mesh was taken out.The patient also claims that her symptoms have gotten worse and that she is experiencing a different kind of discomfort.Her leg pain has gotten worse.She still feels stiff in her legs and hips.She experiences increasing back discomfort as the day goes on.The area of her left groin where incisions were made is also causing her severe discomfort and muscle spasms.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.The patient's use of a transcutaneous electrical nerve stimulation (tens) unit on her lower back, bio freeze, and hot showers all help.She had imaging of her hip and back and was sent to physical therapy.She underwent physical therapy for her pelvis and low back.This has also only slightly helped.Reportedly, flexeril is no longer covered if it is not authorized beforehand.The patient is being referred to a specialist because she also has jaw problems.A ct of the lumbar spine was performed, but results were not reported in the medical records provided.The patient was asked to come to the clinic with the ct scan results so a physical exam could be performed and it could be determined if facet arthropathy or si joint injections could help with her pain.The patient had a follow-up for imaging on (b)(6) 2021.The patient reported that no one had followed up with her on imaging which had been ordered 8 months ago.The patient was informed that a computed tomography (ct) scan of her abdomen revealed an expanding hemangioma that required repeat imaging in six months.She said that her primary care physician (pcp) had not told her about this.She hasn't followed up on this discovery in any way.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She complains of generalized body ache, which can sometimes be made worse by stress and other times for no apparent reason.The patient's neck, trapezius areas, arms, thoracic back, lumbar spine, sacral area, and circumferentially down both of her lower extremities (ble) are all painful.Even after sleeping more than eight hours, she has poor sleep quality and doesn't feel rested when she wakes up.She mentions headaches, bloating, and abdominal discomfort.She is undergoing physical therapy, which she finds beneficial.She is also learning breathing exercises and stretching from them.On exam, the patient had total body pain, reported head-to-toe pain associated with poor sleep quality.The patient was diagnosed with fibromyalgia and was given information about the diagnosis and treatment options.Changes to the treatment included increasing lyrica to 100 mg twice daily and consider cymbalta.The patient was also signed up for occupational therapy and pain psych and was referred to hepatology to follow up on ct scan findings.The patient had a telemedicine visit on (b)(6) 2021, for a follow-up regarding her persistent pelvic pain.Following a morning dose of 100mg of lyrica, the patient was feeling drowsy, so she was taking 50 mg in the morning and 100mg at night.The patient still experiences 7/10 pain with intermittent pain on this visit.On other days, she feels almost pain-free, with just a little hip and groin stiffness, but as soon as she starts moving around or working, her pain flares up.The patient still occasionally has neck pain, and she is seeing physical therapy for her jaw, which is helping her.She did experience a flare-up of 10/10 left flank pain, and she subsequently went to the er for her pain 1 week ago.She received labs and x-rays, was diagnosed with lumbar spine sprain, was given 10mg cyclobenzaprine, and was discharged.The patient's back pain is better now compared to before, and she takes cyclobenzaprine 5 mg every night at bedtime as needed (qhs).Moreover, the patient otherwise denies any new numbness, weakness, bowel or bladder incontinence.Changes to the plan included starting robaxin during the day and using flexeril 5mg as needed at night for insomnia from pain.On (b)(6) 2021, the patient had a follow-up telemedicine visit.She reported continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period worsened her pain.The patient had appropriate follow up set up with her surgeon.Patient was stable on current pain medication regiment.Opioids help manage her pain and improve functional status.She also denies any adverse side effects to current regiment.On (b)(6) 2022, the patient had a telemedicine visit and reported worsening groin pain.She states that obgyn must schedule surgery to remove mesh.Reportedly, additional mesh has been found and will be removed.For now, the patient will continue with the same regiment.Boston scientific received an additional information on september 13, 2022, as follows: on (b)(6) 2019, a robotic-assisted hysterectomy, bilateral salpingectomy, obtryx sling implantation, and cystoscopy were performed on the patient to treat abnormal uterine bleeding, pelvic pain, dysmenorrhea, dyspareunia, uterine didelphys, and stress urine incontinence.The following are the results of the surgery: upon entry into the abdomen, there was no sign of vascular or visceral harm.The irregular contour of the uterus suggests fibroids.Normal-appearing bilateral fallopian tubes with scarring consistent with tubal ligation history; normal-appearing left and right ovaries, each with a small hemorrhagic cyst.The anterior uterus has a moderate amount of adhesions.Cystoscopy revealed no signs of bladder injury or bilateral ureteral jets.Reportedly, the patient tolerated the procedure well and will have a voiding trial prior to discharge from the hospital with appropriate follow-up and a prescription for pain medication.On (b)(6) 2019, the patient came at the clinic for a check-up concerning pelvic pain.Her dyspareunia has also gotten much worse since her surgery, as stated by the patient.She claims she can't tolerate even a minute of intercourse.During her visit, the patient become emotional and claimed that she and her husband had recently married and that she could not even enjoy their honeymoon because of her pain.She says the pain is near the introitus and that she experiences a sharp clenching sensation that travels up into her bladder.She also complains of vaginal bleeding that is deeper and worse on the left side.The patient desperately wants to find a solution.She was encouraged to make an appointment for physical therapy and she states she has an appointment coming up on (b)(6) 2019.A gynecologic examination also identified a 1 cm region of mesh erosion just below the mid urethra.When the midurethral sling is palpated, blue mesh can be seen.In the midline, a remnant of the membranous septum can be seen.The vaginal cuff has fully healed.When the speculum was inserted, the patient experienced discomfort, although it was more severe in the left vaginal cuff than the right.During the bimanual exam, the left vaginal cuff looked to be tighter than the right.Additionally, the patient was prescribed with premarin cream after a mesh exposure was noted.The patient presented at the clinic on (b)(6) 2019, complaining of worsening pelvic pain.The patient claims that her pain has gotten worse in the last two weeks, and that her bilateral groin and back pain are now a 10/10, affecting her ability to walk, sit for long periods of time, and even sleep.During her visit, the patient was hunched over the exam table, rocking side to side in pain, and was emotional and easily moved to tears.The patient claims that the pain became unbearable and that she was at a loss for what to do.She was also asked if she had ever experienced back pain, and her husband, who was also there, stated that she had experienced back pain prior to the surgery, as well as a history of sciatica.The patient was asked if she was using the premarin cream as prescribed for the mesh exposure, and she responded that she was.On (b)(6) 2019, the patient reports applying the premarin cream as prescribed has not assisted her symptoms.Moreover, the patient was prescribed with norco 10/325 mg for moderate to severe pain management.The patient states she would like to seek a second opinion regarding exposure of the urethral mesh.On (b)(6) 2019, the patient came to the clinic for a check-up regarding vaginal mesh exposure.The patient's lower back pain has also improved, but she still has vaginal and bilateral groin pain.According to reports, the doctor intends to bring the patient to the operating room for revision of the vaginal mesh, injection of local steroids, cystoscopy, and possible vaginal septum resection because she has been using premarin cream for 8 weeks and the vaginal mesh exposure remains symptomatic.The doctor informed the patient that removing the mesh could result in a recurrence of urinary incontinence.Furthermore, the patient claims that she occasionally leaks urine with a cough or sneeze, but that this has improved since surgery, and that she has recently felt unable to void entirely.They also considered the possibility of narrowing her vagina or causing further scarring by adjusting the mesh exposure and bringing that tissue together.The patient was informed that she would need to reduce her activities and not work for two weeks, as well as refrain from bathing and relaxing her pelvic for six weeks.The patient agrees to the surgery because she is so upset with the pain and complication from the robotic hysterectomy.The patient arrived at the clinic for a postoperative visit on (b)(6) 2019.She has pain where the mesh was exposed, as well as bilateral groin pain and lower back pain.The patient claims that the pain was better the next day after surgery, but that it has now significantly worsened six days later.She has difficulty sitting and walking.She denies having a fever, chills, nausea/vomiting, or experiencing vaginal bleeding.She also says she has dysuria and a slow urinary stream.The patient was once again quite frustrated that she was still in pain, and she was encouraged to continue her recuperation and limit her activity.On (b)(6) 2019, the patient reported that she still has groin pain and points to the retropubic areas, where she did not have pain despite having abundant old scar tissue from previous cesarean sections.Given this history, it's likely that her pain is being exacerbated by existing surgical scarring that has been crossed by the otherwise proper placement of the sling arms.Moreover, a well-estrogenized vaginal epithelium and good repair/closure in the areas underlying the urethra were observed during the examination, as well as good healing after septoplasty with good access for the medium-sized speculum along the full depth of the vaginal vault.There is a tighter right side of the vaginal canal with less elasticity, and it is likely the less developed or less used compartment during coital activity in the past.The doctor indicated that the side of vaginal didelphys that was more stiff and brittle may have resulted in postoperative mesh exposure as it rubbed against a more rigid underlying floor with her increased movement and transfer of greater intra-abdominal pressure.On (b)(6) 2019, the patient underwent a physical exam and it was observed that the patient has bilateral thigh tenderness to touch in the area of the transobturator sling.Vaginal exam shows no mesh exposure.The patient has a small vaginal caliber consistent with previous surgery for removal of the vaginal septum with some scarring.According to the reports, the patient may need to undergo thigh dissection with removal of the mesh in the thigh.Patient may need an autologous fascial sling for her incontinence.Patient may need vaginal dilations for her dyspareunia.On (b)(6) 2020, the patient reported that she had recently received 14 days of antibiotics for a vaginal candidiasis characterized by itching and clumps of cottage cheese-thick fried discharge.The patient was given 1 tablet of 300 mg econazole and was counseled about the necessity for prophylactic antifungal medication for future antibiotic courses.Furthermore, during her clinic appointment, the patient's main complaint was that she experienced very foul discharge and severe pain during coital activity.The exam observed that the patient had an odorous vaginal discharge without any signs of the posterior compartment having been surgically addressed for the patient having any grossly detectable signs and symptoms of fistula during her visit.The following were observed during the pelvic exam: 1.The patient has a distinct locus of acute severe pain reproducible with every palpation and only gentle upward pressure on the left periurethral at the level of the subpubic ramus.The doctor believes it is related to the sling's remaining left arm, which is still low enough that any stretch during penile penetration for any straining lowering the abdominal contents and compressing them against the vaginal paravaginal tissues leads to impingement/thinking by the sharp ends of the embedded, in this case likely in scar tissue sling, the arm retained piece.2.The speculum exam was unremarkable but somewhat inadequate due to vaginal folds and associated tenderness with stretch and guarding from the patient, even after gradual removal of the dry, thick clumped secretions at the cuff.There was some redness in the right paramedian near the cuff, but no indication of a fistula or visible separation.3.Bimanual exam revealed very severe acute pain in the same area as the very limited redness, implying that the pain was caused by a looser cuff closure with an area of only scarred superficial epithelium layer without strong, full-thickness vaginal epithelium and rectovaginal septum tissue to support it against penile thrust or during straining and torque movements as part of her daily activities.The patient arrived at the clinic on (b)(6) 2021, for trigger point injections.During the procedure, the ends of mesh palpated in medial to the ischio pubic ramus.Palpation of the overlying skin reproduced the pain.17 ml of a 50/50 solution of 1 % lidocaine with sodium bicarb with 1 ml of kenalog with injected on the medial side of the mesh and infiltrated around the skin overlying the mesh.The tissue was then manually manipulated and elevated in an attempt to free the mesh from surrounding tissues.The patient reports numbness and resolution of her pain upon completion of the procedure.Additionally, the patient also claims to be undergoing pelvic floor physiotherapy and intravaginal trigger point therapy.She claims to be in constant pain.She has also seen a pain management specialist and is currently taking gabapentin and naproxen to relieve her pain.She has also attempted injection of the pudendal nerve, which provided her with two weeks of relief.She has also been evaluated and claims that she was advised to have the remaining mesh removed.The patient reports continued stress urinary incontinence, especially with sneezing or coughing, that has not improved since the surgery.She also reports discomfort when voiding, especially the urge to urinate and a sensation of straining with urination.The patient states that her stress urinary incontinence has not improved since the surgery, particularly while sneezing or coughing.She also reports urinary discomfort, particularly the urge to urinate and a sensation of straining with urination.The patient also reports chronic migraines with normal magnetic resonance imaging on (b)(6) 2021, seasonal allergies, a hepatic cyst with a hemangioma observed on (b)(6) 2020, and the need to repeat liver ultrasonography in six to twelve months to ensure stability, as well as hyperlipidemia.The following conditions require further testing: atherosclerotic cardiovascular disease (ascvd), gastroesophageal reflux disease (gerd), chronic pelvic pain following pudendal nerve block, allergic rash requiring triamcinolone and loratadine, and constipation.On (b)(6) 2021, the patient had a suburethral sling mesh resection, cystoscopy, and pelvic ultrasound.An incision was made in the midline anterior vaginal epithelium from the mid-urethra to within 3-4 cm of the vaginal cuff during the surgery.Laterally under the vaginal epithelium, the dissection was extended to expose the periurethral and vesicovaginal connective tissue to the level of the descending pubic rami bilaterally.No mesh was found after palpating the full length of the descending pubic ramus bilaterally.There were fibers of subepithelial foreign material on the left, consistent with mesh versus semi-permanent suture, and this was submitted to pathology.The same examination was carried out on the right vaginal dissection, and no palpable mesh was found.The subepithelial area was also observed with the non-bsc lighted retractor, which revealed the foreign material fibers, thought to be mesh, but no other mesh could be identified other than a 2 cm length of blue foreign material.After two hours of thorough dissection in the paravaginal and periurethral regions, no additional mesh was located, and the groin approach was chosen.With the ultrasound technician present, no mesh was found in the muscle bellies of the adductor brevis or gracillis, or in the adductor longus tendon.The obturator foramen was seen on its medial aspect to the descending pubic ramus, but no mesh was found.After that, an incision was made just inferior to the adductor longus tendon, just lateral to the descending pubic ramus.The subcutaneous adipose tissue was dissected away to the fascia level.The incision was palpated down the length of the left descending pubic ramus, lateral to the bone, and no perceptible mesh was found.Given the negative ultrasound findings and the lack of palpable discernible mesh, it was decided to postpone any dissection into the muscle.The incision was closed in two layers subcutaneously with 2-0 vicryl and then with a series of mattress sutures to relieve stress on the incision with 4-0 monocryl.The skin was subsequently closed in a subcuticular fashion with 4-0 monocryl.Hemostasis was found to be adequate.The vaginal epithelial incision was closed with a continuous 2-0 vicryl suture.A vaginal pack was put and will be withdrawn later in the evening.On (b)(6) 2021, the patient is doing very well.Her pain is well controlled with intravenous and prn oral medications.She is tolerating a regular diet.She denies nausea and vomiting.She is voiding spontaneously.She does report some urgency/frequency.She has not passed flatus.She has ambulated.She feels tired and was dizzy with ambulation.On (b)(6) 2021, the patient complains of bilateral temporomandibular joint (tmj) pain, stiffness, difficulty in eating/chewing since 1 year without any injury.She also complains of daily headaches, occasional eat pain and feels like her head is in a "bubble".She also complains of occasional light-headedness but denies any falls, chronic low back and severe pelvic pain following multiple mesh surgeries for stress incontinence since 2019.She also reports limited improvement with pain management and physical therapy at another clinic.Reportedly, the patient shows a high score on patient health questionnaire (phq-9) for depression screening, recommend further evaluation.The patient was referred to physical therapy on (b)(6) 2022, due to stress incontinence following hysterectomy and bladder prolapse surgery.The patient claims that she tried physical therapy but that it was ineffective.Instead, the pain worsened over time.She tried physical therapy for two years without success.She further claims that the lack of reduction in pain intensity drove her to have another operation to remove the mesh in (b)(6) 2021, which was unsuccessful.The patient claims that the mesh insertion failed, causing her ongoing issues.The pain is still severe, and she is suffering from stress incontinence.The patient claims that she does not have to wear pads all of the time, but she does have to wear one when she is among family and friends or working.She can tolerate intercourse, but she experiences pain after orgasm, which can persist for more than 24 hours.The patient was given valium, which she introduces into her vagina to relieve pain.She does not want to go through physical therapy again because she did it for two years and saw no difference.She is currently enrolled in a gym and has attempted to walk at a slow speed for 20 minutes before experiencing pain in the groin to the low back.The patient plans to see her doctor next week to discuss various options for pain relief and removal of the mesh in her left groin.

Manufacturer Narrative

Block h2: block b5 narrative and h6 patient codes has been updated based on the additional information received on october 13, 2022.Block b3 date of event: date of event was approximated to (b)(6) 2019, implant procedure date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block b5 continuation: boston scientific received additional information on october 13, 2022, as follows: on (b)(6) 2020, the patient went to the clinic with pain that predates either surgery.Her periods were quite painful, and she also had pain in between periods.The patient did experience some dyspareunia prior to the initial surgery with deep penetration; nevertheless, intercourse remained unbearable following hysterectomy and did not improve after mesh excision.She claims that the pain is so bad that it causes her chills at times, and that even the touch of her underwear on her vulva is painful.During a pelvic examination, there is an increase in tone bilaterally of the superficial perineal muscles at the posterior fourchette, but no point tenderness.According to reports, the patient has bilateral thrombotic thrombocytopenic purpura of the levator ani and obturators.The patient's relaxation was delayed and impaired.The patient also had significant pain while flexing the obturators (adducting knee).There is also pain with knee and hip flexion.There is no evidence of sciatica.Tenderness along the path of the transobturator tape at the superior aspect of the pubic rami was elicited bilaterally, though it was difficult to distinguish from tenderness at the obturator foramen.There was no palpable mesh or indication of mesh exposure.The patient reported chronic pelvic pain throughout her menstrual period on (b)(6) 2020, and was diagnosed with endometriosis and urinary incontinence.The patient also had constant groin pain.Her pain was described as radiating to her inner thigh, hip, and back, with an intensity of 7-8 to 10, with some breakthrough pain (intensity 10/10), sharp/throbbing, and increasing by walking/standing/sitting for a time.She stated that she felt more pain during intercourse and sat down for a bit.She noticed her legs were weaker (particularly hip flexion) than previously, and she felt a tingling feeling within her thigh.She claims that when she touches her skin around her groin, it becomes extremely sensitive and painful, sometimes radiating all the way to her rectum.The patient was called for a follow-up physical therapy appointment on (b)(6) 2020.The patient only received one session and is complaining of increasing pain.She said that she could feel the mesh moving while doing all of her household chores.During her follow-up, she reported a pain level of 7 out of 10 on the pain scale.Because of the bleeding, the patient was encouraged to see her doctor.She was still unable to sleep for more than a few hours and was unable to have intercourse.The patient mentioned that she will be having a pudendal nerve block.This will be when she has completed her physical therapy program.Transcutaneous electrical nerve stimulation (tens) and an ice pack were also recommended to the patient.Transcutaneous electrical nerve stimulation (tens) can be used to target the origin of the pudendal nerve at level s 2.3.4 for 25 minutes while applying an ice pack to the pelvis and hips.A tens unit for home use can assist patients gain some pain relief after 5 sessions if it decreases the pain, although activities such as kegel are prohibited until the mesh placement is changed.On (b)(6) 2020, the patient evaluated her pain as an 8 on a scale of 10.She further reported that the pain became worse when she got in swimming pool and that no other activities were out of the normal to her.According to reports, the patient did not respond well to her therapy during her visit, and the internal tissue of her vaginal canal has increased inflammation and pain in the groin area.The patient continued to complain about the mesh's hypermobility.The patient was told to keep using ice for pain relief and to hold soft tissue mobilization of the internal cavities and vaginal walls.When the pain decreases, the physical therapist will proceed with transcutaneous electrical nerve stimulation (tens) in the sacral area for 20 minutes, followed by soft tissue mobilization (stm) of the vaginal canal and exercises.Despite two instances of increasing pain due to external factors, the patient was improving with physical treatment, and the physical therapist had high expectations for further treatment when the patient received a pudendal nerve injection.On (b)(6) 2020, the patient says that it took around two weeks for her to experience relief following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on june 5, 2020.She was feeling better and moving more freely.She started having bilateral pelvic pain that extended down both legs to her ankles around two weeks ago.Her legs felt somewhat swollen, and she experienced tingling in both of her feet.She also felt pressure on both of her legs.She took tylenol 500 mg and ibuprofen 800 mg, which relieved her pain but did not completely alleviate it.Transcutaneous electrical nerve stimulation (tens) is also used, and the leg is elevated with a pillow to provide some relief.During her appointment, she notes that her pain is a 6 out of 10 and worse than normal, and that no specific movement has made it worse.The patient had telemedicine visit on (b)(6) 2020 and stated that she still experienced pelvic pain that radiated from inside the vagina to the lower back.The pain is either sharp and acute and usually goes away quickly, or it is dull.When the sharp pain is felt, the patient stops what she is doing and feels her hips give out.The patient denies falling or losing balance.She continues taking tylenol and motrin.The patient tried naproxen 500 mg with significant improvement, more than tylenol or ibuprofen.The patient continues to go for physical therapy for her lower back, with improvement when she goes, but she has increased pain afterwards.The patient went to pelvic physical therapy three weeks ago, which she felt was beneficial.Reported aggravating factors are: bending over, walking, and sitting.On (b)(6) 2021, the patient had a telemedicine visit and reported new complaints of pain in the inner left inner thigh along the saphenous distribution.She has pending imaging by her neurologist, which they will review once done.They may also consider saphenous nerve block.On (b)(6) 2021, the patient still reports pain.It is located in her pelvis and low back that radiates to her legs.She feels that she has not gotten adequate relief with pudendal pulsed radiofrequency ablation or blocks and is looking for more definitive treatment.The patient finds medicines minimally helpful.Reportedly, lyrica was increased to 50 mg twice daily which she finds helpful and denies any adverse side effects to and she was started on naproxen.On (b)(6) 2021, the patient reports that for the past three months, her pelvic pain has been progressively getting worse.Pain is worse in left groin.Experiences daily muscle spasms and sharp pain in bilateral groin (especially left).Spasm radiates to leg and back.Pain makes it difficult to sit, stand, or get into comfortable sleeping position.Patient reports getting trigger point injection two weeks ago but pain seems to have worsened since then.The patient says that her urogyn wants to remove her mesh but she wants to get a second opinion first before going for repeat surgery.Patient reports she is amenable to getting repeat pulsed radiofrequency of pudendal nerve once she gets more info about potential surgery from urogyn.On (b)(6) 2021, the patient connects with her physician via telephone for continued evaluation for her pelvic pain.She reports it's difficult to tell whether she had improvement with the pudendal radiofrequency because her pain tends to be up and down regularly.She had resection of her mesh on (b)(6) 2021 but is also unsure whether this helped.She reports having new pain since this surgery that is different than her prior pain.This new pain is in the hip, buttock, and posterior thigh.She reports having some swelling in her knees.She does report some weakness in her hip and legs, which manifests as tightness and pain after walking for long periods with loss of strength.She also says when the pain is severe she feels it in her pelvic bones.On (b)(6) 2021, the patient continues to have stiffness in her hips and legs.As the day goes by she has worsening back pain.She also has sharp pain and muscle spasms on her left groin which is where incisions were made.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.She uses transcutaneous electrical nerve stimulation (tens) unit on her lower back which helps, bio freeze, hot showers.She had imaging of her hip and back and was sent to physical therapy.She did physical therapy for her low back and pelvis.This has also been minimally helpful.On (b)(6) 2021, the patient was made aware of her computerized tomography (ct scan) result that shows an abdominal hemangioma which is growing and needs 6 months repeat imaging.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She reports all over body pain which is exacerbated at times due to stress and at times not associated with any factors she can think of.She has pain along her neck, trapezius regions, along her arms, in thoracic back, lumbar spine, radiating to sacral area and along bilateral lower extremities in circumferential manner.Sleep quality is poor and she wakes up not feeling refreshed even if she sleeps over 8 hours.She reports bloating and abdominal discomfort as well as headaches.She is currently in physical therapy, which she finds helpful.They are teaching her stretches and breathing techniques.On (b)(6) 2021, the patient still feels the same, in 7 out of 10 pain scale, which she described as an intermittent pain.She has days where she feels like almost no pain, with a little groin and hip stiffness, but once she starts performing activity, working, she experiences flare-ups of her pain.Sometimes, she has difficulty sleeping because of her pain.She still occasionally has neck pain, and she is seeing physical therapy for her jaw, and this is helping her.She did experience a flare-up of 10 out of 10 left flank pain, and she subsequently went to the emergency room.In the emergency room, she received labs and x-ray, and she was diagnosed with lumbar spine sprain, was given 10 mg cyclobenzaprine, and was discharged.Her back pain is better now compared to before, and she takes cyclobenzaprine 5 mg as needed.On (b)(6) 2021, the patient had a follow-up consultation.She reports continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period of time tends to worsen her pain.She has appropriate follow up set up with her surgeon.Patient is stable on current pain medication regiment.Reportedly, opioids help manage her pain and improve functional status.Denies any adverse side effects to current regimen.After a hiatus of several months, the patient returned to the care of a pelvic physical therapist in november 2021.The physical therapist told the patient that her pelvic floor has gotten worse, with weaker bladder control.The patient has been working with pelvic physical therapist but did not think her therapist was focused on the specifics of her reason for physical therapy and had her doing exercised that were too hard for her which flared her symptoms (she describes being instructed to squeeze a ball between her legs, which resulted in worse pain for several days).As recommended by her physician, the patient went for a session with a new physical therapy, and she was told by the facility that they didn't think they would be able to help her pain as long as the mesh remained in place.Moreover, the patient also has clinic notes from her local neurologist, and he described to her that she has nerve damage that is likely permanent impacting her bilateral genitofemoral nerves, pudendal nerves, inferior cluneal nerves and has recommended an electromyography study for evaluation of bilateral lumbosacral plexopathy.They have also suggested that she could increase her dose of lyrica.On (b)(6) 2022, the patient underwent a removal of foreign body bilateral groins to address chronic pelvic pain, pain due to genitourinary prosthetic devices, spastic pelvic syndrome and groin pain.During the surgery, a palpable subcutaneous irregularity of right lateral vulva at spot previously identified as likely site of previous incision from mesh placement, corresponding to location palpated while patient awake and marked.Possible some mucosal nodule on the right lateral vaginal wall corresponding to medial aspect of suspected retained mesh.No palpable subcutaneous irregularities on the left lateral vaginal wall.Palpable subcutaneous irregularity of left lateral vulva, symmetric to the right sided lesion, at location identified and marked in triage while patient awake as site of pain and placed that patient occasionally palpates a subcutaneous irregularity.Both sites located at level of clitoral hood and slightly medial to groin crease.Left site noted to be located 2+ centimeters anterior to and slightly medial to previous incision from 2021 surgery.During dissection, blue mesh identified subcutaneously bilaterally and followed to the level of the obturator foramen: on right groin this was removed in 3 segments due to tearing of mesh during dissection, measuring approximately 6 cm in total length.From left groin, similar blue mesh removed in single segment measuring 5 cm.No mesh palpable on either side after removal of mesh segments.After mesh removal, no submucosal irregularities palpated on either vaginal lateral wall corresponding to internal aspect of inferior pubic ramus, estimated to be about 1 cm medial to deepest aspect of groin dissections.Surgical pathology findings were skeletal muscle and fibrous tissues with foreign body type giant cells.On (b)(6) 2022, the patient had a telemedicine visit for a surgical follow-up.She was treated with keflex for suspected left groin incision first week post-operative.She had reports having a strong smell to her urine prior to taking the antibiotic, as well as vaginal odor for which she was treated with vaginal metrogel antibiotic.The vaginal odor improved, but she still noted urine odor.She had urine and std/vaginitis testing and would have an appointment upcoming next week for results.During this visit, she reported that her groin incisions looked good and were healing well.She still has pain, but it has improved since her surgery.She can tolerate more physical activity, but increased activity is associated with pain.She reported some pain with sitting, and sharp pain in her abdomen medial to the asis (anterior superior iliac spine), present bilaterally.She recently started physical therapy, tolerated short period of stretching but had significant pain afterwards.She returned to work over the past two weeks, working a few days per week with increased pain associated with work.She previously reported decreased clitoral sensation on the left.She reported being able to achieve orgasm with her new boyfriend, which is still the case.During the visit, the patient requested for replacement prescription for her previously prescribed tens unit as it was partly broken.Assessments at that time included chronic pelvic pain in female, spastic pelvic floor syndrome and vaginal discharge.She was advised to continue pelvic pt.Pain improvement is expected by 3 months from this visit.For a full recovery, she will likely need to continue with her physical therapy longer.Work may prolong the patient's recovery, but she does not have an option to not work.She was recommended to follow-up with pain management for lyrica renewal.Lyrica physiologic dependence and the risks of withdrawal vs the risks of addiction from lyrica was discussed.Valium was encouraged to continue with judicious usage, and the need for gradual taper was explained as opposed to abrupt discontinuation to prevent physiologic withdrawal.She was also advised to start vaginal estradiol twice a week to reduce risk for recurrent bv (bacterial vaginosis).It was also discussed the option to use otc boric acid suppository at first sign of vaginal odor or after sex to counteract ph shift caused by semen.Furthermore, it was planned to readdress sexual dysfunction persists despite improvement in pelvic pain over time.The patient was scheduled for a follow-up via telemedicine visit within three months.Block e1: (b)(6).The explant surgeon: (b)(6) block h6: patient codes e020201, e1301, e1715, e1906, e1309, e0123, e2326, e1401, e2338, e2330, e2006, e1405, e2401 capture the reported events of anxiety, dysuria, scar tissue, infection, urinary retention, nerve damage, inflammation, abnormal vaginal discharge, swelling/edema, pain, erosion, dyspareunia, possible mucosal nodule on the right lateral vaginal wall and subcutaneous irregularity.Impact code f23, f2303, f1905, f18 capture the reportable events of unexpected medical intervention, medication required, mesh resection and rehabilitation.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.On (b)(6) 2019, the patient underwent mesh removal.Boston scientific received an additional information on july 13, 2022, as follows: on (b)(6) 2020, the patient had a telemedicine consultation for evaluation of chronic pelvic pain.Reportedly, the patient had chronic pelvic pain during the menstrual period and was diagnosed with endometriosis and urinary incontinence.As a result, the patient underwent a hysterectomy and mesh placement in february 2019 (date is per the medical records provided).Following the surgery, the patient developed constant groin pain and underwent a revision (reported in the same records as an "excision of vaginal mesh exposure x 2 and resection of vaginal septum" in october 2019), but she reports her groin pain got worse.She stated that her pain is located at the groin and radiates to her inner thigh, hip and back, is persistent, intensity is 7-8/10 with some breakthrough pain (intensity 10/10), described as sharp and throbbing, and gets better with nothing, but gets worse with prolonged walking, standing, or sitting.The patient reports that she had more pain during intercourse and sat down for a while.She noticed that both of her legs were weaker than previously, especially her hip flexion, and that her thighs were tingling.Additionally, she claims that the skin around her groin is painful and sensitive when touched, occasionally radiating to her rectum.Review of systems noted constipation in the past and anxiety (onset dates not provided).The patient also states that it took her around two weeks to feel better following her bilateral radiofrequency ablation (rfa) of the pudendal nerve on (b)(6) 2020.She felt better and could move more easily.She did, however, start to have bilateral pelvic pain two weeks before her telemedicine session on (b)(6) 2020, and it spread to her bilateral legs and ankles.The patient experiences some tingling in her bilateral feet and a small swelling in her legs.Additionally, she had pressure in both legs.The patient took ibuprofen and tylenol, which helped but did not completely alleviate her pain.She also utilized a transcutaneous electrical nerve stimulation (tens) system, and elevated her leg with a pillow which helped.Additionally, the pain during her consultation on (b)(6) 2020, was around 6/10.The patient reported she had restarted her job as a housekeeper 2 weeks prior to her telemedicine appointment.The patient was instructed to start lyrica for 5 days in addition to continuing pelvic floor exercises, transcutaneous electrical nerve stimulation (tens) when necessary, tylenol, and ibuprofen.During a telemedicine visit on (b)(6) 2020, the patient reported that her back discomfort and calf pain have areportedly subsided since her most recent appointment and the time she began taking lyrica.She still experiences pelvic pain, which originates in the vagina.Either sharp, acute, and short-lived pain was reported, or it was dull.The patient stops what she was doing when a searing pain strikes, but she denies falling or losing her balance even though she feels her hips give way.More so than tylenol or ibuprofen, the patient tried taking naproxen and saw a significant improvement.She keeps going to physical therapy for her lower back; she feels better while she's there, but the pain becomes worse afterward.Bending, walking, and sitting are reportedly the most pain- aggravating activities for the patient.The plan was to start naproxen 500 mg twice daily and stop ibuprofen; increase lyrica to 25 mg qam and 50 mg qhs for 5 days, then continue at 50 mg twice daily; continue tylenol, tens, pt, and home pelvic floor physical exercise.According to the patient's telemedicine visit note on (b)(6) 2021.The patient has continued to suffer low back and pelvic pain that radiates to her legs since her last appointment.She believes that pudendal pulse radiofrequency ablation (rfa) or blocks have not provided her with enough comfort, and she is looking for a more permanent solution.She also finds that medications are only marginally beneficial.Since she was last seen, she reportedly started taking naproxen and her lyrica dosage was increased to 50 mg twice daily, which she finds beneficial and denies having any negative side effects.On (b)(6) 2020, the patient visited a doctor, who determined that the patient's pain "appears to come from the free ends of the transobturator mesh, which can be palpated on exam." in order to find the mesh and hydrodissect the nerves and tissue away from the mesh, the doctor intended to perform ultrasound-guided trigger point injections (tpi).Another doctor who treated the patient suggested that she have the transobturator mesh removed.On (b)(6) 2021, the patient states that her pelvic pain has gotten worse over the past three months on (b)(6) 2021.The left groin is where the pain is the worst.She experiences everyday groin pain on both sides and muscular spasms (particularly the left).Back and leg spasms are radiated.It is difficult for her to sit, stand, or lie down comfortably due to her agony.The patient claims that two weeks ago, she had a trigger point injection, but since then, the discomfort has gotten worse.She is aware of the surgical mesh's discomfort.She also mentioned having bladder pain.The patient additionally claims that recent relief from jaw pain.She also reports that she has occasionally clenched her jaw.The patient received 5 mg of flexeril for jaw pain and only took three times since it was too disabling.She noted that her spasm was somewhat relieved by the medication.She reports to her urogyn doctor who wants to remove her mesh, but she wants to wait before getting another operation once she receives further information about a potential surgery from urogyn, the patient indicates she is open to having repeat radiofrequency ablation (rfa) of the pudendal nerve.The patient connected with a physician via telephone for continued evaluation of her pelvic pain on (b)(6) 2021.She claims that because her pain is frequently up and down, it is difficult to discern whether she has improved since having the pudendal radiofrequency ablation (rfa).On (b)(6) 2021, the patient had her mesh resection, but she is unsure if it helped, and she claims that after the surgery, she is experiencing new pain that is distinct from her previous pain.The discomfort occurs in the hip, buttock, and back of the leg.The patient claims that her knees are a little swollen.She also mentions having some weakness in her legs and hips, which shows up as tightness and soreness after strenuous walking and a lack of strength.The patient adds that when the pain is severe, she feels it in her pelvic bones.The patient's problem list/past medical history at this time included chronic female pelvic pain, groin pain, neuralgia of both pudendal nerves, pelvic pain, spastic pelvic floor syndrome, and pain due to genitourinary devices/implants/grafts.On (b)(6) 2021, the patient reported that at her 6-week follow-up, the doctor released her from pelvic rest and said she was recovering well and could resume her normal activities.Seven weeks after the surgery, she resumed her job.Considering that only a portion of the mesh was removed, the procedure was not entirely effective.The doctor does not believe that all the mesh was taken out.The patient also claims that her symptoms have gotten worse and that she is experiencing a different kind of discomfort.Her leg pain has gotten worse.She still feels stiff in her legs and hips.She experiences increasing back discomfort as the day goes on.The area of her left groin where incisions were made is also causing her severe discomfort and muscle spasms.The radiating pain going down her leg and to her knee has worsened.She finds that she is unable to fulfill her daily chores after returning home from work.The patient's use of a transcutaneous electrical nerve stimulation (tens) unit on her lower back, bio freeze, and hot showers all help.She had imaging of her hip and back and was sent to physical therapy.She underwent physical therapy for her pelvis and low back.This has also only slightly helped.Reportedly, flexeril is no longer covered if it is not authorized beforehand.The patient is being referred to a specialist because she also has jaw problems.A ct of the lumbar spine was performed, but results were not reported in the medical records provided.The patient was asked to come to the clinic with the ct scan results so a physical exam could be performed and it could be determined if facet arthropathy or si joint injections could help with her pain.The patient had a follow-up for imaging on (b)(6) 2021.The patient reported that no one had followed up with her on imaging which had been ordered 8 months ago.The patient was informed that a computed tomography (ct) scan of her abdomen revealed an expanding hemangioma that required repeat imaging in six months.She said that her primary care physician (pcp) had not told her about this.She hasn't followed up on this discovery in any way.As far as her chronic pain, she is still recovering from mesh excision but finds that her pain has not changed much.She complains of generalized body ache, which can sometimes be made worse by stress and other times for no apparent reason.The patient's neck, trapezius areas, arms, thoracic back, lumbar spine, sacral area, and circumferentially down both of her lower extremities (ble) are all painful.Even after sleeping more than eight hours, she has poor sleep quality and doesn't feel rested when she wakes up.She mentions headaches, bloating, and abdominal discomfort.She is undergoing physical therapy, which she finds beneficial.She is also learning breathing exercises and stretching from them.On exam, the patient had total body pain, reported head-to-toe pain associated with poor sleep quality.The patient was diagnosed with fibromyalgia and was given information about the diagnosis and treatment options.Changes to the treatment included increasing lyrica to 100 mg twice daily and consider cymbalta.The patient was also signed up for occupational therapy and pain psych and was referred to hepatology to follow up on ct scan findings.The patient had a telemedicine visit on (b)(6) 2021, for a follow-up regarding her persistent pelvic pain.Following a morning dose of 100mg of lyrica, the patient was feeling drowsy, so she was taking 50 mg in the morning and 100mg at night.The patient still experiences 7/10 pain with intermittent pain on this visit.On other days, she feels almost pain-free, with just a little hip and groin stiffness, but as soon as she starts moving around or working, her pain flares up.The patient still occasionally has neck pain, and she is seeing physical therapy for her jaw, which is helping her.She did experience a flare-up of 10/10 left flank pain, and she subsequently went to the er for her pain 1 week ago.She received labs and x-rays, was diagnosed with lumbar spine sprain, was given 10mg cyclobenzaprine, and was discharged.The patient's back pain is better now compared to before, and she takes cyclobenzaprine 5 mg every night at bedtime as needed (qhs).Moreover, the patient otherwise denies any new numbness, weakness, bowel or bladder incontinence.Changes to the plan included starting robaxin during the day and using flexeril 5mg as needed at night for insomnia from pain.On (b)(6) 2021, the patient had a follow-up telemedicine visit.She reported continued healing from surgical site and improving pain.However, increased activity such as walking, sitting, or standing for a prolonged period worsened her pain.The patient had appropriate follow up set up with her surgeon.Patient was stable on current pain medication regiment.Opioids help manage her pain and improve functional status.She also denies any adverse side effects to current regiment.On (b)(6) 2022, the patient had a telemedicine visit and reported worsening groin pain.She states that obgyn must schedule surgery to remove mesh.Reportedly, additional mesh has been found and will be removed.For now, the patient will continue with the same regiment.Boston scientific received an additional information on september 13, 2022, as follows: on (b)(6) 2019, a robotic-assisted hysterectomy, bilateral salpingectomy, obtryx sling implantation, and cystoscopy were performed on the patient to treat abnormal uterine bleeding, pelvic pain, dysmenorrhea, dyspareunia, uterine didelphys, and stress urine incontinence.The following are the results of the surgery: upon entry into the abdomen, there was no sign of vascular or visceral harm.The irregular contour of the uterus suggests fibroids.Normal-appearing bilateral fallopian tubes with scarring consistent with tubal ligation history; normal-appearing left and right ovaries, each with a small hemorrhagic cyst.The anterior uterus has a moderate amount of adhesions.Cystoscopy revealed no signs of bladder injury or bilateral ureteral jets.Reportedly, the patient tolerated the procedure well and will have a voiding trial prior to discharge from the hospital with appropriate follow-up and a prescription for pain medication.On (b)(6) 2019, the patient came at the clinic for a check-up concerning pelvic pain.Her dyspareunia has also gotten much worse since her surgery, as stated by the patient.She claims she can't tolerate even a minute of intercourse.During her visit, the patient become emotional and claimed that she and her husband had recently married and that she could not even enjoy their honeymoon because of her pain.She says the pain is near the introitus and that she experiences a sharp clenching sensation that travels up into her bladder.She also complains of vaginal bleeding that is deeper and worse on the left side.The patient desperately wants to find a solution.She was encouraged to make an appointment for physical therapy and she states she has an appointment coming up on (b)(6) 2019.A gynecologic examination also identified a 1 cm region of mesh erosion just below the mid urethra.When the midurethral sling is palpated, blue mesh can be seen.In the midline, a remnant of the membranous septum can be seen.The vaginal cuff has fully healed.When the speculum was inserted, the patient experienced discomfort, although it was more severe in the left vaginal cuff than the right.During the bimanual exam, the left vaginal cuff looked to be tighter than the right.Additionally, the patient was prescribed with premarin cream after a mesh exposure was noted.The patient presented at the clinic on (b)(6) 2019, complaining of worsening pelvic pain.The patient claims that her pain has gotten worse in the last two weeks, and that her bilateral groin and back pain are now a 10/10, affecting her ability to walk, sit for long periods of time, and even sleep.During her visit, the patient was hunched over the exam table, rocking side to side in pain, and was emotional and easily moved to tears.The patient claims that the pain became unbearable and that she was at a loss for what to do.She was also asked if she had ever experienced back pain, and her husband, who was also there, stated that she had experienced back pain prior to the surgery, as well as a history of sciatica.The patient was asked if she was using the premarin cream as prescribed for the mesh exposure, and she responded that she was.Physical exam revealed pain with mild/moderate palpation of the external and internal oblique muscles bilaterally, patrick test and thomas test performed bilaterally also caused extreme pain.The mesh exposure was still present and caused the patient a great deal of pain when palpated.Levator ani muscles were extremely tender to palpation and patient asked to stop exam at that point.The assessment was lumbar back pain/sacroiliac joint pain; pelvic pain; dyspareunia; mesh exposure.The patient was advised that the patient's pain seemed to be musculoskeletal, and that while the groin pain could be from the sling, it did not have the classic physical findings.The physician was concerned about a possible herniated disc and advised the patient to consult her primary care physician right away.The patient was to continue premarin for the mesh exposure.On (b)(6) 2019, the patient presented to the emergency department (ed) for vaginal pain.She had seen her primary care physician on august 7 where a ct of the abdomen and pelvis were not significant for any abnormalities.The patient reported that applying the premarin cream as prescribed has not assisted her symptoms.The patient was given norco and zofran with improvement in her symptoms.Moreover, the patient was prescribed with norco 10/325 mg for moderate to severe pain management.The patient states she would like to seek a second opinion regarding exposure of the urethral mesh.On (b)(6) 2019, the patient came to the clinic for a check-up regarding vaginal mesh exposure.The patient's lower back pain has also improved, but she still has vaginal and bilateral groin pain.According to reports, the doctor intends to bring the patient to the operating room for revision of the vaginal mesh, injection of local steroids, cystoscopy, and possible vaginal septum resection because she has been using premarin cream for 8 weeks and the vaginal mesh exposure remains symptomatic.The doctor informed the patient that removing the mesh could result in a recurrence of urinary incontinence.Furthermore, the patient claims that she occasionally leaks urine with a cough or sneeze, but that this has improved since surgery, and that she has recently felt unable to void entirely.They also considered the possibility of narrowing her vagina or causing further scarring by adjusting the mesh exposure and bringing that tissue together.The patient was informed that she would need to reduce her activities and not work for two weeks, as well as refrain from bathing and be on pelvic rest for six weeks.The patient agrees to the surgery because she is so upset with the pain and complication from the robotic hysterectomy.On (b)(6) 2019, the patient underwent pelvic exam under anesthesia, removal of vaginal mesh, vaginal septoplasty, and cystoscopy for vaginal mesh exposure, pelvic pain, dyspareunia, and lower back pain.Findings were noted as two areas of exposure, one midline just below the urethra and the other off to the left of the other area of exposure.Both were 0.5 -1cm in size.The vaginal septum was then palpated, and the left vagina was much tighter and shorter than the right vagina.The vaginal cuff was palpated in both vaginal pouches.No defect was palpated in the vaginal cuff or septum.Cystoscopy was performed and no vaginal mesh or bladder injury was seen.The mesh of the area of exposure was grasped with an allis clamps and the area beneath the mesh of the midurethral sling was undermined with a hemostat.There was an area between the two mesh exposures which the mesh went beneath, this area was undermined as well and traveled to the midline exposure which was also undermined with a hemostat.Then the mesh was grasped and the remaining attachment scar formation beneath the mesh was cut with metzenbaum scissors to free the mesh from the vagina.The mesh was then cut on the lateral portions of the mesh where the mesh was not exposed.Once the mesh was released, it was removed with traction and sent to pathology.The patient arrived at the clinic for a postoperative visit on (b)(6) 2019.She has pain where the mesh was exposed, as well as bilateral groin pain and lower back pain.The patient claims that the pain was better the next day after surgery, but that it has now significantly worsened six days later.She has difficulty sitting and walking.She denies having a fever, chills, nausea/vomiting, or experiencing vaginal bleeding.She also says she has dysuria and a slow urinary stream.The patient was once again quite frustrated that she was still in pain, and she was encouraged to continue her recuperation and limit her activity.On (b)(6) 2019, the patient reported that she still has groin pain and points to the retropubic areas, where she did not have pain despite having abundant old scar tissue from previous cesarean sections.Given this history, it's likely that her pain is being exacerbated by existing surgical scarring that has been crossed by the otherwise proper placement of the sling arms.Moreover, a well-estrogenized vaginal epithelium and good repair/closure in the areas underlying the urethra were observed during the examination, as well as good healing after septoplasty with good access for the medium-sized speculum along the full depth of the vaginal vault.There is a tighter right side of the vaginal canal with less elasticity, and it is likely the less developed or less used compartment during coital activity in the past.The doctor indicated that the side of vaginal didelphys that was more stiff and brittle may have resulted in postoperative mesh exposure as it rubbed against a more rigid underlying floor with her increased movement and transfer of greater intra-abdominal pressure.On (b)(6) 2019, the patient underwent a physical exam and it was observed that the patient has bilateral thigh tenderness to touch in the area of the transobturator sling.Vaginal exam shows no mesh exposure.The patient has a small vaginal caliber consistent with previous surgery for removal of the vaginal septum with some scarring.According to the reports, the patient may need to undergo thigh dissection with removal of the mesh in the thigh.Patient may need an autologous fascial sling for her incontinence.Patient may need vaginal dilations for her dyspareunia.On (b)(6) 2020, the patient reported that she had recently received 14 days of antibiotics that complicated a vaginal candidiasis characterized by itching and clumps of cottage cheese-thick dried discharge.The patient was given 1 tablet of 300 mg econazole and was counseled about the necessity for prophylactic antifungal medication for future antibiotic courses.Furthermore, during her clinic appointment, the patient's main complaint was that she experienced very foul discharge and severe pain during coital activity.The exam observed that the patient had an odorous vaginal discharge without any signs of the posterior compartment having been surgically addressed for the patient having any grossly detectable signs and symptoms of fistula during her visit.The following were observed during the pelvic exam: 1.The patient has a distinct locus of acute severe pain reproducible with every palpation and only gentle upward pressure on the left periurethral at the level of the subpubic ramus.The doctor believes it is related to the sling's remaining left arm, which is still low enough that any stretch during penile penetration for any straining lowering the abdominal contents and compressing them against the vaginal paravaginal tissues leads to impingement/thinking by the sharp ends of the embedded, in this case likely in scar tissue sling, the arm retained piece.2.The speculum exam was unremarkable but somewhat inadequate due to vaginal folds and associated tenderness with stretch and guarding from the patient, even after gradual removal of the dry, thick clumped secretions at the cuff.There was some redness in the right paramedian near the cuff, but no indication of a fistula or visible separation.3.Bimanual exam revealed very severe acute pain in the same area as the very limited redness, implying that the pain was caused by a looser cuff closure with an area of only scarred superficial epithelium layer without strong, full-thickness vaginal epithelium and rectovaginal septum tissue to support it against penile thrust or during straining and torque movements as part of her daily activities.The patient arrived at the clinic on (b)(6) 2021, for trigger point injections.The patient reported pain that starts in her groin area and radiates to her hips as well as her low back.She reported chronic muscle tightness as well.She reported that she experiences pain with walking, bending, any other movements.She is a housekeeper and stated that this was affecting her job and at times she doubles over in pain and cries during work.She also reported pain with wearing tight pants.Additionally, the patient also claims to be undergoing pelvic floor physiotherapy and intravaginal trigger point therapy.She claims to be in constant pain.She has also seen a pain management specialist and is currently taking gabapentin and naproxen to relieve her pain.She has also attempted injection of the pudendal nerve, which provided her with two weeks of relief.She has also been evaluated and claims that she was advised to have the remaining mesh removed.The patient reports continued stress urinary incontinence, especially with sneezing or coughing, that has not improved since the surgery.She also reports discomfort when voiding, especially the urge to urinate and a sensation of straining with urination.The nature of the pain appeared to be primarily from the bilateral free ends of the transobturator mesh, which could be palpated on exam and reproduced her pain upon manipulation.There did not seem to be any significant pelvic floor or obturator myofascial pain, nor any point tenderness along the suburethral profile of the sling.The patient agreed to proceed with localized injections.During the procedure, the ends of mesh palpated in medial to the ischio pubic ramus.Palpation of the overlying skin reproduced the pain.17 ml of a 50/50 solution of 1 % lidocaine with sodium bicarb with 1 ml of kenalog with injected on the medial side of the mesh and infiltrated around the skin overlying the mesh.The tissue was then manually manipulated and elevated in an attempt to free the mesh from surrounding tissues.The patient reports numbness and resolution of her pain upon completion of the procedure.The patient also reports chronic migraines with normal magnetic resonance imaging on (b)(6) 2021, seasonal allergies, a hepatic cyst with a hemangioma observed on (b)(6) 2020, and the need to repeat liver ultrasonography in six to twelve months to ensure stability, as well as hyperlipidemia.The following conditions require further testing: atherosclerotic cardiovascular disease (ascvd), gastroesophageal reflux disease (gerd), chronic pelvic pain following pudendal nerve block, allergic rash requiring triamcinolone and loratadine, and constipation.On (b)(6) 2021, the patient had a suburethral sling mesh resection, cystoscopy, and pelvic ultrasound.An incision was made in the midline anterior vaginal epithelium from the mid-urethra to within 3-4 cm of the vaginal cuff during the surgery.Laterally under the vaginal epithelium, the dissection was extended to expose the periurethral and vesicovaginal connective tissue to the level of the descending pubic rami bilaterally.No mesh was found after palpating the full length of the descending pubic ramus bilaterally.There were fibers of subepithelial foreign material on the left, consistent with mesh versus semi-permanent suture, and this was submitted to pathology.The same examination was carried out on the right vaginal dissection, and no palpable mesh was found.The subepithelial area was also observed with the non-bsc lighted retractor, which revealed the foreign material fibers, thought to be mesh, but no other mesh could be identified other than a 2 cm length of blue foreign material.After two hours of thorough dissection in the paravaginal and periurethral regions, no additional mesh was located, and the groin approach was chosen.With the ultrasound technician present, no mesh was found in the muscle bellies of the adductor brevis or gracillis, or in the adductor longus tendon.The obturator foramen was seen on its medial aspect to the descending pubic ramus, but no mesh was found.After that, an incision was made just inferior to the adductor longus tendon, just lateral to the descending pubic ramus.The subcutaneous adipose tissue was dissected away to the fascia level.The incision was palpated down the length of the left descending pubic ramus, lateral to the bone, and no perceptible mesh was found.Given the negative ultrasound findings and the lack of palpable discernible mesh, it was decided to postpone any dissection into the muscle.The incision was closed in two layers subcutaneously with 2-0 vicryl and then with a series of mattress sutures to relieve stress on the incision with 4-0 monocryl.The skin was subsequently closed in a subcuticular fashion with 4-0 monocryl.Hemostasis was found to be adequate.The vaginal epithelial incision was closed with a continuous 2-0 vicryl suture.A vaginal pack was put and will be withdrawn later in the evening.On (b)(6) 2021, the patient is doing very well.Her pain is well controlled with intravenous and prn oral medications.She is tolerating a regular diet.She denies nausea and vomiting.She is voiding spontaneously.She does report some urgency/frequency.She has not passed flatus.She has ambulated.She feels tired and was dizzy with ambulation.On (b)(6) 2021, the patient complains of bilateral temporomandibular joint (tmj) pain, stiffness, difficulty in eating/chewing since 1 year without any injury.She also complains of daily headaches, occasional eat pain and feels like her head is in a "bubble".She also complains of occasional light-headedness but denies any falls, chronic low back and severe pelvic pain following multiple mesh surgeries for stress incontinence since 2019.She also reports limited improvement with pain management and physical therapy at another clinic.Reportedly, the patient shows a high score on patient health questionnaire (phq-9) for depression screening, recommend further evaluation.The patient was referred to physical therapy on (b)(6) 2022, due to stress incontinence following hysterectomy and bladder prolapse surgery.The patient claims that she tried physical therapy but that it was ineffective.Instead, the pain worsened over time.She tried physical therapy for two years without success.She further claims that the lack of reduction in pain intensity drove her to have another operation to remove the mesh in april 2021, which was unsuccessful.The patient claims that the mesh insertion failed, causing her ongoing issues.The pain is still severe, and she is suffering from stress incontinence.The patient claims that she does not have to wear pads all of the time, but she does have to wear one when she is among family and friends or working.She can tolerate intercourse, but she experiences pain after orgasm, which can persist for more than 24 hours.The patient was given valium, which she introduces into her vagina to relieve pain.She does not want to go through physical therapy again because she did it for two years and saw no difference.She is currently enrolled in a gym and has attempted to walk at a slow speed for 20 minutes before experiencing pain in the groin to the low back.The patient plans to see her doctor next week to discuss various options for pain relief and removal of the mesh in her left groin.Boston scientific received additional information on october 13, 2022.

• Brand Name: OBTRYX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12512512
• MDR Text Key: 272681300
• Report Number: 3005099803-2021-04892
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female