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

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Flatus (1865); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Fecal Incontinence (4571); Urinary Incontinence (4572)

Event Date 12/01/2011

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, implant date occurred in (b)(6) 2011.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during an unknown procedure performed in (b)(6) 2011.As a result of the mesh implant, the patient claimed to have suffered the following for which she is still receiving treatment: vaginal pain, pelvic pain, hip pain, dyspareunia, inflammation, foreign body reaction, urinary problems, and emotional distress.She added that she had incurred past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.

Event Description

It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during an unknown procedure performed in december 2011.As a result of the mesh implant, the patient claimed to have suffered the following for which she is still receiving treatment: vaginal pain, pelvic pain, hip pain, dyspareunia, inflammation, foreign body reaction, urinary problems, and emotional distress.She added that she had incurred past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.***additional information received on june 27, 2023*** the patient underwent total abdominal hysterectomy and enterocele repair, abdominal sacral colpopexy, suburethral sling, cystoscopy, and abdominal scar revision on (b)(6) 2011, to treat her pelvic organ prolapse and stress urinary incontinence.Findings include: before surgery: 1.Grade 2 uterine prolapse.2.Grade 2 cystocele.3.Grade 2 rectocele.4.Disfiguring anterior abdominal wall scar.During surgery: the entire abdominal scar was removed, and a small right functional ovarian cyst was found on the right side.After surgery: 1.Bilateral spill of urine from both ureteral orifices.2.No foreign body in the bladder or urethra.3.Normal rectal examination.Specimens removed include the uterus and cervix weighing 65.2 grams.The patient's condition at the conclusion of the procedure was stable, with an excellent prognosis.On (b)(6) 2018, the patient presented to the emergency room for pelvic pain, especially on the right.She also has recurrent rectal prolapse.She reports the following surgeries.A pelvic exam on 10/31/19 showed grade 1 cystocele and grade 1 rectocele.The pain was elicited over the right end of the sling.The patient underwent a hysterectomy and pelvic floor reconstruction in 2013 with a urethral sling.Multiplanar sonograms were performed, including static images, video clips, and 3d datasets.There was evidence of a mesh transurethral sling adjacent to the mid-urethra.There was twisting of the sling material laterally on the right.No vaginal or rectal abnormality was noted.On straining, there was a rotation of the urethra, and mild to moderate rectocele was noted.On (b)(6) 2019, the patient was seen and examined for complaints of bladder prolapse and dyspareunia.The patient denied having stress urinary incontinence.The patient reported rectal bleeding.Upon pelvic examination, the patient's vaginal epithelium was well estrogenized.The introitus had normal caliber, and the levator strength was 3/4.The trigger points - right sulcus with an indurated sling was noted to have no exposures.The pelvic floor tone was increased in the right levator.The patient's pelvic organ prolapse was pop-q tvl 10 gh 3 pb 3 aa -2 ba -2c-9 ap -3 bp -3 dx.In the physician's assessment, the patient has bladder prolapse, female, acquired.The patient was also experiencing dyspareunia and complication of implanted vaginal mesh.The patient has an induration and vaginal pain on the right sulcus from the sling that was palpable but not exposed.She has right levator tenderness that the physician suspect was referred from a sling.Minimal pain suprapubically.On (b)(6) 2019, the patient was seen and examined for complaints of bladder prolapse, dyspareunia, pop in 2013, anxiety, and urinary tract infection (uti).The patient was having pain after the sling placement.The pain radiated after vaginal trigger points were triggered.The patient felt stabbing pain intermittently.She felt pain in front close to the pelvic bone-pinching sensation.She developed bladder pain and hip pain with holding urine.She leaked urine in certain positions and did double voiding to empty to completion.She needed to push urine out with her hands.She felt a reoccurrence of prolapse for the last three years.She was not aware of the previous uti.She denied dysuria.She performed douching 2x a day with hydrogen peroxide.She had a history of recurrent yeast infections.The patient verbalized that her "bowels are coming out with intercourse." during intercourse, the patient's boyfriend felt mesh.Upon genitourinary examination, the patient was positive for difficulty urinating, dyspareunia, dysuria, genital sores, pelvic pain, urgency, and vaginal pain.The patient was also found to have a urinary tract infection at the time of the visit.Upon physical examination, it was noted that the patient had an anterior wall grade 1 cystocele and a posterior wall grade 1 cystocele.The patient felt tenderness at the levator plate on the right side.Paraurethral pain and sling were palpated on the right side.In the physician's assessment, the patient needed a cystoscopy to rule out mesh erosion, a translabial ultrasound to evaluate mesh vaginally, and uds to evaluate for voiding dysfunction.They discussed surgical options for mesh removal and sling removal.On (b)(6) 2019, the patient sent a communication to the physician asking a non-urgent medical question.The patient stated that she had hashimoto's thyroiditis after the mesh sling implant.The patient was curious about the correlation between the mesh and autoimmune diseases.The patient sent photos of her hip, abs, and elbow, which presented allergic reactions.The patient took benadryl, which reportedly took away the symptoms.The physician responded that autoimmune response related to mesh is very rare, but it could be possible.The physician wanted to finish the evaluation to determine a plan.On (b)(6) 2019, findings from the us pelvis for pelvic floor eval - 3d revealed that when multiplanar sonograms were performed, including static images, video clips, and 3d datasets.There was evidence of a mesh transurethral sling adjacent to the mid-urethra.There was twisting of the sling material laterally on the right.No vaginal or rectal abnormality was noted.On straining, there was a rotation of the urethra, and mild to moderate rectocele was noted.On (b)(6) 2019, the patient was seen and examined for complaints of bladder prolapse, dyspareunia, anxiety, uti, and dysfunctional voiding.Upon physical examination, the patient had an anterior wall grade 2 cystocele and a posterior wall grade 3-4 rectocele.Tenderness was also noted at the levator plate.The patient underwent a cystoscopy procedure for the recurrent uti.Findings include cystitis, abundant erythematous changes, trigonitis, decreased bladder sensation, mmk, and no mesh erosions.The anterior urethra revealed no strictures or masses.The urethral sphincter has good coaptation.The bladder revealed no masses, lesions, or stones.The ureteral orifices were in normal anatomical positions and effluxing urine.The patient tolerated the procedure, and there were no complications.The patient was provided discharge instructions and will call with any concerns.They planned for the removal of the suburethral sling, translabial us, placement of vaginal wall sling, cystoscopy, harvest and placement of vaginal wall sling, cystocele repair, urethrolysis, rectocele repair, levator plasty, and vaginal reconstruction.On (b)(6) 2020, the patient's history and laboratory results were reviewed.On (b)(6) 2020, the patient underwent a translabial ultrasound, cystoscopy, mesh removal, urethrolysis, cystocele repair, levator plasty, perineocele repair, and harvest and placement of vaginal wall sling procedures to treat the patient's cystocele, dyspareunia, rectocele, and stress urinary incontinence.There were no patient complications noted at the conclusion of the procedure, and the patient was then taken to the recovery room in stable condition with a good prognosis.The patient was discharged home in stable condition on (b)(6) 2020.Discharge instructions were given.The patient was also instructed to follow up on (b)(6) 2020.On (b)(6) 2022, the patient was referred to pelvic floor physical therapy with complaints of pelvic/groin pain, dyspareunia, and bladder, bowel, and gas control problems.The patient described the symptom as groin pain, stabbing, getting better, and going away with exercise; pain with coitus piercing (feels like punching pain).Activities that increase the symptoms include sitting, driving, inactivity, and coitus.Activities that decrease the symptoms include movement and exercise.The patient's pain was described as deep vaginal pain 0/10 at rest; 8/10 with intercourse (the patient expressed she was very concerned about the pain with intercourse) and felt like "i'm hitting something on the sides of the vagina." groin pain is typically at 3/10 with occasional 7-8/10 pain with exercise - 0/10 on active weeks.Sometimes hiking felt great, and sometimes it made it worse.Neck/shoulders - tight, stiff to almost sharp, i/m, when it stayed, it stayed for months (currently have had pain for six months to a year and going down the patient's shoulders).In their assessment, the patient reported symptoms consistent with mixed urinary incontinence, fecal incontinence, groin and pelvic pain, and dyspareunia, significantly limiting functional activity.Suspect soft tissue mobility deficit and strength deficits of the pelvis will continue to assess with follow-up treatment sessions secondary to complexity and time restrictions with evaluation.The patient's rehab potential was good.The patient's care plan included therapeutic exercise, manual, modalities as indicated, education/hep, and functional activities.Musculoskeletal assessment, pelvic assessment, and treatment as indicated were the patient's treatment plan for the next visit.On (b)(6) 2022, the patient was seen and examined for complaints of pelvic floor pain after her procedure.Medications were prescribed for pain, and a neurologist referral was planned for further medication changes and long-term treatment for pain.On (b)(6) 2022, the patient underwent physical therapy for her third visit.The patient's pain on arrival was 2-3/10 pain b hips after sitting 25 minutes and reported a stinging labia b outside.No complaints or adverse effects with treatment.All treatments completed to patients reported tolerance and consent.Noted significant pelvic soft tissue mobility deficits with reproduction of familiar pain with palpation.Suspect patient with a high pain threshold may have limited treatment today.Patient with minimal improvement in soft tissue mobility with treatment today.Progress may possibly be limited until a normalized gait pattern is completed.The patient has not been seen since january 2022.Reviewed/updated history and completed soft tissue re-assessment focusing on current primary concerns.On (b)(6) 2022, the patient had a phone conversation with the physician about complaints of pelvic pain.In the physician's assessment, the patient was experiencing female urinary stress incontinence, fecal incontinence, complex regional pain syndrome type ii, obturator neuralgia, pudendal neuralgia, spastic pelvic floor syndrome, and other specified complications due to genitourinary prosthetic materials, sequela.The physician planned to review the patient's operative report from the placement and removal of pelvic mesh.The physician would like to schedule her to remove the arms of obtryx mesh from her groins, bilateral pudendal nerve block, and botox injection to pelvic floor muscles.The patient will need a repeat botox every three months, together with pudendal nerve blocks.If there was no improvement in pain, she might be a candidate for right trans gluteal pudendal neurolysis and/or robotic-assisted laparoscopic obturator nerve neurolysis.The patient reported to the physician that she received interstim in august of 2022 which has been somewhat helpful with her pain and fecal incontinence.She also described to the physician that her symptoms have led to depression and relationship difficulties.She reports that the pain symptoms have impacted her ability to participate in rock climbing, an activity she enjoys.On (b)(6) 2023, the patient underwent removal of retained mesh from the right and left groin, bilateral pudendal nerve block, and botox injection of the pelvic floor muscles procedures to treat the patient's complication of implanted vaginal mesh, obturator neuralgia, pudendal neuralgia, complex regional pain syndrome type ii, spastic pelvic floor syndrome, stress urinary incontinence, and fecal incontinence.Findings include bilateral spasm of the pelvic floor muscles right more than left, especially the right obturator internus muscle and right proximal part of the pubococcygeus muscle, right portion of the mesh very densely adherent to superior pubic ramus (a medial superior aspect of the obturator foramen), and left portion of the mesh not adherent to the bone.Specimens were sent out to pathology for gross examination.There were no complications reported at the conclusion of the procedure.The patient tolerated the procedure well and was taken to the recovery room in stable condition.

Manufacturer Narrative

Block b3: exact date unknown, implant date occurred in december 2011.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.Additional attorneys for the patient: atty.Ben c.Martin atty.Laura j.Baughman atty.Rachel l.Wright martin baughman, pllc 3141 hood street, level 6, dallas, tx 75219 +1(214)761-6614 bmartin@martinbaughman.Com lbaughman@martinbaughman.Com rwright@martinbaughman.Com the implanting surgeon is dr.(b)(6) (b)(6) institute block h6: patient code e1405 captures the reportable event of dyspareunia.Patient code e2326 captures the reportable event of inflammation.Patient code e2330 captures the reportable event of pain.Patient code e1311 captures the reportable event of unspecified kidney or urinary problem.Patient code e2311 captures the reportable event of discomfort.Patient code e0402 captures the reportable event of allergic reaction.Block h11: blocks a2 (patient's date of birth), b2 (outcomes attrib to adv event), b5, b7, d6a, d6b, h2, h6 and h10 have been updated based on the additional information received on june 27, 2023.Block e1: the explanting surgeon on (b)(6) 2020 is dr.(b)(6) (b)(6) university health (b)(6) the explanting surgeon on (b)(6) 2023 is dr.(b)(6) (b)(6) center for chronic pelvic pain (b)(6) phone: (b)(6) fax: +(b)(6) block h6: patient code e2311 captures the reportable event of discomfort.Patient code e2330 captures the reportable event of pain.Patient code e0402 captures the reportable event of allergic reaction.Patient code e1405 captures the reportable event of dyspareunia.Patient code e020201 captures the reportable event of anxiety.Patient code e1715 captures the reportable event of scar tissue.Patient code e1301 captures the reportable event of dysuria.Patient code e1311 captures the reportable event of unspecified kidney or urinary problem.Patient code e0206 captures the reportable event of unspecified mental, emotional or behavioural problem.Patient code e1307 captures the reportable event of urethral stenosis/stricture.Patient code e1309 captures the reportable event of urinary retention.Patient code e1310 captures the reportable event of urinary tract infection.Patient code e0123 captures the reportable event of nerve damage.Patient code e2326 captures the reportable event of inflammation.Patient code e0506 captures the reportable event of hemorrhage/blood loss/bleeding.Patient code e020202 captures the reportable event of depression.Impact code f2303 captures the reportable event of medication required.Impact code f1901 captures the reportable event of additional surgery.Impact code f1903 captures the reportable event of device explantation impact code f12 has been used in the light of this patient seeking legal recourse for an unspecified personal injury related to the device.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15712289
• MDR Text Key: 302827384
• Report Number: 3005099803-2022-06399
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female