MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Cerebrospinal Fluid Leakage (1772); Fatigue (1849); Fever (1858); Fistula (1862); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Diaphoresis (2452); Prolapse (2475); Cognitive Changes (2551); Weight Changes (2607); Dysuria (2684); Constipation (3274); Paresthesia (4421); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Localized Skin Lesion (4542); Fecal Incontinence (4571); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2017

Event Type Injury

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The removed mesh 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

Manufacturer Narrative

Event Description

Manufacturer Narrative

Correction to block h6: patient code.Block b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient codes e2006, e1309, e2330, e1002, e1405, e2101, e1715, e2340, e020201, e020202, and e2326, capture the reportable events of extrusion (sling palpable but minimal tenderness/sling palpable as a rope-like band/foreign material in vagina), urinary retention (difficulty emptying her bladder), pain (bladder, pelvic pain, perineal pain, chronic back pain, unspecified back pain laterality), pain, abdominal, dyspareunia, adhesions (bowel adhesions, ureteral adhesions), scar tissue (cicatrix) for urethral scarring, dehiscence (vaginal cuff), anxiety, depression, and inflammation respectively.Impact codes f19, f1903, f1905, f23, f22, and f2303 capture the reportable events of surgical intervention (exploratory laparotomy, removal of davinci, lysis of bowel adhesions, ureterolysis, urethral lysis), device explantation (partial removal of mid-urethral sling, removal of obtryx sling, vaginal paravaginal removal of mesh from obturators and adductor muscles), device revision or replacement (laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy), unexpected medical intervention (blood transfusion), unexpected diagnostic intervention (cystoscopy), and medication required (0.25% marcaine with epinephrine was used for hydrodissection) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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 b3 date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(6).Block h6: patient codes e2006, e1309, e2330, e1002, e1405, e2101, e1715, e2340, e020201, e020202, and e2326, capture the reportable events of extrusion (sling palpable but minimal tenderness/sling palpable as a rope-like band/foreign material in vagina), urinary retention (difficulty emptying her bladder), pain (bladder, pelvic pain, perineal pain, chronic back pain, unspecified back pain laterality), pain, abdominal, dyspareunia, adhesions (bowel adhesions, ureteral adhesions), scar tissue (cicatrix) for urethral scarring, dehiscence (vaginal cuff), anxiety, depression, and inflammation respectively.Impact codes f19, f1903, f1905, f23, f22, and f2303 capture the reportable events of surgical intervention (exploratory laparotomy, removal of davinci, lysis of bowel adhesions, ureterolysis, urethral lysis), device explantation (partial removal of mid-urethral sling, removal of obtryx sling, vaginal paravaginal removal of mesh from obturators and adductor muscles), device revision or replacement (laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy), unexpected medical intervention (blood transfusion), unexpected diagnostic intervention (cystoscopy), and medication required (0.25% marcaine with epinephrine was used for hydrodissection) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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.Block h11: block g2 has been corrected.Blocks b5, b7, h6 and h10 have been updated based on the additional information received on september 29.2022.Block h6: patient code 2101 was utilized to capture the reportable event of adhesions.Patient code e2320 was utilized to capture the reportable event of hypertension.Patient code e013403 was utilized to capture the reportable event of paresthesia.Patient code e1301 was utilized to capture the reportable event of dysuria.Patient code e232401 was utilized to capture the reportable event of fecal incontinence.Patient code e1906 was utilized to capture the reportable event of unspecified infection.Patient code e1310 was utilized to capture the event of urinary tract infection.Patient code e2314 was utilized to capture the reportable event of fistula.Patient code e1621 was utilized to capture the reportable event of muscle weakness.Patient code e1311 was utilized to capture the reportable event of unspecified kidney or urinary problem.Patient code e0123 was utilized to capture the reportable event of nerve damage.Patient code e0506 was utilized to capture the reportable event of hemorrhage.Patient code e0127 was utilized to capture the reportable event of numbness.

Event Description

Note: this report pertains to one of two devices used on the same patient.It was reported to boston scientific corporation that an upsylon mesh was implanted during a laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy, and cystoscopy procedure on (b)(6) 2017, for the treatment of vaginal vault prolapse, rectocele, and perineocele.The operative report notes a finding of "dense scarring of the bladder to the anterior vagina".There were no complications.Medical and surgical history included implantation with an obtryx ii system- halo on (b)(6) 2017, during a total laparoscopic hysterectomy, bilateral salpingectomy, trans-obturator bladder neck suspension, cystoscopy, anterior repair procedure performed for the treatment of stress incontinence, symptomatic pelvic relaxation, cystocele, and menorrhagia; the apical portion of her prolapse was not repaired and she had not had a posterior repair either.The patient returned to the or later that day for postoperative bleeding and also had postoperative complications noted as voiding dysfunction/urinary retention.After the (b)(6) 2017, procedure, the patient continued to have a bulge that she could see and feel, difficulty with bowel movements (bm) because of the bulge, and she could not splint to have a bm or to void.On (b)(6) 2017, exam revealed prolapse was stage 2 apical/posterior, the obtryx sling was palpable but minimal tenderness, and the vaginal cuff was tender to palpation.Some sui was noted on exam.Additional medical and surgical history included discomfort and a lot of pressure from her pelvic relaxation that causes problems with sexual activity and dyspareunia; acute lymphoblastic leukemia (in remission since 2001); cesarean section x 3; former smoker; allergy to non-steroidal anti-inflammatory medications (nsaids); exploratory laparotomy in 2016; intracranial hypertension (ich).On (b)(6) 2017, after the upsylon and other procedures, the patient was agitated postoperatively about how long it was taking to administer additional pain medication.She left the hospital against medical advice on (b)(6) 2017, after pulling out her own iv as she felt she was not getting enough for pain control.On (b)(6) 2018, the patient stated that she had bladder/pelvic pain that had worsened over the last few days.She felt that there was a pulling sensation and pain that can be nearly debilitating at times, especially later in the day.She also had some obstructive defecatory symptoms, and she thought that she may have a recurrence of her cystocele.Physical exam revealed mild tachycardia, no prolapse, palpable sling as a rope-like band, and extreme tenderness to palpation especially at the insertion points to the obturators.The medical records note the patient's pelvic pain and defecatory dysfunction were suspected to be at least partially related to her sling and muscle spasm.It was highly unlikely she will be able to tolerate pfpt, so the plan was for sling removal.The patient understood she may need pt and/or another sling for sui since her sui is likely to return after removal.She also understands that she is not guaranteed to have resolution of her pain with the sling removal.A prescription was vaginal valium was sent to the pharmacy for suspected muscle spasm as cause of defecatory dysfunction and pain.On (b)(6) 2018, she had undergone a partial removal of mid-urethral sling, and cystoscopy procedure for the treatment of pelvic pain, and dyspareunia suspected due to mid-urethral sling.Moreover, the sling was palpable, consistent with the preoperative exam and a 0.25% marcaine with epinephrine was used for hydrodissection, and a vertical midline incision was made along the periurethral vaginal epithelium where her prior incision was.The vaginal epithelium was then carefully dissected free until the level of the sling was reached.The mesh was clearly visible and was carefully dissected it free of the underlying fibromuscular tissue and transected it at the level of insertion into the obturators bilaterally.On (b)(6) 2018, the patient was status post sling removal.She needed a refill on her vaginal valium since this is what is working best for her pain.Reportedly, she did not feel like she was emptying her bladder completely.Her postvoid residual (pvr) was normal.On (b)(6) 2018, she had a follow-up visit discussing about laparoscopic colpopexy mesh (upsylon) removal.She had been experiencing complications related to her ich and was worried that the mesh and the capture clips are the cause of her neurologic problems.She does understand that based on previous conversations, it is highly unlikely that they are actually related.However, she says she wants the mesh out, because she has tried everything else and there have been no answers.She feels like it is something she has to do to at least get the answer of whether the mesh as part of the problem.She also reported chronic back pain, (unspecified back location, unspecified back pain laterality).She was offered a referral to another provider.On (b)(6) 2019, the patient had an exploratory laparotomy with removal of 0-6 sacral tacks.The operative report for this procedure was not provided to bsc.On (b)(6) 2019, the patient presented for mesh problems.She reported pelvic, abdominal and back pain managed with oxycontin 15 mg 5x/day.She was also experiencing constipation, dyschezia, splinting, dysuria, urinary retention, frequency, and dyspareunia after orgasm.Exam revealed pain at the obturator internus muscles (left and right), pain at cords (left and right), and pain at apex.Surgical removal of the obtryx and uphold mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy, and abdominal enterocele repair was offered.On (b)(6) 2019, she underwent removal of davinci placed upsylon abdominal mesh, lysis of bowel adhesions, ureterolysis, removal of obtryx sling, urethral lysis, vaginal paravaginal, removal of mesh from obturators and adductor muscles procedure for the treatment of pain with coitus, vaginal pain, pelvic pain, foreign material in vagina and in the pelvic muscle, bowel adhesions, ureterai adhesions, and urethral scarring the bowl and omentum were found to be adherent to the vaginal apex at the site of the mesh and cul-de-sac.The loops of small bowel, large bowel and omentum were adherent to the vaginal apex, cul-de-sac as well as to the ovaries.All the adhesions were taken down sharply.The right ureter was disoriented and putted to the midline next to the mesh.This was a very difficult surgery due to scarring from previous surgery and the dissection required to remove the mesh from the groins that was very deeply implanted.The lateral end of the mesh was identified and freed from the adductor muscles with sharp dissection and from the soft tissue muscular attachments to the pubic ramus.This was very difficult due to the significant muscle mass as well the very deep mesh placement.The entire remaining obtryx sling was removed.Of note, one page of the operative report was illegible.The pathology results on both the excised upsylon and obtryx mesh included mild chronic inflammation.On (b)(6) 2020, the patient had a post-operative visit, and stated that she does note vaginal pressure and bulging, especially with bowel movements, and was splinting.She reported some urinary leakage with laughing, cough, and sneeze, and also felt in pain at the end of urination.Exam revealed the tissues were healed.The assessment was that the patient was "well after surgery" and she was to follow up as needed.***additional information received on september 29, 2022*** on (b)(6) 2018, the patient was seen and examined following an mri on her left spine done the previous week.The patient brought the report with her.The mri was ordered by her obgyn due to back pain post bladder mesh removal.The mri results revealed a bilateral mass effect on one of her nerves and a disc problem at s1-l5 cs.The patient was previously diagnosed with osteophytes at t11-12.The patient reported that her lower back was always tender.She had episodes that her movement was severely limited.Her gyn told her that the area where her problem was had some clips.The patient had a lot of labs done.She has a very low ch50 and igm.She was told that all of her immunoglobulins were on the edge of being out of range.No specific diagnosis was provided.She was advised to be revaccinated against pneumococcus but not until she did some more research.The patient was referred to oncology for evaluation but did not get any real advice from her oncologist.The patient also visited the clinic for a transition of care from another physician and a summary of care was not provided.The patient reported that the zoloft medication was working well for her.The patient was also on diamox to keep her fluid levels low.Her physicians cut her dose down by half and within five days, she was right back to where she was before the medication.She had to go back to the whole dose.The patient also reported that her medication was cut down by 1/3 about five days ago and this resulted in feeling bad and she was swollen.On (b)(6) 2018, the patient was seen and examined with findings of immune deficiency disorder, bipolar affective disorder, current episode depressed, current episode severity unspecified, chronic bilateral low back pain with bilateral sciatica, hib, meningococcal conj, and overweight.The patient had a prior laparoscopic hysterectomy and a prior laparoscopic sacrocolpopexy with tack devices used at the sacral promontory for placement of mesh.On january 4, 2019, the patient experienced a foreign body reaction to the metal tacks including pelvic pain and abdominal pain.She desired removal of these tacks.X-ray preoperatively showed 6 tacks at the level of the anterior longitudinal ligament at the location of l5-s1 disk.Neurosurgery was consulted who was available if needed injury intraoperatively.The patient did not desire laparoscopic removal and desired an open abdominal approach.Risks were reviewed including the possibility that removal of these tacks may not completely resolve the patient's symptoms.Informed consent was obtained.The patient was taken to the operating room.She underwent a laparotomy, exploratory, with removal of foreign body and cystoscopy (removal of 6 sacral tacks).There were no patient complications following the procedure and the patient was then taken to the recovery room for comparison.Findings include six sacral tacks at the promontory, cystourethroscopy revealed a normal bladder and urethral mucosa.No foreign body or suture in the bladder, no evidence of injury to the bladder.There was brisk bilateral ureteral orifice efflux seen.Right ovary appeared normal, left ovary not visualized, sigmoid adherent in that area.No other significant adhesive disease.Mesh was visualized in the peritoneal reflection from the uterosacral ligament on the right side to the sacral promontory.Vaginal exam under anesthesia showed good support of all 3 compartments, normal urethral meatus and no evidence of foreign body in the vagina.Hemostasis postoperatively.The foley catheter removed and patient taken to the recovery room after tap block for admission prompt extirpation and the sacral tacks x6 were sent to pathology.On (b)(6) 2019 the patient was seen and examined for complains of chronic pain and for therapeutic purposes for chronic in person prescription renewal.Upon examination, the patient has bladder prolapse.The patient was seen for a medication check and refill on oxycodone.The patient had a procedure done last thursday on her right ovary.They ended up not being able to do it laparoscopic and had to make an incision and the physician removed multiple adhesions.The patient was admitted for one night.The patient's head pressure increased and the physician increased her medication.The patient went to an ophthalmologist and the physician increased the patient's intercranial hypertension to stage two.As the patient was seen for medication recheck, the patient has been feeling like her oxycodone dose was working pretty well for her at this time.The patient made it for a whole month without running out and she tolerated the medications without problems.The patient also had a cyst removed from her left ovary the previous week.The patient was informed that the mesh in her abdomen was hardened and was advised to seek gyne consult.The patient had a lot of complications after surgery and her intracranial pressure (icp) increased again.She was on high dose diamox from neuro-ophtho for two weeks to try to get her icp back down.She was having significant headache.In the physician's assessment, the patient has extremely complicated history in 2017 a few months after her 3rd svd she had complete pelvic prolapse which was repaired with placement of bladder mesh.The patient had recurrence a few months later and underwent a sacrocopopexy with anchor placement.She also complained of chronic back pain as well as increased intracranial pressure (icp) and cerebrospinal fluid (csf) leakage starting at that time.She has been told by neuro-ophtho and neurosurgeon that if she cannot get the mesh removed, she will require a vp shunt to control her icp.She managed to find a doctor in texas to remove the anchors which has improved a lot of her symptoms, namely the back pain but she continued to have problems with her icp.Multiple surgeons have told her that the mesh was encased in thick scar tissue and was essentially hardened in place.She will have to consult gyn/oncologist to see if this was a case they may be willing to attempt even though she did not have a pelvic cancer.Current plans included a longer duration of class ii opioid treatment (or other opioid treatment).The following were assessed or performed: 1.Current and past medical history was reviewed in context of this evaluation, including the experience of the patient with non-opioid medication and nonpharmacological pain-management approaches and substance abuse history.2.The patient's compliance with the "patient provider agreement and informed consent chronic pain" was reviewed and determined to be amicable.3.The course of treatment has been reviewed and any new information about the etiology of the pain documented as applicable.The progress of the patient toward treatment objectives has been reviewed and deemed to be stable and/or progressing as expected and planned.4.Reasonable efforts were made to either stop the use of the opioid, decrease the dosage or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or physiological dependence.5.The patient has been assessed to determine whether the patient was experiencing problems associated with physical and psychological dependence and has not been found to experience these problems.6.The longer durations prescription was chosen to be the lowest effective dose of opioid drug for patient's condition.The opioid therapy was felt to be warranted and continued as prescribed and planned.Risk of opioid medications were discussed with the patient, including but not limited to: 1.The risks of addiction and overdose associated with opioid drugs and the dangers of taking opioid drugs with alcohol, benzodiazepines and other central nervous system depressants.2.The reason(s) the prescription was necessary was discussed as well as alternative treatments that may be available.3.Risk associated with the use of the drugs being prescribed, specifically that opioids are highly addictive, even when taken as prescribed, that there is a risk of developing a physical or psychological dependence on the controlled dangerous substance.4.The patient or the parent or guardian of the patient has verbalized understanding of these risks.The oklahoma prescription monitoring program (pmp) was accessed and reviewed and found to be appropriate in regard to the current pomp information checked pain management plan.On october 10, 2019, the patient was seen and examined for a medication consultation.The patient was seen for medicine check and refills.During the visit it was noted that the patient has a productive cough and sinus congestion which was reportedly experienced by the patient for five days now.The patient stated that she has been coughing up with green phlegm.The patient had a previous abdominal end of the shunt clipped since last visit.The patient's pain has improved.The patient has a consult next month to evaluate for mesh removal and bladder repair.In the physician's assessment, once the patient has the mesh removed her pelvic pain will improve.She reported that any sort of movements like coughing, having a bowel movement, or rapid movement, the patient has a searing, tearing type pain from her diaphragm to her vagina.She reported that she has barely taken the adderall at all because it made her heart race.She as only taking vyvanse, tolerating it without problems.The patient was advised to continue to take pain medication until she saw the surgeon.Once she has the mesh removed she will begin to wean the pain medication.Precautions given, and was also advised to call if problems arise.On (b)(6) 2019, the patient was seen and examined for a medication consultation.The patient was seen for medicine check and refills.The patient also reported that she felt very sore and achy all over like she had a fever the day prior.The patient saw her shunt physician the day prior and she was not sure if the shunt was working properly.She has been having burning pain between her shoulder blades and was experiencing headaches again.She was advised that the reservoir was working fine but there could be a problem with the tubing in her abdomen.She was to see her eye doctor to make sure her eyes were ok.The patient has an appointment for consult for the removal of her mesh in about two weeks.She reported that her pelvic pain has been severe at times bringing her to her knees.The patient was advised to continue the current regimen and follow up with specialists as scheduled.Precautions were discussed and was advised to call for any problems.On (b)(6) 2019, the patient was seen and examined for a wound check after having surgery to remove her bladder mesh which was performed on (b)(6) 2019.The patient was able to return home and she was concerned that an area of one of the incisions was coming apart.The patient did not report any drainage or tenderness.Overall, the patient was feeling good.The patient was scheduled for a follow up with her surgeon at the end of january.The physician applied two steri strips to the small area of dehiscence on the right lateral aspect of the mons pubis.The patient tolerated well and precautions were given.On (b)(6) 2019, the patient was seen and examined for a medication consult.The patient was seen for medicine check and refills.The patient had a previous abdominal surgery to remove her mesh and what remained of her sling.She reported that she has not had a headache since she had the mesh removed.The patient has been experiencing a lot of pain in her sacrum where the scar tissue was pulled off.The patient was also experiencing abdominal pain post operation so she was not able to really gauge how that pain was.The patient was also having some urinary retention.She has been taking muscle relaxers for pelvic muscle spasms.The patient verbalized that she wanted to work on weaning but was not sure she was ready yet.In the physician's assessment, the patient may work on weaning pain medication as able.Her medications were refilled at the current dose as she was only a week post operation.Instructions and precautions were advised.On (b)(6) 2020, the patient was seen and examined for a follow up visit.The patient was also seen to get a refill on her xanax for 1 day.She was also scheduled to follow up with her mesh removal surgeon and she would like to take xanax prior to the flight as she reported that she was afraid of flying.The patient was taking half the amount of painkillers currently than prior to her surgery.The patient was feeling much better after having the mesh removed.The patient also had flu since her last visit and reportedly mentioned that everyone in her household had it.The patient was almost due to refill her pain medications.She has been working on weaning from the pain medications and would like for fewer doses in a day.The patient was hoping to be off of the pain medications before she has her next surgery so that pain control will be easier after the surgery.In the physician's assessment, the patient's dose will be reduced today.Instructions and precautions were provided.As reported by the patient's attorney, the patient experienced the following symptoms: pelvic, back, vaginal, neuromuscular and joint paint.The patient also reported recurrence of prolapse, rectocele and cystocele which led to bowel problems, urinary problems and chronic infections.The patient also reported to experience bleeding and dyspareunia.The patient had vaginal spasms and fistulae causing bowel, vagina, bladder and neuromuscular problems.Moreover, the patient experienced extreme fatigue.She also reported numbness and pins and needles feelings in her vulva, groin, and lower abdomen; fecal incontinence with flatus; muscle weakness after little activity.As reported by the patient's attorney, the patient suffered from the following: adhesions, bleeding or clotting disorders, cancer, chronic constipation, connective tissue disorder, cystocele, dyspareunia, enterocele, fistulas, hypertension, neuromuscular disease or disorder, obesity, pelvic trauma, rectocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, and wound healing problems.On (b)(6) 2021, the patient was seen and evaluated with pelvic floor tension myalgia and pudendal neuralgia.During evaluation, the patient was able to tolerate with minimal positioning changes.Upon examination, the patient reported tenderness as well as a numb sensation along bilateral medial sacrotuberous ligaments as well as towards medial ischial tuberosities.She reported numbness across lower abdomen to just above the pubic symphysis.The patient experienced pain into bilateral groin and into r>l labia.The patient reported pain with palpation at vaginal entrance as well as into bilateral anterior pelvic floor (l>r), bilateral obturator/iliococcygeus/posterior pubococcygeus towards bilateral ischial spines.She was able to complete some space and release with cues for inhalation however overall significant noted.She demonstrated severe pelvic floor tension bilaterally as well as sensory changes as noted above.The patient demonstrated pain consistent with pelvic floor tension myalgia as well as pudendal neuralgia.The patient would likely benefit from suppositories and botox to help with pelvic floor tension as well as follow-up pfpt as well as pudendal nerve block.All of the above discussed with the patient and physician who will develop further treatment planning with the patient.

Event Description

Note: this report pertains to one of two devices used on the same patient.It was reported to boston scientific corporation that on (b)(6) 2017, the patient was implanted with an obtryx ii system - halo during a total laparoscopic hysterectomy, bilateral salpingectomy, trans-obturator bladder neck suspension, cystoscopy, anterior repair procedure performed for the treatment of stress incontinence, symptomatic pelvic relaxation, cystocele, and menorrhagia.Medical and surgical history included discomfort and a lot of pressure from her pelvic relaxation that causes problems with sexual activity and dyspareunia; acute lymphoblastic leukemia (in remission since 2001); cesarean section x 3; former smoker; allergy to non-steroidal anti-inflammatory medications (nsaids); exploratory laparotomy in 2016; intracranial hypertension (ich).It was reported that the patient had to return to the operating room for postoperative bleeding on (b)(6) 2017, and that there was no obvious source of the bleeding.Medical records also note that there were "complications of postop voiding dysfunction/urinary retention".On (b)(6) 2017, the patient presented for evaluation of prolapse.She said that she had a bulge that she can see and feel it, and it was bothersome for her.She has difficulty with bowel movements (bm) because of the bulge, and she could not splint to have a bm or to void.She was previously diagnosed with uterine prolapse and stress urinary incontinence (sui) and underwent hysterectomy and sling.Unfortunately, she continued to have a palpable bothersome bulge.According to her medical records, it was mentioned that the apical portion of her prolapse was not repaired and she had not had a posterior repair either.In addition, during the physical examination, it was observed that the prolapse was stage 2 apical/posterior, the sling was palpable but minimal tenderness, and the vaginal cuff was tender to palpation.Some sui was noted on exam.The plan was to repair prolapse and likely refer for pelvic floor physical therapy (pfpt) and further address her sui if no improvement from that.On (b)(6) 2017, upsylon mesh was implanted during a laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy, and cystoscopy procedure on (b)(6) 2017, for the treatment of vaginal vault prolapse, rectocele, and perineocele.The operative report notes a finding of "dense scarring of the bladder to the anterior vagina".There were no complications.The patient was agitated postoperatively about how long it was taking to administer additional pain medication.She left the hospital against medical advice on (b)(6) 2017, after pulling out her own iv as she felt she was not getting enough for pain control.On (b)(6) 2018, the patient stated that she had bladder/pelvic pain that had worsened over the last few days.She felt that there was a pulling sensation and pain that can be nearly debilitating at times, especially later in the day.She also had some obstructive defecatory symptoms, and she thought that she may have a recurrence of her cystocele.Physical exam revealed mild tachycardia, no prolapse, palpable sling as a rope-like band, and extreme tenderness to palpation especially at the insertion points to the obturators.The medical records note the patient's pelvic pain and defecatory dysfunction were suspected to be at least partially related to her sling and muscle spasm.It was highly unlikely she will be able to tolerate pfpt, so the plan was for sling removal.The patient understood she may need pt and/or another sling for sui since her sui is likely to return after removal.She also understands that she is not guaranteed to have resolution of her pain with the sling removal.A prescription was vaginal valium was sent to the pharmacy for suspected muscle spasm as cause of defecatory dysfunction and pain.On (b)(6) 2018, she had undergone a partial removal of mid-urethral sling, and cystoscopy procedure for the treatment of pelvic pain, and dyspareunia suspected due to mid-urethral sling.Moreover, the sling was palpable, consistent with the preoperative exam and a 0.25% marcaine with epinephrine was used for hydrodissection, and a vertical midline incision was made along the periurethral vaginal epithelium where her prior incision was.The vaginal epithelium was then carefully dissected free until the level of the sling was reached.The mesh was clearly visible and was carefully dissected it free of the underlying fibromuscular tissue and transected it at the level of insertion into the obturators bilaterally.On (b)(6) 2018, the patient was status post sling removal.She needed a refill on her vaginal valium since this is what is working best for her pain.Reportedly, she did not feel like she was emptying her bladder completely.Her postvoid residual (pvr) was normal.On (b)(6) 2018, she had a follow-up visit discussing about laparoscopic colpopexy mesh (upsylon) removal.She had been experiencing complications related to her ich and was worried that the mesh and the capture clips are the cause of her neurologic problems.She does understand that based on previous conversations, it is highly unlikely that they are actually related.However, she says she wants the mesh out, because she has tried everything else and there have been no answers.She feels like it is something she has to do to at least get the answer of whether the mesh as part of the problem.She also reported chronic back pain, (unspecified back location, unspecified back pain laterality).She was offered a referral to another provider.On (b)(6) 2019, the patient had an exploratory laparotomy with removal of 0-6 sacral tacks.The operative report for this procedure was not provided to bsc.On (b)(6) 2019, the patient presented for mesh problems.She reported pelvic, abdominal and back pain managed with oxycontin 15 mg 5x/day.She was also experiencing constipation, dyschezia, splinting, dysuria, urinary retention, frequency, and dyspareunia after orgasm.Exam revealed pain at the obturator internus muscles (left and right), pain at cords (left and right), and pain at apex.Surgical removal of the obtryx and uphold mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy, and abdominal enterocele repair was offered.On (b)(6) 2019, she underwent removal of davinci placed upsylon abdominal mesh, lysis of bowel adhesions, ureterolysis, removal of obtryx sling, urethral lysis, vaginal paravaginal, removal of mesh from obturators and adductor muscles procedure for the treatment of pain with coitus, vaginal pain, pelvic pain, foreign material in vagina and in the pelvic muscle, bowel adhesions, ureterai adhesions, and urethral scarring the bowl and omentum were found to be adherent to the vaginal apex at the site of the mesh and cul-de-sac.The loops of small bowel, large bowel and omentum were adherent to the vaginal apex, cul-de-sac as well as to the ovaries.All the adhesions were taken down sharply.The right ureter was disoriented and putted to the midline next to the mesh.This was a very difficult surgery due to scarring from previous surgery and the dissection required to remove the mesh from the groins that was very deeply implanted.The lateral end of the mesh was identified and freed from the adductor muscles with sharp dissection and from the soft tissue muscular attachments to the pubic ramus.This was very difficult due to the significant muscle mass as well the very deep mesh placement.The entire remaining obtryx sling was removed.Of note, one page of the operative report was illegible.The pathology results on both the excised upsylon and obtryx mesh included mild chronic inflammation.On (b)(6) 2020, the patient had a post-operative visit, and stated that she does note vaginal pressure and bulging, especially with bowel movements, and was splinting.She reported some urinary leakage with laughing, cough, and sneeze, and also felt in pain at the end of urination.Exam revealed the tissues were healed.The assessment was that the patient was "well after surgery" and she was to follow up as needed.Additional information received on september 29, 2022: on (b)(6) 2018, the patient was seen and examined following an mri on her left spine done the previous week.The patient brought the report with her.The mri was ordered by her obgyn due to back pain post bladder mesh removal.The mri results revealed a bilateral mass effect on one of her nerves and a disc problem at s1-l5 cs.The patient was previously diagnosed with osteophytes at t11-12.The patient reported that her lower back was always tender.She had episodes that her movement was severely limited.Her gyn told her that the area where her problem was had some clips.The patient had a lot of labs done.She has a very low ch50 and igm.She was told that all of her immunoglobulins were on the edge of being out of range.No specific diagnosis was provided.She was advised to be revaccinated against pneumococcus but not until she did some more research.The patient was referred to oncology for evaluation but did not get any real advice from her oncologist.The patient also visited the clinic for a transition of care from another physician and a summary of care was not provided.The patient reported that the zoloft medication was working well for her.The patient was also on diamox to keep her fluid levels low.Her physicians cut her dose down by half and within five days, she was right back to where she was before the medication.She had to go back to the whole dose.The patient also reported that her medication was cut down by 1/3 about five days ago and this resulted in feeling bad and she was swollen.On (b)(6) 2018, the patient was seen and examined with findings of immune deficiency disorder, bipolar affective disorder, current episode depressed, current episode severity unspecified, chronic bilateral low back pain with bilateral sciatica, hib, meningococcal conj, and overweight.The patient had a prior laparoscopic hysterectomy and a prior laparoscopic sacrocolpopexy with tack devices used at the sacral promontory for placement of mesh.On (b)(6) 2019, the patient experienced a foreign body reaction to the metal tacks including pelvic pain and abdominal pain.She desired removal of these tacks.X-ray preoperatively showed 6 tacks at the level of the anterior longitudinal ligament at the location of l5-s1 disk.Neurosurgery was consulted who was available if needed injury intraoperatively.The patient did not desire laparoscopic removal and desired an open abdominal approach.Risks were reviewed including the possibility that removal of these tacks may not completely resolve the patient's symptoms.Informed consent was obtained.The patient was taken to the operating room.She underwent a laparotomy, exploratory, with removal of foreign body and cystoscopy (removal of 6 sacral tacks).There were no patient complications following the procedure and the patient was then taken to the recovery room for comparison.Findings include six sacral tacks at the promontory, cystourethroscopy revealed a normal bladder and urethral mucosa.No foreign body or suture in the bladder, no evidence of injury to the bladder.There was brisk bilateral ureteral orifice efflux seen.Right ovary appeared normal, left ovary not visualized, sigmoid adherent in that area.No other significant adhesive disease.Mesh was visualized in the peritoneal reflection from the uterosacral ligament on the right side to the sacral promontory.Vaginal exam under anesthesia showed good support of all 3 compartments, normal urethral meatus and no evidence of foreign body in the vagina.Hemostasis postoperatively.The foley catheter removed and patient taken to the recovery room after tap block for admission prompt extirpation and the sacral tacks x6 were sent to pathology.On (b)(6) 2019 the patient was seen and examined for complains of chronic pain and for therapeutic purposes for chronic in person prescription renewal.Upon examination, the patient has bladder prolapse.The patient was seen for a medication check and refill on oxycodone.The patient had a procedure done last thursday on her right ovary.They ended up not being able to do it laparoscopic and had to make an incision and the physician removed multiple adhesions.The patient was admitted for one night.The patient's head pressure increased and the physician increased her medication.The patient went to an ophthalmologist and the physician increased the patient's intercranial hypertension to stage two.As the patient was seen for medication recheck, the patient has been feeling like her oxycodone dose was working pretty well for her at this time.The patient made it for a whole month without running out and she tolerated the medications without problems.The patient also had a cyst removed from her left ovary the previous week.The patient was informed that the mesh in her abdomen was hardened and was advised to seek gyne consult.The patient had a lot of complications after surgery and her intracranial pressure (icp) increased again.She was on high dose diamox from neuro-ophtho for two weeks to try to get her icp back down.She was having significant headache.In the physician's assessment, the patient has extremely complicated history in 2017 a few months after her 3rd svd she had complete pelvic prolapse which was repaired with placement of bladder mesh.The patient had recurrence a few months later and underwent a sacrocopopexy with anchor placement.She also complained of chronic back pain as well as increased intracranial pressure (icp) and cerebrospinal fluid (csf) leakage starting at that time.She has been told by neuro-ophtho and neurosurgeon that if she cannot get the mesh removed, she will require a vp shunt to control her icp.She managed to find a doctor in (b)(6) to remove the anchors which has improved a lot of her symptoms, namely the back pain but she continued to have problems with her icp.Multiple surgeons have told her that the mesh was encased in thick scar tissue and was essentially hardened in place.She will have to consult gyn/oncologist to see if this was a case they may be willing to attempt even though she did not have a pelvic cancer.Current plans included a longer duration of class ii opioid treatment (or other opioid treatment).The following were assessed or performed: 1.Current and past medical history was reviewed in context of this evaluation, including the experience of the patient with non-opioid medication and nonpharmacological pain-management approaches and substance abuse history.2.The patient's compliance with the "patient provider agreement and informed consent chronic pain" was reviewed and determined to be amicable.3.The course of treatment has been reviewed and any new information about the etiology of the pain documented as applicable.The progress of the patient toward treatment objectives has been reviewed and deemed to be stable and/or progressing as expected and planned.4.Reasonable efforts were made to either stop the use of the opioid, decrease the dosage or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or physiological dependence.5.The patient has been assessed to determine whether the patient was experiencing problems associated with physical and psychological dependence and has not been found to experience these problems.6.The longer durations prescription was chosen to be the lowest effective dose of opioid drug for patient's condition.The opioid therapy was felt to be warranted and continued as prescribed and planned.Risk of opioid medications were discussed with the patient, including but not limited to: 1.The risks of addiction and overdose associated with opioid drugs and the dangers of taking opioid drugs with alcohol, benzodiazepines and other central nervous system depressants.2.The reason(s) the prescription was necessary was discussed as well as alternative treatments that may be available.3.Risk associated with the use of the drugs being prescribed, specifically that opioids are highly addictive, even when taken as prescribed, that there is a risk of developing a physical or psychological dependence on the controlled dangerous substance.4.The patient or the parent or guardian of the patient has verbalized understanding of these risks.The (b)(6) was accessed and reviewed and found to be appropriate in regard to the current (b)(6) information checked pain management plan.On (b)(6) 2019, the patient was seen and examined for a medication consultation.The patient was seen for medicine check and refills.During the visit it was noted that the patient has a productive cough and sinus congestion which was reportedly experienced by the patient for five days now.The patient stated that she has been coughing up with green phlegm.The patient had a previous abdominal end of the shunt clipped since last visit.The patient's pain has improved.The patient has a consult next month to evaluate for mesh removal and bladder repair.In the physician's assessment, once the patient has the mesh removed her pelvic pain will improve.She reported that any sort of movements like coughing, having a bowel movement, or rapid movement, the patient has a searing, tearing type pain from her diaphragm to her vagina.She reported that she has barely taken the adderall at all because it made her heart race.She as only taking vyvanse, tolerating it without problems.The patient was advised to continue to take pain medication until she saw the surgeon.Once she has the mesh removed she will begin to wean the pain medication.Precautions given, and was also advised to call if problems arise.On (b)(6) 2019, the patient was seen and examined for a medication consultation.The patient was seen for medicine check and refills.The patient also reported that she felt very sore and achy all over like she had a fever the day prior.The patient saw her shunt physician the day prior and she was not sure if the shunt was working properly.She has been having burning pain between her shoulder blades and was experiencing headaches again.She was advised that the reservoir was working fine but there could be a problem with the tubing in her abdomen.She was to see her eye doctor to make sure her eyes were ok.The patient has an appointment for consult for the removal of her mesh in about two weeks.She reported that her pelvic pain has been severe at times bringing her to her knees.The patient was advised to continue the current regimen and follow up with specialists as scheduled.Precautions were discussed and was advised to call for any problems.On (b)(6) 2019, the patient was seen and examined for a wound check after having surgery to remove her bladder mesh which was performed on (b)(6) 2019.The patient was able to return home and she was concerned that an area of one of the incisions was coming apart.The patient did not report any drainage or tenderness.Overall, the patient was feeling good.The patient was scheduled for a follow up with her surgeon at the end of (b)(6).The physician applied two steri strips to the small area of dehiscence on the right lateral aspect of the mons pubis.The patient tolerated well and precautions were given.On (b)(6) 2019, the patient was seen and examined for a medication consult.The patient was seen for medicine check and refills.The patient had a previous abdominal surgery to remove her mesh and what remained of her sling.She reported that she has not had a headache since she had the mesh removed.The patient has been experiencing a lot of pain in her sacrum where the scar tissue was pulled off.The patient was also experiencing abdominal pain post operation so she was not able to really gauge how that pain was.The patient was also having some urinary retention.She has been taking muscle relaxers for pelvic muscle spasms.The patient verbalized that she wanted to work on weaning but was not sure she was ready yet.In the physician's assessment, the patient may work on weaning pain medication as able.Her medications were refilled at the current dose as she was only a week post operation.Instructions and precautions were advised.On (b)(6) 2020, the patient was seen and examined for a follow up visit.The patient was also seen to get a refill on her xanax for 1 day.She was also scheduled to follow up with her mesh removal surgeon and she would like to take xanax prior to the flight as she reported that she was afraid of flying.The patient was taking half the amount of painkillers currently than prior to her surgery.The patient was feeling much better after having the mesh removed.The patient also had flu since her last visit and reportedly mentioned that everyone in her household had it.The patient was almost due to refill her pain medications.She has been working on weaning from the pain medications and would like for fewer doses in a day.The patient was hoping to be off of the pain medications before she has her next surgery so that pain control will be easier after the surgery.In the physician's assessment, the patient's dose will be reduced today.Instructions and precautions were provided.As reported by the patient's attorney, the patient experienced the following symptoms: pelvic, back, vaginal, neuromuscular and joint paint.The patient also reported recurrence of prolapse, rectocele and cystocele which led to bowel problems, urinary problems and chronic infections.The patient also reported to experience bleeding and dyspareunia.The patient had vaginal spasms and fistulae causing bowel, vagina, bladder and neuromuscular problems.Moreover, the patient experienced extreme fatigue.She also reported numbness and pins and needles feelings in her vulva, groin, and lower abdomen; fecal incontinence with flatus; muscle weakness after little activity.As reported by the patient's attorney, the patient suffered from the following: adhesions, bleeding or clotting disorders, cancer, chronic constipation, connective tissue disorder, cystocele, dyspareunia, enterocele, fistulas, hypertension, neuromuscular disease or disorder, obesity, pelvic trauma, rectocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, and wound healing problems.On (b)(6) 2021, the patient was seen and evaluated with pelvic floor tension myalgia and pudendal neuralgia.During evaluation, the patient was able to tolerate with minimal positioning changes.Upon examination, the patient reported tenderness as well as a numb sensation along bilateral medial sacrotuberous ligaments as well as towards medial ischial tuberosities.She reported numbness across lower abdomen to just above the pubic symphysis.The patient experienced pain into bilateral groin and into r>l labia.The patient reported pain with palpation at vaginal entrance as well as into bilateral anterior pelvic floor (l>r), bilateral obturator/iliococcygeus/posterior pubococcygeus towards bilateral ischial spines.She was able to complete some space and release with cues for inhalation however overall significant noted.She demonstrated severe pelvic floor tension bilaterally as well as sensory changes as noted above.The patient demonstrated pain consistent with pelvic floor tension myalgia as well as pudendal neuralgia.The patient would likely benefit from suppositories and botox to help with pelvic floor tension as well as follow-up pfpt as well as pudendal nerve block.All of the above discussed with the patient and physician who will develop further treatment planning with the patient.Additional information received on november 3, 2022 and november 22, 2022: on (b)(6) 2018, the patient was seen and examined for lower back pain, and pain from implanted hardware.The patient reported that since she had the mesh sling placed approximately one year ago, she developed intracerebral brain hemorrhage (ich), pseudo tumor cerebri, and spinal stenosis.The patient would like to have this coil tracks removed as soon as possible.She reported that she was scheduled for nickel allergy testing the following week.The patient reported that nickel was in the coils and that was likely why she was having so many problems.The patient had multiple stays in the hospital.On (b)(6) 2018, a correspondence was sent by the primary care physician of the patient for a referral.The patient has a history of leukemia at the age of 7 which was treated with chemotherapy.She has been otherwise healthy for the last 15 years.Approximately 18 months ago, after the birth of her third child, the patient had uterine prolapse that was repaired with partial hysterectomy and mesh placement for bladder suspension.Shortly after that repair, she had reoccurrence of pelvic prolapse with rectocele.That was repaired with sacrocolpopexy using nickel anchors in (b)(6) of 2017.Within a month of that surgery, the patient started feeling ill with systemic symptoms.She had severe, debilitating headaches and back pain with intermittent fevers and vomiting.She was found to have increased intracranial pressure of unknown origin.She had multiple cerebrospinal fluid leaks in the following months and required several hospitalizations.She has had multiple ct scans and mrls of her head and entire spine through the course of her neurosurgical workup.The patient then began to develop new symptoms, including nodules forming in the subcutaneous tissue of her skin throughout her body and inflammation of multiple lymph nodes.She was seen by immunology and was found to have significantly decreased immunity across all lines of cells.She has since begun the re-immunization process.Additionally, immunology found that she has a significant reaction to nickel.Several of the lymph nodes were removed but were mistakenly disposed of rather than sent for pathology.Through all of these other problems, the patient's back pain has persisted and progressed.She consulted with a radiologist who reviewed all of her imaging.It was noted that the anchors used for her sacrocolpopexy were not placed into the bone and appear to have moved slightly, possibly as a result of her multiple mrls.The movement in combination with her allergy to the metal implanted in her disc was the likely cause of the majority of her symptoms through the last 18 months.It was the physician's opinion that removal of these anchors was medically necessary.Until they were placed, the patient was healthy.She was medically optimized for surgery at this time, even one as intensive as would be required to remove the anchors.She should require no care outside of the standard surgical or post-operative care.On (b)(6) 2019, the patient was seen and examined for medication consultation.The patient had her vp shunt placed.The tubing in the patient's abdomen was too long and was getting entangled in her mesh so she was going to have another surgery to trim it.The patient reported pain that was somewhat positional but changes as the tip of the shunt moves.The patient has pain in her pelvic floor and various places in her abdomen intermittently.The patient also reported pain in her surgical site.The patient also reported that eventually, the reservoir would scar down and be stable but until then it will shift around some.It caused a severe stabbing pain in her head when that happens.She has as of yet been unable to wean her pain medication but she did report that her back felt better and her eyes no longer hurt.The pressure in her head was improved and her only head pain was post surgical.She has been having pain in her right ear for days.The day prior, her ear had bloody drainage.No known fever, but the patient just did not feel well.The patient was not really having urinary symptoms.She felt like her vyvanse was not as effective as it once was.She had tried multiple different doses.She felt like her short-term memory was improving since the surgery.The patient felt overly fatigued all the time.Even with the vyvanse she was struggling to get things done.In the physician's assessment, the patient's baseline pain was improved but her surgical pain was still severe.Once she was able to have the follow up surgery her abdominal and pelvic pain should improve.The physician will continue current medications and monitor.After the next surgery they will work on weaning.On (b)(6) 2020, the patient was seen and examined for refills on sertraline and oxycodone for her chronic pain.She was requesting a change in the dose and frequency of the pain medication.The patient requested an increase with the dose from 10mg to 15mg.The patient also requested to take the 15mg four times a day rather than the 10mg five times daily.She tolerated it well without problems.She said the sertraline worked well for her and she was tolerating it well without problems.She was requesting an mri of her thoracic spine due to pain as the result of a surgery to remove the bladder mesh.She complained of pain in her thoracic spine when standing for more than five minutes, as well as pain with bending.She took oxycodone, ibuprofen and gabapentin, and uses a heating pad but still has pain.Biofreeze helped a little.She has open sores on the back of her neck that have become painful.The patient was washing this with soap and water.In the physician's assessment, the patient's pain medications were decreased in frequency to four per day while increasing the dose from 10mg to 15 mg.Instructions and precautions given.The patient was also instructed to call with problems.The physician will order mri of thoracic spine to evaluate.The patient was also started with oral antibiotics.Patient has mupirocin at home to put on open areas on posterior scalp and neck.Encouraged hand washing and not picking at skin to reduce chances of scarring and further infection.The patient was also instructed to call the physician's office with questions, concerns or worsening of symptoms.On (b)(6) 2021, the patient was seen and examined for a follow up visit and to discuss her medications.She also needed a referral to a surgeon in (b)(6) for pelvic floor injury.The patient was here for medication recheck.She has been on pain medication for chronic back, head and pelvic pain.She felt like her current regimen was working ok for her.She tolerated it without problems.The patient would like to continue current dose for now.She needed a referral to a physician in (b)(6) that has a pelvic floor nerve injury center.The patient needed an order that says she had mesh placed that caused problems.The patient was concerned about pudendal nerve entrapment as a result of the mesh.She was interested in increasing her adderall.She was having a lot of fatigue during the day.She was having a hard time keeping up with the kids that were home all day.She has been tolerating it without problems.She was also concerned because she was gaining weight.The patient has been gaining steadily for some time.She had to be very sedentary for a while after her pelvic surgery and the complications.She also felt like she was very intolerant to heat.She sweats all the time even when it was not a particularly hot in the room.In the physician's assessment, the patient needed an increased adderall dose during her visit.Instructions and precautions were given.The patient was instructed to call with problems.As for the patient's weight gain, she was ordered for labs so she can go to the draw station fasting one morning.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to september 22, 2017, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: k.Anthony shambour, md mercy hospital 4300 w memorial rd oklahoma city, ok 73120 integris 4833 integris parkway suite 200, edmond ok 73034 angela k morgan, md 1404 east 9th street edmond ok, 73034 phone no: +1(405)330-8819 dr.Dena e.O'leary integris 4801 integris parkway edmond ok 73034 dr.Dionysios k.Veronikis 621 s.New ballas rd., suite 2022 b, saint louis, mo 63141-8265 phone no: +1(314)251-6753 fax no: +1(314)251-4492 block h6: patient codes e2006, e1309, e2330, e1002, e1405, e2101, e1715, e2340, e020201, e020202, and e2326, capture the reportable events of extrusion (sling palpable but minimal tenderness/sling palpable as a rope-like band/foreign material in vagina), urinary retention (difficulty emptying her bladder), pain (bladder, pelvic pain, perineal pain, chronic back pain, unspecified back pain laterality), pain, abdominal, dyspareunia, adhesions (bowel adhesions, ureteral adhesions), scar tissue (cicatrix) for urethral scarring, dehiscence (vaginal cuff), anxiety, depression, and inflammation respectively.Impact codes f19, f1903, f1905, f23, f22, and f2303 capture the reportable events of surgical intervention (exploratory laparotomy, removal of davinci, lysis of bowel adhesions, ureterolysis, urethral lysis), device explantation (partial removal of mid-urethral sling, removal of obtryx sling, vaginal paravaginal removal of mesh from obturators and adductor muscles), device revision or replacement (laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy), unexpected medical intervention (blood transfusion), unexpected diagnostic intervention (cystoscopy), and medication required (0.25% marcaine with epinephrine was used for hydrodissection) respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh 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.Block h11: block g2 has been corrected.Blocks b5, b7, h6 and h10 have been updated based on the additional information received on september 29.2022.Block h6: patient code 2101 was utilized to captures the reportable event of adhesions.Patient code e2320 was utilized to captures the reportable event of hypertension.Patient code e013403 was utilized to captures the reportable event of paresthesia.Patient code e1301 was utilized to captures the reportable event of dysuria.Patient code e232401 was utilized to captures the reportable event of fecal incontinence.Patient code e1906 was utilized to captures the reportable event of unspecified infection.Patient code e1310 was utilized to captures the event of urinary tract infection.Patient code e2314 was utilized to captures the reportable event of fistula.Patient code e1621 was utilized to captures the reportable event of muscle weakness.Patient code e1311 was utilized to captures the reportable event of unspecified kidney or urinary problem.Patient code e0123 was utilized to captures the reportable event of nerve damage.Patient code e0506 was utilized to captures the reportable event of hemorrhage.Patient code e0127 was utilized to captures the reportable event of numbness.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on november 3, 2022 and november 22, 2022.Block h6: patient code e1710 captures the reportable event of "nodules forming in the subcutaneous tissue of her skin throughout her body." patient code e0106 captures the reportable event of "multiple cerebrospinal fluid leaks in the following months." patient code e2402 captures the reportable event of "found to have increased intracranial pressure of unknown origin." impact code f08 captures the reportable event of "required several hospitalizations." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Manufacturer Narrative

Patient codes have been updated based on the additional information received on august 2, 2023.Date of event: date of event was approximated to (b)(6), implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) integris 4833 integris parkway suite 200, edmond ok 73034 dr.(b)(6), dr.(b)(6), dr.(b)(6), imdrf patient codes e2006, e1309, e2330, e1002, e1405, e2101, e1715, e2340, e020201, e020202, e2326, e2320, e013403, e1301, e232401, e1906, e1310, e2314, e1621, e1311, e0123, e0506, e0127, e1710, e0106, e2402, e1705, e1304 and e1401 capture the reportable events of extrusion (sling palpable but minimal tenderness/sling palpable as a rope-like band/foreign material in vagina), urinary retention (difficulty emptying her bladder), pain (bladder, pelvic pain, perineal pain, chronic back pain, unspecified back pain laterality), pain, abdominal, dyspareunia, adhesions (bowel adhesions, ureteral adhesions), scar tissue (cicatrix) for urethral scarring, dehiscence (vaginal cuff), anxiety, depression, inflammation, hypertension, paresthesia, paresthesia, fecal incontinence, unspecified infection, urinary tract infection, fistula, muscle weakness, unspecified kidney or urinary problem, nerve damage, hemorrhage, numbness, nodules forming in the subcutaneous tissue of her skin throughout her body, multiple cerebrospinal fluid leaks in the following months, multiple cerebrospinal fluid leaks in the following months, found to have increased intracranial pressure of unknown origin, vaginal burning, urgency, and vaginal discharge.Imdrf impact codes f19, f1903, f1905, f23, f22, f2303 and f08 capture the reportable events of surgical intervention (exploratory laparotomy, removal of davinci, lysis of bowel adhesions, ureterolysis, urethral lysis), device explantation (partial removal of mid-urethral sling, removal of obtryx sling, vaginal paravaginal removal of mesh from obturators and adductor muscles), device revision or replacement (laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy), unexpected medical intervention (blood transfusion), unexpected diagnostic intervention (cystoscopy), and medication required (0.25% marcaine with epinephrine was used for hydrodissection), and required several hospitalizations.

Event Description

Note: this report pertains to one of two devices used on the same patient.It was reported to boston scientific corporation that an upsylon mesh was implanted during a laparoscopic sacrocolpopexy, posterior repair, perineorrhaphy, and cystoscopy procedure on (b)(6) 2017, for the treatment of vaginal vault prolapse, rectocele, and perineocele.The operative report notes a finding of "dense scarring of the bladder to the anterior vagina".There were no complications.Medical and surgical history included implantation with an obtryx ii system- halo on june 2, 2017, during a total laparoscopic hysterectomy, bilateral salpingectomy, trans-obturator bladder neck suspension, cystoscopy, anterior repair procedure performed for the treatment of stress incontinence, symptomatic pelvic relaxation, cystocele, and menorrhagia; the apical portion of her prolapse was not repaired and she had not had a posterior repair either.The patient returned to the or later that day for postoperative bleeding and also had postoperative complications noted as voiding dysfunction/urinary retention.After the (b)(6) 2017, procedure, the patient continued to have a bulge that she could see and feel, difficulty with bowel movements (bm) because of the bulge, and she could not splint to have a bm or to void.On (b)(6) 2017, exam revealed prolapse was stage 2 apical/posterior, the obtryx sling was palpable but minimal tenderness, and the vaginal cuff was tender to palpation.Some sui was noted on exam.Additional medical and surgical history included discomfort and a lot of pressure from her pelvic relaxation that causes problems with sexual activity and dyspareunia; acute lymphoblastic leukemia (in remission since 2001); cesarean section x 3; former smoker; allergy to non-steroidal anti-inflammatory medications (nsaids); exploratory laparotomy in 2016; intracranial hypertension (ich).On (b)(6) 2017, after the upsylon and other procedures, the patient was agitated postoperatively about how long it was taking to administer additional pain medication.She left the hospital against medical advice on (b)(6) 2017, after pulling out her own iv as she felt she was not getting enough for pain control.On (b)(6) 2018, the patient stated that she had bladder/pelvic pain that had worsened over the last few days.She felt that there was a pulling sensation and pain that can be nearly debilitating at times, especially later in the day.She also had some obstructive defecatory symptoms, and she thought that she may have a recurrence of her cystocele.Physical exam revealed mild tachycardia, no prolapse, palpable sling as a rope-like band, and extreme tenderness to palpation especially at the insertion points to the obturators.The medical records note the patient's pelvic pain and defecatory dysfunction were suspected to be at least partially related to her sling and muscle spasm.It was highly unlikely she will be able to tolerate pfpt, so the plan was for sling removal.The patient understood she may need pt and/or another sling for sui since her sui is likely to return after removal.She also understands that she is not guaranteed to have resolution of her pain with the sling removal.A prescription was vaginal valium was sent to the pharmacy for suspected muscle spasm as cause of defecatory dysfunction and pain.On (b)(6) 2018, she had undergone a partial removal of mid-urethral sling, and cystoscopy procedure for the treatment of pelvic pain, and dyspareunia suspected due to mid-urethral sling.Moreover, the sling was palpable, consistent with the preoperative exam and a 0.25% marcaine with epinephrine was used for hydrodissection, and a vertical midline incision was made along the periurethral vaginal epithelium where her prior incision was.The vaginal epithelium was then carefully dissected free until the level of the sling was reached.The mesh was clearly visible and was carefully dissected it free of the underlying fibromuscular tissue and transected it at the level of insertion into the obturators bilaterally.On (b)(6) 2018, the patient was status post sling removal.She needed a refill on her vaginal valium since this is what is working best for her pain.Reportedly, she did not feel like she was emptying her bladder completely.Her postvoid residual (pvr) was normal.On (b)(6) 2018, she had a follow-up visit discussing about laparoscopic colpopexy mesh (upsylon) removal.She had been experiencing complications related to her ich and was worried that the mesh and the capture clips are the cause of her neurologic problems.She does understand that based on previous conversations, it is highly unlikely that they are actually related.However, she says she wants the mesh out, because she has tried everything else and there have been no answers.She feels like it is something she has to do to at least get the answer of whether the mesh as part of the problem.She also reported chronic back pain, (unspecified back location, unspecified back pain laterality).She was offered a referral to another provider.On (b)(6) 2019, the patient had an exploratory laparotomy with removal of 0-6 sacral tacks.The operative report for this procedure was not provided to bsc.On (b)(6) 2019, the patient presented for mesh problems.She reported pelvic, abdominal and back pain managed with oxycontin 15 mg 5x/day.She was also experiencing constipation, dyschezia, splinting, dysuria, urinary retention, frequency, and dyspareunia after orgasm.Exam revealed pain at the obturator internus muscles (left and right), pain at cords (left and right), and pain at apex.Surgical removal of the obtryx and uphold mesh, paravaginal dissection, urethral lysis and anterior colporrhaphy, and abdominal enterocele repair was offered.On (b)(6) 2019, she underwent removal of davinci placed upsylon abdominal mesh, lysis of bowel adhesions, ureterolysis, removal of obtryx sling, urethral lysis, vaginal paravaginal, removal of mesh from obturators and adductor muscles procedure for the treatment of pain with coitus, vaginal pain, pelvic pain, foreign material in vagina and in the pelvic muscle, bowel adhesions, ureterai adhesions, and urethral scarring the bowl and omentum were found to be adherent to the vaginal apex at the site of the mesh and cul-de-sac.The loops of small bowel, large bowel and omentum were adherent to the vaginal apex, cul-de-sac as well as to the ovaries.All the adhesions were taken down sharply.The right ureter was disoriented and putted to the midline next to the mesh.This was a very difficult surgery due to scarring from previous surgery and the dissection required to remove the mesh from the groins that was very deeply implanted.The lateral end of the mesh was identified and freed from the adductor muscles with sharp dissection and from the soft tissue muscular attachments to the pubic ramus.This was very difficult due to the significant muscle mass as well the very deep mesh placement.The entire remaining obtryx sling was removed.Of note, one page of the operative report was illegible.The pathology results on both the excised upsylon and obtryx mesh included mild chronic inflammation.On (b)(6) 2020, the patient had a post-operative visit, and stated that she does note vaginal pressure and bulging, especially with bowel movements, and was splinting.She reported some urinary leakage with laughing, cough, and sneeze, and also felt in pain at the end of urination.Exam revealed the tissues were healed.The assessment was that the patient was "well after surgery" and she was to follow up as needed.***additional information received on (b)(6) 2022.On (b)(6) 2018, the patient was seen and examined following an mri on her left spine done the previous week.The patient brought the report with her.The mri was ordered by her obgyn due to back pain post bladder mesh removal.The mri results revealed a bilateral mass effect on one of her nerves and a disc problem at s1-l5 cs.The patient was previously diagnosed with osteophytes at t11-12.The patient reported that her lower back was always tender.She had episodes that her movement was severely limited.Her gyn told her that the area where her problem was had some clips.The patient had a lot of labs done.She has a very low ch50 and igm.She was told that all of her immunoglobulins were on the edge of being out of range.No specific diagnosis was provided.She was advised to be revaccinated against pneumococcus but not until she did some more research.The patient was referred to oncology for evaluation but did not get any real advice from her oncologist.The patient also visited the clinic for a transition of care from another physician and a summary of care was not provided.The patient reported that the zoloft medication was working well for her.The patient was also on diamox to keep her fluid levels low.Her physicians cut her dose down by half and within five days, she was right back to where she was before the medication.She had to go back to the whole dose.The patient also reported that her medication was cut down by 1/3 about five days ago and this resulted in feeling bad and she was swollen.On (b)(6) 2018, the patient was seen and examined with findings of immune deficiency disorder, bipolar affective disorder, current episode depressed, current episode severity unspecified, chronic bilateral low back pain with bilateral sciatica, hib, meningococcal conj, and overweight.The patient had a prior laparoscopic hysterectomy and a prior laparoscopic sacrocolpopexy with tack devices used at the sacral promontory for placement of mesh.On (b)(6) 2019, the patient experienced a foreign body reaction to the metal tacks including pelvic pain and abdominal pain.She desired removal of these tacks.X-ray preoperatively showed 6 tacks at the level of the anterior longitudinal ligament at the location of l5-s1 disk.Neurosurgery was consulted who was available if needed injury intraoperatively.The patient did not desire laparoscopic removal and desired an open abdominal approach.Risks were reviewed including the possibility that removal of these tacks may not completely resolve the patient's symptoms.Informed consent was obtained.The patient was taken to the operating room.She underwent a laparotomy, exploratory, with removal of foreign body and cystoscopy (removal of 6 sacral tacks).There were no patient complications following the procedure and the patient was then taken to the recovery room for comparison.Findings include six sacral tacks at the promontory, cystourethroscopy revealed a normal bladder and urethral mucosa.No foreign body or suture in the bladder, no evidence of injury to the bladder.There was brisk bilateral ureteral orifice efflux seen.Right ovary appeared normal, left ovary not visualized, sigmoid adherent in that area.No other significant adhesive disease.Mesh was visualized in the peritoneal reflection from the uterosacral ligament on the right side to the sacral promontory.Vaginal exam under anesthesia showed good support of all 3 compartments, normal urethral meatus and no evidence of foreign body in the vagina.Hemostasis postoperatively.The foley catheter removed and patient taken to the recovery room after tap block for admission prompt extirpation and the sacral tacks x6 were sent to pathology.On (b)(6) 2019 the patient was seen and examined for complains of chronic pain and for therapeutic purposes for chronic in person prescription renewal.Upon examination, the patient has bladder prolapse.The patient was seen for a medication check and refill on oxycodone.The patient had a procedure done last thursday on her right ovary.They ended up not being able to do it laparoscopic and had to make an incision and the physician removed multiple adhesions.The patient was admitted for one night.The patient's head pressure increased and the physician increased her medication.The patient went to an ophthalmologist and the physician increased the patient's intercranial hypertension to stage two.As the patient was seen for medication recheck, the patient has been feeling like her oxycodone dose was working pretty well for her at this time.The patient made it for a whole month without running out and she tolerated the medications without problems.The patient also had a cyst removed from her left ovary the previous week.The patient was informed that the mesh in her abdomen was hardened and was advised to seek gyne consult.The patient had a lot of complications after surgery and her intracranial pressure (icp) increased again.She was on high dose diamox from neuro-ophtho for two weeks to try to get her icp back down.She was having significant headache.In the physician's assessment, the patient has extremely complicated history in 2017 a few months after her 3rd svd she had complete pelvic prolapse which was repaired with placement of bladder mesh.The patient had recurrence a few months later and underwent a sacrocopopexy with anchor placement.She also complained of chronic back pain as well as increased intracranial pressure (icp) and cerebrospinal fluid (csf) leakage starting at that time.She has been told by neuro-ophtho and neurosurgeon that if she cannot get the mesh removed, she will require a vp shunt to control her icp.She managed to find a doctor in texas to remove the anchors which has improved a lot of her symptoms, namely the back pain but she continued to have problems with her icp.Multiple surgeons have told her that the mesh was encased in thick scar tissue and was essentially hardened in place.She will have to consult gyn/oncologist to see if this was a case they may be willing to attempt even though she did not have a pelvic cancer.Current plans included a longer duration of class ii opioid treatment (or other opioid treatment).The following were assessed or performed: 1.Current and past medical history was reviewed in context of this evaluation, including the experience of the patient with non-opioid medication and nonpharmacological pain-management approaches and substance abuse history.2.The patient's compliance with the "patient provider agreement and informed consent chronic pain" was reviewed and determined to be amicable.3.The course of treatment has been reviewed and any new information about the etiology of the pain documented as applicable.The progress of the patient toward treatment objectives has been reviewed and deemed to be stable and/or progressing as expected and planned.4.Reasonable efforts were made to either stop the use of the opioid, decrease the dosage or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the development of physical or physiological dependence.5.The patient has been assessed to determine whether the patient was experiencing problems associated with physical and psychological dependence and has not been found to experience these problems.6.The longer durations prescription was chosen to be the lowest effective dose of opioid drug for patient's condition.The opioid therapy was felt to be warranted and continued as prescribed and planned.Risk of opioid medications were discussed with the patient, including but not limited to: 1.The risks of addiction and overdose associated with opioid drugs and the dangers of taking opioid drugs with alcohol, benzodiazepines and other central nervous system depressants.2.The reason(s) the prescription was necessary was discussed as well as alternative treatments that may be available.3.Risk associated with the use of the drugs being prescribed, specifically that opioids are highly addictive, even when taken as prescribed, that there is a risk of developing a physical or psychological dependence on the controlled dangerous substance.4.The patient or the parent or guardian of the patient has verbalized understanding of these risks.The oklahoma prescription monitoring program (pmp) was accessed and reviewed and found to be appropriate in regard to the current pomp information checked pain management plan.On (b)(6) 2019, the patient was seen and examined for a medication consultation.The patient was seen for medicine check and refills.During the visit it was noted that the patient has a productive cough and sinus congestion which was reportedly experienced by the patient for five days now.The patient stated that she has been coughing up with green phlegm.The patient had a previous abdominal end of the shunt clipped since last visit.The patient's pain has improved.The patient has a consult next month to evaluate for mesh removal and bladder repair.In the physician's assessment, once the patient has the mesh removed her pelvic pain will improve.She reported that any sort of movements like coughing, having a bowel movement, or rapid movement, the patient has a searing, tearing type pain from her diaphragm to her vagina.She reported that she has barely taken the adderall at all because it made her heart race.She as only taking vyvanse, tolerating it without problems.The patient was advised to continue to take pain medication until she saw the surgeon.Once she has the mesh removed she will begin to wean the pain medication.Precautions given, and was also advised to call if problems arise.On (b)(6) 2019, the patient was seen and examined for a medication consultation.The patient was seen for medicine check and refills.The patient also reported that she felt very sore and achy all over like she had a fever the day prior.The patient saw her shunt physician the day prior and she was not sure if the shunt was working properly.She has been having burning pain between her shoulder blades and was experiencing headaches again.She was advised that the reservoir was working fine but there could be a problem with the tubing in her abdomen.She was to see her eye doctor to make sure her eyes were ok.The patient has an appointment for consult for the removal of her mesh in about two weeks.She reported that her pelvic pain has been severe at times bringing her to her knees.The patient was advised to continue the current regimen and follow up with specialists as scheduled.Precautions were discussed and was advised to call for any problems.On (b)(6) 2019, the patient was seen and examined for a wound check after having surgery to remove her bladder mesh which was performed on (b)(6) 2019.The patient was able to return home and she was concerned that an area of one of the incisions was coming apart.The patient did not report any drainage or tenderness.Overall, the patient was feeling good.The patient was scheduled for a follow up with her surgeon at the end of january.The physician applied two steri strips to the small area of dehiscence on the right lateral aspect of the mons pubis.The patient tolerated well and precautions were given.On (b)(6) 2019, the patient was seen and examined for a medication consult.The patient was seen for medicine check and refills.The patient had a previous abdominal surgery to remove her mesh and what remained of her sling.She reported that she has not had a headache since she had the mesh removed.The patient has been experiencing a lot of pain in her sacrum where the scar tissue was pulled off.The patient was also experiencing abdominal pain post operation so she was not able to really gauge how that pain was.The patient was also having some urinary retention.She has been taking muscle relaxers for pelvic muscle spasms.The patient verbalized that she wanted to work on weaning but was not sure she was ready yet.In the physician's assessment, the patient may work on weaning pain medication as able.Her medications were refilled at the current dose as she was only a week post operation.Instructions and precautions were advised.On (b)(6) 2020, the patient was seen and examined for a follow up visit.The patient was also seen to get a refill on her xanax for 1 day.She was also scheduled to follow up with her mesh removal surgeon and she would like to take xanax prior to the flight as she reported that she was afraid of flying.The patient was taking half the amount of painkillers currently than prior to her surgery.The patient was feeling much better after having the mesh removed.The patient also had flu since her last visit and reportedly mentioned that everyone in her household had it.The patient was almost due to refill her pain medications.She has been working on weaning from the pain medications and would like for fewer doses in a day.The patient was hoping to be off of the pain medications before she has her next surgery so that pain control will be easier after the surgery.In the physician's assessment, the patient's dose will be reduced today.Instructions and precautions were provided.As reported by the patient's attorney, the patient experienced the following symptoms: pelvic, back, vaginal, neuromuscular and joint paint.The patient also reported recurrence of prolapse, rectocele and cystocele which led to bowel problems, urinary problems and chronic infections.The patient also reported to experience bleeding and dyspareunia.The patient had vaginal spasms and fistulae causing bowel, vagina, bladder and neuromuscular problems.Moreover, the patient experienced extreme fatigue.She also reported numbness and pins and needles feelings in her vulva, groin, and lower abdomen; fecal incontinence with flatus; muscle weakness after little activity.As reported by the patient's attorney, the patient suffered from the following: adhesions, bleeding or clotting disorders, cancer, chronic constipation, connective tissue disorder, cystocele, dyspareunia, enterocele, fistulas, hypertension, neuromuscular disease or disorder, obesity, pelvic trauma, rectocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, and wound healing problems.On (b)(6) 2021, the patient was seen and evaluated with pelvic floor tension myalgia and pudendal neuralgia.During evaluation, the patient was able to tolerate with minimal positioning changes.Upon examination, the patient reported tenderness as well as a numb sensation along bilateral medial sacrotuberous ligaments as well as towards medial ischial tuberosities.She reported numbness across lower abdomen to just above the pubic symphysis.The patient experienced pain into bilateral groin and into r>l labia.The patient reported pain with palpation at vaginal entrance as well as into bilateral anterior pelvic floor (l>r), bilateral obturator/iliococcygeus/posterior pubococcygeus towards bilateral ischial spines.She was able to complete some space and release with cues for inhalation however overall significant noted.She demonstrated severe pelvic floor tension bilaterally as well as sensory changes as noted above.The patient demonstrated pain consistent with pelvic floor tension myalgia as well as pudendal neuralgia.The patient would likely benefit from suppositories and botox to help with pelvic floor tension as well as follow-up pfpt as well as pudendal nerve block.All of the above discussed with the patient and physician who will develop further treatment planning with the patient.***additional information received on (b)(6) 2022 and (b)(6) 2022* on (b)(6) 2018, the patient was seen and examined for lower back pain, and pain from implanted hardware.The patient reported that since she had the mesh sling placed approximately one year ago, she developed intracerebral brain hemorrhage (ich), pseudo tumor cerebri, and spinal stenosis.The patient would like to have this coil tracks removed as soon as possible.She reported that she was scheduled for nickel allergy testing the following week.The patient reported that nickel was in the coils and that was likely why she was having so many problems.The patient had multiple stays in the hospital.On (b)(6) 2018, a correspondence was sent by the primary care physician of the patient for a referral.The patient has a history of leukemia at the age of 7 which was treated with chemotherapy.She has been otherwise healthy for the last 15 years.Approximately 18 months ago, after the birth of her third child, the patient had uterine prolapse that was repaired with partial hysterectomy and mesh placement for bladder suspension.Shortly after that repair, she had reoccurrence of pelvic prolapse with rectocele.That was repaired with sacrocolpopexy using nickel anchors in (b)(6) 2017.Within a month of that surgery, the patient started feeling ill with systemic symptoms.She had severe, debilitating headaches and back pain with intermittent fevers and vomiting.She was found to have increased intracranial pressure of unknown origin.She had multiple cerebrospinal fluid leaks in the following months and required several hospitalizations.She has had multiple ct scans and mrls of her head and entire spine through the course of her neurosurgical workup.The patient then began to develop new symptoms, including nodules forming in the subcutaneous tissue of her skin throughout her body and inflammation of multiple lymph nodes.She was seen by immunology and was found to have significantly decreased immunity across all lines of cells.She has since begun the re-immunization process.Additionally, immunology found that she has a significant reaction to nickel.Several of the lymph nodes were removed but were mistakenly disposed of rather than sent for pathology.Through all of these other problems, the patient's back pain has persisted and progressed.She consulted with a radiologist who reviewed all of her imaging.It was noted that the anchors used for her sacrocolpopexy were not placed into the bone and appear to have moved slightly, possibly as a result of her multiple mrls.The movement in combination with her allergy to the metal implanted in her disc was the likely cause of the majority of her symptoms through the last 18 months.It was the physician's opinion that removal of these anchors was medically necessary.Until they were placed, the patient was healthy.She was medically optimized for surgery at this time, even one as intensive as would be required to remove the anchors.She should require no care outside of the standard surgical or post-operative care.On (b)(6) 2019, the patient was seen and examined for medication consultation.The patient had her vp shunt placed.The tubing in the patient's abdomen was too long and was getting entangled in her mesh so she was going to have another surgery to trim it.The patient reported pain that was somewhat positional but changes as the tip of the shunt moves.The patient has pain in her pelvic floor and various places in her abdomen intermittently.The patient also reported pain in her surgical site.The patient also reported that eventually, the reservoir would scar down and be stable but until then it will shift around some.It caused a severe stabbing pain in her head when that happens.She has as of yet been unable to wean her pain medication but she did report that her back felt better and her eyes no longer hurt.The pressure in her head was improved and her only head pain was post surgical.She has been having pain in her right ear for days.The day prior, her ear had bloody drainage.No known fever, but the patient just did not feel well.The patient was not really having urinary symptoms.She felt like her vyvanse was not as effective as it once was.She had tried multiple different doses.She felt like her short-term memory was improving since the surgery.The patient felt overly fatigued all the time.Even with the vyvanse she was struggling to get things done.In the physician's assessment, the patient's baseline pain was improved but her surgical pain was still severe.Once she was able to have the follow up surgery her abdominal and pelvic pain should improve.The physician will continue current medications and monitor.After the next surgery they will work on weaning.On (b)(6) 2020, the patient was seen and examined for refills on sertraline and oxycodone for her chronic pain.She was requesting a change in the dose and frequency of the pain medication.The patient requested an increase with the dose from 10mg to 15mg.The patient also requested to take the 15mg four times a day rather than the 10mg five times daily.She tolerated it well without problems.She said the sertraline worked well for her and she was tolerating it well without problems.She was requesting an mri of her thoracic spine due to pain as the result of a surgery to remove the bladder mesh.She complained of pain in her thoracic spine when standing for more than five minutes, as well as pain with bending.She took oxycodone, ibuprofen and gabapentin, and uses a heating pad but still has pain.Biofreeze helped a little.She has open sores on the back of her neck that have become painful.The patient was washing this with soap and water.In the physician's assessment, the patient's pain medications were decreased in frequency to four per day while increasing the dose from 10mg to 15 mg.Instructions and precautions given.The patient was also instructed to call with problems.The physician will order mri of thoracic spine to evaluate.The patient was also started with oral antibiotics.Patient has mupirocin at home to put on open areas on posterior scalp and neck.Encouraged hand washing and not picking at skin to reduce chances of scarring and further infection.The patient was also instructed to call the physician's office with questions, concerns or worsening of symptoms.On july 13, 2021, the patient was seen and examined for a follow up visit and to discuss her medications.She also needed a referral to a surgeon in arizona for pelvic floor injury.The patient was here for medication recheck.She has been on pain medication for chronic back, head and pelvic pain.She felt like her current regimen was working ok for her.She tolerated it without problems.The patient would like to continue current dose for now.She needed a referral to a physician in arizona that has a pelvic floor nerve injury center.The patient needed an order that says she had mesh placed that caused problems.The patient was concerned about pudendal nerve entrapment as a result of the mesh.She was interested in increasing her adderall.She was having a lot of fatigue during the day.She was having a hard time keeping up with the kids that were home all day.She has been tolerating it without problems.She was also concerned because she was gaining weight.The patient has been gaining steadily for some time.She had to be very sedentary for a while after her pelvic surgery and the complications.She also felt like she was very intolerant to heat.She sweats all the time even when it was not a particularly hot in the room.In the physician's assessment, the patient needed an increased adderall dose during her visit.Instructions and precautions were given.The patient was instructed to call with problems.As for the patient's weight gain, she was ordered for labs so she can go to the draw station fasting one morning.Instructions and precautions were given.The patient was instructed to call with problems.For the patient's chronic pain, it was agreed to will continue current treatment plan for now and refer to the specialist.Instructions and precautions were given.The patient was instructed to call with problems.---additional information received on (b)(6) 2023--- during an office visit on (b)(6) 2018, review of systems included vaginal discharge, vaginal itching and burning, nocturia, and urgency.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name

UPSYLON

Type of Device

MESH, SURGICAL, SYNTHETIC

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

PROXY BIOMEDICAL LIMITED

coilleach spiddal

galway

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

13618297

MDR Text Key

286233457

Report Number

3005099803-2022-00801

Device Sequence Number

Product Code

OTO

UDI-Device Identifier

08714729839217

UDI-Public

08714729839217

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K122794

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

02/28/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

05/31/2020

Device Model Number

M0068318200

Device Catalogue Number

831-820

Device Lot Number

C003453

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

08/02/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

05/16/2017

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Hospitalization; Required Intervention;

Patient Age

26 YR

Patient Sex

Female

Patient Weight

96 KG

Patient Ethnicity

Non Hispanic

Patient Race

White

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Links on this page:

Links on this page: