MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Scarring (2061); Urinary Tract Infection (2120); Injury (2348); Dysuria (2684); No Code Available (3191); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2016 (implant date) as no event date was reported.Although the reported lot number was 00003076, that lot number is invalid and information for lot ml00003076 was provided as it is the only match corresponding to the partial lot number provided.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) hospital, (b)(6) by dr.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

As reported by the patient's attorney, an solyx sling was implanted on (b)(6) 2016.According to the complainant, the patient experienced the following injuries: mesh erosion, protrusion, recurrence and worsening of stress urinary incontinence, pelvic and vaginal scarring, pain, chronic infections, dyspareunia, additional correction or revision surgery, lost wage, medical expenses, out of pocket expenses, emotional distress, suffering and loss of consortium.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

As reported by the patient's attorney, an solyx sling was implanted on (b)(6) 2016.According to the complainant, the patient experienced the following injuries: mesh erosion, protrusion, recurrence and worsening of stress urinary incontinence, pelvic and vaginal scarring, pain, chronic infections, dyspareunia, additional correction or revision surgery, lost wage, medical expenses, out of pocket expenses, emotional distress, suffering and loss of consortium.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

Correction to the field b2 (outcomes attrib to adv event).Block b3: date of event: date of event was approximated to (b)(6) 2016 (implant date) as no event date was reported.Block d4, h4: although the reported lot number was 00003076, that lot number is invalid and information for lot ml00003076 was provided as it is the only match corresponding to the partial lot number provided.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6) by dr.(b)(6).Block h2 (additional information): e1 (initial reporter's information and initial reporter facility information) updated.Block h6: patient codes 1750, 3191, 1994, 2348 and 1930 capture the reportable event of erosion, revision surgery, pain, unspecified injury and infection.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Additional information to the fields b5 (describe event or problem), b7 (describe event or problem), and h6 (patient codes, impact codes).Block b3: date of event: date of event was approximated to (b)(6) 2016 (implant date) as no event date was reported.Block d4, h4: although the reported lot number was 00003076, that lot number is invalid and information for lot ml00003076 was provided as it is the only match corresponding to the partial lot number provided.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at lake (b)(6) hospital, (b)(6).(b)(6) dr.Block h2 (additional information): e1 (initial reporter's information and initial reporter facility information) updated.Block h6: patient codes 1750, 3191, 1994, 2348 and 1930 capture the reportable event of erosion, revision surgery, pain, unspecified injury and infection.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a solyx sling was implanted into the patient on (b)(6) 2016.As reported by the patient's attorney, the patient experienced the following injuries: mesh erosion, protrusion, recurrence and worsening of stress urinary incontinence, pelvic and vaginal scarring, pain, chronic infections, dyspareunia, additional correction or revision surgery, lost wage, medical expenses, out of pocket expenses, emotional distress, suffering and loss of consortium.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.***additional information received on march 23, 2022*** during an office visit on (b)(6) 2018, the patient visited the clinic to have a check of her tvt (tension-free vaginal tape) which was performed in (b)(6) 2016.The patient was on cipro for a urinary tract infection.The patient experienced low back pain, dysuria, and urgency that was relieved by cipro.In addition, the patient felt a poking sensation in the vagina for several months.Upon vaginal inspection, strings of mesh were noted eroding at the midline.In the physician's assessment, the patient needed a revision of sling.During an office visit on (b)(6) 2019, the patient visited the clinic for follow-up after revision of exposed vaginal sling on (b)(6) 2018.Reportedly, the patient was feeling better and the tugging sensation has been resolved.Stress urinary incontinence has increased and the patient experienced leak when sneezing.The patient was expected to return in two months and to discuss a repeat tvt versus macroplastique.On (b)(6) 2021, the patient visited the gyn clinic for complaints of aub (abnormal uterine bleeding) and pelvic pain.The patient reported a history of abnormal uterine bleeding with heavy cycles to the point where the patient became anemic.The patient was started on ocps (oral contraceptive pills) in the past and reported improvement in her cycles.However, she did have some occasional cycle with heavy bleeding.She did report some cramping associated with her cycles, but nothing that prevented her from doing daily activities.She did report worsening dyspareunia and to the point where she has had to stop having intercourse.She did have a history of a bladder suspension with mesh and reported to have the mesh cut in places in the past.She was interested in having a hysterectomy and she did not desire to continue taking the birth control pills.She has no other complaints to date.The patient was counseled on possible causes of her pelvic pain and dyspareunia.The patient was currently on ocps for abnormal uterine bleeding and the pills appear to be working.The patient did not desire to continue taking them and opted for surgery at this time.Patient reported her pap smear was up-to-date and she had a vaginal ultrasound done last year.Gonorrhea and chlamydia tests were performed.Pelvic ultrasound was ordered.The patient was counseled that her dyspareunia may not be completely resolved with hysterectomy, as it could be likely caused by mesh placement during bladder sling.On (b)(6) 2021, the patient presented to gyn clinic for follow up.The patient was previously seen for aub and dysmenorrhea.Pelvic ultrasound was performed.The patient is currently on ocps for aub.She reported her cycles somewhat improved, but she still has some heavy cycles and cramping.She was interested in hysterectomy for treatment.She also reported dyspareunia and she did have a h/o bladder suspension with mesh.The mesh was cut later after erosion into the vagina.She has no other complaints to date.The patient denied f/c (fever/chills), n/v (nausea/vomiting), cp (chest pain), sob (shortness of breath), vb (vaginal bleeding), vd (vaginal discharge), dysuria, le pain.On (b)(6) 2021, the patient was presented to gyn clinic for pre op visit.Patient was scheduled for total laparoscopic hysterectomy secondary to abnormal uterine bleeding and pelvic pain.Patient with history of heavy menstrual cycles in the past with anemia.Patient had been started on ocps; however, reports of having heavy bleeding still although she did have some improvement with her cycles.She did report continued increased cramping with her cycles that prevented her from doing daily activities.She did have a history of dyspareunia following her bladder suspension with mesh.She desired a definitive surgical management and opted hysterectomy for her abnormal bleeding and dysmenorrhea.She has no other complaints to date.The patient consented for both blood and procedure.The patient was thoroughly counseled on the risks of tlh (total laparoscopic hysterectomy) including but not limited to risk of damage to the surrounding organs and tissues, injury to vessels requiring acute blood loss and possible transfusion, injury to the bladder or ureters requiring prolonged or intermittent catherization, loss of fertility, possible conversion to open procedure, injury to the bowel resulting in permanent or reversible colostomy and postoperative complications including pain, infection, bleeding, possible wound breakdown or fistula formation.The patient accepted all these risks and persisted in her desire for surgery at this time.Patient was counseled that her dyspareunia may not be completely resolved with hysterectomy, as it could likely be caused by mesh placement during bladder sling, the patient voiced understanding and the patient met with pre op nurse.Pre op labs were ordered.Rtc 1 week following surgery.On (b)(6) 2021, the patient mentioned in an email correspondence that regarding her surgery from 2016, her bladder mesh caused her excruciating pain for 2 years, dyspareunia and mesh extrusion.She could not have sex or wipe herself without crying.On (b)(6) 2021, the patient presented to gyn clinic for follow up.The patient was doing well to date.Reported no pain or vb.She was ambulating, voiding and tolerating po diet.She was still concerned about some of her previous surgery with mesh.She has no other complaints to date.Ros negative unless mentioned above.On bimanual exam, the physician was able to palpate mesh laterally in the anterior vagina and found it does not protrude through vagina.The cuff was intact and non-tender.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8965442
• MDR Text Key: 156615377
• Report Number: 3005099803-2019-04371
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00003076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 04/15/2020; 03/23/2022
• Supplement Dates FDA Received: 05/12/2020; 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female