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

Model Number M0068507000

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

Patient Problems Erosion (1750); Fever (1858); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Discomfort (2330); Injury (2348); Numbness (2415); Paresthesia (4421); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, the implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a total laparoscopic hysterectomy + bilateral salpingo-oophorectomy + diagnostic cystoscopy + midurethral sling procedure performed on (b)(6) 2018 for the treatment of fibroid uterus and stress urinary incontinence.On (b)(6), 2018, the patient had first office visit after the implant due to mesh exposure.Granulation tissue, a defect in the mucosa where the midurethral sling was lying down and some dryness and atrophy in the vaginal area were also noticed.The patient was given high dose of topical estrogen applied twice a day and follow up in a month.Follow up visit on (b)(6), 2018, patient showed significant improvement on dryness and vaginal burning.Vaginal epithelium was found to be improved in the atrophy.Had been applying the estrogen as instructed and had no complaints.However, there was an increase in granulation tissue.Due to lack of symptoms and to the small amount of exposure ranging between 0.5 to 1 cm, the patient had to complete 12 weeks of topical estrogen.If not resolved by 2 months, the different options between in office removal versus plication of tissue on top of the sling versus complete removal.On (b)(6) 2018, office note indicated that the patient could feel the sling during intercourse but denied any significant pain or any other concerns.However, the exposure was loose and there was a loop of the sling coming out.Referral to gynecology to have an excision of the mesh was discussed due to failed conservative treatment.During preoperative evaluation, the patient reported more pelvic pain, pain with intercourse and husband had a cheesegrater feeling, some vaginal discharge but no vaginal bleeding.Had trouble sitting for periods of time and symptoms became worse.On (b)(6) 2019, transvaginal removal of mesh with cystoscopy was performed.The mesh appeared not in the correct anatomical position.Mesh was dissected all the way down to the pubic bone on the right side.The mesh on the left side was then mobilized and in a similar fashion, by way of just a tunnel, the mesh was dissected and cut.Cystoscopy showed no evidence of bladder or urethral injury, all areas were irrigated and no complications.In rehab evaluation post mesh removal, primary complaint is perineal pain that radiates also into the right groin region and right thigh which began after placement of the sling.Patient reports the left anchor and some of the mesh still remains.She currently rates her pain at a 7/10 while sitting and gradually increases the longer she sits and a 4/10 pain during intercourse and reports it increases to about 6/10.On (b)(6), 2020, patient had another office visit and described symptoms as aching, soreness, spasms, numbness, burning, and tingling.She is still having pain after the surgical intervention.On (b)(6), 2020, it appeared the patient had right ilioinguinal nerve block and had both lidocaine and betamethasone.Pain reduced by 90 percent for approximately four months.Returned to office in august for a repeat right ilioinguinal nerve block but did not provide relief.Patient was advised to completing a right ilioinguinal nerve ablation.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6), 2018, the date the patient had first office visit post implant due to symptoms.Block e1: this complaint was reported by the patient's attorney.The implanted surgeon is: dr.(b)(6).Block h6: patient codes e2006, e2006, e1715, e1405, e2311 and e0127 capture the reportable events of erosion, pain, granulation tissue, dyspareunia, discomfort and numbness impact code f1903 captures the reportable event of mesh repair or excision.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

Correction: blocks b5, h6: impact codes.Additional information: b5.Block b3 date of event: date of event was approximated to (b)(6), 2018, the date the patient had first office visit post implant due to symptoms.Block e1: this complaint was reported by the patient's attorney.The implanted surgeon is: dr.(b)(6) (b)(6).Excision surgery surgeon is: (b)(6).Block h6: patient codes e2006, e2006, e1715, e1405, e2311 and e0127 capture the reportable events of erosion, pain, granulation tissue, dyspareunia, discomfort and numbness impact code f1903 captures the reportable event of mesh repair or excision.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.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a total laparoscopic hysterectomy + bilateral salpingo-oophorectomy + diagnostic cystoscopy + midurethral sling procedure performed on (b)(6), 2018 for the treatment of fibroid uterus and stress urinary incontinence.On (b)(6), 2018, the patient had first office visit after the implant due to mesh exposure.Granulation tissue, a defect in the mucosa where the midurethral sling was lying down and some dryness and atrophy in the vaginal area were also noticed.The patient was given high dose of topical estrogen applied twice a day and follow up in a month.Follow up visit on (b)(6) 2018, patient showed significant improvement on dryness and vaginal burning.Vaginal epithelium was found to be improved in the atrophy.Had been applying the estrogen as instructed and had no complaints.However, there was an increase in granulation tissue.Due to the lack of symptoms and to the small amount of exposure ranging between 0.5 to 1 cm, the patient had to complete 12 weeks of topical estrogen.If not resolved by 2 months, the different options between in office removal versus plication of tissue on top of the sling versus complete removal.On (b)(6), 2018, office note indicated that the patient could feel the sling during intercourse but denied any significant pain or any other concerns.However, the exposure was loose and there was a loop of the sling coming out.Referral to gynecology to have an excision of the mesh was discussed due to failed conservative treatment.During preoperative evaluation, the patient reported more pelvic pain, pain with intercourse and husband had a cheesegrater feeling, some vaginal discharge but no vaginal bleeding.Had trouble sitting for periods of time and symptoms became worse.On (b)(6) 2019, transvaginal removal of mesh with cystoscopy was performed.The mesh appeared not in the correct anatomical position.Mesh was dissected all the way down to the pubic bone on the right side.The mesh on the left side was then mobilized and in a similar fashion, by way of just a tunnel, the mesh was dissected and cut.Cystoscopy showed no evidence of bladder or urethral injury, all areas were irrigated and no complications.In rehab evaluation post mesh removal, primary complaint is perineal pain that radiates also into the right groin region and right thigh which began after placement of the sling.Patient reports the left anchor and some of the mesh still remains.She currently rates her pain at a 7/10 while sitting and gradually increases the longer she sits and a 4/10 pain during intercourse and reports it increases to about 6/10.On (b)(6), 2020, patient had another office visit and described symptoms as aching, soreness, spasms, numbness, burning, and tingling.She is still having pain after the surgical intervention.On (b)(6), 2020, it appeared the patient had right ilioinguinal nerve block and had both lidocaine and betamethasone.Pain reduced by 90 percent for approximately four months.Returned to office in august for a repeat right ilioinguinal nerve block but did not provide relief.Patient was advised to completing a right ilioinguinal nerve ablation.On (b)(6), 2021, the patient had an occupational therapy appointment due to a treatment diagnosis of segmental and somatic dysfunction of the pelvic region and dyspareunia.She described her symptoms as burning or pulsating in the right vaginal region and a pulling sensation at the area of her right ovary.On (b)(6), 2021 the patient was seen for a preoperative history and physical exam.The patient was scheduled for dorsal root ganglion stimulator implant on (b)(6), 2021 for her chronic pain in her groin, back, and pelvis.She has seen ot to help with the pain with minimal relief.Her pain is a 5/10; due to this she wished to proceed with surgical management.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during a total laparoscopic hysterectomy + bilateral salpingo-oophorectomy + diagnostic cystoscopy + midurethral sling procedure performed on (b)(6) 2018 for the treatment of fibroid uterus and stress urinary incontinence.On (b)(6) 2018, the patient had first office visit after the implant due to mesh exposure.Granulation tissue, a defect in the mucosa where the midurethral sling was lying down and some dryness and atrophy in the vaginal area were also noticed.The patient was given high dose of topical estrogen applied twice a day and follow up in a month.Follow up visit on (b)(6) 2018, patient showed significant improvement on dryness and vaginal burning.Vaginal epithelium was found to be improved in the atrophy.Had been applying the estrogen as instructed and had no complaints.However, there was an increase in granulation tissue.Due to the lack of symptoms and to the small amount of exposure ranging between 0.5 to 1 cm, the patient had to complete 12 weeks of topical estrogen.If not resolved by 2 months, the different options between in office removal versus plication of tissue on top of the sling versus complete removal.On (b)(6) 2018, office note indicated that the patient could feel the sling during intercourse but denied any significant pain or any other concerns.However, the exposure was loose and there was a loop of the sling coming out.Referral to gynecology to have an excision of the mesh was discussed due to failed conservative treatment.During preoperative evaluation, the patient reported more pelvic pain, pain with intercourse and husband had a cheesegrater feeling, some vaginal discharge but no vaginal bleeding.Had trouble sitting for periods of time and symptoms became worse.On (b)(6) 2019, transvaginal removal of mesh with cystoscopy was performed.The mesh appeared not in the correct anatomical position.Mesh was dissected all the way down to the pubic bone on the right side.The mesh on the left side was then mobilized and in a similar fashion, by way of just a tunnel, the mesh was dissected and cut.Cystoscopy showed no evidence of bladder or urethral injury, all areas were irrigated and no complications.In rehab evaluation post mesh removal, primary complaint is perineal pain that radiates also into the right groin region and right thigh which began after placement of the sling.Patient reports the left anchor and some of the mesh still remains.She currently rates her pain at a 7/10 while sitting and gradually increases the longer she sits and a 4/10 pain during intercourse and reports it increases to about 6/10.On (b)(6) 2020, patient had another office visit and described symptoms as aching, soreness, spasms, numbness, burning, and tingling.She is still having pain after the surgical intervention.On (b)(6) 2020, it appeared the patient had right ilioinguinal nerve block and had both lidocaine and betamethasone.Pain reduced by 90 percent for approximately four months.Returned to office in august for a repeat right ilioinguinal nerve block but did not provide relief.Patient was advised to completing a right ilioinguinal nerve ablation.On (b)(6) 2021 the patient was seen for a preoperative history and physical exam.The patient was scheduled for dorsal root ganglion stimulator implant on october 4, 2021 for her chronic pain in her groin, back, and pelvis.She has seen ot to help with the pain with minimal relief.Her pain is a 5/10; due to this she wished to proceed with surgical management.***additional information received on march 23, 2022*** on (b)(6) 2021, the patient had an occupational therapy appointment due to a treatment diagnosis of segmental and somatic dysfunction of the pelvic region and dyspareunia.The patient reported to have felt pain primarily on the right labial and pelvic floor with a pain score of 6/10.In addition, the patient also described to have felt a "pulling" sensation at the area of the right ovary and noted that the symptoms are interrelated and these have been present since the hysterectomy and bladder suspension surgery wherein a mesh was used; the mesh has since been removed.

Manufacturer Narrative

Correction: b5 h6 impact code f1905 captures the reportable event of mesh repair or excision.Additional information: b5, h6 block b3 date of event: date of event was approximated to (b)(6) 2018, the date the patient had first office visit post implant due to symptoms.Block e1: this complaint was reported by the patient's attorney.The implanted surgeon is: (b)(6) dr.(b)(6).(b)(6).Excision surgery surgeon is: (b)(6) dr.(b)(6).Block h6: patient codes e2006, e2006, e1715, e1405, e2311, e0127, and e0123 capture the reportable events of erosion, pain, granulation tissue, dyspareunia, discomfort, numbness, and nerve damage.Impact codes f1905 and f1903 captures the reportable events of mesh repair or excision and device explantation.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.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10560603
• MDR Text Key: 207739942
• Report Number: 3005099803-2020-03885
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0021830540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 86 KG