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

Model Number M0068502110

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Erosion (1750); Fatigue (1849); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Tract Infection (2120); Burning Sensation (2146); Hot Flashes/Flushes (2153); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Numbness (2415); Dysuria (2684); Fibrosis (3167); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/05/2020

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a total vaginal hysterectomy, colpopexy, cystoscopy, and tension-free vaginal tape sling procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence, abnormal uterine bleeding, and fibroid uterus.On an unspecified date, the patient developed vaginal pain, bladder pain, abdominal pain, and pain with coitus.On (b)(6) 2021, the patient underwent advantage sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, removal of abdominal mesh, and repair of cystotomy.The postoperative diagnoses also included urinary stricture.This was a very difficult surgery due to the right sling arm being in the bladder wall and the left sling arm in the obturator muscle.The previous sling was identified deep in the urethra on the right and freed from the scar tissue.The mesh was incised in the midline and dissected as far as lateral as possible.The dissection was carried to the contralateral side.The paravaginal space was opened, and the mesh was felt with the scissors but was embedded in the bladder wall on the right and during dissection the bladder was entered.Sutures approximated the vaginal defect with a watertight repair.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.The sling on the left was freed from the underlying sub-urethral tissues, and bladder wall and dissected from the obturator muscle into the retropubic space as far as possible.The paravaginal space was opened bilaterally for exposure, and the sling mesh was held with a clamp.Then, attention was directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh dissected free exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh, progressive dissection completely freed the left sling arm.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The fascia was closed with running sutures of #0 dexon.Subcutaneous tissues were reapproximated with interrupted sutures of #2-0 dexon.A 19f drain was placed in the subcutaneous layer.Skin edges were reapproximated with staples.Cystoscopy revealed that the bladder defect was high, and urology was consulted.The vaginal repair was opened and repaired by urology.A second layer was placed over the primary vaginal portion of the bladder repair with interrupted sutures of #2-0 dexon.The anterior vaginal wall was closed with running suture of #2-0 dexon.The abdominal incision was opened and the retropubic space was entered.Once the right bladder defect was repaired by urology, the fascia was closed with running sutures of #0 dexon.Subcutaneous tissues were reapproximated with interrupted sutures of #2-0 dexon.A 19f drain was placed in the subcutaneous layer.Skin edges were reapproximated with staples.Hemostasis was excellent.The vagina was lightly packed with lodoform gauze packing.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021, the date when the patient had an advantage sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, removal of abdominal mesh, and repair of cystotomy, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: (b)(6).The revision surgeon is: (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.

Manufacturer Narrative

Additional information: blocks a5 (ethnicity), a6 (race), b3 (date of event), b5, e1 (healthcare facility address and phone number), and h6 (patient and impact codes) were updated based on the additional information received on june 27, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2020, the date when the patient first started to experience the symptoms, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).The revision surgeon is: (b)(6).Other physicians and healthcare facilities: (b)(6).Block h6: imdrf patient codes: e2006 captures the reportable event of erosion (mesh have partially grown into the bladder wall on the right side), e2330 captures the reportable event of pain (vaginal pain, bladder pain, low back pain, chronic pelvic pain, left lower extremity pain, complex regional pain syndrome type ii, soreness), e0123 captures the reportable event of nerve damage (pudendal neuralgia, obturator neuralgia), e1002 captures the reportable event of abdominal pain, e1405 captures the reportable event of dyspareunia (pain with coitus), e1310 captures the reportable event of urinary tract infection, e1307 captures the reportable event of urethral stenosis/ stricture (urinary stricture), e1715 captures the reportable event of scar tissue (granulation tissue at the vaginal vault), e2114 captures the reportable event of perforation (right sling arm being in the bladder wall), e0402 captures the reportable event of hypersensitivity/allergic reaction (systemic rejection of sling, allergic reaction), and e2326 captures the reportable event of inflammation (chronic inflammation).Imdrf impact codes: f1903 has been used to capture device explantation (advantage sling removal, removal of abdominal mesh), f1901 has been used to capture additional surgery (urethral lysis, anterior colporrhaphy, paravaginal dissection, repair of cystotomy), and f2303 has been used to capture the medication required (one suppository vaginally or rectally before bedtime and one during the day for pain).Block h11: correction: block e1 has been corrected.

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a total vaginal hysterectomy, colpopexy, cystoscopy, and tension-free vaginal tape sling procedure performed on (b)(6) 2019, for the treatment of stress urinary incontinence, abnormal uterine bleeding, and fibroid uterus.On (b)(6) 2020, the patient had dysuria and frequency.Dysuria was mild and was first noted three weeks ago.The patient stated she needed to void approximately 4-6 times daily.The patient also had left lower extremity (lle) pain.She noted that nothing tends to alleviate her symptoms.She reported that intercourse tends to aggravate her symptoms.She also reported bleeding after sex.She was extremely anxious that her sling was the cause of all her problems, so much so that she complained of flushing and hives, somewhat relieved by benadryl.Additionally, during the review of the genitourinary system, the patient mentioned urgency, frequency, dysuria, and post-coital bleeding.The patient had a urinary tract infection (uti) and granulation tissue in the vaginal vault.On (b)(6) 2020, the patient had a follow-up regarding her granulation tissue and still had problems.She stated that the problem was mild and had been present for two weeks.The patient stated that there were no aggravating or alleviating factors.Also, she had no additional genitourinary problems.The patient also complained of bladder discomfort.She described severe bladder discomfort for the past two weeks.During the review of systems, the patient admitted that she experienced fatigue and dysuria.The patient was convinced that her symptoms today were caused by her body rejecting the sling.At least 20 minutes were spent with the patient, reassuring her that the symptoms were not because of the sling.The patient showed several signs of overwhelming anxiety during the visit.Attempts were made to offer reassurance, resulting in minimal relief.The physician mentioned that the itchy skin and hives that the patient experienced could be related to this anxiety.A follow-up one week later for reevaluation.If the uti and granulation tissue resolve completely and the patient still complains of lle, discomfort, and systemic rejection of the sling, a referral to urology and neurology was planned, and the patient voiced understanding.The patient presented with mesh problems and had a burning and pulling sensation in her region, with the left side being worse than the right.She reported that it was worse sitting.She had soreness at her pubic bone, with the left side worse than the right.The pain radiated down her left leg, and there was pulling around her buttocks and hips.On an unspecified date, the patient developed vaginal pain, bladder pain, abdominal pain, and pain with coitus.On (b)(6) 2021, the patient underwent advantage sling removal, urethral lysis, anterior colporrhaphy, paravaginal dissection, abdominal mesh removal, and cystostomy repair.The postoperative diagnoses also included urinary strictures, chronic pelvic pain, implanted mesh complications, and mesh identified within the bladder wall (intramural).This was a complicated surgery due to the right sling arm being in the bladder wall and the left sling arm in the obturator muscle.The previous sling was identified deep in the urethra on the right and freed from the scar tissue.The mesh was incised in the midline and dissected as laterally as possible.The dissection was carried to the contralateral side.The paravaginal space was opened, and the mesh was felt with the scissors but was embedded in the bladder wall on the right, and during dissection, the bladder was entered.Sutures approximate the vaginal defect with a watertight repair.A urethral lysis was performed with sharp dissection to free the urethra and scar tissue further.The sling on the left was released from the underlying sub-urethral tissues and bladder wall and dissected from the obturator muscle into the retropubic space as far as possible.The paravaginal area was exposed bilaterally, and the sling mesh was held with a clamp.Then, attention was directed to the abdominal component.A transverse skin incision was made, sharply taken down to the fascia level.The mesh was identified in the fascia, and the fascia was incised around the mesh dissected free, exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the mesh, and progressive dissection completely freed the left sling arm.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The fascia was closed with running sutures of #0 dexon.Subcutaneous tissues were reapproximated with interrupted sutures of #2-0 dexon.A 19f drain was placed in the subcutaneous layer.Skin edges were reapproximated with staples.Cystoscopy revealed that the bladder defect was high, and urology was consulted.The vaginal repair was opened and repaired by urology.A second layer was placed over the primary vaginal portion of the bladder repair with interrupted sutures of #2-0 dexon.The anterior vaginal wall was closed with a running suture of #2-0 dexon.The abdominal incision was opened, and the retropubic space was entered.Once the correct bladder defect was repaired by urology, the fascia was closed with running sutures of #0 dexon.Subcutaneous tissues were reapproximated with interrupted sutures of #2-0 dexon.A 19f drain was placed in the subcutaneous layer.Skin edges were reapproximated with staples.Hemostasis was excellent.The vagina was lightly packed with iodoform gauze packing.The patient tolerated the procedure well and was transferred to the recovery room in perfect condition.According to pathology results, the patient had soft tissue and foreign mesh removed.It showed foreign mesh surrounding fibrosis, chronic inflammation, and foreign body giant cells.Microscopic inspection showed dense fibrous tissue containing chronic inflammation and multinucleated giant cells.Pathology revealed two pieces of mesh measuring 11 cm and 11.7 cm.During the surgery, the patient sustained a small injury to the bladder because the mesh seemed to have partially grown into the bladder wall on the right side.This injury was repaired without any consequences.The patient also showed me photographs of the sling very close to the surface of the vaginal epithelium.It is unclear to the physician if there was true erosion or mesh, which was very close to the surface of the epithelium and visible.The patient's pain had improved since the removal, especially in her buttocks.She still complains of significant numbness in her left suprapubic area, numbness in her medial thigh, and burning pain on the medial thigh and inside the vagina.On (b)(6) 2021, the patient had a follow-up visit, and it was observed that the sling was embedded in the bladder.The patient just wanted to get established to ensure that if she has any problems in the future, she'll have a doctor.The patient was also concerned about prolapse.Additionally, she had disorders of urogenital prostheses or implants and female stress incontinence.On (b)(6) 2022, the patient had another visit with the problems of complex regional pain syndrome type ii, urgent desire to urinate, obturator neuralgia, other specified complications due to other genitourinary prosthetic materials, sequela, pudendal neuralgia disorder, and spastic pelvic floor syndrome.There is tenderness in the left paraspinal muscles.This left lower abdominal tenderness with a positive garnett's sign is a significant spasm of the left pelvic floor muscles, especially the left obturator internus muscle.Specifically, there is significant tenderness in the approximate area of the exit of the obturator muscle through the obturator canal.Significant tenderness at the tip of the left ischial spine is consistent with the left pudendal nerve.There was a slight hypersensitivity to touch in the clitoris and no hypersensitivity in the left or right labia majora or minora.Furthermore, the patient had one suppository vaginally or rectally before bedtime and one during the day for pain.She states that underwear significantly irritates her perineal area, and she cannot wear any underwear that has elastic in it.She can also not wear tight jeans.The patient also had low back pain.She is sexually active.The patient has significant soreness and pain with intercourse on the left side of her vagina, which starts with penetration and lasts about 2 hours after intercourse.This sensation started after mesh placement and has improved slightly since mesh removal, but intercourse is still significantly painful.The patient experienced urinary frequency and nocturia four times.The physician had a long discussion with the patient.Her symptoms were consistent with an injury caused by retropubic mesh leading to left obturator neuralgia, possible left pudendal neuralgia, and all the consequences of those two.According to the likely mechanism, the mesh placed in the pelvic floor muscles caused the muscles to spasm.The patient developed hives after the mesh placement, which most likely means she was allergic to polypropylene, possibly because her body was trying to reject the mesh.Spasming muscles caused compression of both the pudendal and the obturator nerves.However, her symptoms were more obturator than pudendal.The patient already had complete mesh removal.However, she continued to be in significant pain.On physical exam, there was a severe left-sided spasm of the pelvic floor muscles with severe tenderness around the pudendal and obturator nerves.The patient must undergo pelvic floor physical therapy and use vaginal suppositories to help relax the muscles.She will need a botox injection into the pelvic floor muscles if this is unsuccessful.If there was no improvement with botox, the patient would be a great candidate for robotic-assisted laparoscopic compression of the left obturator nerve.If she continues to be in pain, she may need her left pudendal nerve decompressed.The patient will almost certainly need ongoing pelvic floor physical therapy, most likely for life, and botox injections to pelvic floor muscles every three months, possibly for life.This was discussed in detail with the patient.She understands and would like to start with suppositories and physical therapy.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14672687
• MDR Text Key: 294543200
• Report Number: 3005099803-2022-03124
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

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: 03/04/2022
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0023439046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/12/2022
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White