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); Pain (1994); Abnormal Vaginal Discharge (2123); Depression (2361); Prolapse (2475); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)

Event Date 10/15/2012

Event Type  Injury  

Manufacturer Narrative

There was no information available regarding the event date.Therefore, it was approximated to (b)(6), 2012, the implant date has been selected.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Other attorneys: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a solyx single incision sling (sis) system was implanted during a procedure performed on (b)(6), 2012.As per patient's attorney, the patient experienced the following injuries as a result of the implantation of the prior designated pelvic mesh product: erosion of vaginal mesh into vagina, vaginal bleeding, pelvic pain, back pain, failed sling, rectocele, overactive bladder, urge urinary incontinence, urinary urgency, and more to be determined in the course of discovery.Furthermore, the patient mentioned that she had the following damages as a result of the implantation of the prior designated pelvic mesh product(s): economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Blocks a2 (date of birth), b5, d4 (lot number and expiration date), and e1 (initial reporter's email), h4 (device manufacture date) were updated based on the additional information received on february 27, 2023.Block b3: there was no information available regarding the event date.Therefore, it was approximated to october 15, 2012, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).

Event Description

It was reported to boston scientific corporation that a solyx single incision sling (sis) system was implanted during a robotically assisted laparoscopic sacrocolpopexy with supracervical hysterectomy, bilateral salpingo-oophorectomy, suburethral sling, lysis of dense omental adhesions, enterolysis, and cystoscopy procedures performed on october 15, 2012.The patient's diagnoses were vaginal vault prolapse, which was unresponsive to conservative therapy, and dense abdominal adhesions.The operative findings were uterine prolapse, a small uterus, and normal ovaries.Dense omental adhesions extend from the umbilicus, across the mid abdomen, and up to the upper abdomen.Multiple loops of small bowel are densely adherent to the anterior abdominal wall between the umbilicus and the symphysis, with 8 loops of bowel adherent to the abdominal wall.Adhesions of the sigmoid colon to the left adnexa.As per patient's attorney, the patient experienced the following injuries as a result of the implantation of the prior designated pelvic mesh product: erosion of vaginal mesh into vagina, vaginal bleeding, pelvic pain, back pain, failed sling, rectocele, overactive bladder, urge urinary incontinence, urinary urgency, and more to be determined in the course of discovery.Furthermore, the patient mentioned that she had the following damages as a result of the implantation of the prior designated pelvic mesh product(s): economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, depression, physical impairment, permanent physical injury, and more.

Manufacturer Narrative

Block h2: additional information blocks a6 (race), b2 (outcomes attrib to adv event), b7 (other relevant history) and h6 (patient and impact codes) has been updated based on the additional information received on august 15, 2023.Block b3: there was no information available regarding the event date.Therefore, it was approximated to october 15, 2012, the implant date has been selected.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explanting surgeon is: dr.(b)(6).Other attorneys: (b)(6).Block h6: imdrf patient codes: e2006 captures the reportable event of extrusion (erosion of vaginal mesh into vagina).E0506 captures the reportable event of hemorrhage/bleeding (vaginal bleeding).E2330 captures the reportable event of pain (pelvic pain, back pain).E020202 captures the reportable event of depression.E1401 captures the reportable event of discharges.E2015 captures the reportable event of atrophy.Imdrf impact code: f1905 captures the reportable event of revision and removal of eroded mesh.F2203 captures the reportable event of patient had to undergo cystoscopy due to mesh complications.

Event Description

It was reported to boston scientific corporation that a solyx single incision sling (sis) system was implanted during a robotically assisted laparoscopic sacrocolpopexy with supracervical hysterectomy, bilateral salpingo-oophorectomy, suburethral sling, lysis of dense omental adhesions, enterolysis, and cystoscopy procedures performed on october 15, 2012.The patient's diagnoses were vaginal vault prolapse, which was unresponsive to conservative therapy, and dense abdominal adhesions.The operative findings were uterine prolapse, a small uterus, and normal ovaries.Dense omental adhesions extend from the umbilicus, across the mid-abdomen, and up to the upper abdomen.Multiple loops of small bowel are densely adherent to the anterior abdominal wall between the umbilicus and the symphysis, with 8 loops of bowel adherent to the abdominal wall.Adhesions of the sigmoid colon to the left adnexa.As per the patient's attorney, the patient experienced the following injuries as a result of the implantation of the prior designated pelvic mesh product: erosion of vaginal mesh into the vagina, vaginal bleeding, pelvic pain, back pain, failed sling, rectocele, overactive bladder, urge urinary incontinence, urinary urgency, and more to be determined in the course of discovery.Furthermore, the patient mentioned that she had the following damages as a result of the implantation of the prior designated pelvic mesh product(s): economic damages such as medical bills, out-of-pocket expenses, and lost wages, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, depression, physical impairment, permanent physical injury, and more.***additional information was received on august 15, 2023*** on september 14, 2021, the patient reported that she has been bleeding since her surgery in october 2013.She also had overactive bladder symptoms and urge urinary incontinence.No stress urinary incontinence.She empties well.She is not now sexually active due to her bleeding, but she would be otherwise.Physical examination: the vagina was atrophic, had some discharge, and exposed a significant quantity of mesh at the post fornix.On october 19, 2021, the patient underwent a cystoscopy due to urgency, overactive bladder and urge incontinence.The following are the findings from the procedure: urethra findings: negative for lesions, negative for erythema, and negative for diverticulum.Bladder findings: negative for mucosal lesions, negative for erythema, negative for diverticulum, negative for trigone metaplasia, and negative for cystocele.There was no significant urgency with filling.There was no significant bladder pain with filling.Vaginoscopy with obvious mesh noted.Ureteral orifices: peristalsis noted bilaterally.Moreover, the patient tolerated the procedure and was stable upon completion.On october 27, 2021, the patient underwent a revision and removal of eroded vaginal mesh, rectocele repair, and cystoscopy with hydrodistension for the treatment of erosion of the vaginal mesh into the vagina, rectocele, bladder pain, overactive bladder, urge urinary incontinence, and urinary urgency.During the procedure, a large piece of mesh eroded in the upper posterior vaginal wall with some attached gore-tex sutures.The remaining rectocele after excision was repaired without difficulty.Cystoscopy with hydrodistension revealed a bladder capacity of 500 ml and multiple trabeculations throughout the bladder, but no other abnormalities or patent ureteral orifices at completion.Furthermore, there were no complications throughout the procedure, and the patient was woken and sent to the post-anesthesia care unit in stable condition.On february 10, 2022, the patient visited a clinic for her third month's check-up on diabetes mellitus, chronic back pain, and arthritis.She has had surgery to remove the mesh that was causing vaginal bleeding.The bleeding has stopped, and she states that her chronic pain and discomfort have improved drastically.

• 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: 15524779
• MDR Text Key: 300995097
• Report Number: 3005099803-2022-05520
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00000646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White