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

Model Number M0068507001

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Abnormal Vaginal Discharge (2123); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Insufficient Information (4580)

Event Date 07/20/2010

Event Type  Injury  

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure, solyx sis system.Please refer to mfr report 3005099803-2022-05609 for the associated device.It was reported to boston scientific corporation that a solyx sis system and uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6), 2010.According to reports, the patient have suffered the following injuries as a result of the implantation : abdominal pain and tenderness, abnormal discharge, infections, cramping, vaginal bleeding, cystocele, rectocele.Moreover, the patient claims to have suffered the following damages as a result of the implantation: economic damages such as medical bills and out-of-pocket expenses, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment and permanent physical injury.

Manufacturer Narrative

Date of event was approximated to (b)(6), 2010, implant procedure 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 complainant indicated that the device is not available for return; therefore, a device 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 h2: additional information blocks a2 (date of birth), b5 (narrative), d6b (explant date) and h6 (patient and impact codes) have been updated based on the additional information received on march 20 and 21, 2023.Correction: block b2 (outcomes attrib to adv event) have been updated based on the on the additional information received on march 20 and 21, 2023.Block b3 date of event: date of event was approximated to july 20, 2010, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).The explanting surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1906 - infections e1002 - pain e2006 - mesh exposure e1401 - abnormal vaginal discharge e2401 - physical impairment and permanent physical injury e020201 - anxiety e020202 - depression.The following imdrf impact codes capture the reportable events of: f12 - patient had sought for a legal recourse for injuries related to the device.F1903 - complete mesh removal.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure, solyx sis system.Please refer to mfr report 3005099803-2022-05609 for the associated device.It was reported to boston scientific corporation that a solyx sis system and uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6), 2010.According to reports, the patient has suffered the following injuries as a result of the implantation: abdominal pain and tenderness, abnormal discharge, infections, cramping, vaginal bleeding, cystocele, rectocele.Moreover, the patient claims to have suffered the following damages as a result of the implantation: economic damages such as medical bills and out-of-pocket expenses, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment and permanent physical injury.Additional information received on march 20 to 21, 2023.On (b)(6), 2010, the following procedures were carried out for the treatment of vaginal vault prolapse, post-hysterectomy, cystocele, rectocele, and urinary incontinence: anterior repair with an uphold mesh, sacral spinous ligament fixation with an uphold mesh, posterior repair, and solyx mid-urethral sling placement with cystoscopy procedures.The cystocele and a grade 2 rectocele are among the major vaginal vault prolapses that were found during surgery.A cystoscope was used both after the surgery and during the solyx placement, and it showed that the bladder anatomy was normal and there was no evidence of a foreign body.Strong ureteral jets on either side are seen.Over the course of the treatments, no complications were found.The patient has mesh exposure and prolapse after the procedure.On (b)(6), 2021, the patient had transvaginal mesh removal along with posterior and anterior repairs.A 2x4cm mesh exposure was made in the apex and anterior wall during surgery, and the entire exposed mesh was removed with no remnants left behind.Small anterior and posterior repairs were used to treat a mild rectocele and cystocele.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure, solyx sis system.Please refer to mfr report 3005099803-2022-05609 for the associated device.It was reported to boston scientific corporation that a solyx sis system and uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6) 2010.According to reports, the patient has suffered the following injuries as a result of the implantation: abdominal pain and tenderness, abnormal discharge, infections, cramping, vaginal bleeding, cystocele, rectocele.Moreover, the patient claims to have suffered the following damages as a result of the implantation: economic damages such as medical bills and out-of-pocket expenses, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment and permanent physical injury.On july 20, 2010, the following procedures were carried out for the treatment of vaginal vault prolapse, post-hysterectomy, cystocele, rectocele, and urinary incontinence: anterior repair with an uphold mesh, sacral spinous ligament fixation with an uphold mesh, posterior repair, and solyx mid-urethral sling placement with cystoscopy procedures.The cystocele and a grade 2 rectocele are among the major vaginal vault prolapses that were found during surgery.A cystoscope was used both after the surgery and during the solyx placement, and it showed that the bladder anatomy was normal and there was no evidence of a foreign body.Strong ureteral jets on either side are seen.Over the course of the treatments, no complications were found.The patient has mesh exposure and prolapse after the procedure.On august 9, 2021, the patient had transvaginal mesh removal along with posterior and anterior repairs.A 2x4cm mesh exposure was made in the apex and anterior wall during surgery, and the entire exposed mesh was removed with no remnants left behind.Small anterior and posterior repairs were used to treat a mild rectocele and cystocele.The patient went to the clinic on (b)(6) 2021, with her primary complaints of vaginal mesh exposure and postmenstrual bleeding.The patient stated that she is in her fourth month of postmenstrual bleeding, was evaluated by another physician, and had 2x4cm mesh exposure confirmed.Furthermore, the patient had stopped engaging in sexual intercourse as a result of this problem.The patient recalls no issues following her surgery in 2010, but she has recently noticed a bulge and pressure in her vagina.

Manufacturer Narrative

Block h2: additional information blocks b5 (event description) and b7 (other relevant history) has been updated based on the additional information received on june 21, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2010, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1906 - infections, e1002 - pain, e2006 - mesh exposure, e1401 - abnormal vaginal discharge, e2401 - physical impairment and permanent physical injury, e020201 - anxiety, e020202 - depression.The following imdrf impact codes capture the reportable events of: f12 - has been used in the light of this patient had filed a legal claim for the injuries related to the device.F1903 - complete mesh removal.

Manufacturer Narrative

Block h2: additional information blocks b5 (event description) and h6 (patient codes) has been updated based on the additional information received on august 15, 2023.Block b3 date of event: date of event was approximated to (b)(6) 2010, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).The explanting surgeon is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e1906 - infections, e1002 - pain, e2006 - mesh exposure, e1401 - abnormal vaginal discharge, e2401 - physical impairment and permanent physical injury, e020201 - anxiety, e020202 - depression, e231501 - purulent discharge.The following imdrf impact codes capture the reportable events of: f12 - has been used in the light of this patient had filed a legal claim for the injuries related to the device.F1903 - complete mesh removal.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure, solyx sis system.Please refer to mfr report 3005099803-2022-05609 for the associated device.It was reported to boston scientific corporation that a solyx sis system and uphold vaginal support system device was implanted into the patient during a procedure performed on (b)(6) 2010.According to reports, the patient has suffered the following injuries as a result of the implantation: abdominal pain and tenderness, abnormal discharge, infections, cramping, vaginal bleeding, cystocele, rectocele.Moreover, the patient claims to have suffered the following damages as a result of the implantation: economic damages such as medical bills and out-of-pocket expenses, as well as non-economic damages including but not limited to pain and suffering, loss of enjoyment of life, anxiety, depression, physical impairment and permanent physical injury.On (b)(6) 2010, the following procedures were carried out for the treatment of vaginal vault prolapse, post-hysterectomy, cystocele, rectocele, and urinary incontinence: anterior repair with an uphold mesh, sacral spinous ligament fixation with an uphold mesh, posterior repair, and solyx mid-urethral sling placement with cystoscopy procedures.The cystocele and a grade 2 rectocele are among the major vaginal vault prolapses that were found during surgery.A cystoscope was used both after the surgery and during the solyx placement, and it showed that the bladder anatomy was normal and there was no evidence of a foreign body.Strong ureteral jets on either side are seen.Over the course of the treatments, no complications were found.The patient has mesh exposure and prolapse after the procedure.On (b)(6) 2021, the patient had transvaginal mesh removal along with posterior and anterior repairs.A 2x4cm mesh exposure was made in the apex and anterior wall during surgery, and the entire exposed mesh was removed with no remnants left behind.Small anterior and posterior repairs were used to treat a mild rectocele and cystocele.The patient went to the clinic on (b)(6) 2021, with her primary complaints of vaginal mesh exposure and postmenstrual bleeding.The patient stated that she is in her fourth month of postmenstrual bleeding, was evaluated by another physician, and had 2x4cm mesh exposure confirmed.Furthermore, the patient had stopped engaging in sexual intercourse as a result of this problem.The patient recalls no issues following her surgery in 2010, but she has recently noticed a bulge and pressure in her vagina.On (b)(6) 2021, the patient reported doing okay but stated having vaginal bleeding and an odor.The patient stated these symptoms were due to her prolapse surgery ten years ago and noted being able to feel the mesh and seeing it come out in pieces.She reported using vaginal douche every couple of days due to the foul odor.The patient was recommended to see an urgent care facility to ensure there was no infection.

• 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: 15494524
• MDR Text Key: 300701514
• Report Number: 3005099803-2022-05599
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729784784
• UDI-Public: 08714729784784
• 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,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Model Number: M0068507001
• Device Catalogue Number: 850-700
• Device Lot Number: 1ML0031701
• 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: 04/26/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female