MAUDE Adverse Event Report: JOHNSON & JOHNSON / [ETHICON, INC.] YD VAGINAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Incontinence (1928); Pain (1994); Cramp(s) (2193)

Event Type  Injury  

Event Description

Caller reported she had 5 surgeries related to her vaginal mesh.Since her initial implant, she has experienced incontinence causing embarrassment due to involuntary urination in public.Caller also expressed pain, cramping, emotional and mental health issues.Her marriage is suffering due to her inability to engage in intercourse and financial strain caused by the mesh.Caller was contacted by (b)(6) whom offered her (b)(6) dollars for damages as part of a settlement offer.However, they are requiring her to sign a contract awarding them 40% of money.Caller is unaware who (b)(6) is, and what his intentions are.

Event Description

Add'l info received from reporter on 06/12/2019 for mw5085949; (b)(6) 2012: on completion of the ablation, the wand was removed and necrotic tissue was visible on the mesh.(b)(6) 2013: vaginal erosion and exposure of previous urethral sling, right pelvic pain.Laparoscopic adhesiolysis, excision of exposed and eroded vaginal urethral mesh.Dyspareunia and right sided pelvic pain, following sling surgery performed in the past by another practitioner.After a detailed discussion she decided to proceed with diagnostic with possible operative laparoscopy as well as excision of the mid portion of the mid urethral sling.Laparoscopic assessment, along the infraumbilical and suprapubic incision revealed no obvious injury to the omentum, bowel or other structures.It was noted that there was a piece of omentum that was adherent to the uteroovarian ligament on the right side.A second 5 mm trocar was inserted into the right lower quadrant under direct vision.The omentum was then grasped with an atraumatic grasper and this was excised off the uteroovarian ligament with the use of the thunderbeat system using the coagulation setting.After thick adhesion was excised, the cut ends were noted to be hemostatic.Excision of portion of vaginal erosion and exposure of urethral mesh.This allowed us to identify the urethral sling.It also allowed us to follow the course of the sling from the mid portion of the urethra to the opposite left side.This dissection was extended to the left side to length of approx 1.5 cm before i went into a deeper tunnel.The left lateral portion of the sling was grasped with the hemostat and excised using metzenbaum scissors.Next, we concentrated on the right portion of the mesh which had been seen to be exposed through the vagina.The vagina and underlying periurethral tissues were dissected off the mesh as far laterally as we could see.Two portions of the graft were excised to a point that was far lateral in location.(b)(6) 2015: urethral erosion of previously inserted urethral sling by another provider.Excision of eroded urethral sling by cystoscopic excision.Urinary anti-incontinence sling by another provider several years ago, in 2005.In 2013, she required excision of the urethral sling due to pain and erosion.Erosion of mesh through the urethra and agreed to have a cystoscopic excision of the eroded portion of the urethral mesh.The 30 degree cystoscope was inserted into the urethra.The area of the erosion.A 23 sheath and 9 french cystoscopic scissors the eroded portion of the mesh was excised into several tiny pieces.

• Brand Name: VAGINAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): JOHNSON & JOHNSON / [ETHICON, INC.] YD
• MDR Report Key: 8523259
• MDR Text Key: 142461380
• Report Number: MW5085949
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention