MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Device Problems Material Erosion (1214); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Bleeding (1738); Erosion (1750); Unspecified Infection (1930); Pain (1994); Burning Sensation (2146); Other (for use when an appropriate patient code cannot be identified) (2200); Discharge (2225); Surgical procedure (2357); Therapy/non-surgical treatment, additional (2519); Treatment with medication(s) (2571)

Event Date 02/06/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecologic surgical procedure on (b)(6) 2006 and mesh was implanted.Approximately 6-8 weeks post-operatively, the patient experienced erosion and the patient reports worsened mesh erosion with mesh shrinkage which has caused bleeding, yeast infections, bladder pain with difficult urination.The patient has also experienced constipation, pain extending from right side of the abdomen to the ankle, vaginal burning and inability to have intercourse with spouse.The patient reports ongoing orthopedic muscle and leg pain and has undergone three different surgical procedures for overuse issues from tightened pelvic and hip muscles.The patient underwent a sphincterotomy two years ago to allow for regular bowel movements and patient reports that has now stopped performing well due to newer pelvic symptoms.The patient has had several rounds of physical therapy, multiple health and orthopedic tests where no diagnosis was found.The patient reports that the physician opined that mesh was stable for 9 years and other problems must exist not associated with the mesh.The patient reports that the physician opined the patient¿s problems must be related to post hysterectomy bladder symptoms.The patient experienced yellow discharge and reported that the physician opined the discharge was from mesh and did not follow up with tests for yeast until the patient did a self-examination and found green and white material on a latex glove.The physician performed a yeast test which was positive.The patient reports the yeast has been ongoing with treatment failing to resolve it.The patient was advised by the physician that the mesh could be cut in operating room and was advised to use vaginal estrogen cream to cover mesh over with tissue.The patient reports this has failed to happen and ongoing pain and disability has caused the patient to seek other medical opinions.(.

Manufacturer Narrative

(b)(4).The patient reports that urogynecologists have opined that the erosion is too advanced for vaginal cream to help, and should be removed due to the shrinkage.The patient plans to have mesh removed.The patient has also experienced fatigue, depression over pain and life altering circumstances, marital problems, increased allergies, bloating and weight gain.No additional information was provided.(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(4).This medwatch report is in response to receipt of maude event report mw5040706.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4875024
• MDR Text Key: 6063973
• Report Number: 2210968-2015-07647
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention