MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Abscess (1690); Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Blood Loss (2597); Not Applicable (3189)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have copies of your operative reports 2005, 2007, 2008 and final removal in 2019? does ethicon have your permission to contact your surgeons, in the event ethicon would like to contact your surgeons for more clinical information to be used for a product quality complaint investigation? if so, please review and sign release of medical information form attached in order to contact your surgeons for additional information? note: events occurred after mesh #1 implanted in 2005 and mesh # 2 implanted in 2007 were captured in the related files and submitted via 2210968-2019-87949, 2210968-2019-87961 and 2210968-2019-87966 accordingly.

Event Description

It was reported that the patient underwent a gynecological procedure in (b)(6) 2008 and the unknown mesh was implanted to replace the previous implanted mesh due to recurrent bladder prolapse.The patient was released on (b)(6) 2008.Starting in 2017 to the mesh removal in 2019, the patient went through multiple doctors.It was reported that skin was growing into the mesh which disintegrated and embedded in her skin.The patient experienced a pain, uncontrollable discharge and an odor.The doctor opined that the odor was coming from the mesh, but it was not confirmed.The patient was having bleeding because the mesh tore into her vaginal walls.The patient was treated with estrogen cream internally applied to help the lining of the vaginal wall.It was also reported that the doctors were attempting to thicken the patient¿s skin to fix the issue.In 2019 the patient had excessive vaginal bleeding.Due to previously done hysterectomy on unknown date, the vaginal bleeding was not expected.On (b)(6) 2019, the patient underwent a mesh removal surgery which should be outpatient procedure but due to the length of the surgery the patient was kept and later released on (b)(6) 2019.It was found that the mesh was ripped in pieces and it was a little more sensitive to remove it.The patient developed excessive bleeding post-surgery, serious abdominal pain and was unable to walk.She was receiving a codeine, morphine and ibuprofen 800mg.At the beginning it was twice a day, and then it was as needed.The patient was readmitted to the hospital on (b)(6) 2019.Blood work showed that the patient needed a blood transfusion requiring two pints of blood.An ultrasound was performed, and it was then determined that the patient had the abscess, 8cm in diameter filled blood and puss.The doctor opined that it was from the development of the bacterial infection from the mesh.It was also reported that when it was measured it was believed to of been within the patient for a while, exact time frame unknown.The patient was given zosyn an antibiotic for the bacterial infection.On (b)(6) 2019 the drainage was started for abscess and bad odor continued.The patient was released from the hospital on (b)(6) 2019 with antibiotic amoxicillin clav.Three days later, a drain was removed, but the patient was still experiencing nausea, bad odor and pain, lost at least seven pounds and unable to walk.The patient is barely getting her strength back, gaining appetite, has a pain 4-5, more motivated, move around better and still has some nausea.Two weeks ago the patient couldn't keep food down and was having mobility issues again.The next day, she's feeling better but still having nausea issues.The patient has had vomiting, sometimes just nausea occasionally vomiting.On 09/05/2019, the patient has a follow up appointment to check the blood work and make sure that everything is removed, that there is no bacterial infection left.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 01/09/2020.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.May we have a copy of operative report for mesh removal surgery on (b)(6) 2019? mesh product name, code and lot number implanted in 2008 and removed on (b)(6) 2019? if applicable, will product be returned, return date, tracking information? the patient demographic info: age, weight, bmi at the time of procedure? other relevant patient comorbidities (including prior surgeries) / concomitant medications? surgical findings of mesh removal on (b)(6) 2019? what are culture results? what is physician¿s opinion as to the etiology of or contributing factors to these events (bleeding, blood transfusion, bacterial infection, abscess and mesh erosion into vaginal walls)? what is the patient's current status?.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9101290
• MDR Text Key: 162278467
• Report Number: 2210968-2019-87970
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention