MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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

Patient Problems Cyst(s) (1800); Hemorrhage/Bleeding (1888); Inflammation (1932); Itching Sensation (1943); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Ambulation Difficulties (2544); Skin Inflammation/ Irritation (4545)

Event Date 03/19/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeons name, contact information and sign release of medical information form attached.

Event Description

It was reported that a patient underwent a sling procedure on an unknown date in (b)(6) 2008 and the mesh was implanted.It was reported that the patient had recurring uti's, constant inflammation and acute/ chronic pain in the left groin, jagged, serrated sensation down into vaginal tissue that feels like the patient is sitting on a plastic picnic knife, offensive smell internally that the patient can also taste at the back of the throat, chronic and acute vaginal, pelvic pain, that is worsened by any movement.It was also reported that the vaginal mesh was too tight that it pulls the patients right hip in toward the pelvis causing extreme pain and irregular gait and reduces the patients walking significantly.It was reported that the patient is walking with the aid of elbow crutches.It was reported that the patient constantly falls, injuring the right shoulder, collar bone, right hip, breaking tibia and tearing the cartlidge in the left knee.It was reported that the patient suffers chronic back, pelvic, vaginal, hip, and leg pain.It was reported that the device caused intercourse to become too painful for the patient, left the patient with uti's and cystitis, and the pain became too uncomfortable for the patient to continue any "normal " intercourse.It was reported that the patient was diagnosed with lichen sclerosis around the vaginal area that required steroid cream to keep the intense itching and inflammation at bay which in turn caused the vaginal tissue and peritoneal tissue to become scarred, tight, tear, and bleed.It was reported that the patent could not have a sexual relationship because of the pain, the tightness of surrounding tissue, the utis that having intercourse causes, and the emotionally and mental scarring.It was also reported that the patient has elevated urinary frequency and a tendency to faint with a sudden drop in blood pressure.The patient still leaks urine after using the toilet, and the bowel leaks.It was reported that the patients 20-minute implant procedure took an hour and a half, and the patient could not pass urine for hours after it.This resulted in several hours of a longer stay in hospital being on fluid drips.It was reported that the patient contracted e.Coli in the bladder after discharge from the hospital.It was reported that the patient has been seen by two gynecologists regarding the pain, complications, and side effects of the device.The patient has nerve damage in the left leg, and constant pains in both legs.It was reported that the patient cannot stand for any length of time, and short walks are interrupted with rest stops because the pain in hips and legs are too much to bear.It was reported that the patient cannot sleep properly because of the pain.It was also reported that the patient is on 100 mg of amitriptyline, co-codamol 8/500, tramadol for pain.It was reported that the patients consultation with the urogynecologist in 2008 about the complications resulted in the doctor saying the prognosis was not good.It was reported that since the implant, in (b)(6) 2009 the patient was rushed to the hospital exactly one year after mesh implant with cysts wrapped around the left fallopian tube and ovary and bladder which ruptured at home after the patient collapsed in pain and hemorrhage into the toilet.The patient had to have a lifesaving salpingo oophorectomy surgery.It was reported that the patient has since been in constant visits to gynecologists, urologists, five physios, two pain doctors, two neurologists, spinal mri, pelvic mri, cystoscopies, including a recent rigid cystoscopy under anesthesia.It was reported that the patient is now waiting on an appointment to have the mesh implant fully removed.Additional information has been requested.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11682896
• MDR Text Key: 245991793
• Report Number: 2210968-2021-03474
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention