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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Cyst(s) (1800); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Burning Sensation (2146); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Ambulation Difficulties (2544); Neuralgia (4413)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned related events captured via 2210968-2024-00863.

Event Description

It was reported that a patient underwent a sling procedure along with a hysterectomy and bladder reconstruction on (b)(6) 2016 and mesh was implanted.The patient reported that during early 2017, they began experiencing lower abdominal pain, which required reduction in daily activities.When the pain became worse, the patient took analgesia and presented to their gp multiple times.Investigations included lower abdominal ct, x-ray, mri and ultrasound, with incidental findings of small ovarian cysts and hernias.The patient underwent inguinal and femoral hernia surgery.The pain continued as before, despite many consultations with the gp and referrals to a specialist, to function in daily life, the patient has increased the frequency of pain relief, and since on (b)(6) 2022, takes painkillers every day.The patient has occasionally taken endone, but prefers not to take opioids as it causes constipation and exacerbates problems.Since early 2017, the patient has not been able to work in preferred areas in nursing due to constant pain, urinary frequency, anxiety, the patient's symptoms continued unabated.By 2019, due to pain and discomfort, the patient was unable to walk any longer distance or to exercise, and consequently, has gained weight, which has impacted mental wellbeing.The patient experiences pain and feels constantly downhearted.After developing pudendal neuralgia, the patient was seen by a doctor in (b)(6) 2019.The patient had pudendal nerve block then and has had some relief from pain for few months.In (b)(6) 2021, the patient was prescribed antidepressants.The pain continued severe in the lower abdomen, radiating to the pelvic area and to the right leg when sleeping on the right side.The pain was occasionally on both sides of the pelvic floor area.The urinary frequency has become worse and the patient needs to go to the toilet at least 10 times a night, impacting sleep.Sometimes, the patient felt the urge to urinate but with minimal result.Since late (b)(6) 2022, the patient has started leaking urine a few times each day.The patient has since about six months back been experiencing severe pain during the intercourse, which has gradually refrained the patient to be sexually active.Additionally, the patient reported experiencing bowel problems since the beginning of 2017, with the bowels not emptying.The patient must manually push the stomach to assist the bowels to move.The patient had a consultation with a urogynecologist and explained the problems with lower abdominal pain, difficult bowel movements and burning sensation in the vagina, radiating to the legs started in the beginning of 2017.The doctor performed an internal assessment and said that the mesh was a definite cause of the pain and that the options were to have an immediate mesh removal surgery, alternatively control the pain with eventually in need to take it out due erosion and unmanageable pain in about 6 months¿ time.As the patient's health continued to deteriorate with severe unmanageable pain and effecting mobility, the patient was urgently booked for a mesh removal surgery for (b)(6) 2022.The patient was advised about the serious risks and possible complications with this surgery, but made the decision to go ahead with the surgery.No further information available as reporter details have not been disclosed (confidential).

• 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 ; 9083863534
• MDR Report Key: 18622404
• MDR Text Key: 334319714
• Report Number: 2210968-2024-00862
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention