The Mentor ObTape is a type of medical device called transobturator vaginal sling that is used to help patients suffering from stress urinary incontinence (SUI) due to weakening of the muscles supporting the bladder. However, within three years after the device was introduced to the market, the Mentor ObTape was taken off the market in March of 2006 due to the large number of complains and complications reported to the FDA. By design, the Mentor ObTape was supposed to treat SUI by replacing the muscles in the urethra. But instead of controlling urine flow, the device blocked the necessary flow of oxygen and nutrients, causing side effects such as:
- Vaginal pain
- Vaginal infection
- Urinary tract erosion
- Mesh-related vaginal extrusion
- Vaginal discharge
SUI Causes and Treatment
Stress incontinence occurs because the muscles the muscles supporting the bladder are weak and even minor pressure (such as sneezing, bending over, laughing, or lifting) can trigger unintended urine release. Depending on the severity of the condition, patients may require surgery to improve closure of the urinary sphincters or support the bladder neck. Surgical procedures used to treat SUI include:
- Injecting bulking agents: increase the pressure on the urethra
- Open retropubic colposuspension: lifting the area near the bladder neck and upper portion of the urethra by attaching sutures to ligaments or bones
- Sling procedures: generally performed on women, surgeons use the patient’s own tissue or synthetic material to create a sling supporting the urethra
FDA Approval and Device Failure
The ObTape was approved for U.S. markets under the FDA 510(k) process that enables medical device manufacturers to certify their products without conducting important clinical trials. In order to gain FDA approval, Mentor claimed that the ObTape was “substantially similar” to other surgical mesh devices for pelvic organ prolapse. However, according to medical experts, Mentor’s ObTape design deviated significantly from the other types of transvaginal mesh devices FDA approved. The ObTape vaginal slings posed a unique risk of vaginal erosion, 10 to 20 percent of patients who received an ObTape implant suffered complication as a result of mesh erosion.
Liability for Mentor ObTape Complications
While the FDA may have approved a defective product, the responsibility to the patients ultimately lies with the manufacturer. Mentor should have conducted some clinical trials before seeking approval from the FDA and marketing a seriously hazardous medical device. With such a high rate of mesh erosion (10-20%), even a small clinical trial could have revealed the potential dangers associated with the ObTape device.
Transvaginal Mesh Injury Lawsuits
Whether it is designed for use in pelvic organ prolapse treatment or stress urinary incontinence, the FDA has found little evidence in nearly ten years worth of medical literature demonstrating the safety and effectiveness of the transvaginal mesh devices. On the contrary, thousands of women have filed reports of complications and side effects, causing the FDA to issue a warning against transvaginal mesh implants. Many of these women are filing lawsuits against medical device manufacturers for the damages related to their injury, if you too have been seriously harmed as a result of a transvaginal mesh implant, please consult one of our professional Mentor ObTape injury attorneys for a free consultation.