ObTape is a transvaginal mesh (TVM) device that is a vaginally inserted bladder sling used to treat women with stress urinary incontinence (SUI). Also known as ObTape Transobturator Tape, ObTape is manufactured by Mentor Corporation, a subsidiary of Johnson & Johnson.
After surgical implantation, though patients’ problems with SUI subsided, they began developing new complication involving ObTape. The surgically-implanted bladder sling began to cause serious injury and pain. Injuries and health complications related to the TVM ObTape include the following:
Patients with ObTape also experienced erosion of the vaginal sling into their surrounding tissues, causing a severe amount of pain. In most cases, these patients required several surgical procedures to remove parts of the eroding and deteriorating vaginal mesh sling.
ObTape was approved by the U.S. Food and Drug Administration (FDA), though the FDA did not conduct a thorough investigation into the safety of ObTape. The reason for the FDA’s lack of investigation was due to ObTape’s structural and material similarities to existing and approved transvaginal mesh products. Essentially, the FDA placed ObTape on a fast track approval process. Furthermore, many transvaginal mesh products already on the market prior to ObTape’s approval turned out to be defective, causing many of the same severe health complications as ObTape.
Complaints filed with the FDA regarding serious side effects linked to surgical implantation of the ObTape vaginal sling began in 2004. Since then, there have been over 300 patients complaints filed with the FDA.
In its introduction of the device to the FDA, Mentor made a strong claim as to ObTape’s similarity to previously approved transvaginal mesh devices in an effort to receive clearance. However, upon receiving approval, Mentor marketed ObTape as a revolutionary transvaginal mesh device, with unique features that would decrease health complications related to TVM devices. Such marketing efforts proved to be false.
In an order provided by the United States District Court for the Middle District of Georgia Columbus Division, it is stated that plaintiffs in the ObTape Multi-District Litigation (MDL) experienced erosion of ObTape into their surrounding bodily tissues. Plaintiffs and expert witnesses involved in the ObTape Georgia-based MDL both claimed that Mentor did not warn patients and doctors about the inherent design flaw in ObTape causing it to erode, thus resulting in severe health complications for patients.
If you or a loved one has suffered immensely as a result of the Mentor ObTape vaginal sling, you amay be entitled to receive compensation for your losses.
For more information about filing an ObTape lawsuit, contact an experienced transvaginal mesh defective medical device attorney at Carey Danis & Lowe. Call 800.721.2519 for a free legal consultation regarding your ObTape case.References: Defective Medical Device litigation, Transvaginal Mesh