Obtryx Lawsuit Added to Vaginal Mesh MDL

A lawsuit alleging serious transvaginal mesh complications from Boston Scientific’s “Obtryx” was recently transferred to the vaginal mesh MDL in the Southern District of West Virginia. The plaintiffs, a Tennessee woman and her husband, had originally filed the lawsuit on July 13, 2012 in the U.S. District Court for the Eastern District of Tennessee before it was transferred to the MDL.

Plaintiff allegedly suffered painful complications after being implanted with Obtryx

According to her lawsuit, the woman had surgery and was implanted with the Obtryx vaginal mesh device on March 17, 2006 with the goal of treating her stress urinary incontinence (SUI). SUI is a common condition in older women in which they involuntarily leak urine when pressure is put on the bladder, such as when the woman coughs, laughs, or sneezes. The plaintiff states that before her surgery, she and her doctor had reviewed materials from Boston Scientific that included assurances that the Obtryx vaginal mesh product was safe and effective.

But following her surgery, the woman began to suffer from transvaginal mesh complications including pain, urinary issues, and dyspareunia (pain during intercourse). She has been forced to undergo ongoing treatment for these issues, and will continue to need treatment in the future, according to her lawsuit.

Obtryx was fast-tracked to FDA approval without undergoing safety studies

According to the suit filed by the plaintiff’s vaginal mesh lawyer, Obtryx was approved via the FDA’s 510(k) process, a fast-track process that does not require a product to undergo clinical trials proving its safety as long as it is “substantially similar” to a product that was already approved.

The lawsuit further states that at the time the plaintiff was implanted with the Obtryx, Boston Scientific was already aware of “numerous defects in the pelvic mesh products,” and that even though the company’s marketing materials present the Obtryx as safe, the mesh device in fact has high rates of failure, injury, and complications, frequently requires revision surgeries, fails to perform as intended, and has caused severe irreversible injuries, conditions, and damage.

The plaintiff brings counts of negligence, failure to warn, defective manufacture and design, breach of warranties, common law and constructive fraud, and negligent misrepresentation, while her husband claims loss of consortium.

[SmartLink vaginalmeshlawsuit]