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Mentor Ob Tape Lawsuit Joins Transvaginal Mesh MDL

On May 14, 2013, a transvaginal mesh lawsuit was filed as a potential tag-along case to the multidistrict litigation involving Mentor Corporation’s ObTape Transobturator sling, known as MDL 2004. The case is proceeding in the U.S. District Court for the Middle District of Georgia (Columbus). According to court documents, the plaintiffs allege that the defendant manufactured and sold a vaginal sling called ObTape, despite knowledge of its defects, causing the recipient to sustain serious and permanent injuries.

After the plaintiff was implanted with the ObTape for the treatment of her stress urinary incontinence (SUI), she claims that the vaginal sling eroded through her bodily tissues, resulting in chronic infections, pain, exacerbation of her urinary incontinence, and the need for additional surgeries and medical treatment for her subsequent complications.

Mentor withdraws ObTape from market in 2006

The plaintiff’s transvaginal mesh lawyer alleges that Mentor deliberately made blatant misrepresentations to the FDA regarding the efficacy and safety of its ObTape vaginal sling. The manufacturer first launched the product in the U.S. in 2003, after limited testing which was only performed on rabbits. The few animals it was tested on showed adverse tissue reactions, but according to allegations raised in the complaint, Mentor made no efforts to perform further clinical trials on human tissues despite these risks.

Despite the adverse reactions in rabbits and inadequate safety tests on humans, the complaint says that Mentor continued to manufacture and distribute their ObTape from 2003 through 2006, even though they were aware their product contained major design flaws that posed avoidable risks to patients.

The plaintiff was implanted with the Mentor ObTape in a Texas hospital in 2005, at the suggestion of her physician. However, prior to this vaginal mesh surgery, the defendant had notice of many patients who had suffered injuries from the ObTape transobturator vaginal sling, including a large number of women who  were harmed by complications arising from vaginal mesh erosion, infection, perforation and/or abscess after receiving the device. Mentor finally withdrew the ObTape vaginal sling from the market in March of 2006, but allegedly failed to provide sufficient warning to health care providers about appropriate methods for treating recipients who were already implanted with the device.

The claimant says she only discovered the defective nature of the Mentor ObTape after she saw a television commercial in 2011. Like others who have filed a transvaginal mesh lawsuit, the victim is seeking compensation for personal injuries, pain and suffering, emotional distress, financial loss, including past and future medical expenses, and other damages.

ObTape lawsuit to join multidistrict litigation

Multiple counts are leveled against Mentor Corporation including strict liability, manufacturing defect, design defect, negligence, and breach of express and implied warranties. The plaintiff’s husband is also demanding damages for loss of spousal consortium. And for Mentor’s “conscious disregard of, and/or reckless indifference to the consequences of their actions and the safety of those persons who might foreseeably have been harmed by the ObTape,” the claimants are also seeking punitive damages to deter future similar conduct.

Transvaginal mesh lawsuit actions involving Mentor ObTape were centralized under U.S. District Judge Clay Land in the Middle District of Georgia for more efficient pre-trial proceedings. The actions in MDL No. 2004 share factual issues as to whether the vaginal sling was defectively designed and/or manufactured, and whether the defendant failed to provide adequate warnings concerning the medical device.