FDA Ordered Transvaginal Mesh Manufacturers to Conduct Safety Studies: Boston Scientific Commits $1 Million to SUPeR Trial

transvaginal_mesh_implants_lawsuit_litigation_settlements_obtapeBoston Scientific recently contributed a $1 million research grant to the Pelvic Floor Disorders Network (PFDN). The research funds will be used in the SUPeR clinical trial, a study examining ways to treat a type of pelvic organ prolapse (POP) known as uterine prolapse

Participants in the SUPeR study will be selected for one of two treatment alternatives. The first uses a Boston Scientific transvaginal mesh product known as the Uphold LITE, and the other treatment option involves the more traditional method of surgery and a hysterectomy.

The study will span 5 years, during which researchers will regularly check in with participants every six months. Study data from the SUPeR clinical trial will be released in 2018.

Following increasing reports of problems linked to the use of transvaginal mesh, the U.S. Food and Drug Administration (FDA) ordered manufacturers of transvaginal mesh products to initiate studies examining its health risks. Boston Scientific’s research grant comes in response to the FDA’s research order in January 2012.

Boston Scientific faces a multidistrict litigation (MDL) in a federal court in West Virginia. As of July 16, 2013, there are 5,234 transvaginal mesh lawsuits consolidated into the Boston Scientific MDL. Along with Boston Scientific, transvaginal mesh lawsuits have been consolidated into MDLs against C.R. Bard, American Medical Systems, Ethicon, Coloplast, and Cook Medical. All six of these transvaginal mesh MDLs are being heard in the U.S. District Court for the Southern District of West Virginia.

Women have filed transvaginal mesh lawsuits alleging that these products resulted in serious health issues, including mesh erosion and contraction, infection, bleeding, pelvic area pain, pain during intercourse, and organ damage. Furthermore, plaintiffs who have filed transvaginal mesh lawsuits go on to claim that transvaginal mesh manufacturers created poorly designed products, marketed these products without issuing safety warnings, and did not thoroughly research the product.

Carey Danis & Lowe transvaginal mesh lawyers are encouraged to see Boston Scientific making an effort to study their transvaginal mesh products, especially in light of the thousands of individuals who claim to have been injured by their products.

Our transvaginal mesh lawyers are currently investigating transvaginal mesh cases, and are offering free legal evaluations, in addition to assistance with filing a transvaginal mesh lawsuit. Contact Carey Danis & Lowe today by calling 800.721.2519 or by submitting a personal injury claim form.

References: Defective Medical Device litigation, Transvaginal Mesh
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