Vaginal mesh manufacturer Boston Scientific Corporation is facing more litigation over its Uphold Vaginal Support System, with plaintiffs alleging the company did not properly study the potential serious adverse effects that could result from implantation of the mesh product used to help treat pelvic organ prolapse and stress urinary incontinence.
According to a recent lawsuit, the design of the Uphold Vaginal Support System incorporates the use of collagen and a monofilament polypropylene -- materials that plaintiffs allege cause serious adverse effects and immune reactions that cause affected tissue to break down. The suit alleges that these materials are "biologically incompatible with human tissue."
Surgery for POP, which occurs when pelvic muscles become weakened, stretched or torn and can no longer support pelvic organs, is often performed using a minimally invasive transvaginal technique where mesh inserts are implanted to reinforce the pelvic muscles. Over the past decade, the FDA has received thousands of complaints about complications from the mesh inserts, including pelvic pain, bleeding, organ damage, infection and urinary problems.
The FDA provided fast-track approval for transvaginal mesh products because they were believed to be similar to mesh products long used in hernia surgeries. The agency later issued warnings in 2008 and 2011 to doctors and consumers about an increase in reports of complications due to the use of transvaginal mesh for POP repair. In 2012, the agency issued orders to manufacturers to conduct post market surveillance studies amid reports that 10 percent of women experienced mesh erosion within a year that required one or more surgeries to repair.
Women who claim the mesh products have caused them pain and injuries have filed thousands of lawsuits. Major manufacturers including Johnson & Johnson, Boston Scientific and C.R. Bard have agreed to settlements totaling hundreds of millions of dollars to resolve thousands of cases to date.
If you have suffered injuries from an unsafe or defective product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.