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The manufacturers of the Coloplast Aris Transobturator Tape face a product liability lawsuit filed by a Texas woman who alleges that she has suffered debilitating injuries as a result of complications from the pelvic mesh, which was implanted transvaginally to treat stress urinary incontinence.
The Coloplast Aris sling lawsuit (PDF) was filed by Linda Channell on June 18, in the U.S. District Court for the Northern District of Texas, naming Coloplast Corporation, Mentor Worldwide, LLC. and Analytic Biosurgical Solutions as defendants.
The Aris Transobturator Tape was developed and manufactured by Coloplast and Mentor, and Analytic Biosurgical Solutions provided the companies with quality assurances, according to the complaint.
Channell alleges that she received a Coloplast Aris sling in October 2008, where the pelvic mesh was used to support her bladder and treat stress urinary incontinence. Following the transvaginal surgery, Channell indicates that she developed a number of serious complications, including severe and debilitating pain, and discovered that the Coloplast sling had eroded and protruded into her vagina. As a result of the problems, she had the mesh removed in March 2011, but that led to further complications and hospitalization.
The lawsuit accuses the defendants of manufacturing and marketing a defective product, failure to warn Channell or her doctor of possible complications, negligence, breach of warranty and fraud. The lawsuit also accuses the company of attempting to misrepresent the product and of concealing that vaginal mesh could lead to severe injuries, suggesting the defendants should be subject to punitive damages, as well as compensatory damages for Channell’s injuries, disfigurement, loss of enjoyment of life and medical expenses.
The Coloplast Aris is a transvaginal pelvic mesh first developed by Mentor and launched in May 2005. However, Mentor then sold the Aris to Coloplast, with all of its other surgical, urological and healthcare-related business aspects in 2006.
Pelvic mesh and transvaginal products like the Aris sling have come under close scrutiny in recent years, after the FDA indicated in 2011 that it has received thousands of reports of complications from doctors and women who had the products implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The complaints reported by women throughout the United States were nearly identical to those described by Channell, and the FDA indicated at that time that it could find no benefit to the use of transvaginal pelvic mesh for treatment of POP when compared to other treatment techniques.
Channell’s lawsuit is one of more than a dozen against Coloplast’s various transvaginal mesh products in courts nationwide. Other Coloplast products targeted by litigation include the Novasilk, Restorelle and Supris Suprapubic slings.
Thousands of similar lawsuits have also been filed against the manufacturers of other pelvic mesh products, including C.R. Bard, American Medical Systems (AMS), Boston Scientific and Ethicon/Gynecare. All of the complaints involve allegations that the manufacturers aggressively promoted the pelvic mesh for repair of SUI or POP without adequately researching the safety or effectiveness of the products, or warning about the risk of debilitating complications and disfiguring injuries.