Lawsuits on the Rise

Pelvic Mesh Lawsuits on the Rise

Both individually and as mass torts, lawsuits involving mesh used to treat pelvic organ prolapse (POP) are on the rise. These suits name dozens of manufacturers — including Bard, American Medical Systems, Boston Scientific, and Johnson & Johnson — of pelvic mesh, patch and sling devices as defendants. Plaintiffs have suffered from devastating side effects and many have had to have additional surgeries to repair damage caused by mesh implanted transvaginally.

The rapid increase in claims involving defective mesh devices can be connected to the July 13, 2011 report released by the Food and Drug Administration (FDA) concerning the dangers of transvaginal mesh implants used to treat POP and stress urinary incontinence (SUI) in women who do not respond well to other treatments. Cases have involved women from throughout the United States, Canada and Europe, with plaintiffs seeking compensation for medical expenses, physical pain and suffering, and punitive damages.

Allegations concerning mesh devices

One of the strongest arguments made in transvaginal mesh lawsuits deals with the product itself. On behalf of their clients, pelvic mesh lawyers are arguing that these mesh devices were not designed to withstand the constant movement that occurs in a woman’s pelvic area. The device effectively grates against the tissues and causes them to erode.

Attorneys also argue that devices made with polypropylene — a synthetic material — and bovine material are at odds with the natural pH balance of a woman’s vaginal area. This incompatibility results in infections and chronic inflammation.

The 510(k) process has put women unnecessarily at risk

Another argument made in lawsuits involving transvaginal mesh devices stems from the way in which these products were introduced to the marketplace. Instead of going through the customary approval process, manufacturers used the 510(k) process the FDA offers as an expedited path to releasing a new product. The 510(k) process allows manufacturers to forgo an in-depth premarket approval process where their products are rigorously inspected for potential risks.

The 510(k) process can only be used when the product in question is substantially similar to a product already on the market, and makers of pelvic mesh devices claimed that their products were similar to existing surgical mesh products, such as hernia mesh implants. However, plaintiffs’ attorneys are challenging the introduction of such products into the market on the grounds that devices made to treat hernias are substantially different from devices made to treat POP and should not have been allowed to go through the 510(k) process.

Help is only one step away — reach out to us today for a free consultation

Phillips Law Offices stands ready to pursue compensation on your behalf if you have been harmed as a result of a TVM implant. Contact our Chicago office online or at (312) 346-4262 for a free consultation with an experienced products liability lawyer.