A new mesh device has been approved by the U.S. Food and Drug Administration (FDA), despite backlash from injured patients who have transvaginal mesh litigation claims. The latest surgical mesh product, Vertessa Lite, was approved through the FDA 510(k) process. This system essentially allows devices to expedite procedures by showing similarities to a device already on the market. If a company can do this, then clinical trials are not required for approval.
Troubles with the 510(k) Process
Many transvaginal mesh devices used to treat pelvic organ prolapse (POP) and urinary incontinence (UI) have passed through the 510(k) process. According to Transvaginal Mesh Lawsuits, the first FDA approved vaginal mesh product, ProteGen, passed through this process in 1996. However, when the manufacturers of this device issued a recall, vaginal mesh products similar to the withdrawn product were not required to undergo further testing or trials for safety. Instead, devices modeled after the defunct device continue to permeate the market.
The FDA attempted to address the health risks associated with transvaginal mesh (TVM) in 2014 by proposing vaginal surgical mesh be reclassified from a moderate-risk device to a high-risk device. High-risk devices also require manufacturers to submit a pre-market approval application. New precautions on transvaginal mesh devices will benefit future patients who seek treatment for POP and UI, but the safety measure came too late for many women who already had transvaginal mesh implanted.
Problems Associated with TVM
Women experienced many adverse side effects from the original TVM device ProteGen, including mesh erosion and infection. Today, women experience these same complications after having TVM implanted as well as other side effects, such as organ perforation, pain, scarring, and return of POP and UI symptoms.
The problems associated with this device can also negatively affect relationships. Women with UI are frequently embarrassed by their condition and it makes performing daily activities difficult. Surgical mesh injuries also affect intimacy because intercourse can become quite painful.
People all over the country have begun seeking compensation for the troubles associated with TVM. According to Mesh Medical Device News Desk, around 100,000 lawsuits have been filed against makers of pelvic mesh devices.
Transvaginal Mesh Litigation Settlements
C. R. Bard, manufacturer of the Avaulta TVM, agreed to pay more than $200 million to settle 3,000 TVM injury cases, Bloomberg Business reported. The women will receive about $67,000 per case. The compensation will be help many women who had surgery to have the mesh removed. Medical procedures are expensive and the money received from the settlement will help ease financial burden.
Boston Scientific is another company facing transvaginal mesh litigation. The device maker reached its first settlement agreement in April 2015. The company agreed to pay around $119 million to resolve almost 3,000 cases, Reuters reported. A month later, the company awarded a woman $100 million after her transvaginal mesh trial.
Compensation helps ease stress caused by painful TVM complications, but won’t make up for everything these women have experienced.
Have You Suffered a Transvaginal Mesh Injury?
If you or a loved one has been implanted with TVM to treat POP or UI and have experienced adverse side effects, talk to an attorney today. You may be entitled to monetary compensation, so discuss your next steps with a lawyer before proceeding with transvaginal mesh litigation.