Despite major transvaginal mesh manufacturers spending millions of dollars defending and settling thousands of lawsuits contending the risks and injuries due to vaginal mesh far outweigh their effectiveness, the U.S. Food and Drug Administration has approved yet another type of vaginal mesh for pelvic organ prolapse.
Recently, the FDA approved a new iteration of the Vertessa Lite pelvic mesh produced by Caldera Medical. Caldera claims that this newer version will have larger pores that will improve the tolerance of the mesh by the host tissue. While Caldera did change the mesh material, claiming that it is now lighter and stronger, they did not cite any specific safety advantages for Vertessa Lite. The new product will be offered in different shapes including Y-mesh, flat mesh sheets, and mesh strips. It is also in a light blue color, which Caldera claims makes it easier for physicians to use. Caldera pointed out in the application for the new product that about 40% of women have some form of pelvic prolapse, with as many as 250,000 surgeries to treat it annually.
Caldera’s Vertessa Lite was fast-tracked by the FDA through its 510(k) approval process, which allows the FDA to approve a new drug or device based off its similarity to other products already on the market. However, the FDA was advised early this year by the Center for Devices and Radiological Health to reclassify pelvic mesh as a “high-risk”, class III device that would require the more stringent premarket approval application. The FDA obviously took this advice to heart because in April 2015, it proposed to raise transvaginal mesh risk from moderate to high.
Even as the risks seem apparent to agencies like the FDA, new, seemingly improved transvaginal mesh and sling products continue to enter the market.
In January, Ethicon (subsidiary of Johnson & Johnson) also released its recently FDA approved Artisyn mesh used to treat vaginal vault prolapse. Ethicon is the same major manufacturer who removed four vaginal mesh implants including its Prolift mesh, one of the largest and most problematic, from the market in June 2012. The FDA was informed of this decision and the manufacturer agreed to adjust the warnings of its remaining transvaginal mesh products on the market.
Manufacturers of transvaginal mesh and sling products continue to push for approval of new products, while lawsuits continue to escalate. The complications caused by these devices have left many hundreds of women to suffer with horrible recoveries, medical bills, and ongoing pain.
Our firm is proud to represent women who are the victims of the complications from the transvaginal mesh device. Women who had a vaginal mesh or bladder sling implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have been put at needless risk and suffer catastrophic complications from these medical devices.
Written By:
Paige Boldt
Watts Guerra LLP
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San Antonio, Texas 78257
Phone (210) 447-0500
© Watts Guerra LLP 2015
