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Despite Controversy, New Pelvic Mesh Wins FDA Approval

A privately-owned medical device company will market what it hails as a next-generation of its vaginal mesh.

Caldera Vertessa Lite
Caldera Medical's Vertessa Lite mesh, as shown on the company's website

Brian Buntz

Vaginal mesh have emerged as one of the most scandal-prone medical devices in recent memory, and have cost big device companies like Boston Scientific, Johnson & Johnson, and others millions of dollars in lawsuit fees. Boston Scientific, for instance, was recently compelled to pay $100 million in damages in a single case.

Now, Caldera Medical (Agoura Hills, CA), has won FDA clearance for its new Vertessa Lite mesh for treating pelvic organ prolapse--a condition affecting up to 40% of women. It can be implanted via open or laparoscopic approaches.

The company had received a 510(k) for an earlier version of the mesh in 2013, which itself was a modification of its Vertessa mesh.

Caldera boasts that the new mesh is mechanically superior to the market-leading mesh on the market--it is stronger and has a larger pore size.

Related Slideshow: 10 Unsafe Medical Devices That Hit the Market

According to the company, using the product in abdominal sacrocolpopexy provides one of the most effective means of treating vaginal vault prolapse.

The new mesh will be available in three form factors: Y-shaped, flat sheets, and strips.

In 2008, FDA released a warning stating that vaginal mesh can cause rare but severe complications when used to treat pelvic organ prolapse and stress urinary incontinence. Within three years, the agency had received more than 1000 reports of complications linked to the mesh.

FDA is considering reclassifying the product from a Class II device to a Class III product. The latter classification would require manufacturers to submit clinical data in order to receive market approval.

"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, deputy director of science and chief scientist at CDRH said in a statement.

Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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