Washington, DCDespite the fact that several transvaginal mesh manufacturers, such as American Medical Systems, have settled mesh lawsuits for millions of dollars and thousands more lawsuits are outstanding, the FDA has approved another type of vaginal mesh for pelvic organ prolapse. Approved, despite the fact that the FDA is currently considering reclassifying pelvic mesh from a moderate risk to a high-risk device.
This decision doesn’t sit too well with AMS transvaginal mesh victims like Valerie. “There is nothing good about this mesh and I can’t understand why some makes are still on the market,” she said. Valerie has suffered with painful intercourse for nine years, ever since she had the AMS transvaginal mesh implanted for incontinence. She was simply prescribed a vaginal cream for the discomfort.
“Of course that did nothing to relieve the pain, and to make matters worse, my incontinence came back.”
Patti had an AMS mesh product implanted to treat pelvic organ prolapse (POP) in January 2009. “Since that time I have pain urinating, leakage and I can’t completely empty my bladder,” she said in an e-mail. “I have constant lower back pain and fatigue. When I called my doctor three months after the surgery, he said it was ‘all in my head’ and these symptoms would go away. He never took my calls again. I wish doctors like him could live with these mesh side effects just for one day - that would change their thinking.”
Patti would no doubt like to see FDA officials live with transvaginal mesh complications. If they did so, perhaps start-up Caldera Medical wouldn’t have been cleared to treat POP. TVM lawsuits have already been filed against Caldera, claiming its T-Sling is defective. So how did its new mesh get fast-tracked and approved?
A Georgia federal judge in October 2012 refused to dismiss claims against Caldera Medical Inc. in a suit in multidistrict litigation accusing the J&J unit and others of making defective pelvic mesh implants, rejecting the contention the allegations are too vague, according to Law360.
Since 2011, the FDA has said that transvaginal complications are not rare. Further, the jury is still out regarding the use of mesh in POP; there is surgical repair that does not include the use of mesh that may be more effective.
And how is this for timing: in April 2015, the FDA proposed to raise transvaginal mesh risk from moderate to high. Just a few months later, the agency allows Caldera’s “new” mesh on the market.
But Caldera doesn’t cite any specific safety advantages for Vertessa Lite, which the agency first signed off on in 2013, according to FierceMedicalDevices. The medical news site said it tried to contact Caldera for comment, but hadn’t received a response at press time. Caldera’s Vertessa Lite has been fast-tracked by the FDA through its 510(k) approval process. AMS took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market, before having to follow up with the FDA order of post-market monitoring.
Caldera pointed out that about 40 percent of women have some form of pelvic prolapse, with as many as 250,000 surgeries to treat it annually. Let’s hope Caldera saves some of its profits for TVM lawsuits.
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