FDA Approves New American Medical System Transvaginal Mesh Sling
American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal.
The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does not require any clinical trials but relies on naming a similar “predicate device” that is already being sold.
AMS, an Endo Health Solutions Inc. subsidiary located in Minnetonka, Minn. provides devices for male and female pelvic health, according to a news release issued today which adds the RetroArc System was developed with “leading physicians.”
It joins AMS’s family of single-incision minislings, “Transobturator Slings that facilitate an “outside in” approach; and Retropubic Slings that allow surgeons to take a “top down” or “bottom up” transvaginal retropubic approach.”
What is the same is the sling is made of polypropylene, a plastic that incites an inflammatory response and it is still implanted transvaginally. The expert panel gathered by the FDA in September 2011 heard that a transvaginal placement is a “clean-contaminated” field that introduces bacteria into the pelvic area.
AMS says more than 13 million Americans suffer from stress urinary incontinence (SUI) and slings are the “surgical standard of care” in treating these women.
According to the company, 850,000 units of the AMS sling have been sold worldwide, that include the Monarc Subfascial Hammock and the SPARC Self-Fixating Sling System. The press release does not mention that Endo/AMS also makes the Apogee, Perigee and Elevate, among other mesh slings and pelvic organ repair mesh devices.
AMS agreed in July to settle an undisclosed number of Perigee, Elevate and Apogee defective product cases last July for $54.5 million. The amount should settle state and federal lawsuits without any company admission of guilt. Attorney David Matthews of Houston represented the majority of plaintiffs. DrugWatch reports at least 95 percent of the plaintiffs must agree or the settlement will be retracted.
AMS is facing more than 12,651 cases consolidated in federal court in West Virginia as of December 6, more than any of the five other defendants. There are currently almost 40,000 cases consolidated before Judge Joseph R. Goodwin. He has set the first two bellwether cases for April 7 and May 5, 2014. Trial date background story is here.
In 2011 AMS was purchased by Endo Pharmaceuticals so some plaintiffs are suing both companies. Other doctors would argue that if a woman is able to have surgical stitching might be preferable to introducing the polypropylene sling, a permanent implant.
A physician who implanted the first RetroArc on December 2 is Dr. Neeraj Kohli of Newton Wellesley Hospital and Brigham and Women’s Hospital, Boston.
Mesh Warning Issued
The news release warns the device is contraindicated in women who are pregnant, have active infections or signs of tissue necrosis,
“have known sensitivity or allergy to propylene mesh products or in patients with pre-existing conditions that pose unacceptable surgical risk. Although rare, some of the most severe risks with sling procedures include infection, erosion and vessel or urethra perforation. Some of the most common risks include urinary tract infections, urge symptoms and urinary retention” which is why you are having the implant in the first place.
AMS Introduces New Mini-Sling