These are studies that should have been conducted before the devices were approved by the FDA
(PRWEB) January 09, 2012
On January 3, 2012, the U.S. Food and Drug Administration (FDA) mandated postmarket surveillance studies be performed by manufacturers of urogynecologic surgical mesh devices. The FDA issued 88 postmarket study orders to 33 manufacturers of transvaginal mesh for pelvic organ prolapse (POP) and 11 postmarket study orders to seven manufacturers of mesh mini-slings for stress urinary incontinence (SUI). “These are studies that should have been conducted before the devices were approved by the FDA,” commented attorney Holly Ennis of Ennis & Ennis, P.A.
The manufacturers, which include American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson, are required to submit study plans to the FDA that address specific safety and effectiveness concerns related to the surgical mesh devices. Data from the studies will enable the FDA to better understand the safety and effectiveness profiles of these devices.
This Order follows years of reports of serious injuries associated with the devices such as vaginal mesh erosion, pain, painful sexual intercourse, infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems and vaginal scarring. Additionally, an FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence, according to The New York Times. That same year, researchers reported in a medical journal that about 15 percent of the women treated with vaginal mesh experienced potential complications. The study, which appeared in the journal Obstetrics and Gynecology, also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.
According to a Safety Communication dated July 13, 2011, the FDA has already identified surgical mesh placed transvaginally for POP repair as an “area of continuing serious concern,” as it is unclear that “transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
The FDA approved of these devices under the controversial 510(k) approval process, which allows devices to be cleared for market, without any studies performed on patients, as long as they are “substantially equivalent” to existing products.
On November 21, 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a Joint Committee Opinion opining that due to the concerns about the safety and efficacy of the use of transvaginal mesh to treat pelvic organ prolapse (POP), it should be reserved for high-risk women for whom the benefit may justify the risk.
In September 2011, an advisory panel recommended the FDA reclassify the mesh as “high-risk” devices that require human testing. Despite this request and study findings, the FDA has yet to make that decision.
If you or a loved one has suffered from any of these injuries caused by a transvaginal mesh device, contact Ennis & Ennis, P.A. for a FREE nationwide confidential consultation toll free at 1-800-856-6405 or complete an online case evaluation form at http://www.ennislaw.com.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.
Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
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