FDA Recalls the Elevate Transvaginal Mesh System, Manufactured by American Medical Systems
Online PR News – 26-August-2011 – – According to Ennis & Ennis, P.A., on July 7, 2011, the US Food and Drug Administration (FDA) recalled the Elevate Anterior and Apical Prolapse Systems manufactured by American Medical Systems, Inc. (AMS) between August 3, 2010 and January 17, 2011. The Elevate System is made of the synthetic material, polypropylene, and is implanted solely for prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. This recall was prompted after complaints that the eyelets were missing from the center of the graft of some of the units. The FDA reported that the complaint rate for the affected product was .045% and that no injuries had been reported to AMS.
AMS, which is headquartered in Minnetonka, MN, is just one of several companies that has been named in transvaginal mesh lawsuits over the past several years. These mesh devices are used for treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Last October, C.R. Bard’s Avaulta mesh was consolidated as part of a multidistrict litigation for pretrial proceedings in the US District Court for the Southern District of West Virginia. Additionally, as of last month, more than 400 people had filed claims in NJ state court against Ethicon, Inc. and Johnson & Johnson as a result of the injuries associated with their Gynecare mesh products.
While the FDA initially approved of transvaginal mesh devices to treat POP and SUI, they issued an advisory on July 13, 2011 reporting that there is little evidence that the mesh implants improve these conditions and that the devices actually expose the patients to a number of risks and complications that are not rare.
On September 8-9, 2011, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet to make recommendations regarding how to proceed. In the meantime, Attorney Holly Ennis recommends that all patients with symptoms first seek medical attention. Then they should report the incident to the FDA by filing a voluntary report at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, patients should seek the opinion of an experienced lawyer to explore their legal rights.
Ennis & Ennis is offering free nationwide confidential consultations to all women who have a transvaginal mesh implant by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. specializes in mass torts and represents individuals against pharmaceutical companies worldwide as well as 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.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.
Remember the law limits the time in which you can file a claim so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.