Home » Surgery Articles » FDA Advisory Panel Meeting on Transvaginal Mesh Devices: Ennis & Ennis, P.A. Provides Update
FDA Advisory Panel Meeting on Transvaginal Mesh Devices: Ennis & Ennis, P.A. Provides Update
The FDA Advisory Panel Supports More Studies and Tougher Regulation on Transvaginal Mesh Devices.
September 12, 2011 /Surgery PR News/ -- The U.S. Food and Drug Administration (FDA) Advisory Panel is in Day 2 of the meeting addressing the risks posed by transvaginal mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). This meeting follows an FDA advisory issued 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. As a result, yesterday the advisory panel called for more clinical studies and a tougher regulation on mesh devices.
Currently the mesh used for transvaginal POP repair is classified under Class II, which allows the devices to be cleared for market under the FDA's controversial 510(k) approval process, as long as they are "substantially equivalent" to existing products. However, the panel is proposing that future transvaginal mesh devices be moved to Class III, which would require clinical studies in people prior to submission for FDA market approval. Existing mesh products would be permitted to remain on the market. A formal vote was not obtained as of the end of the day yesterday.
Several transvaginal mesh device manufacturers, such as American Medical Systems, Inc., C.R. Bard, and Johnson & Johnson, are the subject of recent lawsuits where the mesh devices have caused vaginal mesh erosion (also called exposure, extrusion or protrusion), pain, painful sexual intercourse (also called dyspareunia), infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.
While consumer groups such as Public Citizen request a recall on the mesh devices, manufacturers request that the products remain as Class II, reporting that "serious adverse event (erosion) are very rare" and "adverse events (exposure) are manageable" according to their slide show presentation. Manufacturers agree with further studies and agreed to conduct proper professional training of the physician performing such procedures.
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. concentrates its practice 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.
Media Contact:
Jami Angelini Haggerty
Ennis & Ennis, P.A.
(954) 543-4452
www.ennislaw.com
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