- Ennislaw

08/17/2011 - With a significant increase in the amount of complaints associated with the surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP), the US Food and Drug Administration ((FDA)) will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee on September 8-9, 2011. Ennis and Ennis, P.A. reports that the purpose of the meeting is to consider regulatory changes that may improve the understanding and effectiveness of the devices. Some of the regulatory changes being considered include:

- A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III,, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices.
- Clinical studies to address the risks and benefits of mesh used to treat POP and SUI.
- Expanded post-market monitoring of device performance.

Attorney Holly Ennis reports that this meeting could be critical for women considering a pelvic organ prolapse procedure in the future. 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. Ennis commented “This 510(k) process, particularly with the mesh devices, fails to consider consumer’s safety.” Meanwhile, Class III medical devices undergo the most stringent of testing before FDA market approval.

While awaiting the outcome of this committee meeting, Ennis recommends that all transvaginal mesh device patients with symptoms first seek medical attention. Then they should report the incident to the FDA by filing a voluntary report at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm prior to the Committee Meeting. 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.

If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page.

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