FDA’s Recommendations to Women Considering Pelvic Organ Prolapse Surgery
Transvaginal Mesh Lawsuit News
- Ennislaw
08/11/2011 - Last month the U.S. Food and Drug Administration (FDA) updated a Safety Communication, warning of the dangers associated with the surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP). According to Ennis & Ennis, P.A., this update follows a recent significant increase in the number of adverse events reported to the FDA.
For women who are considering surgery for pelvic organ prolapse, it is important to know that within this updated Safety Communication, the FDA makes the following recommendations:
- Be aware of the risks associated with transvaginal POP repair.
- Know that having a mesh surgery may increase the risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
- Ask surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why surgeon may be recommending treatment of POP with mesh.
On September 8-9, 2001, 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 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, P.A. 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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