FDA Issues Post Operative Recommendations for Women with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
08/04/2011 - On July 13, the U.S. Food and Drug Administration (FDA) updated an advisory on vaginal mesh implants reporting that there is little evidence that the implants improve pelvic organ prolapse and that patients are exposed to a number of risks and complications, which are not rare. According to Ennis & Ennis, P.A., the FDA then issued a Safety Communication, which provided an Overview, a Summary of Adverse Event Reports, a Review of their Literature, a Summary of their Key Findings and Recommendations with regards to these transvaginal mesh devices.
Within in the Safety Communication, the FDA made the following recommendations for women after the surgery:
- Patients should continue with annual and other routine check-ups and follow-up care.
- Patients should notify their health care provider if they develop complications or symptoms, including persistent vaginal bleeding or discharge, pelvic pain, groin pain, painful intercourse, or urinary problems.
- Patients should let their health care provider know if they have surgical mesh, especially if planning to have another related surgery or other medical procedure.
- Patients should talk with the health care provider about any questions or concerns.
- Patients should ask their surgeon at the next routine check-up if they received mesh for the POP surgery if they are unsure that mesh was used.
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 http://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 http://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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