"after reviewing the Updated FDA Communication the complications that are being reported confirm what we have been hearing from our clients this past year."
(PRWEB) July 20, 2011
The FDA has recently issued a Safety Communication Update Regarding the Serious Complications Associated With Transvaginal Placement Of Surgical Mesh For Pelvic Organ Prolapse.
The L.A. Times reported on July 13, 2011 the FDA released an updated advisory on serious complications associated with Transvaginal placement of surgical mesh for pelvic organ prolapse. The FDA has scheduled a meeting for a panel of outside experts for recommendations on how to proceed
on September 8-9, 2011.
Highlights of the FDA Update are as follows:
- 100,000 women were treated for Pelvic Organ Prolapse with surgical mesh last year
- 75,000 women were treated with Transvaginal Mesh
- Between 2005-2007 manufacturers reported over 1000 reports of serious complications
- Since 2008 reports of serious complications have jumped 5 fold, and include erosion, when the skin breaks and the device protrudes
- TVM exposes patients to a number of serious risks
Dr. William Maisel, a chief scientist for the FDA's medical devices arm was quoted, " We feel that the routine use of mesh for Transvaginal POP treatment is not necessary."
The FDA is not recommending removal at this time, but wants to make physicians and patients aware of the reported risks.
The most common complications reported after Transvaginal Mesh Implant are: erosion, pain, infection, urinary problems, bleeding and organ perforation.
Attorney Holly Ennis stated: "after reviewing the Updated FDA Communication the complications that are being reported confirm what we have been hearing from our clients this past year."
Attorney Ennis is recommending that all patients with symptoms should first seek medical attention. Secondly, they should fill out a MedWatch form (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm) prior to the FDA hearing in September to make the FDA aware since these types of complications are underreported. Thirdly, 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 at 1-800-856-6405 or going to http://www.ennislaw.com and filing out 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. Ennis & Ennis, P.A. has recovered over $100 million in settlements for it's clients.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, 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 you can file a claim so don't wait to explore your legal rights by calling toll free 1-800-856-6405 or going to http://www.ennislaw.com.