New FDA Report on Risks of Surgical Mesh Designed to Strengthen Vaginal Tissue


September 02, 2011

A new FDA study recently released reveals an increase in the number of complications associated with surgical mesh that is designed to reinforce vaginal tissue which has had its strength compromised during child birth.

The new report supplements two earlier safety reports regarding transvaginal mesh complications. Surgical mesh is used to address pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP involves a weakening of anatomical structures that support organs such as the bladder, bowel and uterus that can result in these organs shifting from their normal position and bulging into the vagina.

The new FDA report indicates that an analysis of medical literature and patient data has revealed that there is minimal evidence that implanting the medical device improves POP. While the surgical mesh can be implanted either through the vagina or the abdomen, the majority of the complications were associated with vaginal implants.

A safety communication issued by the FDA July 13, 2011 indicated that the FDA had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures that were implanted from January 2008 through December 2010. The FDA reports that 1,503 of these complications were associated with POP procedures that needed repair while 1,371 were associated with SUI procedures. As many as 10 percent of patients that have the mesh implanted vaginally experience mesh erosion during the first twelve-month period following the procedure which necessitates painful revisionary surgery. In some cases, the patient needs multiple surgeries to correct the problem.

The FDA first warned of complications associated with the surgical mesh implants in 2008 when it released an alert indicating that more than a thousand complications were reported from the period of 2005-2007. The new FDA data reveals a 500 percent increase in serious POP complications and indicates that POP complications are not rare, which is a shift from the position of the FDA based on its earlier alerts. The new report also indicates for the first time adverse erosion complication, which occurs when the skin breaks and the mesh protrudes as well as complications linked to contraction of the mesh causing the vagina to shrink.

While the FDA has not recommended the medical device be removed from the market, patient advocacy groups contend that the FDA did not go far enough. It has been estimated that approximately 100,000 patients have received treatment for POP with implants of the surgical mesh during the last year with approximately three-quarters of those implanted vaginally.

If you have received treatment of POP or SUI and suffered serious adverse effects and complications after being treated with surgical mesh, including erosion, urinary pain or infection or you have had to undergo revisionary surgery, you may be entitled to compensation for your injuries. Montlick and Associates, Attorneys at Law, represents clients in Atlanta and throughout Georgia who are injured by dangerous or defective medical devices, and will provide a free consultation to review your claim.

Our Georgia surgical mesh lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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