The FDA is now beginning to look more closely into the serious public safety concerns relating to these products that, frankly, the manufacturers should have studied and addressed before ever putting these products on the market.
Athens, GA (PRWEB) January 10, 2012
Georgia transvaginal mesh lawyer Henry G. Garrard III said today that he supports the U.S. Food and Drug Administration’s decision to require new post-market studies by the manufacturers of surgical mesh devices that are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in female patients.
Garrard also expressed concern that these products are still being sold and implanted in women, saying the FDA should take further and stronger action against these devices in the interest of women’s health.
On January 4, the FDA announced that it had sent post-market study orders to 33 manufacturers of urogynecologic surgical mesh products used for POP repair. The FDA also sent orders to 11 manufacturers of single-incision mini-slings for SUI treatment. The studies that the FDA ordered are also known as “522 studies.”
The FDA said that data from the studies will help the agency to “better understand the safety and effectiveness profiles of these devices” amid growing concerns about them.
Under the FDA’s current process, the surgical mesh products were allowed to be sold without a formal evaluation by the FDA or any other government body to determine whether they are safe or effective, Garrard pointed out.
An FDA committee recently published its findings that it “has not seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk.”
Garrard said that these transvaginal mesh products were not only allowed to be implanted in women without first being shown to be safe, they were also not required to be tracked by the manufacturers.
“By ordering these new post-market studies, the FDA will at least increase its ability to monitor this significant, industry-wide problem affecting women’s health,” Garrard said.
Garrard, who serves as the managing partner of the Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C, has been on the forefront of litigation involving transvaginal mesh products since 2006.
He currently serves as lead counsel for the plaintiffs in defective transvaginal mesh claims against C.R. Bard, Inc., and subsidiaries of Covidien, plc. (In re Avaulta Pelvic Support Systems Product Liability Litigation, MDL No. 2187, U.S. District Court for the Southern District of West Virginia).
He previously served as plaintiffs’ lead counsel in the In Re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation in the U.S. District Court for the Middle District of Georgia (MDL No. 2004).
Together with lawyers from other law firms from around the country, Garrard has recently petitioned the Judicial Panel for Multidistrict Litigation to create three new MDLs to handle the growing number of cases filed on behalf of women who have been injured by transvaginal mesh products sold by American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326), and by Ethicon, Inc. (MDL No. 2327).
“For years, we have called for tighter scrutiny of transvaginal mesh devices,” Garrard said.
“Based on our experience in litigating these cases, we believe these products have harmed thousands of women across the country.”
Garrard said he supports the FDA’s increased scrutiny of these products. However, he said it will do little to help the women who have already been harmed by transvaginal mesh products.
“The FDA is now beginning to look more closely into the serious public safety concerns relating to these products that, frankly, the manufacturers should have studied and addressed before ever putting these products on the market,” he said.
In addition to the post-market surveillance studies, the FDA is also considering a recommendation to upgrade transvaginal mesh used for POP treatment to Class III status, which would require pre-market testing.
The agency has said it will continue to monitor and evaluate the effects of using surgical mesh to treat SUI.
About Blasingame, Burch, Garrard & Ashley, P.C.
Blasingame, Burch, Garrard & Ashley, P.C., is an Athens, Georgia-based law firm that has been widely recognized for its ethics, skill and professionalism by Martindale-Hubbell®, The Best Lawyers in America, American College of Trial Lawyers, Super Lawyers and Law & Politics Media/Atlanta Magazine. Since 2006, the firm’s defective medical device and product liability lawyers have pursued claims involving defective transvaginal mesh products, including handling attorney referrals from co-counsel across the country. For more information, call the firm at (866) 354-3544 or use its online contact form.