After they get into the marketplace, the companies selling these products need to do more to identify problems early on in order to prevent patients from suffering the serious damage these products can cause.
Athens, GA (PRWEB) December 30, 2011
Henry G. Garrard III, one of the country’s leading transvaginal mesh attorneys, said today that he supports Federal lawmakers’ efforts to improve monitoring of the safety and effectiveness of medical devices such as surgical mesh implants.
On December 14, a bipartisan group of U.S. Senators introduced legislation that would give the U.S. Food and Drug Administration (FDA) the power to force medical device companies to track their medical devices, including pelvic mesh implants, after they’ve been sold or used, according to the New York Times.
The newspaper reported that a trio of senators also wrote letters to five of the nation’s largest medical device manufacturers, including pelvic mesh manufacturer C.R. Bard, Inc., requesting information on how the companies handle recalls and post-marketing surveillance of their products.
Garrard currently serves as lead counsel for the plaintiffs in the In re Avaulta Pelvic Support Systems Product Liability Litigation (MDL No. 2187), which involves claims against C.R. Bard, Inc., and subsidiaries of Covidien PLC relating to those companies’ women’s pelvic repair products.
“The problem is that too many defective and dangerous medical devices make it to the market in the first place under the FDA’s 510(k) process because they are never demonstrated to be safe or effective before being cleared for sale,” said Garrard, the managing partner of the Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C.
“After they get into the marketplace, the companies selling these products need to do more to identify problems early on in order to prevent patients from suffering the serious damage these products can cause,” he said. “This legislation and the information requested by the senators would be positive steps towards achieving that goal.”
According to the New York Times, the bill sponsored by Sens. Herb Kohl (D-Wisconsin), Richard Blumenthal (D-Connecticut) and Charles E. Grassley (R-Iowa) would apply to medical devices that were cleared by the FDA under the 510(k) process, such as surgical mesh implants.
The 510(k) process does not require pre-market clinical testing to establish the safety or efficacy of the device. Instead, the manufacturer has to show only that the product is “substantially similar” in safety and effectiveness to a product that is already on the market.
The proposed legislation would give the FDA the authority to require companies to collect data on a device’s performance and tighten its scrutiny of product recalls, the Times article said.
The letter sent by the three senators to Timothy M. Ring, the chairman and CEO of C.R. Bard, Inc., requested the company to disclose information by January 23 that includes:
- Outlining the systems and safeguards in place for monitoring devices, such as a device tracking system;
- How the company derived the device’s failure rates or rates of serious adverse events;
- How many individual complaints the company has received about its Avaulta pelvic repair mesh devices, how many were reported to the FDA, how many removal surgeries have been done to date (and how many surgeries are generally necessary to remove the mesh), and what percentage of the mesh is left in the body;
- How the company works with medical device registries, including the name and purpose of each registry, and how the company reconciles disparities in failure rates between registries; and
- Whether the company applies lessons from past recalls to present and future recalls, such as problems with communicating with patients in a recall.
“These are all important questions that need to be answered,” said Garrard.
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.