Citing the need for increased follow-up measures, the U.S. Senate has proposed a bill which would allow the tracking of potentially defective medical devices, such as hip implants and vaginal mesh implants.
The proposed bill would grant the U.S. Food and Drug Administration the authority to order companies to conduct safety studies after a product as been approved. The measure is intended to safeguard consumers from potentially defective products that would normally be approved under the FDA’s 510(k) system.
Under the current guidelines, companies that manufacture medical devices only have to prove that they are substantially similar to products already on the market in order to gain approval. The 510(k) process was used to approve defective DePuy ASR hip implants that were later recalled in 2010 as well as a number of vaginal mesh devices, which have also proven problematic. In July 2011, the Institute of Medicine recommended that the FDA retire the 510(k) guidelines and introduce new safety standards for approving medical devices.
Numerous lawsuits have already been filed against DePuy Orthopedics, alleging that the devices caused serious pain and other complications, including metal poisoning. In some cases, plaintiffs who received a DePuy ASR hip implant had to undergo additional surgery to correct the injuries caused by the device.
Bard, Boston Scientific, Johnson & Johnson, and American Medical Systems collectively face thousands of lawsuits from women who claim that they experienced severe pain, infection, scarring, blood vessel damage and other complications after receiving a defective transvaginal mesh implant. The first bellwether trials in the vaginal mesh litigation are scheduled to begin in November 2012, when a federal court will hear arguments from approximately 600 plaintiffs who filed suit against Johnson & Johnson over the company’s Ethicon Gynecare vaginal mesh system.
The Senate has sent letters to both Johnson & Johnson and Bard, requesting more information about how the companies monitor the safety of their products once they reach the market and how recalls are typically handled.
While the Senate argues that the additional oversight is needed to prevent additional injuries to consumers, a device industry lobby group is strongly opposed to the move. The Advanced Medical Technology Association calls the proposed bill unnecessary, claiming that less than .5% of all devices approved by the FDA are subject to a recall.
While it remains unclear what will become of the Senate’s proposed bill, it is more than evident that concerns over the safety of these medical devices are growing. As the lawsuits against Bard, Johnson & Johnson and other companies continue to mount, the FDA may be required to change its practices in order to ensure public safety.
If you or a loved one has suffered injuries or other complications after receiving a vaginal mesh implant or a DePuy ASR hip replacement, you need to speak with an experienced personal injury attorney immediately. The law firm of Nadrich & Cohen LLP specializes in handling injury claims from patients in all 50 states who’ve experienced serious side effects after receiving one of these devices.
Call our Injury Hotline today at to schedule your free initial case evaluation. You may also visit our Vaginal Mesh Resource center or our Hip and Knee Replacement information site for more information. Call now to get the expert legal representation you need to prove your defective medical device injury claim.