Vaginal Mesh Complications
Senators Introduce Legislation to Protect Patients from Unsafe Medical Products
Three senators have introduced new legislation to help better protect patients from unsafe medical devices like defective hip implants and controversial vaginal mesh products. Called the “Medical Device Patient Safety Act,” the bill was introduced by republican Chuck Grassley from Iowa, democrat Richard Blumenthal from Connecticut, and democrat Herb Kohl from Wisconsin, and is most likely prompted by the many injury lawsuits filed against companies like DePuy, Johnson & Johnson, Zimmer, and C.R. Bard.
FDA’s 510(k) Process Blamed for Problems with Vaginal Mesh
Plaintiffs claiming injuries from medical devices like vaginal mesh and hip and knee implants have often partially blamed the FDA’s 510(k) approval process for their woes. The 510(k) does not require that a company produce clinical trials to prove their product is safe, but only that they prove their product is “substantially similar” to one that is already on the market.
The FDA’s 510(k) process allows manufacturers to more quickly provide new medical technology to consumers without years of delays for paperwork and studies. The process has been criticized, however, for allowing devices like vaginal mesh and artificial implants to be used in patients before safety has been adequately established.
The FDA has been encouraged to revamp or replace it’s 510(k) process, but the debate is heated, and so far no change has taken place. Those in support of the Medical Device Safety Act hope that new legislation will help protect patients in the meantime.
New Act Allows for Improved Product Safety Monitoring
This new act would allow the FDA to more quickly discover problems with new devices, and better manage recalls when problems do occur—without slowing down the approval process with changes to the 510(k).
For example, part of the bill proposes allowing the FDA to grant “conditional” clearance to devices approved through the 510(k), meaning that the agency would have more authority to evaluate the safety, effectiveness, and reliability of a device once it’s on the market. They would also have more authority to require changes to labels and advertising, and could rescind the conditional clearance if they determined proper conditions hadn’t been met.
If the FDA had had such authority concerning vaginal mesh products, for example, they may have set a conditional clearance on products like Bard Avaulta mesh, and required stricter warnings at an earlier time, or even rescinded clearance once the problems became clear.
New Act Also Improves Recall Tracking
The FDA currently has authority to track recalls, but the new act would require them to track all recalls, whether requested by them or the manufacturer, and to use the information to identify strategies for reducing health risks. The bill also seems to give the FDA the authority to assess whether or not a company implemented an effective recall of a defective product.
Overall, the act seeks to provide the FDA with more authority to evaluate and assess the safety of products once they are on the market, in the hopes that problems will be detected more quickly, and more injuries prevented. The three senators also sent letters to five companies asking them how they conducted post-market surveillance of their recalled products. CR Bard, which produces vaginal mesh products including Bard Avaulta mesh, was one of those companies that received a letter.
Bard avaulta lawsuits have been brought by vaginal mesh lawyers for women across the United States who have been injured from vaginal mesh complications.