February 1, 2012 ~ Bloomberg reports on a bill introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that's been recalled or found to be defective. The bill was introduced by Democratic lawmakers including Rep. Edward Markey (D-MA) on Tuesday, January 31 (here).
The proposed legislation HR3847, refers to the recalled ProteGen mesh, used as a predicate device for almost every synthetic mesh on the market today. Despite the fact the Boston Scientific mesh device was recalled for safety concerns in 1999, manufacturers hoping for a fast-tracked 510(k) approval for marketing cited their new device as “substantially equivalent” to the ProteGen mesh. The proposed legislation would close that loophole and require the FDA to review any devices named as a predicate to determine if there were any recalls. (see story here).
In a statement, Rep. Markey said:
“If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” said Rep. Markey. “The SOUND Devices Act is based on the common sense principle that patients should not be put at risk by devices that are allowed to be sold only by proving their similarity to a defective product. The SOUND Devices Act closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”
There is no vehicle within the FDA that allows for a reexamination of medical device when its stated predicate has been found to be defective (see series, Suffering in Silence, 2009 here). Unlike drug approvals, the majority of medical devices do not have to undergo the more stringent premarket approval (PMA) requiring evidence of safety and efficacy.
In a news release, Rep. Markey cites defective bladder slings that cause pain, nerve damage and bleeding. They were approved based on the recalled ProteGen sling; metal-on-metal hip implants that were also cleared through the 510(k) process which are causing patients metal poisoning.
The bill will need to be approved by the House (Republican-controlled) and the Senate before going to the president for his signature.
About 3,000 medical devices are approved for sale by the FDA every year under the 510(k) process. #