Congressman introduced the SOUND Devices Act to close loophole in flawed medical device approval process
WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, released the following statement today after Johnson & Johnson’s Ethicon unit announced it will not continue marketing four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. This announcement comes after passage in both the House and Senate of the Food and Drug Administration (FDA) Reform Act of 2012, which failed to address a major flaw in our nation’s device approval process. Under current law, FDA is required to clear certain medical devices as long as they demonstrate their similarity to an earlier product, even if the earlier product was defective and recalled for a significant safety problem. Rep. Markey introduced H.R. 3847, the Safety Of Untested and New Devices (SOUND Devices) Act to close a major loophole in the device approval process and allow FDA to reject a device if it is based on an earlier product that had to be recalled from the market for causing serious harm to patients.
Johnson & Johnson’s decision to stop marketing the mesh implants that caused massive internal injuries to thousands of women is a welcome announcement that will hopefully spare other unsuspecting patients who would otherwise have suffered a similar fate.  But we must still address the loophole in our nation’s medical device approval process that continues to be a major public health threat. The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves. As long as this defective and deadly device loophole remains in place, ‘copycat killers’ will continue entering the market, seriously jeopardizing patients’ health.”
The FDA cleared J&J’s Gynecare TVT mesh implant based on its similarity to Protegen. Though Protegen was recalled shortly after Gynecare received clearance, mesh implants on the market today continue to trace their origin back to Protegen, despite its history of causing internal bleeding, life-threatening infections, and even death.
In February, Rep. Markey released the comprehensive new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices” that highlights the federal loophole that requires the FDA to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect.