"The 510(k) process should really be called â€˜510 pray since patients should hope and pray that the medical device implanted in them wont cause serious harm," said Rep. Markey, a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA). "The SOUND Devices Act closes a major loophole in the current 510(k) device approval process. I will fight to include this bill in the FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act to ensure that medical devices are not repeating known defects."
A copy of Rep. Markeys report, "Defective Devices, Destroyed Lives" can be found HERE.
"What, exactly, is the purpose of the FDA if not to insure that the public is kept safe from harm?" said Jaye Nevarez, a victim injured by a vaginal mesh implant patient. "The FDA does not have the power to keep the public safe under the current 510(k) process where substantially equivalent devices enter the market place based on a predicate device recalled for safety issues. Nothing can change what happened to me but supporting the SOUND Act will give the FDA the power to protect others in the future."
"That the FDA does not have the ability to reject new devices based on the current flawed model is unconscionable," said Dr. Tom Margolis, a pelvic surgeon who has performed scores of "salvage" operations on women who have experienced serious complications from transvaginal mesh implants over the last decade. "I want to be a voice for the scores of women Ive treated over the last decade whove suffered devastating injuries from a flawed device that should never have been allowed on the market. I hope that Congress will work together to save future patients from a fate that has caused too much suffering in too many women to date."
"The National Womens Health Network urges Congress to stand up for womens health and pass the SOUND Devices Act," said Cynthia A. Pearson, Executive Director of The National Women's Health Network. "Women need to know that the FDA is able to take the necessary actions to ensure that devices implanted in our bodies are safe and effective, and at the very least women should have assurance that a device which has already been proven unsafe wont be left on the market to cause avoidable and devastating harm, like the account we heard today."
Four years ago, Jaye Nevarez, a 50 year-old mother of three, was a healthy truck driver who earned a decent living and paid her bills on time. However, she now lives in constant pain caused by a transvaginal mesh implant she received in 2008. The debilitating pain forced Jaye to quit her job. She cannot walk without the help of a cane or a walker. She lost her insurance, and costly medical bills led to the recent foreclosure of her longtime home where she lives with her 79-year old mother.
Thousands of patients like Jaye have suffered grave health effects from faulty medical devices cleared by the Food and Drug Administration (FDA) solely because the devices were deemed to be similar to other previously approved devices. Under current law, the majority of new medical devices go through what is known as the 510(k) process. Rather than conducting clinical trials to show safety and effectiveness, a 510(k) device must only be "substantially equivalent" to an already-approved device, even if the original device was recalled for major safety problems. As long as the device meets the "substantial equivalence" threshold, FDA has no legal authority to reject the application.
In February Reps. Markey, Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill closes a major loophole in the device approval process known as the 510(k) by ensuring that a new device is not cleared by the FDA if it is based on an earlier product that was pulled from the market for causing serious harm to patients. The SOUND Devices Act provides FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems.