Did you know that medical devices – even devices that get implanted inside your body -- can legally be put on the market without ever being studied for safety and effectiveness in human beings?
You’ve heard from the National Women’s Health Network before about the millions of women hurt by dangerous devices and the need to strengthen the Food and Drug Administration’s (FDA) medical device review process. Whether it’s a defective hip replacement or surgical mesh intended to treat reproductive health problems that has caused infections and permanent damage, the FDA has failed to keep these harmful devices off the market. I’m writing today to tell you about a chance we have to protect women’s health by strengthening the FDA review process and improving the likelihood that the medical devices we rely on will be safe.
Under current law, the FDA can allow companies to market a medical device based only on evidence that it is similar to a device already on the market. And time and again, the FDA has done this – leading to many cases where women experience serious health problems because of unsafe medical devices. But champions of women’s health have introduced a bill in Congress that would offer women better protection.
The SOUND Devices Act, introduced by Representatives Ed Markey (D-MA), Henry Waxman (D-CA), Jan Schakowsky (D-IL) and Rosa DeLauro (D-CT), would give the FDA the authority to:
- Require more information about a device and the product it is based on before the device is put on the market
- Reject a device application based on a product that has been recalled or is in the process of being removed from the market because of major safety problems
- Review the safety of a device if the product its approval was based on is recalled
These reforms will greatly improve medical device safety and better protect patients and consumers. The SOUND Devices Act has the potential to prevent future tragedies, like the terrible damage done by vaginal mesh that should never have been implanted in women in the first place.
Contact your Representative and urge them to stand for women’s health by co-sponsoring H.R. 3847, the SOUND Devices Act – the FDA needs the authority to protect patients and consumers from devices that have never been proven to be safe or effective.
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