BISA Represents in Washington, DC for Medical Device Patient Safety
In May of 2019, two of our BISA representatives, Maria Gmitro and Julie Lykins, joined the Medical Device Problems advocates and traveled to Washington, DC for medical device patient safety.
In the US, the current approval process and loopholes for medical devices are harming patients. These failing devices are causing healthcare and insurance rates to rise. The current statistics are not a true representation of the problem because less than 10% of adverse events are reported and doctors are currently not required to report adverse events. The FDA recently released six million hidden reports, which included over 350,000 reports related to breast implants. Breast implants are also considered to be a Class III medical device. Thankfully, the FDA has now stopped the use of alternative summary reporting.
The Medical Device Guardians Act (HR2915) would mandate doctors to report adverse events to the FDA. The Medical Device Safety Act (HR2669) would amend the Food, Drug and Cosmetic Act to restore patient rights, hold manufacturers accountable and require safer medical devices.
Advocates also were invited to attend the “Foremothers and Health Policy Heroes Award Luncheon” presented by the National Center for Health Research (NCHR) and Cancer Prevention and Treatment Fund. The 2019 awards luncheon, organized by NCHR President Diana Zuckerman, Ph.D., was held at the Mayflower Hotel in Washington D.C. Those honored were Congresswoman Rosa DeLauro, Dorothy Butler Gilliam, and Deborah Tannen as Foremothers for their lifetime achievements in breaking down barriers and improving lives. Dr. Marsha Griffin and Dr. Cristina Muñiz de la Peña both were also honored as Health Policy Heroes.
MedTruth joined the advocates in DC and wrote about the trip in the article, “ 14 Patient Advocates Traveled to D.C. — Here's Why.”
Recommended Viewing:
The Bleeding Edge
The Bleeding Edge documentary can be seen on Netflix which examines the $400 billion medical device industry and the profit-driven mind-set that rushes implanted devices into the marketplace with proper clinical trials.
John Oliver: Medical Devices
HBO's Last Week Tonight with John Oliver produced a segment on the medical device industry's troubling lack of regulation, which can be viewed on YouTube.
