BREAKING NEWS: Medical Device Recall Improvement Act Introduced in Congress to Advance Patient Safety
New legislation was introduced today, September 21, 2023, to improve patient safety with implanted medical devices, including breast implants. BISA has endorsed this new legislation that would make device tracking and recall notification mandatory.
Introduced by Senator Durbin and Representative Jan Schakowsky, the goal of the Medical Device Recall Improvement Act is to improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes.
Patients and advocates have been pushing for better safety measures with regard to implanted medical devices tracking and recall notification for years. Representative Jan Schakowsky appeared in the documentary The Bleeding Edge, which is currently available to stream on Netflix. Schakowsky co-sponsored the now defunct Medical Device Safety Act and patient advocates are happy to see she has continued to root for patients and push for better safety measures.
Since many plastic surgery procedures are done outside of hospitals, this will require the health provider to record the Unique Device Identifier (UDI) of the exact implants used and require that the patient be contacted directly in the event of a Class I or Class II recall. Currently, the process is only a suggestion or guidance.
“We highly recommend watching The Bleeding Edge streaming on Netflix.”
BISA witnessed the failure of device tracking and recall notification when the implant manufacturer Allergan recalled and lost track of patients with a particular type of textured breast implants in 2019 with a high risk of causing lymphoma. Patients were not aware of which implants they had and surgeons were not alerting their patients of the recall. To this day, BISA is still contacted by patients who are unaware that they have a recalled breast implant with a high risk of causing cancer.
Madris Kinard, CEO and founder of Device Events is a healthcare IT expert and data advocate. She serves on Breast Implant Safety Alliance (BISA) advisory board and has been working on issues related to device tracking, recall notification and analyzing adverse event reports submitted to the FDA for many years.
“The practice of medicine has changed so much in the last 10 years. Many procedures previously done in hospitals are now done in clinics and physicians’ offices, especially plastic surgery devices. This bill requires that the manufacturer electronically notify user facilities and health professionals (regardless of whether they perform surgery in a hospital or a physician’s office). The health professional or hospital must then contact the patient directly if a recall affects them. This bill will help increase the adoption of the UDI.
The current process is a notification to hospitals that can be faxed, sent by FedEx, or emailed to a hospital/user facility. There will now be a standardized format that is reliable and includes the Unique Device Identifier (UDI). This bill will streamline the process and fund the FDA to institute and mandate these changes—this is critical for successful implementation.”
-Madris Kinard, CEO of Device Events
BISA’s president and founder Maria Gmitro stated, “I started advocating for the now defunct Medical Device Safety Act and Medical Device Guardians Act in 2019. I am so thankful to see this specific legislation being introduced because I have witnessed how the lack of regulation continues to harm patients and cause fear. Patients take a risk when they have surgery and they need the assurance that they will be notified in case of recall.”
It is important to note that the tracking of breast implants using the National Breast Implant Registry and Aesthetic One is not mandatory and not all surgeons are using the service. Information from these breast implant registries are not available to the public and all adverse events still need to be reported to the FDA Medwatch program.
RESOURCES
Fortune: ‘They killed her’: Why are breast implants still putting millions of women at risk?
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
The Guardian: The Bleeding Edge: behind the terrifying new Netflix documentary
Breast Implant Safety Alliance (BISA) is a 501(c)3 women-owned nonprofit, patient-centered organization dedicated to improving breast implant safety and awareness—through direct collaboration with consumers, medical professionals, manufacturers, regulators, and advocates. BISA is a 100% volunteer organization not funded by implant manufacturers.
Contact: Maria Gmitro, President | 843.501.6873 | maria@bisanonprofit.org