The FDA just released millions of records from an internal, nonpublic database used by many medical device manufacturers for reporting adverse events that arise in connection with their products. These records show nearly six million reports of medical device-related injuries and malfunctions that were previously hidden from the public. These reports, found in the Alternative Summary Reporting Program (ASR) were only seen by the FDA, so even doctors were unaware of the health risks of common medical devices such as surgical staplers, pacemaker electrodes, mechanical breathing machines, and defibrillators. The FDA formally terminated the ASR Program this month, largely due to public outcry over the lack of transparency.
Public Database Versus FDA Secret Database
A public database, known as MAUDE (the Manufacturer and User Facility Device Experience), tracks serious injuries or deaths associated with the use of certain medical devices. MAUDE is utilized by the medical community to promote public awareness of the hazards associated with certain medical devices. Recent investigations by Kaiser Health News and The Star Tribune revealed the existence of the FDA’s Alternative Summary Reporting Program. The ASR allowed medical device manufacturers to request the FDA for an exemption for MAUDE reporting requirements if they submitted adverse event reports to an internal FDA database that was inaccessible to the public.
According to the FDA, the ASR program began as a kind of resource management measure for reducing redundant documentation of multiple injuries and malfunction reports related to medical devices. The manufacturers who were granted an exemption from MAUDE reporting were permitted to submit quarterly, semiannual, or annual data sheets to the FDA regarding any adverse events associated with their medical devices. The FDA claims that their staff reviewers could more easily detect issues with devices by looking at these consolidated spreadsheets.
Medical Device Injuries and Malfunctions Were Kept Hidden from the Public Eye
The problem with this reporting system is that it made it easier for the medical device manufacturers to report problems, but it was essentially a way to keep serious health risks associated with these devices from becoming public. Doctors did not have access to ASR so they could not necessarily make knowledgeable decisions and recommendations to their patients regarding medical devices.
The lack of information has allegedly led to thousands of patient injuries associated with such devices as:
- Transvaginal Mesh (TVM)
- Hip Replacement Implants
- Surgical Staplers and Surgical Staples
- Breast implants
- IVC Blood Clot Filters
- Drug-coated Stents
- Pacemaker Electrodes
- Defibrillators
- Surgical Robots
- Dental implants
The release of this information illustrates that the medical device industry needs better oversight. The FDA is supposed to be providing this oversight, but the existence of the ASR leads to the question, who is the FDA protecting, the public or the medical device industry?
Contact Brett H. Oppenheimer, PLLC Today For More Information
Brett H. Oppenheimer, PLLC has stood up on behalf of clients against medical device and pharmaceutical companies, holding them accountable for injuries resulting from their defective medical devices. If you feel that a faulty medical device has severely injured you, it is in your interests to consult an experienced attorney about your legal rights.
Please call Brett Oppenheimer at (502) 242-8877 or submit a request online today for a free consultation about your legal rights.