Concerned by the decade long lack of scientific evidence last July, The TMJ Association asked the FDA to analyze all the Medwatch reports they received on TMJ total joint devices. They did and found that 52% of TMJ devices had to be explanted within the first three years because of severe pain and other problems. This continues a sordid history beginning with the Silastic and Vitek implants which have caused irreparable harm to TMJ patients.
There are those whose lives have been improved for a time by TMJ implants, but without the bioengineering, basic and clinical studies needed about these implants, the FDA and the patients, will continue to not know who will have a positive outcome, who won’t and why and if there are device issues causing problems. The FDA needs to have this information in order to make decisions that will fulfill their mission – to protect the health of the American people and we need to have this information so that we can make informed health care decisions. In this absence, this is still TMJ lotto.
Right now, there are some members of the U.S. Senate that believe their obligation is to protect the profitability of the medical device industry and are devising ways to lessen the Food and Drug Administration’s regulations – regulations that are already inadequate to protect the public as is demonstrated by the multitude of people that have received not only TMJ devices that caused harm.
The Medical Device Regulatory Improvement Act, which was introduced by Senators Amy Klobuchar (D-MN), Richard Burr (R-NC) and Michael Bennet (D-CO) that would change the FDA’s device approval process. We provide the link to the entire bill for your reading. Items that we especially feel should be addressed are:
allowing experts with financial ties to drug or device manufacturers to serve on FDA advisory panels as long as they meet certain disclosure requirements
restricting the FDA’s ability to request more data about the product
restricting the FDA’s ability to evaluate off-label uses for the device
considering alternative methods of evaluating safety and effectiveness of devices in order to reduce approval time frames and costs, and to consider whether pre-clinical rather than clinical data can be used to determine approval of some devices
I recently discussed this legislation with Marsha Love, a TMJ Silastic implant patient who is in need of a total joint device. Within hours and without my asking she e-mailed a letter to me for my opinion – a letter she intended to send to these Senators. I thought the letter was so “from the heart” and reflective of so many implant patient’s sentiments that I asked if we could use it as a sample letter for others to tailor their letter upon.
Whether you are in need of a TMJ device now, may need one in the future, or simply care about those who do, why not take the time to speak up and let elected officials know that talking is a gift that many TMJ patients no longer have.
We are providing a list of the Senators on the Health, Education, Labor and Pensions (HELP) Committee who will be deciding this issue. Also listed below are the names of FDA officials. Send them a letter with your story and concerns.
President & Co-Founder
Margaret A. Hamburg, Commissioner, FDA
Jeffery Shuren, Director, Center for Devices and Radiological Health, FDA
Mailing Address: FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993
Amy Klobuchar (D-MN)
HELP Committee Members
Democrats by Rank
Tom Harkin (IA)
Barbara A. Mikulski (MD)
Jeff Bingaman (NM)
Patty Murray (WA)
Bernard Sanders (I) (VT)
Robert P. Casey, Jr. (PA)
Kay R. Hagan (NC)
Jeff Merkley (OR)
Al Franken (MN)
Michael F. Bennet (CO)
Sheldon Whitehouse (RI)
Richard Blumenthal (CT)
Republicans by Rank
Michael B. Enzi (WY)
Lamar Alexander (TN)
Richard Burr (NC)
Johnny Isakson (GA)
Rand Paul (KY)
Orrin G. Hatch (UT)
John McCain (AZ)
Pat Roberts (KS)
Lisa Murkowski (AK)
Mark Kirk (IL)
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