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FDA Orders Safety Review of TMJ Implants

In recent years, the food and drug administration has ordered a review of the performance of TMJ implants after discovering a number of product problems.
Just a few months ago, a survey by the Sentinel and MedPage found that the agency had approved four such dental lab equipments despite potential conflicts of interest.
In announcing the move, the agency said it had found a large number of adverse events involving the device between 2004 and 2010, including those implanted with extreme pain.
Today, the FDA issued to the journal Sentinel/MedPage said in an E-mail, found in its review of the device, 52% of the equipment in less than three years after implantation were taken out, which is lower than the expected time for at least five years
It is not clear how many patients have been implanted because they have been approved since 1999 - the first time the FDA has approved it - but it is believed to be among thousands of patients.
"It must have come too late," said Terrie Cowley, President of the TMJ Association. National patient advocacy organization. "The top priority for manufacturers and the FDA is to be safe for patients who receive these implants."
A recent action by the U.S. food and drug administration (FDA) used implants to treat the temporomandibular joint disorder, a group of diseases that affect joint and head connections.
It affected more than 10 million americans, including a handful of people who underwent radical surgery to implant artificial jaw joints.
The food and drug administration says the FDA's review of these devices includes loose, hard-to-remove, noise, fractures and fractures.
In addition to the symptoms of initial surgery and was used, patients also reported a series of adverse events, including pain, additional treatment, non-operative treatment or medication, infections, such as swelling, hospitalization and headaches.
"It's too early to say whether any devices will be removed from the market," FDA spokeswoman Erica Jefferson said in an email. "We will assess the data provided and may take further regulatory action at that time."
Since 1999, the F.D.A. has approved four of the companies' four devices. When approved, it ordered the company to collect market data that is now being reordered.
The agency said the figures were inadequate and noted that it did not indicate the cause or cause of the replacement. In addition, these companies have lost contact with many patients receiving equipment.
Without knowing this information, the agency cannot determine the real safety and effectiveness of the product or whether it should be removed from the market.
"This is something that should have happened early on," says Diana Zuckerman, President of the National Research Center for Women & Families. But it's important that they eventually do. It was in 1999, but there was a new sheriff in town hoping to make a difference.
Mr. Zuckerman noted that the FDA acknowledged that device makers had lost contact with patients with a large number of implants.
In the review of clinical trial data equipment for approval, today's outpost/MedPage found the same problem: a lot of patients withdrew from the experiment, and long-term follow-up data were available, including a test data only 34 patients in the three-year mark.
Zuckerman questioned whether the FDA would seriously request long-term follow-up of patients receiving these devices.
"It's not surprising if they can't track their patients and the FDA approves it," she said. "There is no evidence that these products are safe and effective." We hope this is a new sign of real implementation. Zuckerman published some articles today in the guardian and MedPage, prompting the FDA to act.
Herb kohl, the chairman of the senate special committee on aging (d - wis), said he would pay close attention to the FDA's action, and possibly later in the year on TMJ implants and other medical equipment to hold a hearing. Cole and his staff have been investigating complaints about TMJ equipment.
"The FDA's request for additional research on TMJ devices is a positive step, which is the only way to determine if the devices are working properly and lead to excessive pain," Kohl said in a statement.
The Sentinel/MedPage survey today shows that the process is not only lacking in rigour, but is clearly biased towards supporting dental equipment.