Navigation Links
FDA Orders Postmarket Surveillance of Certain TMJ Implants
Date:2/7/2011

SILVER SPRING, Md., Feb. 7, 2011 /PRNewswire-USNewswire/ -- Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.

The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, make all of the currently approved TMJ devices marketed in the United States. The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.

TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy.

The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.    

The FDA is not recommending any changes on use of the implants. The agency may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies. Patients who have or are considering a TMJ implant should consult with their health care professional.  

TMJ implant manufacturers were required to collect postmarket data on their implants as part of the approval process. However, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.

The TMJ implant postmarket surveillance studies must address the following:

  • Time between initial implant and removal/replacement
  • Association between patient diagnosis and the timeframe between implant and removal/replacement
  • For replacement implants, the time between implant and subsequent removal/replacement
  • Reasons for removal/replacement of the implant
  • Associations between patient demographic and clinical data and the need or removal/replacement
  • Assessment of devices that have been removed from patients

As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices.  

For more information:

522 Postmarket Surveillance Studies

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm

522 Postmarket Surveillance Studies – Frequently Asked Questions

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries:  888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Novo Nordisk Creates First Mobile Application to Help Doctors Diagnose Bleeding Disorders
2. Repligen Licenses Rights to Use of HDAC3 Inhibitors for Memory Disorders
3. Anaphore Enters R&D Partnership with Mitsubishi Tanabe Pharma to Develop and Commercialize Novel Protein Pharmaceuticals for Autoimmune Disorders
4. Tanabe Research Labs Enters R&D Partnership with Anaphore to Develop Novel Protein Pharmaceuticals for Autoimmune Disorders
5. Graymark Healthcare to Focus on Treatment of Sleep Disorders with Completed Sale of Independent Pharmacy Business Assets to Walgreens
6. Karyopharm Therapeutics Inc. Closes $20 Million Series A Financing to Advance Pipeline of Novel Nuclear Transport Modulators for Cancer, Inflammation and Other Disorders
7. Merlot OrthopediX Enters into Exclusive Global Agreement with Alphatec Spine to Develop and Market Merlots Bone Anchorage Technology for the Treatment of Spine Disorders
8. Stereotaxis Announces Third Quarter 2010 Capital Orders of $12.2 Million, Up 94 Percent Year-to-Year
9. Express Scripts Accurately Predicts Which Patients Are Likely to Ignore Doctors Orders
10. All-Time High in Q Orders for Wound Management Technologies, Inc.
11. Depression and Cognitive Disorders: at the Onset of Alzheimers Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016 /PRNewswire/ ... pulmonary function testing company, is now able to perform sophisticated lung ... ndd Medical Technologies , Inc. Patients are ... labs.  Thanks to ndd,s EasyOne PRO ® , ARL patients like ... any needed testing done in the comfort of her own home. ...
(Date:6/24/2016)... 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... inhaled drugs, announced today that it was added to ... its comprehensive set of U.S. and global equity ... an important milestone for Pulmatrix," said Chief Executive Officer ... of our progress in developing drugs for crucial unmet ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... TopConsumerReviews.com recently awarded ... Eyeglasses . , Millions of individuals in the United States and Canada wear ... a way to both correct vision and make a fashion statement. Even celebrities use ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
Breaking Medicine News(10 mins):