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:2/12/2016)... -- Memorial Hermann Health System has teamed up with Houston ... a one-of-a-kind experience to pediatric patients at Children,s ... 360-degree video and Google Cardboard, Howard was able to ... the patients and their families an unexpected, and energetically ... video . Memorial Hermann IRONMAN Sports ...
(Date:2/12/2016)... 12, 2016  Aralez Pharmaceuticals Inc. (Nasdaq: ARLZ ... Company will ring the Nasdaq Closing Bell at the ... at 4:00 p.m. ET on Tuesday, February ... Adrian Adams , will perform the honorary ... 4:00 p.m. ET.  A live webcast will be available ...
(Date:2/12/2016)... 12, 2016 --> ... Chronic Inflammation Global Clinical Trials Review, H2, 2015 ... global clinical trials landscape along with top level ... Country (G7 & E7), Trial Status, Trial Phase, ... top companies involved and enlists all trials (Trial ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... ... With FCPX Overlay Embers from Pixel Film Studios users can now apply ... user can select from up to 40 effect overlays. With FCPX Overlay Embers users ... value, contrast, glow, and more all within a click of a mouse. , ...
(Date:2/13/2016)... ... , ... When an Au Pair comes all the way around the world to ... and they are often worried things won’t go well. More often than not, however, they ... Pair of the Year winner’s all commented how their Au Pairs have become a part ...
(Date:2/12/2016)... ... February 12, 2016 , ... Mystic Buddha Publishing House presents Valentine’s ... Buddha, the biography of Rama - Dr. Frederick Lenz. , According to ... of a Buddhist teacher for teaching and helping others. Valentine’s Day celebrates love ...
(Date:2/12/2016)... ... ... , Back to the Future , Feb. 25, 2016 — 11:00 a.m. – 12:30 p.m. ... learn from history are doomed to repeat it.” , An analysis of CDRH’s enforcement actions ... takes time. , Take a close look at the warning letters the agency sent ...
(Date:2/12/2016)... ... ... Coco Libre, the maker of coconut water beverages with a purpose, is ... Coco Libre will offer musicians and celebrities the company’s signature Organic Coconut Water, a ... suite, held this year at the W Hollywood Hotel, has become a pre-show “must” ...
Breaking Medicine News(10 mins):