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:2/4/2016)... LONDON , Feb. 4, 2016 ... and competitive market to drive long-term market growth ... very common set of chronic disorders that affect ... disparate in terms of their symptoms and key ... by dysregulation of immune pathways and an inappropriate ...
(Date:2/4/2016)... -- Omnicell, Inc. (NASDAQ: OMCL ), a leading provider of ... announced results for its fiscal year and fourth quarter ... --> GAAP results: Revenue for the fourth quarter ... 4.1% from the third quarter of 2015, and up ... 2014. Revenue for the year ended December 31, 2015 was ...
(Date:2/4/2016)... Feb. 4, 2016  Aethlon Medical, Inc. (Nasdaq: ... biofiltration devices to treat life-threatening diseases, today announced ... ended December 31, 2015. --> ... set forth in our last quarterly call, we ... our long-term objective to establish the Aethlon Hemopurifier® ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... ... US Sports Camps , official operators of Nike Yoga Camps, announces ... training. ChildLight Yoga Studio is centrally situated in the picturesque New England city of ... founder Lisa Flynn expresses her excitement, “We are thrilled to be partnering with US ...
(Date:2/5/2016)... Texas (PRWEB) , ... February 05, 2016 , ... ... to allow users to search for and donate to Give To Cure’s campaign that ... an app that lets users make and share payments through a smart device. In ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Justin Scott and Dr. ... Annual No Cost Dental Day to individuals in need. The event is scheduled to ... No Cost Dental Day is to provide dental care to community members in need. ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... In sleep, ... form as a dream. A hallmark feature of patients with eating disorders is significant ... The eating disorder behaviors and obsessions are regarded as maladaptive means for coping with ...
(Date:2/5/2016)... ... ... Calls Blacklist has just been updated by mobile app developer Vlad Lee. The ... known bugs within the app. Calls Blacklist allows its users to only have to ... their device’s battery power or memory. It provides a powerful call blocker that is ...
Breaking Medicine News(10 mins):