Coming Up: FDA Expert Panel Weighs in on Metal Hips

Jun 20th, 2012 | By | Category: FDA News

Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant.

It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA.

The meeting will be held at the Hilton Washington DC North/Gaithersburg , 620 Perry Parkway, Gaithersburg MD. The hotel is 301-977-8900.

The meeting will be webcast live and free of charge on both days and can be accessed at the following Web address:

On June 27, Day 1:   http://fda.yorkcast.com/webcast/Viewer/?peid=12f84ea095b445d78e9b115f495392731d

On June 28, Day 2:   http://fda.yorkcast.com/webcast/Viewer/?peid=901726ab91944b158ac705e48664921c1d

The webcast will be broadcast using Windows Media Player.

What Will Happen

The committee members, who are yet to be announced, will look at the total hip replacement systems using metal components. The FDA has the option to follow the panel’s recommendations or not.

Total Hip Replacement, FDA

Hip replacements are not uncommon among people in their 50s and 60s who have damaged hip joints from lifestyle and genetics.

There are two categories of metal-on-metal (MoM) total hip replacements (THR) – one consists of a metal ball or femoral head that fits into a metal cup in the hip bone, also known as the acetabular component. The THR is recommended when there is degenerative joint disease such as rheumatoid arthritis; to correct a deformity; or to revise a previous surgery.

The other type of MoM hip is the resurfacing system that is made up of a trimmed femoral head that has a metal covering with a metal cup in the hip bone. Resurfacing is intended to reduce pain in patients with non-inflammatory degenerative arthritis or from inflammatory arthritis. Resurfacing is generally recommended for the “younger’ patient who is still active with sports and lifestyle.  

It was one year ago in May that the FDA finally ordered manufacturers of metal hips to conduct post-market surveillance to collect more data on patient injuries after the hips have been implanted. While the UK has a National Joint Registry, the U.S. does not. This data has yet to be released.

BBC/ BMJ Investigation

In February 28, 2012, the British Medical Journal in cooperation with the BBC issued the results of a joint investigation into complications resulting from MoM hips. Researchers have known for at least 10 years that metal debris from the hips was making its way into the bloodstream of some patients and that thousands worldwide may be at risk for metallosis resulting from toxic levels of cobalt and chromium ions. Some patients scheduled to testify to the expert panel have had a metallosis diagnosis.

Howard Sadwin

In the case of metal-on-metal hips, patients are forced to undergo revision or replacement surgery. Infection is not uncommon nor is destroyed muscle and tissue left behind. Many patients have no more tissue left behind to adhere to a new hip. For many patients, the hips are failing well in advance of their expected 15 year life span.

That is the case with Howard Sadwin, 66, of Sarasota, Florida who plans to testify about his BHR hip (Smith & Nephew) that had to be removed after it dislocated and doctors found raging infections that kept him hospitalized for 10 months.

Howard’s story was profiled in Mesh Medical Device News Desk on March 5, 2012. (Here). The full list of those who plan to testify should be issued Monday, June 25.

In a  New York Times story published August 22, 2011, (here),
reporter, Barry Meier said the FDA had received more than 5,000 reports since January 2011 about several widely used MoM hip-related complications, more than the agency had received in the previous four years combined.

Metal hip complaints may eclipse the heart device component by Medtronic which gathered 7,700 complaints.

The DePuy A.S.R. or Articular Surface Replacement was recalled in 2010 by Johnson & Johnson after it accounted for more than three-quarters of the complaints. The Durom cup made by Zimmer Holdings accounted for about 1,600 complaints, reports the New York Times.

It estimated at least 500,000 patients have received MoM hip replacements.

510(k)

An FDA expert panel convened last September still has not issued its decisions on how the agency should deal with synthetic transvaginal mesh, a Class II medical device also intended to be permanently implanted. The agency has to decide whether or not mesh should be reclassified as high-risk (Class III) which would require clinical data be presented to prove safety and efficacy before it is approved for marketing. Metal hips also   Class III medical device yet approved through the 510(K) with the exception of the S&N BHR and two other resurfacing hip replacements, therefore clinical data is not required before they are approved for marketing.

Both issues put the dilemma of the 510(k) fast-tracked approval process squarely on the shoulders of the FDA. Last year an Institute of Medicine report said 510(k) is “fatally flawed” and should be abolished. #

Learn More

Earl’s View- Forum on Hip Replacement- his story
http://earlsview.com/hip-hell/

How safe are metal-on-metal hip implants?
http://www.bmj.com/content/344/bmj.e1410

BBC- Metal hip patients need lifelong checks
http://www.bbc.co.uk/news/health-17192520

Metal-on-metal implants: FDA’s role and activities. www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm

FDA will look at metal on metal hips
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297745.htm

Birmingham Hip Resurfacing System (BHR)
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078189.htm

 

 

 

Tags: , , , , , , , , , , , , , , , , , , , , , , , ,

Leave a Comment