FDA admits mistake in approving knee device

Oct 14, 2010

(AP) -- The Food and Drug Administration says it made a mistake in approving a controversial knee implant against the advice of its scientific reviewers.

The unprecedented announcement comes a year after the agency first acknowledged that its decision to approve ReGen Biologics' Menaflex implant was influenced by outside pressure, including lobbying by four lawmakers from the company's home state of New Jersey.

The 2008 decision to approve the devise was made despite protests by FDA scientists that Menaflex - which reinforces damaged knee tissue - provides little, if any, benefit to patients.

The FDA says it is taking steps to revoke Menaflex's approval, although it also plans to meet with the company to discuss what data would be needed to prove the device is actually safe and effective.

Explore further: Large but unexplained variations in paracetamol-induced liver failure among European countries

0 shares

Related Stories

Device approval exposes political pressure on FDA

Sep 25, 2009

(AP) -- The Food and Drug Administration has taken the unprecedented step of acknowledging that it buckled to "extreme" pressure from Capitol Hill in its approval of a knee repair device last year. While FDA officials call ...

FDA moves toward tighter medical device oversight

Aug 04, 2010

(AP) -- Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed ...

FDA medical device approvals get external review

Sep 23, 2009

(AP) -- The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.

Recommended for you

Obese British man in court fight for surgery

Jul 11, 2011

A British man weighing 22 stone (139 kilograms, 306 pounds) launched a court appeal Monday against a decision to refuse him state-funded obesity surgery because he is not fat enough.

2008 crisis spurred rise in suicides in Europe

Jul 08, 2011

The financial crisis that began to hit Europe in mid-2008 reversed a steady, years-long fall in suicides among people of working age, according to a letter published on Friday by The Lancet.

New food labels dished up to keep Europe healthy

Jul 06, 2011

A groundbreaking deal on compulsory new food labels Wednesday is set to give Europeans clear information on the nutritional and energy content of products, as well as country of origin.

Overweight men have poorer sperm count

Jul 04, 2011

Overweight or obese men, like their female counterparts, have a lower chance of becoming a parent, according to a comparison of sperm quality presented at a European fertility meeting Monday.

User comments : 1

Adjust slider to filter visible comments by rank

Display comments: newest first

CarolinaScotsman
not rated yet Oct 14, 2010
FDA caving to political pressure, nothing new. FDA admitting it, world shaking.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.