MASSDEVICE ON CALL — Despite warnings from advisory panels and pressure from consumer groups, the FDA announced that no recall would be issued for silicone breast implants.
FDA officials decided that a lack of consistent postmarket data gathering wasn’t enough to spur a recall after a two-day General and Plastic Surgery Devices panel discussion this week where consumer groups demanded the devices be taken off the market until sellers like Johnson & Johnson’s (NYSE: JNJ) and Allergan Inc. (NYSE:AGN) fulfilled their promises to track long-term safety for the prosthetics.
Rather than issue a recall, the FDA called on the manufacturers to ramp up their postmarket tracking efforts to gather more data,
JNJ’s Mentor division and Allergan Inc. (NYSE:AGN) won FDA clearance for silicone breast implants in 2006 on the condition that they would collect safety data on 40,000 patients for 10 years.
New discussions were spurred by recent FDA warnings about common side effects of the implants, which include hardened skin around the implant, wrinkled or ruptured implants, scarring, pain and infection.
A depressed market may fuel more mergers in the life sciences
Life sciences companies that went public this year lost nearly $1.3 billion in market capitalization in last month, and that may lead private companies to steer away from IPOs and seek financing through acquisitions, life sciences analyst firm Burrill & Company wrote.
Two-chamber defibrillators present higher risks with no clear benefit
Researchers found a greater chance of surgical problems and death with devices that require electrical leads in two chambers of the heart rather than in one chamber and the devices have never been shown to lead to improved survival or decreased hospitalization rates, according to a press release from the University of Colorado in Denver.
U.S. med-tech job map
The U.S. medical devices field pays an average salary of $58,000, produces $33 billion in exports and directly impacts more than 400,000 jobs, according to an interactive map from industry lobby AdvaMed.
FDA commissioner Margaret Hamburg comments on passing of a predecessor
FDA head Margaret Hamburg the death of former commissioner Dr. Charles Edwards "a great loss to the U.S. Food and Drug Administration and to Americans who enjoy the safest supplies of food and medicine in the world, thanks to his leadership," according to an agency statement.
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