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.
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