It’s amazing what you will find sorting through more than 20 years of stuff. This picture of 3 implants includes: top — an old McGhan double lumen (silicone gel implant surrounded by a saline implant); bottom left – Dow Corning textured silicone implant; and bottom right – Dow Corning smooth silicone implant. Dow Corning has not made breast implants since approximately 1992.
Last week the FDA met to discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. As a condition of placing silicone implants back on the market in 2006, both Mentor and Allergan (McGhan) were supposed to enroll patients in 10-year-long follow up studies on side effects related to implants. The aim was for 80,000 women.
I agree these studies are needed, but it is difficult to get women to return year after year. This is evident in the data presented at the meeting: Read more »
*This blog post was originally published at Suture for a Living*
I was reading my daily MedPage Today news, when I came across this amusing example of regulatory unintended consequences. As we all know, pharmaceutical companies are not allowed to promote off-label uses of their medications – doing so is punishable with billions of dollars in fines (just ask Pfizer). But a new set of rules created by the FDA’s Risk Evaluation and Mitigation Strategies (REMS) program essentially requires Allergan to provide safety information about off-label uses of the drug — uses that are illegal for them to discuss.
So Allergan has to file a law suit to resolve the issue of being required (by the government) to do something the government considers criminal.
And the winner is?