An exercise in clock watching - the fda's review of Allergan's 410 "gummy bear" breast implants
Posted Apr 26 2009 10:11pm
As the plastic surgeons of the United States await approval of Allergan's style 410 breast implant (aka "the gummy bear" implant), I frequently get questions from patients about when this device will be approved.
The short answer is "I don't know!"
The approval of medical devices of all sorts has been heavily politicized. After a number of recent high profile issues with prescription drugs, cardiac pacemakers, and vascular stents (devices used to prop open clogged blood vessels or fix aneurysms), the FDA is under the microscope. Caught up in all this is the fate of the next generation of breast implant devices, for which the FDA has been sitting on the manufacturers approval applications for nearly 3 years.
For some context, "form stable" implants like Allergan's 410 have been used clinically around the world for over 15 years. In clinical trials (like this )they have an unparalleled safety record for this kind of medical device, and offer both superior durability and a reduction in every single kind of indexed complication (pain, capsular contracture, rippling, rupture, etc...) after cosmetic and reconstructive breast surgery that we observe and track.
Allergan's Style 410 implant:
The NY Times reported earlier in April ( here )on the ongoing reexamination of "legacy" devices that were exempted prior to the late 1970's from review as they were already being used. Silicone and saline breast implants actually already went through this review by the FDA in the early 1990's and eventually emerged with a clean bill of health. The only reason the newer implants have to go thru this process at all is the higher cohesiveness of the silicone polymer exceeds some artificial cut-off that would make them fall under the existing approval. This illogical rationale has cost tens of millions of dollars to companies and delayed patients access to improved devices.
As to the fate of the 410 implant, my understanding is that the FDA is satisfied with the safety and clinical efficacy of the implants and is negotiating on the final labeling to be included with the product. Apparently, surgeons will be required to attend an instructional course prior to being given access to the device (even someone like me who actually used these devices as a resident and fellow during clinical trials). We are hopeful that the ongoing activity signals approval is immanent this quarter!