Sunday, April 26, 2009

An exercise in clock watching - the fda's review of Allergan's 410 "gummy bear" breast implants

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!



Anonymous said...

When? I had a deip flap recon in 2007 and due to radiation (previous to the diep) the ca side is about one size smaller, contracted somewhat and higher. My PS told me about gummies and we have been waiting. He feels these would be the best option for me. The only other alternative I have is to do another type implant with alloderm alongside it? Not sure. I have another appt with him to find out more. If these will be approved soon, I will wait. If not, I might go ahead with something else. How can I find out more? I can find almost NO info online about anyone who has had diep and then implants later.

Dr. Rob Oliver Jr. said...

I'm not so sure a more traditional round implant may not be preferred in your case. The more operated a breast has been, the more issues you get into about rotation of the implant, a real problem for shaped devices like the Allergan 410.

I'm told that as soon as they're approved, Allergan is likely to roll out rounder shaped form stable devices for the American market which would be more like the devices we're used to.

Dr. Rob Oliver Jr. said...

Another thought, you may be able to improve the size with fat grafting into the DIEP falp. I ironically, just finished doing that on a radiated TRAM just now

Anonymous said...

I'm supposedly enrolled in a clinical trial for the gummy bear implants and scheduled for sx 12/15. My question is the price - $7900altho she'll be doing a re-lift she did 2 yrs ago that didn't take. Is $2100 right for the implants(I live in NJ)? And what about the compensation structure: the doc has it so she gets the $100 for every visit post sx then doesn't charge the patient.

tmvitale58 said...

Ok how about an update on the 410 implants,we are now nearing the end of 2009 and I am schedual for a "big" revision in Feb 2010 and am told that these would be optimum for me. Since my last surgery from another PS was sooo screwed up I would love to have this be it for a while.Any info please.

tmvitale58 said...

OK, It is now Nov. 2009, and I am scheduled for a complete revision to my reconstruction in Feb. 2010 and am wondering if the 410's are any closer being used in my surgery. MY current PS said they would be ideal for me as I am very thin. Any info would be helpful. Also how can I appeal to Allergan? Any info would be greatly appreciated.