FAQs: Silicone Breast Implants & Breast Augmentation

FDA Approval of Silicone Breast Implants - What Happened?

It's a long story. It finally ended in November of 2006 when the FDA approved the silicone gel implants of Mentor (Memory Gel) and Allergan (Biocell) as safe and effective for use in all women. Previously, only women in studies or who needed breast reconstruction could get these implants. The November 2006 approval did NOT include the "gummy bear" implants (Allergan's 410 and Mentor's CGP implant) but these are available in trials. Ask your doctor. They may be available by late 2007. Stay tuned. Read more about silicone gel breast implants in our Silicone Gel Resource Center.

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OK, here's the long version:

From the FDA:

On April 11-13, 2005, the FDA sought input from an Advisory Panel of outside experts on the data contained in the Inamed and Mentor Premarket Approvals (PMAs) for silicone gel breast implants during an open public meeting. In a 5 to 4 vote, the Panel recommended "not approvable" of the Inamed PMA. In a 7 to 2 vote, the Panel recommended approval of the Mentor PMA with conditions. The Panel makes a recommendation to FDA which then makes the final decision. FDA's review of the Inamed and Mentor PMAs continues.

The FDA Panel agenda, Panel roster, briefing materials (e.g., sponsor information, FDA Panel memo), and FDA slides are available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg= 593 . (the Panel transcript should be available at the same location).

Although Inamed's PMA approval for their silicone gel breast implants was recommended for denial by the panel 5-4 and Mentor's PMA was recommended for approval by the panel 7-2, the FDA body itself does not have to follow the panel. I believe the FDA has up to 90 days to decide. We'll keep you posted.

Note from Nicole: I personally attended the conference on April 11th, 2005 to give testimony on behalf of myself and on behalf of all of the women who visit this website. My sister, Michele, also testified and both of us were interviewed extensively by print and television media. Fortunately, for a change, they picked up a lot of it in the newspapers and my sister and I were quoted extensively for the positive side of breast implants and our opinion that women should be able to choose. See a few samples of news articles at here.

I met quite a few characters that day, including a woman who believes her breast implants made her sick. She was convinced that I too, would be quite sick, and soon. She told me, "You'll be sick soon, just wait." Amy Gandy, President of the pro-choice organization, the National Organization of Women (NOW), also told me that I DO have a choice: "the choice to get sick."

A group of teenage girls who were recruited by Gandy and NOW, wore t-shirts that said "100% All Natural" in an effort to mock women with breast implants (and, I would assume, anyone with dental work, colored hair, make up and any sort of artificial prosthesis). I confronted a dozen of them in the hallway and told them that I thought they were hypocrites and how dare they judge me for fixing a void left by the removal of a breast tumor at the age of 12 and the volume lost from breastfeeding two children. They obviously had no retort so Gandy stepped in on behalf of NOW and told me about my only choice: to be sick. "My choice, my body?" I'm not so sure, Ms. Gandy. Fortunately, the NY times picked up the confrontation and quoted her. Her anti-choice comment was in every paper in the country the next day. Gandy, who is apparently a medical expert as well as an abortion choice proponent, also believes that I will be sick soon. After I told her I have had my implants for 8 years already, she quipped, "Now is when it starts."

I was also interviewed on MSNBC on April 13th, along with a so-called silicone survivor from Colorado and very simply made the point that women want the choice. We want all of the information, and then, we want to choose for ourselves. If we can find a bandwidth-manageable way of putting the TV interview online, we'll announce that here.

There were many well-dressed and well-spoken (and apparently healthy) breast implant recipients who addressed the panel and discussed the right of a well-informed woman to choose. I think that the FDA panel took that into consideration, along with the data presented by Mentor, in recommending approval. Based on the FDA's decision, Inamed could go back to the FDA for another PMA in the future once they have more data to present.

After the 2005 silicone follies at the FDA, many doubted whether the FDA would make good on it's apparent approval. It did so on November 17, 2006. Silicone gel breast implants are now available in the U.S., as they have always been in Canada and Europe, to women (over age 22) who want them for primary or secondary cosmetic breast augmentation as well as breast reconstruction.