FDA Reiterates That Breast Implants Are Safe

FDA Reaffirms Breast Implant Safety The FDA released another report on silicone gel breast implants that again reaffirmed their safety. Yesterday’s FDA statement concluded that silicone gel breast implants are safe and effective when used as labeled in breast augmentation. The FDA admits that there can be complications in some cases, but that the risks are well known and well understood by women. Specifically, the FDA’s conclusion is as follows: Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions.
The FDA also noted that there was no apparent association between silicone gel breast implants and illnesses such as connective tissue disease, breast cancer or reproductive problems. In addition, the FDA concluded that breast implants do not hinder breast feeding nor do they pose risks for children who are breast fed. Silicone gel breast implants were pulled off the market in 1992 over fears that leaking silicone gel caused significant illnesses like the ones mentioned above. The allegations led to litigation and multi-billion dollar settlements, but scientists were never able to determine that the allegations had merit.

The FDA based its opinion on many studies done over a number of years. The largest studies were those begun in 2006 by Allergan’s Natrelle unit and Johnson and Johnson’s Mentor unit. Natrelle and Mentor are the two largest breast implant manufacturers in the United States. Both units are based in California.

The FDA’s recommendations include reviewing the literature about breast implants that will be provided to you by your plastic surgeon. While we believe this is important, we also believe that you should talk about the risks and benefits of breast implants with your plastic surgeon. A discussion with a trained, board certified plastic surgeon will give you much more information on breast implants than a simple brochure. According to Mentor,

We concur with the FDA that women should fully understand there are potential risks associated with breast implants, and they should discuss risks and benefits with their plastic surgeon prior to breast augmentation or reconstruction.
The FDA’s release is just another piece of good news for those with or considering breast implants. It is possible that breast implants are the single most studied medical device in history. The fact that the FDA repeatedly deems them “safe and effective” should help women to feel confident about breast augmentation surgery. While breast implants do have risks that should be understood, a discussion with a board certified plastic surgeon will help you to determine if breast implants are right for you.

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