FDA hearings on breast implant safety

There is currently a hearing in Washington with the FDA and various individuals and organizations in regard to the safety of breast implants. What you should know.

First, the two major issues being explored are what has been termed “breast implant illness” and the other is ALCL, or anaplastic large cell lymphoma.

The first, “breast implant illness” is a constellation of complaints by some women such as joint pains, fatigue, etc. This is very similar to the complaints many years ago during the silicone breast implant litigation which was promoted by nefarious personal injury lawyers. These issues were proved to be false. Surprisingly, many of these women were cured of their symptoms upon receiving a financial settlement.  There has been extensive research into breast implants and their safety since that time many years ago. Importantly, the science, not just unsubstantiated complaints, has shown no evidence of a link between implants and these complaints. That’s not to say that a woman with implants, just like a woman without implants, can’t have these types of complaints. Also, some of these women have capsular contracture, or hardening of the scar tissue around the implant, which can cause breast discomfort. When there is low grade discomfort, especially if the contracture is allowed to continue for a long time, this can also contribute to overall aches and pains. As we have all experienced, when you are not feeling well due to a cold, it affects everything.

The other subject, ALCL, is currently being studied. This is a type of low-grade malignancy in the tissue surrounding a textured breast implant. There has never been a case of ALCL found in a woman who has only had smooth implants. I have only used smooth implants in my career, so if you are my patient, you have smooth implants and this does not apply to you. Even with textured implants, the incidence is very low, and is generally curable by implant exchange and capsulectomy, or removal of the scar tissue around the implant.

Unfortunately, the confusing factor is that there are hidden agendas and motivations going on. There are some groups that do not want women to have the choice of breast implants, and they are jumping on this. Also, and shamefully, there are some surgeons capitalizing on this hysteria and promoting their “en bloc” capsulectomy and implant removal at a very high cost.

The important thing is to not do something that would only put yourself at risk, such as unnecessary surgery. Even with textured implants, this is rare enough that there is no recommendation at this time for implant removal or exchange. Certainly for smooth implants, this problem does not appear to be related at all.

In the coming weeks and months, there will be media reports and social media postings promoting hysteria and a crisis that don’t exist. The plastic surgery societies and the FDA are continuing research into these issues. Don’t fall for information that is half-baked or outright lies. If you ever have an issue with your breast implants, always consult with your plastic surgeon certified by the American Board of Plastic Surgery.

It’s easy to blame implants for issues that we don’t take care of. As we age (myself included), we get aches and pains. As America’s obesity problems accelerate, issues will occur, because being overweight is a serious medical problem that contributes to other medical problems and complaints. Good diet and exercise will cure many things in our United States.




01     Get to know Dr. Wiener.
02    Help him understand you and your goals.
03    Learn about our services and specialties.


* All indicated fields must be completed.
Please include non-medical questions and correspondence only.

Accessibility Toolbar

Scroll to Top