FDA Review: Breast Implant Risks and Benefits

Dr. Mackenzie discusses FDA Review of Breast Implant Risks and Benefits

Last month the FDA held a two day Public Advisory Committee meeting to discuss risks and benefits of breast implants for breast augmentation and reconstruction.  Topics included Breast Implant Associated Anaplastic Large Cell Lymphoma (see my page on BIA-ALCL here), Breast Implant Illness (BII), MRI screening (see my blog post on MRI screening here), the use of surgical mesh, implant registries and data monitoring, and improving informed consent.  

 

Attending the panel discussions were FDA and international regulators, industry representatives and patient advocates.  Presentations were done and panels discussed the issues, and each day had an open public hearing where patients, clinicians, and others talked about their experiences.  Many patients noted they were not informed of risks including BIA-ALCL and BII.

 

Recommendations from the panel included changing current MRI breast implant screening recommendation to begin between 5 and 6 years after surgery and then every 2-3 years thereafter, and allow ultrasound as an option for routine screening.  I agree with this and hope the FDA changes the current screening guidelines. The panel agreed that the breast implant informed consent process needs to be improved, and that this effort should be shared between the FDA, the plastic surgery community, and patient advocacy groups.

 

I’m glad to see that these issues are being discussed, as many surgeons are still unaware or dismissive of some patient concerns.  When I talk to patients about the benefits and risks of breast implants, I also discuss BIA-ALCL and Breast Implant Illness. I believe minimizing or ignoring these concerns is not fair to patients.  

 

BIA-ALCL can be largely avoided by avoiding the most commonly associated implants: Allergan textured implants and polyurethane textured implants (not available in the US). All BIA-ALCL cases to date have involved only textured implants.  Breast Implant Illness (and related Autoimmune Syndrome Induced by Adjuvants) is a controversial topic, but in my opinion is a real disorder in a small subset of patients. This type of condition is not well investigated using population based studies, and I hope that further bench research and properly designed studies will be supported.

 

I have requested a complete transcript of the March FDA Public Advisory Committee Meeting on breast implants.  I’ll post an update once I read it.



Author
Douglas J. Mackenzie M.D., F.A.C.S.

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BIA-ALCL

Maybe you’ve heard of Breast Implant Associated Anaplastic Large Cell Lymphoma. It’s getting more attention, and was even on the front page of the New York Times in May.