Update on Recent FDA Panel on Breast Implants
You may have heard or read about the recent FDA Panel hearings on Plastic Surgical Devices (breast implants) that took place the end of March. The primary information points from the Panel include:
- Recommendations on MRI screening of silicone breast implants including a consensus to remove the current FDA MRI screening recommendations, and to adopt screening recommendations that begin between 5 and 6 years post surgery, then every 2-3 years after that. The use of alternatives to MRI were discussed, and ultrasound was recommended as an acceptable alternative for screening asymptomatic patients. For symptomatic patients as well as patients with equivocal ultrasound results, the Panel recommended MRI for detection of silicone implant ruptures.
- A recommendation for further study of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a lymphoproliferative disorder (LPD) associated with macrotextured implants, and Breast Implant Illness (BII), a term used by women connected through social media groups who have implants and self-identify and describe a variety of symptoms that they feel are directly related to their saline or silicone, textured or smooth implants .
- Recommendation for development of industry/physician/patient generated and shared Informed Consent checklists.
- A recommendation for the use of registries, the importance of capturing patient-reported outcomes, and the need to strike the right balance between data collection requirements and optimizing participation in the registry.
- Recommendation for the need for controlled studies on a surgical mesh called acellular dermal matrix (ADM) in reconstruction patients.
The FDA Panel provided its recommendations during the meeting, a 4 page summary of which you can find at this link:
In addition, here are links to more information about BIA-ALCL and BII:
Of course, if you have further questions or would like personalized information and recommendations, please call my office for an appointment. (561) 833-6688.