FDA Draft Guidance on Breast Implants

This week the FDA issued a draft guidance regarding breast implants. According to 2018 statistics from the American Society of Plastic Surgeons breast augmentation is the most popular cosmetic surgical procedure with more than 300,000 procedures performed. Breast reconstruction after mastectomy accounts for in excess of 100,000 additional procedures. There are two separate issues of concern to the FDA: BIA-ALCL (breast implant associated anaplastic large cell lymphoma) and BII (breast implant illness). ALCL is a rare cancer involving the immune system. It appears to be mostly associated with textured implants from one manufacturer (Allergan). Approximately 600 cases have been reported worldwide with 33 deaths. Symptoms of ALCL are most often swelling and the accumulation of fluid around the breast. There is another small group of patients with breast implants who are reporting multiple types of symptoms which may be related to their implants. These include fatigue, joint pain, headaches, etc. which are possibly associated with an associated auto-immune condition.

The draft guidance from the FDA is now open for public comment. If approved, it would require:

  • A warning on the breast implant boxes
  • Patient-decision checklist
  • Device/materials descriptions, including types and quantities of chemicals and heavy metals that reside in, or are released by, breast implants
  • Silicone gel-filled breast implant rupture-screening recommendations
  • Updated patient device card

What should a patient who has breast implants and no symptoms do? Proactive annual screening including physician examination, mammograms, ultrasound and, if indicated an MRI is recommended. In my opinion, removal of implants and/or capsules in asymptomatic patients with normal studies is not indicated at the present time, but such a decision can only be made after examination by your surgeon and appropriate studies being performed. There are surgeons recommending total removal of the implant and capsule. Significant complications with the removal of the posterior (back) wall of the capsule in patients with submuscular implants have been reported. Such a decision should be made carefully after considering all the options, risks, and alternatives, especially, in the absence of any symptoms or findings on MRI, mammogram or ultrasound. If you are unsure of the best way to proceed, call your surgeon and schedule a consultation to discuss your options. More information can also be found on the websites of the American Society of Plastic Surgeons (https://www.plasticsurgery.org) and the American Society for Aesthetic Plastic Surgery (www.surgery.org).