To my breast reconstruction & augmentation patients

Thank you for the trust you have placed in me to care for your cosmetic and reconstructive surgery needs. I take that responsibility very seriously and strive to remain knowledgeable regarding the most recent data regarding breast implant safety and performance. To be certain, saline and silicone breast implants have been the most studied implantable devices in the past 30 years. In 1992, a sensationalized story by Connie Chung unnecessarily scared millions of women with implants. The subsequent scientific studies performed by the plastic surgery community provided convincing data to show the safety of silicone gel implants. They have been approved by the FDA for use in breast reconstruction since 2000 and or augmentation since 2006.

The implant companies continue to enhance the design of their products and we have made tremendous advances in both reconstruction and augmentation. The most notable recent offering includes the cohesive silicone gel filling for breast implants and the expanded use of textured implants in breast reconstruction, allowing for a more natural shape and little to no risk of extracapsular leak of the gel.

In 1992, I was just beginning my plastic surgery career in central Illinois and remember the many calls from frightened and uninformed patients regarding their breast implants after that sensationalized “news” show presented junk science to condemn their use. Now with the 24 hours news cycle, smart phones and the internet, I am quite sure you will be inundated with opinions, not facts, that surround breast implant use for reconstruction and augmentation.

The gummy bear implants (textured not smooth, shaped not round) were first introduced in Europe approximately 14 years ago, then 10 years later in the United States. They have a more than 90% satisfaction rate at 7 years and are undergoing continual surveillance for their performance and safety. I was part of the original Breast Implant Follow-up Study (BIFS) and rejoined the BIFS study of the 410 (Gummy Bear) last year to continue to study these devices.

In 2011, because of these ongoing studies, Plastic Surgery and the FDA identified a possible association between breast implants and the development of a very rare type of lymphoma, now identified as BIA-ALCL (breast implant associated anaplastic large cell lymphoma.) This is NOT breast cancer – this is a cancer that affects the scar tissue around the breast implant. There were so few cases at that time that it was not possible to determine what factors increased the risk.

A patient registry was developed by the collaboration of the FDA and American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation. It continues to collect data along with the World Health Organization, The American Society for Aesthetic Plastic Surgery (ASAPS) and their research arm, Aesthetic Surgery Education and Research Foundation (ASERF).

What is now known is that as of the March 2017 update, there have been 359 case reports of BIA-ALCL to the FDA Manufacturer and User Facility Device Experience (MAUDE), although several duplications are suspected. 126 confirmed cases have been reported to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). Textured implants appear to be the type associated with BIA-ALCL. Although 4 % of the reports include smooth implants, this has not been confirmed.

Since the first implants were placed in 1963, there have been 12 deaths worldwide and 9 reported deaths by the FDA out of an estimated 550,000 implants placed in the United States each year. None of these patients received complete surgical removal of the implant/capsule and associated mass (if present), none received chemo or radiation therapy, and most were significantly delayed in diagnosis and/or treatment. Current estimates of the incidence of BIA-ALCL is 1 in 30,000 or .003%. For comparison, the risk of breast cancer in women is 12.4 %

What are the symptoms of BIA-ALCL? They begin on average 8 years after surgery, with the first symptom being swelling of the breast from fluid around the implant. They can include pain, lumps, and unevenness between breasts.

How is it treated? Early detection allows for removal of the implant and the scar capsule around it and an implant can be replaced. Other more advanced treatments may be required for more advanced disease.

What should you do? If you have a swollen breast, be seen at your earliest convenience. Only a very small number of patients have positive results from the fluid removed from the pocket. Patients with smooth walled implants seem to be involved in a much lower frequency, if at all, and patients with textured implants risk of developing BIA-ALCL is rare – only .003%

Make an appointment to be seen and I will be happy to discuss your concerns without charge to you.

It is my goal to keep you from unnecessary worry and fear. Plastic surgery partnered with the FDA early to put together the registry and continues to identify additional risk factors and improved care plans for treatment.

I have reliable sources of information regarding BIA-ALCL on my website. And, as always, I am here for you to discuss all your plastic surgery concerns.

Jeffrey S. Poulter, M.D., FACS. Board Certified by the American Board of Plastic Surgery

For more information:

American Society for Aesthetic Plastic Surgery

American Society of Plastic Surgeons

FDA