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A Letter From Dr. Poulter

As a board-certified plastic surgeon, one of the things I pride myself on is staying up to date with the latest safety updates and addressing any potential concerns that my patients may have. Over the past several months, textured breast implants have been in the news. On July 24, 2019 the FDA requested that the Allergan company voluntarily recall its Biocell textured implants. I have received several calls and quite a few office visits to discuss breast implant associated anaplastic large cell lymphoma (known as BIA-ALCL). Hopefully this letter will answer many of your questions, but please feel free to schedule a complimentary office visit with me to discuss further.

What is BIA-ALCL? Breast Implant Associated Anaplastic Large Cell Lymphoma, (BIA-ALCL), is a rare form of lymphoma.  It is not a cancer that develops in the breast.  There are many types of lymphomas.  BIA-ALCL is a slow growing tumor that is more commonly (2/3 of the time) found early as a collection of fluid around the implant and 1/3 of the time as a mass adjacent to the implant.

What Symptoms Should I Be Looking For? Unlike breast cancer, BIA-ALCL most commonly presents with swelling of one breast.  Other less common symptoms include hardening of the breast, an unusually persistent rash, or a palpable mass in the breast or armpit – all easily identified by you. An ultrasound can detect the presence of fluid, and if present, a small amount can be aspirated with a needle and tested. Should this be positive for tests called CD30 and ALK, a diagnosis of BIA-ALCL will be considered.  If the tests are negative, the fluid collection is considered benign. Benign fluid collections, known as seromas, are not uncommon around breast implants so it is important to differentiate them from those associated with ALCL. Anyone with new onset of increased pain, swelling, or breast asymmetry should see their surgeon for evaluation.

Why did the FDA request that Allergan recall its Biocell textured implants? Some breast implants have a textured surface. The texturing of the Biocell implants is different from the texturing of other implants and has been associated with the highest risk of BIA-ALCL. It is important to know that there  have been NO confirmed cases of BIA-ALCL associated with smooth implants.

Why Did Allergan Withdraw Its BioCell Textured Implants? Although there are manufacturers of textured implants other than Allergan, the FDA analysis found that the risk of a BIA-ALCL diagnosis with Allergan products is approximately six times higher than that of other types of texture.  84% of the 573 reported cases have been linked to Allergan BioCell textured products.  The diagnosis of BIA-ALCL is rare; the best estimate is thought to be approximately 1:3,000, although some centers have reported higher incidences.

In my practice, I used Biocell textured expanders and shaped textured implants in all my breast reconstructions before 2017 and used Biocell textured implants for some augmentations between 2014-2017. The last two years, I have switched to smooth round implants for augmentation and have slowly decreased my reconstructions to virtually none this year (with the exception of prior patients needing revision). It has always been my goal to do everything we can to limit the possibility of infection of breast implants.

In order to limit infection, patients wash with antibacterial soap and use chlorhexidine wipes before surgery. During breast surgery, I use techniques which have been shown to minimize bacterial contamination. I also utilize a “14 Point Plan for an Optical Aseptic Approach”. Components include keeping the patient warm, giving meticulous attention to stopping any small bleeding, washing the pocket with antibiotics, changing gloves before taking the implants, providing IV antibiotics before surgery and oral antibiotics 24 hours after, limiting exposure of the implant to air to less than 30 seconds, using a dual plane pocket without dissection of the breast tissue, avoiding drains and using a layered closure. This attention to detail helps prevent bacterial contamination that can cause the patient to develop BIA-ALCL.

So, what are the recommendations for patients with textured implants or a history of having a textured expander used in breast reconstruction?

  • First, don’t panic! The risk is still fairly small and varies widely (1:3,200- 1:30,000 in the United States). The techniques I have used throughout my career also put you at significantly lesser risk.
  • Second, call and schedule an appointment to discuss your options and what makes sense for you. The American Society of Plastic Surgery does not recommend removing your implant(s) if you are not having any problems or symptoms of pain, swelling, or feeling a palpable mass. Additional information is available from the FDA, The American Society of Plastic Surgery, and the American Society for Aesthetic Plastic Surgery (see links below).
  • Third, continue to perform your monthly self-breast exams so you are aware of early symptoms. Early treatment of this disease leads to better outcomes.
  • Finally, if you do decide you would like to have your implants replaced, Allergan will provide you with complimentary smooth round silicone gel implants at no charge until July 2020. (There will be anesthesia and room fees and a reduced surgical fee). We will also perform a capsulectomy to remove the scar tissue (capsule) around the implant where the tumor originates. There are several funds available to help defray the costs when insurance limitations restrict your ability to obtain treatment. Please see links below.

As more information becomes available, I will update my website and would be happy to forward these updates to the email address you provided if so desired.

 

Additional Resources 

http://fda.gov/medical-devices/implants-prosthetics/breast-implants

https://www.plasticsurgery.org/patient-safety/breast-implant-safety/bia-alcl-summary

Mollenkopf Aesthetic Breast Reconstruction Fund 

BIA-ALCL Patient Assistance Fund