25 March 2017
Re: Breast implant-associated ALCL
Dear patients and friends,
Recently, the FDA has updated its position on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This is a phenomenon that has been reported by physicians since at least 2011, when the FDA last weighed-in on the subject. After reports in the media, many of you have had questions regarding your implants and the risk they may pose. I would like to offer my thoughts on the topic and hopefully reassure you.
Breast augmentation and reconstruction are extremely common procedures. Since the mid-1960’s, plastic surgeons have been using implants of many varieties for these purposes; generally with high satisfaction and low complication rates. Many of you will recall the temporary ban on silicone implants, pending their review by the FDA, in the 1990’s. Silicone had been implicated in breast cancers discovered in women with ruptured implants, but without clear evidence that silicone was responsible. After over a decade of study, the FDA approved silicone implants for widespread use in 2006, disproving the association between silicone and adverse events. To this day, 95% of our patients choose silicone implants for their superior feel and longevity.
Rarely, women with implants develop swelling or nodules in the breast many years after their procedure. This can be associated with pain, contracture of the scar tissue around the implant (capsule) or fluid accumulation (seroma). When operating to correct these conditions, surgeons have discovered T-cell lymphoma, a blood-borne proliferation of immune cells, in the fluid or tissue removed. This is known as ALCL and, when associated with breast implants, BIA-ALCL.
While this news is concerning to surgeons and potentially terrifying to patients, it is important to consider the magnitude of the reported cases. The American Society of Plastic Surgeons reports that in 2016 alone breast augmentation was performed over 290,000 times. Breast reconstruction tallied 109,000 cases. Multiplied over decades, there are millions of patients with breast implants worldwide. To date there have been just over 300 cases of BIA-ALCL reported. The chances of getting lymphoma therefore are extremely remote; however since no causative relationship has been proven or excluded between breast implants and ALCL, surgeons, researchers and the FDA have pledged to continued vigilance.
As for particular types of implants causing ALCL, theories abound. Textured (rough-surface) implants have been associated with the disease more often than smooth implants. In the United States, and in our practice, we use primarily smooth surface implants but have, in certain circumstances, recommended textured devices based on our patients’ anatomy and aesthetic goals. The manufacturer whose implants we use has been linked to very few cases of ALCL. Currently, the FDA does not recommend surgery for exchange or removal of implants that are felt to be intact and not associated with pain, swelling, or scar contracture. Rather, if you feel your implants or breasts have changed over time, we would recommend a re-evaluation in our clinic.
Breast augmentation and reconstruction with implants continue to be mainstays of our practice despite this report. We continue to recommend these procedures to friends, family, and patients for their overall safety and excellent results. A thorough discussion of the risks and benefits of these procedures is always undertaken with new patients, and BIA-ALCL will be incorporated into these consultations. As we become aware of any new developments, we will share them with you and, as always, remain interested and available to answer your questions.
Christopher C. Jeffries, MD