Breast health is of the utmost importance to this practice, as is keeping our patients and future patients fully informed with the latest data to promote safe outcomes using evidence-based care in plastic surgery. On July 24, 2019, the largest maker of breast implants, Allergan, released a voluntary recall on its textured breast implant products from the United States and around the world, citing concerns about the risk for patients developing breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL). The news came in an announcement from the US Food and Drug Administration (FDA).
The FDA notes that to date (July 25, 2019), 573 unique cases of BIA-ALCL have been reported around the world out of the millions of patients who have textured implants. Of the 573 unique cases of BIA-ALCL, 481 (84%) have been attributed to Allergan implants (Food and Drug Administration, 2019).
In my practice, I rarely use Allergan textured implants for breast reconstruction and do not use textured implants for cosmetic breast surgery. Furthermore, BIA-ALCL is an exceptionally rare disease that is in most cases completely cured by removing the scar pocket of the breast if caught early. BIA-ALCL is not associated with smooth breast implants. In brief, the current theories are that BIA-ALCL is caused by the irritation of the rough texture and/or by a bacterial biofilm on the surface of the implant (William Adams, Jr., 2016). Currently, due to the low risk of getting BIA-ALCL, it is not necessary to prophylactically remove breast implants if you are not experiencing symptoms.
What are the Symptoms of BIA-ALCL?
Symptoms of BIA-ALCL usually present well after a patient has healed from the initial breast implant surgery. The American Society of Aesthetic Plastic Surgery notes that most patients diagnosed with BIA-ALCL have noticed breast changes between two and 28 years after receiving breast implants, with the average being eight years. The most common symptom is a significant and noticeable swelling of a breast occurring over a few days or weeks. This is due to a collection of fluid, called a seroma, that surrounds the breast implant. Other symptoms may include:
- Firmness of breast following breast implant surgery
- Pain in breast
- Breast asymmetry
- A lump in the breast or armpit
Patients with a suspected seroma should be examined and have an ultrasound of the area. If there is fluid surrounding the implant, it will be aspirated and sent for a cytology workup. An MRI may be required to get a better look at the chest. These tests will assist in developing a plan for future care.
What Happens if I am Diagnosed with BIA-ALCL?
The current recommendation for patients presenting with this illness is to undergo a surgical procedure called a bilateral capsulectomy and removal of breast implants. During this operation, the scar tissue that surrounds the breast implant is removed, any fluid that has collected in the pocket is drained, and the breast implants are removed. If found early, this procedure can effectively cure BIA-ALCL and no further treatment is required. If the disease has spread to the lymphatic system, chemotherapy and radiation may be recommended.
Should I Reconsider Breast Implant Surgery?
BIA-ALCL is a very rare disease that affects a very small portion of patients with breast implants. The FDA’s most recent statement concerning BIA-ALCL states, “Because the risk of ALCL appears very small, the FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”
When considering breast implants for reconstruction after a mastectomy or for cosmetic reasons, it is important to find a board-certified plastic surgeon who will discuss the risks and benefits of this surgery. A successful outcome can be realized when a patient and her surgeon thoroughly communicate both before and after surgery. Dr. Christine Fisher is committed to helping her patients be completely informed during the pre-operative decision-making process and after recovery.
Christine Fisher MD