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Patients with either saline- or silicone gel–filled breast implants may have a very small but significant risk for a rare cancer called anaplastic large-cell lymphoma (ALCL), a cancer of the immune system, adjacent to the implant. This is currently under investigation and its existence should be considered if there is a build up or collection around the implant (seroma) years after the original surgery. Because the risk is very small the current policy is one of data collection only and no changes have been recommended for the use of breast implants or the frequency of follow up after breast implant surgery. The FDA continues to state that breast implants are "safe and effective when used as labeled."
ALCL can occur anywhere in the body in the absence of breast implants. It is diagnosed in 1 of every 500,000 women per year in the United States. ALCL in the breast is rarer still, diagnosed annually in roughly 3 of every 100 million women without implants. In women with breast implants, it is usually inside the fibrous scar tissue — called a capsule — surrounding the implant. It is not a cancer of the breast per se.
ALCL associated with breast implants is limited to the fluid inside the capsule and the inner wall of the capsule. It can occur whether the breast implants were placed for cosmetic (breast augmentation) or reconstructive purposes (reconstruction after breast cancer surgery). It is more common with textured implants and chronic infections with biofilms around an implant are believed to be contributing factors. The use of antibiotic prophylaxis to cover any subsequent procedures that breach skin or mucosa, including dental prophylaxis, should be considered to prevent the formation of biofilms.
Treatment options for ALCL are chemotherapy, radiation, and surgery. The ALCL found related to breast implants is less aggressive and is sometimes treatable by simply removing the implant, the capsule, and the collected fluid resulting in a cure. Those patients who have had new implants placed at the time of lymphoma and prior implant removal have not had a recurrence of the lymphoma to date unless the previous capsule was not completely removed. The problem is in most capsulectomies with implant exchange the back wall of the capsule is frequently left at least partially intact. In cases with ALCL it is imperative that no capsule be left behind. An FDA review of scientific literature published from January 1997 through May 2010 uncovered 31 unique cases of ALCL in women with breast implants throughout the world. As of this writing the FDA is aware of 60 cases in all, some of them identified through other channels. The FDA does not know how many of the 60 may be duplicates of cases found in the literature. An estimated 5 million to 10 million women worldwide have received breast implants, according to the FDA.
Of the 31 published cases of ALCL, 24 involved silicone implants, and 7 saline implants. The median time from implant to ALCL diagnosis was 8 years. For most of the women, the cancer was diagnosed when they sought treatment for implant-related pain, lumps, swelling, or asymmetry, after their surgical sites had healed. The main presenting symptom is an enlarged swollen breast 8 to 10 years after surgery in the absence of infection. Prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
Because of the small number of cases worldwide the vast majority of plastic surgeons will not see a single case in a lifetime of practice and the current recommendations for women with breast implants are:
- Do not change your routine medical care and follow-up because ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants Monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment.
- Get routine mammography screening.
- If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.
The risk for breast cancer is 1 in 9 and the risk for ALCL is 1 in 500,000.
The American Society of Plastic Surgeons is collaborating with the FDA to develop a centralized registry to collect more information on existing case reports and any new cases that may be identified going forward. Only patients with confirmed ALCL will be entered into the registry. It is estimated that only 2 or 3 patients will be entered into the registry per year. It is imperative that late onset seromas are imaged by ultrasound (with lymph node visualization) and aspirated with a syringe. The fluid obtained needs to be stained for specific proteins (CD30 and anaplastic lymphocyte kinase) to make the diagnosis and differentiate implant associated ALCL from other froms of ALCL before proceeding. If the stains are positive additional imaging studies and oncologic consultation are required before proceeding with any surgery.
March 21, 2017 Addendum:
An FDA update release today states there has been no confirmed smooth surface-only case of breast implant associated-ALCL reported and it remains a rare condition that occurs most frequently in patients who have breast implants with textured surfaces. The agency advised patients to discuss the risks and benefits associated with breast implants, particularly devices with textured surfaces, with a surgeon or primary provider before deciding to undergo an implant procedure. Women who already have implants should continue with routine care and follow-up, as advised by their healthcare providers. Prophylactic implant removal in the absence of signs and symptoms (lumps, pain, swelling, asymmetry)is not recommended.
Aaron Stone MD - Plastic Surgeon Los Angeles
Aaron Stone MD - twitter