FDA Believes Breast Implants Linked to Rare Cancer

Friday January 10, 2020

The Food and Drug Administration recently announced a link between breast implants and a rare form of cancer called anaplastic large cell lymphoma, or ALCL. The federal officials decided to warn the public after recently reviewing medical reports and verifying that a small number of women who have had breast implants have developed ALCL. The FDA announced the small but significant risk on January 26.

Of the five to 10 million women with breast implants in the U.S., there have been approximately 60 identified cases (34 of those verified with certainty) of ALCL since 1997. Only one in 500,000 women in the U.S. are diagnosed with ALCL each year. Having the cancer appear in the breasts is even more rare; only three of every 100 million women are diagnosed with ALCL in the breasts each year.

ALCL has been found in the scar tissue that surrounds both silicone gel and saline breast implants and is not the same as breast cancer. One possible explanations of ALCL’s presence in such close proximity to the implants is that the silicone in the implants is involved in stimulating cells which produce lymphoma. It appears in various parts of the body, such as lymph nodes and skin.

Officials warned the public and healthcare providers not to panic; breast implants shouldn’t be removed from patients who don’t show any ALCL symptoms. Symptoms experienced in the few verified cases of the disease include pain, swelling and lumps in the breast, sometimes years after their surgery.

In the U.S., breast implants are made by Allergan Inc. and the Johnson & Johnson company Mentor. The market for both cosmetic and medical breast implants is $820 million a year worldwide. No lawsuits have been filed claiming the implants are defective products yet, and the FDA is planning to work with implant manufacturers to change their product labeling to better inform consumers and healthcare providers of the risk. It is unclear if the linked cases had implants that were used off-label or were improperly implanted.

Though there is a small risk of ALCL in women with breast implants, the FDA has claimed that there is a “reasonable assurance” that implants are safe. Women with breast implants who have exhibited no symptoms of ALCL should continue with regular check-ups with their physician. If you have implants and have noticed any pain or lumps in your breasts well after your surgery, contact a doctor immediately and request that you be tested for ALCL.

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