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Dr. Steven Davis

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What You Need to Know About the Allergan Breast Implant Recall

August 1, 2019 by Davis

Textured breast implants made by Allergan that have been linked to a rare cancer are being recalled in the United States by the Food and Drug Administration (FDA).

According to The New York Times, 573 cases and 33 deaths from the cancer have been reported worldwide, with 481 of the cases clearly attributed to the Allergan Biocell implants. Of the 33 deaths, the FDA said the type of implant was known in 13 cases, and in 12 of those the maker was Allergan.

While the Allergan breast implant recall is newsworthy, the cancer is rare, considering that millions of women have breast implants. Breast augmentation is perennially the most popular cosmetic surgery performed in the United States. In 2018, more than 313,000 procedures were performed, a 4% increase over 2017, according to the American Society of Plastic Surgeons.

The anaplastic large-cell lymphoma is a rare cancer of the immune system. It is usually found within the fibrous scar capsule near the implant or in the fluid surrounding the implant, according to the FDA. It is not in the breast tissue itself, and it is not breast cancer. Researchers have not been able to explain the link between the Allergan Biocell implants and the rare cancer, according to The New York Times.

However, in most cases, removing the implant and the scar tissue around it cures the cancer. But if it is not detected early, it can spread.

Do I need to do anything?

The main symptoms of the lymphoma are usually swelling and fluid accumulation around the implant. There may also be some tenderness, which shouldn’t be confused for post-surgery soreness. The latter is normal.

If you’re experiencing any of these symptoms, see your plastic surgeon. If that’s not practical, consult another plastic surgeon near you. Either way, your doctor will likely recommend an ultrasound or MRI.

If you have Allergan Biocell implants, but no symptoms, you don’t need to have them removed, the FDA says. The recall means that doctors and hospitals should not implant any more of them and should return any in their inventory to Allergan.

Allergan Biocell Implants? What if I don’t know which kind of implants I have?

The contents of the implant, silicone or saline, are not a factor in the lymphoma, the FDA says. The shell, which can be either smooth or textured, is the key. Textured implants, which have a slightly roughened surface that adheres to breast tissue and helps hold the implant in place, have been singled out as the cause.

It’s important to note, however, that the recall only affects the Allergan Biocell textured implants, not all textured implants. The Allergan Biocell implants carry a risk that is about six times that of other textured implants sold in the United States, according to the FDA. Allergan’s textured implants account for only about 5% of the implants used in the United States, according to The New York Times.

If you’re not sure what kind of implants you have, consult your plastic surgeon. Again, if that’s not practical, see a plastic surgeon near you. Even if they can’t tell you the type, they’ll conduct a physical exam to see if you’re having any issues with your implants.

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About Dr. Steven L. Davis

Dr. Steven L. Davis is Board Certified in Cosmetic Plastic Surgery, a Fellow in both The American College of Osteopathic Physicians and Surgeons and the American Academy of Cosmetic Surgery.

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