FDA Issues Breast Implant Safety Warning

Today, the FDA issued a warning about the safety of breast implants. The concern is over a very small link between anaplastic large cell lymphoma (ALCL) and breast implants.

34 identified cases of ALCL were FDA reported since 1989. The warning describes ALCL in 1 out of 500,000 women per year in the United States. In the breast, ALCL is even more rare in about 3 in 100 million women per year. Over 5-10 million women have received breast implants, and this number of 34 cases is indeed quite small. The FDA has not recalled implants, either saline or silicone, nor have they told women not to get them.

The American Society of Plastic Surgery has placed a link on its website with suggestions for patients:
– ALCL is extremely rare – of the estimated 10 million breast implants worldwide, only 34 cases of ALCL have been reported since 1989.
– The FDA believes that any potential risk that women with breast implants will develop ALCL is extremely low.
– A woman is more likely to be struck by lightning than get this condition.
– Both the FDA and ASPS are confident that breast implants remain safe and effective.
– If you have implants, continue your normal routine in medical care.
– Watch for changes – if you notice unusual pain or swelling, contact an ASPS Member Surgeon.
– As always, those considering breast implant surgery should discuss any potential benefits or risks with an ASPS Member Surgeon.

For now, I believe that women should not panic. The risk is very small. Plastic surgeons have known about this very rare disease and this is not news to us. The warning from the FDA is not meant to scare patients, but to tell them that if they have unusual swelling they should contact their surgeon. If you have any questions and would like to discuss this further, please do not hesitate to call me to come in for an appointment.

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