FDA Breast Implant Safety

Following an FDA recall of textured breast implants, breast implant safety is front and center in plastic surgery. Concerned patients are asking about breast implant illness (BII), and breast implant-associated lymphoma (ALCL), two unrelated processes associated with breast implants.

Despite the absence of an official diagnosis for BII, reports indicate an increase in patients with related symptoms such as fatigue, pain, headaches, chills, rash, anxiety, brain fog, sleep disturbance, depression, neurologic and hormonal issues. I have not seen an increase in these patients in my practice.

Studying implant devices and their safety isn’t new. In 1999, the Institute of Medicine established a committee dedicated to investigating the safety of silicone. After an extensive review, the committee concluded there was no demonstrated clear link between silicone implants and any systemic illness.

Plastic surgeons are carefully evaluating BII patients, and the Aesthetic Surgery Education Foundation is funding a formal study. As the medical community’s understanding of BII continues to expand, patient safety and education remain priorities. There is little to no evidence to support implant removal. Although some patients reported feeling back to normal after surgery many symptoms returned or never went away.

The amount of tissue removed with the implant in BII patients who insist on implant removal is even more controversial. My recommendation is to discuss the issue and the options with a board certified plastic surgeon, not the internet.

On the other end of the spectrum is ALCL. This extremely rare lymphoma forms in the fluid and scar tissue around textured implants. ALCL symptoms include persistent swelling and pain of the breast. If caught early, the disease is completely curable.

The current recommendation for patients with textured implants is not to worry because ALCL is extremely rare. If pain and swelling occur, seek medical attention for further evaluation. To read more about BII and ALCL, check out this recent article in Allure.