FDA Issues Communication Regarding a Possible Link Between Breast Implants and Anaplastic Large Cell Lymphoma (ALCL)

  • Posted on: Jan 26 2011
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The FDA has issued a statement alerting physicians and patients to a possible link between breast implants and a rare type of cancer.   Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing the condition.  

ALCL in the presence of breast implants has been noted in sporadic case reports over the past 25 years.  To date, ALCL has only been identified in 34 cases out of an estimated 5 to 10 million women with implants worldwide.  As opposed to systemic ALCL which can occur anywhere in the body, this condition appears in the scar tissue that forms around the implant.  It is encouraging that when this condition occurs in the presence of breast implants the patients have responded to a variety of treatments, including simple removal of the implant and surrounding scar capsule.

ASAPS (American Society for Aesthetic Plastic Surgery) recommends that all women including those with breast implants should follow their normal routine in medical care and follow-up, specifically regular self examination and mammography when appropriate. Any woman should watch for changes in her breasts such as pain and swelling and contact her physician if she has any questions.

For my patients with breast implants, I don’t recommend that they lose any sleep over this.  The disease is very rare and a connection between ALCL and breast implants has not been conclusively proven.  There is some thought that the salt-texturing of the shell of a textured breast implant may be the connection between breast implants and ALCL.  Joan Kron’s excellent article in Allure (which can be found here) touches on this hypothesis.  

Here are the recommendations from the American Society of Plastic Surgeons (ASPS):

What You Should Know

  • 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.

What You Should Do

  • 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 the FDA press release, click here.

For the ASPS website, click here.

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Posted in: Plastic Surgery News

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