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Are These Medical Devices Safe? (Breast Implants)

In January 2011, FDA issued a report saying it was aware of a potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer.

April 20, 2015

3 Min Read
Are These Medical Devices Safe? (Breast Implants)

Breast Implants

In January 2011, FDA issued a report saying it was aware of a potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer. At that time, the agency said it was aware of approximately 60 ALCL cases in patients with breast implants. FDA went on to say that it believes implant patients may have a slightly increased risk of developing ALCL in a scar capsule next to the breast implant.

Industry Says:

A woman is more likely to be struck by lightning than get this condition. Patients' safety is Allergan's absolute first priority and we continue all efforts to collect and analyze further information about the very rarer occurrence of ALCL in patients with breast implants.”

—Caroline Van Hove, spokeswoman for Allergan, maker of breast implants, in an e-mailed statement quoted by Bloomberg in a 2011 article.

Women with breast implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL, in the scar tissue and fluid adjacent to the implant. ALCL is not breast cancer—it is a rare type of non-Hodgkin's lymphoma (cancer of the immune system). ALCL has been reported globally in patients with an implant history that includes Mentor's and other manufacturers' breast implants.”

—Excerpt from a 2013 patient brochure for Mentor breast augmentation product. Mentor

 

Activists Say:

Four hundred people are injured or killed by lightning every year. ALCL may strike fewer women but it is an avoidable risk that most of us would choose to steer clear of, just as we do not go swimming during a thunderstorm. In addition, it is possible that there may be more cases of ALCL than have been reported.”

Maura Duffy, in a January 2014 posting on the Web site for the Cancer Prevention and Treatment Fund

FDA Says:

Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.” 

—Excerpt from FDA's January 2011 report, "Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses." 

 

FDA Actions:

2011: Issued a preliminary report on the potential association between ALCL and breast implants. Also announced it would collaborate with the American Society of Plastic Surgeons and other experts to develop a registry to capture these patients.

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[Image courtesy of Mentor Worldwide LLC]

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