A rare cancer linked to breast implants has killed at least nine patients since 2010, federal health officials warned Wednesday.
Of the 660 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) received in the past decade, 457 unique cases of have now been confirmed, the U.S. Food and Drug Administration said in a letter to health care providers.
“Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL,” the letter said
BIA-ALCL is a kind of non-Hodgkin’s lymphoma – not breast cancer – often found in scar tissue and fluid near the implant, the FDA says.
The agency first reported the link between the cancer and breast implants in 2011, but few cases had been confirmed, limiting how the FDA could advise patients of risk factors.
A lack of data on the number of people who get implants in the United States and globally makes it even more challenging to determine risks, the FDA said.
While the agency is still working with other health agencies and researchers to better understand the cancer, it said that most research shows the cancer occurs for implants with textured rather than smooth surfaces. However, many reports do not include surface texture, the FDA said.
“In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed,” the FDA said in its letter.
A collection of fluid or masses around the implants can cause those symptoms, and exams led to BIA-ALCL diagnoses, according to the health agency.
“If you have breast implants, there is no need to change your routine medical care and follow-up,” the FDA advised.
Doctors and other health care professionals can report cases of BIA-ALCL, and the FDA is asking them to continue to do so.
In recent years, there have been a number of advances in the medical community’s knowledge of the cancer, including the World Health Organization recognizing it as a unique form of ALCL and countries’ health organizations publishing information on their cases and research.
In December, biopharmaceutical company Allergan recalled rough-surface breast implants in Europe due to cancer concerns.
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“One of the most important roles we have as a public health agency is educating patients and health care providers about both the benefits and risks of medical products, including breast implants,” the FDA’s Binita Ashar said in a statement.
Ashar said the topic would be discussed in March at the FDA’s General and Plastic Surgery Devices Panel.
“Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about products,” she said.
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