Women who have saline and silicone gas-filled breast implants have a higher risk of developing ALCL (anaplastic large cell lymphoma), an aggressive type of non-Hodgkin lymphoma that is generally of the T-cell type. The cancer may appear in the liver, lungs, soft tissues, bones, skin, and/or lymph nodes. In cases of breast implant recipients, the cancer risk is in the scar capsule next to the implant.
The Food and Drug Administration (FDA) is urging doctors to report all cases of ALCL in female patients with breast implants.
The FDA says it is liaising with implant manufacturers so that their product labels are updated with this information.
William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health, said:
"We need more data and are asking that health care professionals tell us about any confirmed cases they identify. We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants."
The National Cancer Institute informs that approximately 1 in every 500,000 American females is diagnosed with ALCL annually. Approximately 3 in every 1,000 million females without breast implants develop ALCL in breast tissue.
So far, 60 cases of ALCL in women with breast implants have been reported globally. The FDA warns that this figure is tenuous at the moment and there is a risk there may have been duplication. Between 5 million to 10 million women worldwide have received breast implants.
In a communiqué, the FDA writes:
"The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants."
The FDA has mostly reviewed cases that concerned women who went to their doctors complaining of implant-related symptoms, including lumps, swellings, pain, or asymmetry which developed after the surgical area had healed. Symptoms were caused by peri-implant seroma (fluid accumulation), capsular contracture (breast area around the implant hardens), or masses around the implant. ALCL diagnoses resulted from examination of the fluid and capsule around the implant.
The FDA asks patients and doctors to watch their breast implants closely and:
- Doctors should report all confirmed ACLC cases in females with breast implants to Medwatch, or call 800-332-1088
- If a patient has late onset, persistent peri-implant seroma, doctors should consider the possibility of ALCL. Fresh seroma fluid should be sent for testing to rule out ALCL.
- Patients should not alter their routine medical care and follow up. Even though those with breast implants have a higher risk, their chances of developing ALCL is still extremely small. Females should check their breast implants and tell their doctors if they notice any changes. Those considering having implants should discuss the benefits and risks with their physicians.
January 2011 - Center for Devices and Radiological Health
U.S. Food and Drug Administration
Written by Christian Nordqvist