Pharmaceutical

Breast implants linked to rare form of lymphoma

 Breast implants linked to rare form of lymphomaBreast implants have been linked to a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a designation established by the World Health Organization, which the Food and Drug Administration (FDA) recently announced it agrees with.

“At this time, most data suggests that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces,” the FDA said in a Safety Communication.

ALCL is a rare type of non-Hodgkin’s lymphoma. BIA-ALCL is even more rare. When it does occur, it has been identified most frequently in patients who have undergone implant revision operations for late onset, persistent serum, a collection of fluid that builds up under the surface of the skin, generally occurring after a surgical procedure where an incision was made or tissue was removed.

The exact number of BIA-ALCL is difficult to determine due to significant limitations in reporting around the world and lack of global implant sales data, the FDA said. The agency first identified BIA-ALCL with breast implants in 2011 and continues to collect and evaluate information about ALCL in women with breast implants.

The FDA is advising health care providers who have patients with breast implants to continue to provide routine care and support. Because BIA-ALCL is generally only identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended. Patients who experience these symptoms should also consult their doctors.

Individuals who are considering getting breast implants should talk to their health care provider about the benefits and risks of textured-surface versus smooth-surface implants, as most cases of BIA-ALCL have occurred in patients with textured-surface implants.

Health care providers and patients are encouraged to report confirmed cases of ALCL in women with breast implants to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA Safety Communication