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The US Food and Drug Administration has issued a warning about an association between saline and silicone gel-filled implants and anaplastic large cell lymphoma.
The US Food and Drug Administration (FDA) has issued a warning about an association between saline and silicone gel-filled implants and anaplastic large cell lymphoma (ALCL). Upon reviewing the data, the FDA found that women with implants may have a small but significant risk for the very rare cancer in the scar capsule adjacent to the implant. Thus far, the FDA knows of 60 cases of ALCL worldwide in women with breast implants, but the actual number is difficult to ascertain. Worldwide approximately 5 million to 10 million women have breast implants.
The disease was discovered when the women sought medical treatment for implant-related symptoms, including pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. The symptoms resulted from collection of fluid, hardening of breast area around the implant, or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the implant led to the diagnosis.
FDA recommends that physicians consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). If it occurs, physicians should send fresh seroma fluid for pathology tests to rule out ALCL. Confirmed cases of ALCL in women with breast implants should be reported to FDA's safety information and adverse event reporting program, MedWatch (800-332-1088) or http://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Women are urged to monitor their implants carefully and notify their doctors of any changes. Also, women who are considering implants should talk to their doctors about all the risks and benefits.
US Food and Drug Administration. FDA review indicates possible association between breast implants and a rare cancer: Agency requesting health care professionals to report confirmed cases. January 26, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm. Accessed February 7, 2011.