FDA Concerned Breast Implants May Cause Cancer
Breast implants may not be as harmless as previously thought. According to an announcement made today by the Food and Drug Administration (FDA), there is a possible risk of cancer associated with silicone and saline breast implants.
Based on a scientific review of literature from the past 13 years, the FDA discovered 60 cases of anaplastic large cell lymphoma (ALCL). This rare form of cancer occurs in the lymphatic system, a network of ducts that function as a part of your immune system. ALCL is diagnosed in approximately 1 in 500,000 women each year.
The identified ALCL cases were diagnosed after women received medical treatment for breast related symptoms such as swelling, asymmetry, pain, and lumps. Biopsies revealed ALCL in the scar tissue surrounding the implant.
The link between breast implants and ALCL still requires further investigation, but the FDA reported, “Data reviewed by [the organization] suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.”
Silicone breast implants were initially pulled off the market in 1992 amid safety concerns. There were a large volume of reports of implant rupture as well as concerns that the implants caused other diseases such as lupus and cancer. However, follow up studies revealed no significant evidence to link implants to adverse health conditions and the implants were reinstated in 2006.
The American Society of Plastic Surgeons and other related organizations have agreed to collaborate with the FDA to establish a registry of women diagnosed with ALCL who have breast implants. Breast implant manufacturers, such as Allergen (a division of Johnson & Johnson) and medial professionals will be required to report to the registry any confirmed cases.
The FDA also plans to incorporate these concerns into product warning labels on breast implants as well as patient literature.
A further update on silicone implant safety is expected to be released by the FDA in the Spring of 2011.Implants will remain on the market during this time.