In its announcement, FDA noted that it has received “new information pertaining to risks associated with breast implants."
On October 24, 2019, the Food and Drug Administration (FDA) announced new draft guidance entitled “Breast Implants—Certain Labeling Recommendations to Improve Patient Communication.” The draft guidance “contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants.”
In its announcement, FDA noted that it has received “new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma” and additional illnesses attributed to breast implants. Complications related to breast implants have been widely reported over the last year, with other symptoms, including increased presence of autoimmune disease in women who have received breast implants, as well as muscle and joint pain, fatigue and weakness, and certain cognitive difficulties. These proposed labeling requirements also follow FDA warnings issued to two implant manufacturers who had failed to carry out adequate postmarket surveillance of the implants as a condition of their approval, as well as an FDA request that another manufacturer recall certain textured breast implant products.
Due to these risks, FDA is now recommending that manufacturers “incorporate a boxed warning and a patient decision checklist” into the labeling of breast implants “to better ensure certain information is received and understood by patients.” The draft guidance also recommends updating existing labels by adding information that includes recommendations for screening of potential silicone gel-filled breast implant ruptures. The FDA cautions that the new guidance will supplement and, in some cases, replace recommendations in the previous FDA guidance document entitled “Saline, Silicone Gel, and Alternative Breast Implants” in effect since November 2006. This draft guidance is now available on the Federal Register, with the notice and comment period running until December 23, 2019.
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