Silicone Breast Implants Linked to Number of Complications, but FDA Critical of Study

Many, but not all, women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are many ways to reconstruct a breast. Tissue from the back, belly, buttocks, or other part of the body can be used to create a new breast. Doctors call this autologous reconstruction. Saline or silicone gel implants are another option. In some cases, an implant is added after autologous reconstruction.

A study done by researchers at the University of Texas MD Anderson Cancer Center suggests that silicone breast implants are associated with a higher risk of certain autoimmune disorders, as well as stillbirth and melanoma. Still, the U.S. Food and Drug Administration (FDA) criticized the study and issued a statement disagreeing with the results.

The research was published online on Sept. 14, 2018 by the journal Annals of Surgery. Read the abstract of “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.”

Read the FDA statement on the study.

In the early 1990s, the FDA banned silicone breast implants in response to public concerns about health risks including cancer, connective tissue diseases, and autoimmune disorders. Later research found no link between breast implants and these diseases. In 2006, the FDA approved silicone gel-filled implants from two manufacturers, Allergan and Mentor Corp., requiring the manufacturers conduct large studies to monitor long-term health and safety outcomes.

To do this study, which the researchers said was the largest study done so far on breast implant outcomes, the researchers looked at the medical records of 99,993 women who had implants inserted who were enrolled in the long-term health and safety studies. Mor…

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