November 12, 2015
1 min read

Evidence for association between silicone gel breast implants, long-term health outcomes inconclusive

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact

Results from a systematic review of studies suggest there is inconclusive evidence about any association between silicone gel breast implants and long-term health outcomes.

The FDA removed silicone gel breast implants from the U.S. market for cosmetic use in 1992 due to safety concerns. The implants were reintroduced in 2006 after FDA approval.

Researchers conducted a systematic review of Medline, Embase and Ovid Healthstar from inception through June 30, 2015, and the Cochrane Central Register of Controlled trials and Cochrane Database of Systematic Review through the first quarter of 2015. Articles for longitudinal studies that compared women with and without breast implants and reported long-term health outcomes of interest were double-screened by the researchers, who extracted data on participant and implant characteristics, analytic methods and result.

Eligibility criteria was met by 32 studies presented in 58 publications.

“For most outcomes, there was at most only a single adequately adjusted study, which usually found no significant associations,” the researchers wrote.

Primary breast cancer in women who had breast implants for augmentation was evaluated in 11 studies. Other types of cancers examined in the studies included cervix, endometrium, uterus, vulva, brain, lung, non-Hodgkin lymphoma, leukemia, Hodgkin lymphoma and multiple myeloma. Decreased risk for primary breast and endometrial cancers were possibly associated with the implants. There was a possible increased risk for lung cancer, rheumatoid arthritis, Sjögren syndrome and Raynaud syndrome found in the studies. The relationship between breast implants and other outcomes showed limited evidence or no association.

Limitations included that the evidence was frequently not specific to the implants, the researchers reported.

“The current systematic review finds that to date, the body of comparative study evidence on breast implants still does not provide conclusive evidence regarding whether silicone gel implants affect the risk for cancer, [connective tissue diseases] or other health outcomes,” the researchers concluded. – by Bruce Thiel

Disclosure: Balk and the other researchers report grants from The Plastic Surgery Foundation during the conduct of the study.