Study reports risk of rare adverse outcomes from breast implants

According to a study, silicone breast implants could increase the risk of several rare adverse outcomes in women.

"We are reporting an analysis of the largest prospective study to date on silicone breast implant safety," commented Mark W. Clemens of The University of Texas M.D. Anderson Cancer Center, Houston.

"We are sharing critical information on complication rates and rare associations with systemic harms. This data gives women important safety information about silicone breast implants to have real expectations and to help them choose what is right for them," added Clemens.

Women receiving silicone implants were at increased risk of several rare harms compared to the general population. The elevated risks included three conditions classified as autoimmune or rheumatologic disorders: Sjogren's syndrome, with a risk about eight times higher than in the general population; scleroderma, a seven-fold increase in risk; and rheumatoid arthritis, about a six-fold increase in risk.

"These findings are associations compared to the general population and determining why these associations are observed or any causation requires further study," said Dr. Clemens.

Silicone implants were also associated with a 4.5-fold increase in the risk of stillbirth, but no significant increase in the risk of miscarriage. Risk of melanoma, a serious type of skin cancer, was nearly four times higher in women with silicone implants.

Compared to saline-filled implants, silicone implants were also linked to a higher risk of some surgical complications. These included capsular contracture (scarring around the implant), which occurred at a rate of 5.0 percent with silicone implants versus 2.8 percent with saline-filled implants. Capsular contracture occurred in 7.2 percent of primary breast augmentation procedures, and was the most common reason for reoperation in this group.

While certain rare harms appeared to be more common in women with silicone implants, absolute rates of these adverse outcomes were low.

The findings appear in the journal Annals of Surgery.