Silicone breast implants may increase the risk of certain autoimmune diseases, rheumatologic diseases, melanoma or stillbirth. This is suggested by analyzes of the health condition of almost 100. women who have had breast implants. The results of the research were described in the medical journal “Annals of Surgery”.
In the early 90s, in response to public concerns, the FDA (US Food and Drug Administration) banned the use of silicone breast implants. It was believed that they could be a health risk – promoting cancer, connective tissue diseases and autoimmune diseases.
Subsequent studies did not find any link between breast implants and these diseases. In 2006, the FDA approved silicone gel-filled gel implants from two manufacturers (Allergan and Mentor Corp). However, she stipulated that manufacturers would conduct large post-approval studies (LPAS) to monitor long-term health and safety performance.
Based on this material, Dr. Mark W. Clemens and his colleagues at the University of Texas MD Anderson Cancer Center in Houston conducted the largest analysis of implant results to date. A large database made it possible to assess the risk of rare complications.
Scientists analyzed the data of almost 100. patients enrolled in LPAS between 2007 and 2009-2010. Over 80. patients received silicone implants, the rest – implants filled with sterile saline solution.
72 percent patients underwent the first breast augmentation procedure, 15% had a repeat treatment, 10 percent primary breast reconstruction, and three percent – secondary reconstruction.
Compared to the general population, women receiving silicone implants were at a higher risk of rare pathologies. Three diseases classified as autoimmune or rheumatological disorders were at increased risk: Sjogren’s syndrome (risk eight times greater than in the general population), scleroderma (risk increased by seven), and rheumatoid arthritis – RA (risk increased by about six times).
Silicone implants were also associated with a 4,5-fold increase in the risk of stillbirth, but without a significant increase in the risk of miscarriage. The risk of melanoma, the most dangerous skin cancer, was almost four times higher in women with silicone implants.
There was no significant association with the risk of suicide suggested by previous studies. The database included only one case of breast implant-related anaplastic large cell lymphoma – a rare but serious cancer previously associated with breast implants.
Compared to saline-filled implants, silicone ones were also associated with a higher risk of certain postoperative complications. Scars around the graft occurred at 5 percent. silicone implants compared to 2,8 percent. when filled with saline solution. Capsular contracture occurred in 7,2 percent. basic breast augmentation surgery and was the most common cause of reoperation in this group.
While some rare health problems appear to be more common in women with silicone implants, their absolute incidence has been low. The researchers point out that the results are inconclusive due to database limitations – including a lack of complete patient information and individual follow-up data.
As Dr. Clemens points out, determining where the observed relationships came from and what the causal relationship is will require further research and unbiased analyzes.