Breast implants are a lifeline for some women to feel more confident while for others as part of rebuilding the breast for various conditions. However, women receiving silicone breast implants may be at increased risk of several rare adverse outcomes compared to the general population, reports a study in Annals of Surgery.
“We are reporting an analysis of the largest prospective study to date on silicone breast implant safety,” comments Mark W. Clemens, MD, and colleagues of The University of Texas M.D. Anderson Cancer Centre, 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.” Based on an FDA-mandated “post-approval” database, the analysis is the largest study of breast implant outcomes to date.
First Analysis of Data Collected After Re-Approval of Silicone Breast Implants
The FDA forbade the use of silicone breast implants at the beginning of the 1990s in response to public worries about health hazards such as cancer, connective tissue illnesses, and autoimmune diseases. There is no connection between breast implants and these disorders, according to further study. Two manufacturers (Allergan and Mentor Corp.) submitted silicone gel-filled implants for FDA clearance in 2006, with the FDA requiring that the firms do extensive post-approval studies (LPAS) to track long-term health and safety outcomes.
“Despite abundant data collection and open public access, the LPAS database had not yet been analysed and reported,” according to Dr. Clemens. The researchers analysed data on nearly 100,000 patients enrolled in the LPAS between 2007 and 2009-10. More than 80,000 patients received silicone implants; the rest received implants filled with sterile saline solution.
Risks and rare harms associated with silicone implants
Among the patients, 72% received primary breast augmentation, 15% revision augmentation, 10% initial breast reconstruction, and 3% revision reconstruction surgeries. Researchers were able to evaluate the probability of uncommon bad outcomes due to the size of the database.
Compared to the general population, women who received silicone implants were more likely to experience several unusual problems. Three autoimmune or rheumatologic disorders were associated with increased risks: Sjogren’s syndrome, which had a risk that was approximately eight times greater than that of the general population; scleroderma; and rheumatoid arthritis, which had a risk that was approximately six times higher.
“These findings are associations compared to the general population and determining why these associations are observed or any causation requires further study,” says Dr. Clemens.
A 4.5-fold increase in the probability of stillbirth was also linked to silicone implants, but there was no appreciable change in the risk of miscarriage. Women who had silicone implants had a roughly four times increased chance of developing melanoma, a dangerous form of skin cancer. The risk of suicide was not significantly correlated, contrary to what a prior study had revealed. An uncommon but dangerous form of cancer previously related to breast implants, anaplastic large cell lymphoma, was only one of the cases in the database.
Silicone implants also linked to a higher risk of surgical complications
Silicone implants were also associated with a greater incidence of several surgical complications as compared to saline-filled implants. One of these was capsular contracture, or scarring around the implant, which happened more frequently with silicone implants (5.0%) than with saline-filled implants (2.8%). The most frequent cause of reoperation in this population was capsular contracture, which occurred in 7.2 percent of first breast augmentation surgeries.
Even though some extremely rare side effects seemed to occur more frequently in women who had silicone implants, their overall prevalence was still modest. The researchers stress that the constraints of using post-approval databases, such as the absence of complete patient information and individual follow-up data, render their findings unconvincing.
“To resolve the remaining uncertainty in the evidence base, it is important that this data be analysed in an unbiased manner,” Dr. Clemens and coauthors write. “It remains the plastic surgery community’s duty to provide definitive evidence for the risks associated with breast implants.”
Materials provided by Wolters Kluwer Health. Note: Content may be edited for style and length.
Coroneos, Christopher J., Selber, Jesse C., Offodile, Anaeze C. II, Butler, Charles E., Clemens, Mark W. US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Annals of Surgery, 2018 DOI: 10.1097/SLA.0000000000002990
Wolters Kluwer Health. “Silicone breast implants linked to increased risk of some rare harms.” ScienceDaily. ScienceDaily, 17 September 2018. <www.sciencedaily.com/releases/2018/09/180917191649.htm>.
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