FDA on Breast Implants

On November 17th 2006, the FDA approved silicone gel filled breast implants with the stipulation that the two primary manufacturers would have to provide data for a study on the possible adverse effects cause by the implants.  This information was gathered from that date through December 31, 2010 and the FDA released the results this week.

                According to the FDA there are some possible risks associated with silicone based implants but not to a degree that causes them to be unsafe and therefore the approval was left intact. They received 16,814 reports; most of them were about complications seen with all implants. The main issues reported were: reoperation, scar tissue surrounding the implant, pain, infection and breast lumps. The infections reported were, for the most part, developed directly after surgery and were related to bacteria normally found on skin surfaces that found their way into the wound.

                Overall the FDA was unable to find any major risks associated with silicone breast implant that are not also associated with the risks involved with saline breast implants. Silicone implants however do come with a higher probability of needing reoperation within ten years. Reoperations were mostly due to: rupture, implant malposition/asymmetry, wrinkling and hematoma. The data collected also showed no increase in risk developing of breast cancer or connective tissue diseases, both of which were a concern relating to the previous generation of silicone based implants.

                There is also the possibility of a very slight increase in the risk of developing Anaplastic Large Cell Lymphoma, an extremely rare cancer. There are approximately 60 known cases of ALCL in women with breast implants worldwide, but because of the small sample it is extremely difficult to find a causal link between the implants and developing ALCL.

                It appears women can now choose between two types of implants and rest easy knowing they are unlikely to see a more negative outcome with one type over the other. Whether you support, oppose or don’t really care one way or the other about plastic surgery it is always good to know that people have safe options for any procedure they might choose to undergo.

Sources:  Food and Drug Administration, (2011). FDA update on the safety of Retrieved from http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf

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