Silicone gel implants: Why the FDA Re-Approved Them - By: Patricia Woloch

Since late 2006, many women seeking breast augmentation surgery have been surprised to find that silicone gel breast implants returned to the U.S. marketplace as an accepted option. The reintroduction of silicone gel implants met with very little press, at least in relation to when they were initially banned in the early 1990's. Silicone implants have long been regarded as the most natural looking implant devices available. Their return to the U.S. market is welcome news for plastic surgeons that provide, and American women who seek, breast augmentation surgery.

In the 1990's, in response to several class action lawsuits against Dow-Corning, a major implant manufacturer, the Food and Drug Administration (FDA) banned silicone breast implants for augmentation. Initially, silicone implants were not under the purview of the FDA. When medical device approval was added to the FDA's job duties, silicone implants were grandfathered in, and were never extensively reviewed.

In the lawsuits against Dow-Corning, silicone gel implants were correlated with many physical maladies, including:

· Connective tissue disorder
· Rheumatoid arthritis
· Auto-immune disorders
· Increased risk of breast cancer

After the initial ban, silicone implants were still made available for reconstructive surgery, but were reclassified as investigational devices and subject to strict approval prior to full consideration.

Because of this reclassification, marketing of silicone breast implants in the U.S. dropped considerably. Saline, which is readily absorbed by the human body in the event of a leak, became the de-facto implant device available in the United States. Breast augmentation surgeries also declined in the U.S. because of the negative press surrounding the removal of silicone implants and because most women prefer the more natural appearance silicone implants offered. European countries continued to offer both saline and silicone options.

Silicone was open to reconsideration by the FDA under certain conditions. Companies wanting to market silicone products had to submit to a pre-market analysis, something that was not required previously since silicone implants were around prior to the FDA monitoring these products. After years of extensive study, the FDA finally approved silicone implant devices for augmentation for women age 22 and older, on November 17, 2006.

Using the case studies of reconstructive surgeries performed during the ban and data from Europe, where silicone was still in wide use, the FDA was able to conclude that silicone did not pose great risk for the various maladies that sparked the initial lawsuit. Almost half a dozen studies world wide, including the extensive studies by the FDA concluded that there is insufficient evidence to indicate silicone breast implants are a leading risk factor for any of the above-listed problems.

Since their findings, several companies have come forward for FDA approval, with two companies winning approval in 2005 and 2006.

The approved companies must conduct extensive studies of their patients over the next ten years following surgery to evaluate and report the status of their product. Deciding on whether to use silicone breast implants, or saline breast implants should still be based on a quantitative review of the patient's need and expectations. FDA approval does not in anyway guarantee the safety of silicone devices, but their thorough investigation of the product, and informed consent documents by manufacturers Allergan and Mentor should help alleviate some of the irrational fear perpetuated by the media over the past fourteen years.

About the Author

If you are considering breast augmentation, it is important that you speak to an experienced and knowledgeable cosmetic surgeon. Contact one in your area today for more information about breast augmentation surgery.

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