Wednesday, March 7, 2007

Augmentation Breast Surgery

Breast augmentation surgery has always been controversial but silicone breast implants have been especially controversial. In a world where organizations like "NOW" advocate abortion for women and people can choose to smoke and drink, it is puzzling that so much effort has gone into taking away the rights of women to choose silicone breast implants on claims that they will harm us and that we can't decide what's best for us.

Starting in the late 1980's and culminating with the early 90's ban on silicone implants, women have claimed to get all types of illnesses from silicone gel breast implants. Claims initially included a connection between silicone gel breast implants and autoimmune diseases, connective tissue diseases and even cancer. Class action suits were filed wherein thousands of women claimed that their symptoms of scleroderma, rheumatoid arthritis, chronic fatigue, hair loss, breast and other cancers, were caused by leaking silicone implants. As a result of the claims, and without any conclusive scientific evidence, the FDA imposed a ban on the sale of silicone gel breast implants in 1992, meaning that silicone implants would no longer be available for the general public. In the wake of the claims, companies paid millions of dollars in lawsuit settlements and some filed for bankruptcy, despite a lack of any studies to back up the claims.

The FDA allowed silicone gel implants to remain in use after 1992, but only if a patient met certain criteria and was also enrolled in a study. In April of 2005, after hearing testimony from women and reviewing the available studies and data, the FDA's scientific panel, voted 7-2 that FDA should approve Mentor's gel implants but voted 5-4 that FDA should not approve the Inamed gel implants. On July 28, 2005, Mentor received an "approvable" letter from FDA, indicating that Mentor's silicone gel implants could be approved if Mentor met certain conditions. Inamed (now Allergan) ultimately received a similar "approvable" letter.

On November 17, 2006, after a year and a half of follow ups and further negotiation with the manufacturers regarding what conditions would be imposed, the FDA approved certain silicone gel breast implants for Boston breast augmentation in women aged 22 and over. Not all silicone implants are included in the approval and you should ask your doctor which implants are available.

Today's silicone gel breast implants are made differently than they were in the 1970s and 1980s. Initially, silicone gel breast implants had thick shells and thick silicone gel fills. In the 1970's, manufacturers began to use thinner shells, which were more likely to rupture. Today, both Mentor and Inamed make silicone implants with multiple layers of silicone elastomer surrounding the implant. This reduces the amount of gel bleed but can make the implants feel and look firmer. They are, however, much softer than saline.

Unlike saline breast implants, silicone gel breast implants are pre-filled. Surgeons order them in the requested size and they cannot be changed. Plastic surgeons have to make longer incisions in most cases to place a silicone gel filled breast implant than a saline filled breast implant, all other things being equal. Silicone implants cannot be placed endoscopically through a navel incision.

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