In a narrow vote last month, the Food and Drug Administration (FDA) decided against allowing silicone gel breast implants back on the market. This debate was sparked by the worries of the medical community that the implants could cause cancer, autoimune and connective tissue disorders among other problems.
Inamed Corp., one of the manufacturers of the implants, claimed to be "stunned" by the decision and insisted on that they are safe for women. This ban, however, does not apply to women receiving implants who have undergone mastectomies, had rejection issues with saline implants, are having breast lifts or have chest wall deformities. Also, women willing to be involved in clinical trials are allowed to receive them for periods of five to 10 years.
Breast implants have become one of the most popular cosmetic surgeries available. The American Society of Plastic Surgeons estimates that in 2004 about 260,000 women received breast augmentation for cosmetic purposes only, and about 60,000 women received them after undergoing a mastectomy. This number is expected to increase by 10 percent this year as the procedure is gaining popularity.
The first breast implant was performed in 1920, where fatty tissue was removed from the buttock and abdominal region and then transferred into the breasts. However, this procedure proved unfruitful because the body quickly reabsorbed the fat and left the breasts misshapen and lumpy. The unseemly scarring that also resulted made this procedure unpopular and subsequently it was no longer performed by the 1940s.
Rumor has it that the first silicone implants were utilized by Japanese prostitutes during the WWII era. They injected silicone directly into their breasts to make them appear more voluptuous, thus attracting more customers.
By the 1960s, the American exotic dancing scene began to realize the benefits for their business with breast augmentation. Slowly, this cosmetic surgery, once used solely by a specific population, was received into the mainstream public.
In the 1960s, in order to reduce infections that could result with direct silicone injections, the medical community began to develop a capsular method to contain the silicone and implant them in the breasts. The first surgery for these types of augmentation were made available in 1963.
The FDA has long been unsure of the efficacy of the silicone implants. Their most recent decision to ban the public marketing of such implants resulted because that the claims that the evidence in research that ruptures and complications do not cause cancer or connective tissue diseases has been inconclusive and that more studies need to be done.
Yet the scientific community still remains at odds with the decision, as proof of the narrow five to four vote against allowing them back onto the market. The link between connective tissue disorder and breast implants has not been sufficiently proven as medical experts and implant manufacturers continue their research.
Silicone gel has not been an immediate obvious danger and women appreciate that their feel is much more realistic, unlike the hard saline implants that are currently available.
Another significant concern centers about "silent" ruptures. Data collected shows that 85 percent of ruptured implants would take time, sometimes even years for the women to discover that their procedure had failed.
Silicone presents a few problems already. A rupture not only unevens the breasts, but also causes pain, burning, and other uncomfortable symptoms.
Furthermore, some women run a risk of having an immune response against the silicone, which is a foreign object within the body, which could on occasion prove fatal. Others are more susceptible to infections, especially during surgery and from implants that were not properly sterilized, which could be a possibility also.
Doctors have thought to encourage women who have received silicone gel implants to get regular MRIs to ensure that their breasts are still intact. However, this is a difficult task to ask women. Breast augmentation and some other forms of plastic surgery, as well as their treatment and care are not always approved to be covered on health insurances.
The medical community has sought to seek more information and perform more research on the link between certain diseases and breast implants. Until then, the implants will be prohibited by the federal government.
