The U.S. Food and Drug Administration (FDA) has allowed the resumption of the use of silicone gel implants in breast augmentation operations. Now breast plastic surgery has become accessible to ordinary American women, who will be able to increase their busts without anyone noticing the difference. Wealthy American women had previously undergone the procedure abroad.
The United States is considered the birthplace of silicone implants. Capsules filled with silicone gel have been used here since the early 1960s and immediately became popular with both doctors and patients. However, in the late 1980s, scientists somewhat dampened the enthusiasm of women wishing to enlarge their breasts. Animal studies showed that silicone gel implants lead to the development of oncological diseases. Although it was later found that cancer develops only in animals, not in humans, other negative aspects were identified for such implants. It turned out that under extreme conditions, such as overloading on an airplane, they can tear or decompose.
In 1991, the FDA recommended that manufacturers conduct additional research on the effects of silicone gel implants on human health, and a year later completely banned their use in plastic surgery. An exception was made for women whose breasts had been removed during cancer treatment, as well as for participants in clinical trials. American surgeons switched to saline implants: prostheses with a silicone shell and saline solution inside. If they rupture, they do not harm a woman's health. Practice has shown that such implants are not very natural aesthetically and to the touch. The breast looks like a leather bag filled with water.
For a long time, women, surgeons and, of course, manufacturing companies tried to obtain permission for silicone gel implants. The issue was last raised in 2003, but manufacturers could not prove the reliability of their products. The FDA returned to the topic on April 11, 2005. According to The New York Times, for three days the agency's board discussed the products of two largest manufacturers - Inamed and Mentor (they split the American implant production market in half, and together hold 75% of the global market for such products).
During the FDA hearings, more than 160 people spoke, half of whom passionately asked to bring back silicone and the other half to reject the request. Some women recounted the terrible moments they endured when silicone ruptured in their breasts; others insisted that only such implants could boost their self-esteem. In addition, scientists spoke at the board, stating that silicone does not affect human health. Doctors reported that about 250,000 breast augmentation operations are performed annually in the United States, and with the approval of silicone, the number of those wishing to undergo the procedure will increase significantly. Manufacturers, in turn, argued for the strength and safety of their products.
Mentor was the luckiest: it was able to prove that its implants rupture in 1.4% of cases and do not rupture for ten years. The FDA board recommended allowing the use of this company's silicone gel products. At the same time, the FDA imposed a number of restrictions: the patient must sign a contract informing them of the risks of such an operation; the patient must be given the opportunity to have the implants removed upon request. In addition, implants may be sold only to clinics licensed by the FDA, and the selling company must conduct studies on the survival of implants over ten years of use and examine patients every five years.
The other implant manufacturer, Inamed Corp., failed to prove the safety of its products to the U.S. Food and Drug Administration.