More than one million women in America have had breast implants. Approximately 80 percent of breast implant surgeries are for cosmetic purposes. For years, many physicians, scientists and researchers have believed that silicone breast implants cause autoimmune diseases in women who have them. While there has been no conclusive proof connecting breast implants with autoimmune disease, a U.S. Food and Drug Administration (FDA) study suggests an association between silicone gel and fibromyalgia when women's breast implants rupture and silicone gel escapes into tissue. In addition, breast implants have caused a number of other problems. In fact, another FDA study revealed that one-third of women who have breast implants require a subsequent surgery or surgeries because of breast pain, rupture, displaced implants or infection.
In 1992, the FDA banned the use of silicone breast implants. This ban led to thousands of product liability claims against the silicone implant manufacturers, class action lawsuits, and the bankruptcy reorganization of the largest silicone implant manufacturer. The FDA has rules and regulations regarding each type of breast implants. The rules vary with respect to the type of breast implants: saline, silicone, and alternative.
In 1976, Congress passed the Medical Device Amendments to the Food, Drug, and Cosmetic Act. This law required the U.S. Food and Drug Administration to issue regulations classifying all medical devices into one of three classes, with Class III reserved for the most dangerous devices. In 1988, the FDA classified silicone breast implants as a Class III device. As a result of this classification, since April 1992, silicone breast implant manufacturers were required to acquire premarket approval (PMA) establishing the safety and effectiveness of their implants. As of June 2004, no silicone breast implant manufacturers have obtained PMA of silicone implants. As a result, all silicone breast implants are considered investigational, and patients wishing to receive silicone breast implants are required to participate in a medical research study.
Prior to 1999, saline implants were available in the market. Since May 2000, all saline breast implants require PMA in order to be sold in the market. As of June 2004, only two saline breast implants have been granted PMA. All other saline breast implants are considered investigational and can only be implanted in patients who are part of a medical research study.
Alternative implants are generally constructed of a silicone shell or a shell of some other material with a filling of something other than silicone or saline. The FDA considers alternative implants investigational devices. To obtain alternative breast implants in the United States, patients must be involved in a medical research study.
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