The sad saga of pseudoscience and gold-digging might finally be over. The silicone gel-filled breast implants have been officially cleared by the FDA:
After rigorous scientific review, the U.S. Food and Drug Administration (FDA) today approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif…
Now that the products have been determined to be safe and effective, FDA will continue to monitor them by requiring each company to conduct a large postapproval study following about 40,000 women for 10 years after receiving breast implants. FDA often requires postmarket studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.
FDA’s decision to approve these implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, FDA conducted inspections of each company’s manufacturing facilities to determine that they comply with FDA’s Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.
In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the postapproval studies conducted by the companies…
Full information about the risks and benefits of the devices can be found in the package and patient labeling mandated by FDA. The patient labeling outlines some of the important factors women should consider when deciding whether to get silicone gel-filled breast implants. Some of these factors are: breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman’s breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI examinations over her lifetime to determine if silent rupture has occurred. The device labeling states that a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of MRI screening over a woman’s lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. The labeling also states that if implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.
FDA’s press release…
Well, the truth is that the saga is not over. This Dow Corning’s web page is still up and running…