Breast implants have been in use since 1964. It is estimated that 2 million women have had implant surgery, either to reconstruct breasts after cancer surgery, to augment underdeveloped breasts or to restore a bustline after childbearing.
There are three types of implants: a silicone rubber envelope filled with a soft, silicone gel; a silicone rubber envelope filled with sterile salt water; and a double- walled silicone rubber envelope, with one sac filled with silicone gel and the other with a small amount of saline fluid.The majority of women with breast implants have no problems with the devices. But 155,000 women or 8 percent do.
Common problems include hardening of the scar tissue around the implant, rupture and changes in nipple or breast sensation due to the surgery.
Some women blame silicone leakage from the devices for other, more serious problems, including autoimmune diseases such as lupus, scleroderma and rheumatoid arthritis.
Kathleen Anneken, co-founder of the Command Trust Network, told the Deseret News 85 percent of the 8,000 women who've contacted the network attribute their autoimmune problems to implants. The network, established in 1988, is a national organization that provides information to women who've had problems with implants.
There is no evidence that silicone implants cause cancer at the present, although that possibility can't be ruled out. Studies examining the risk of cancer are under way.
The manufacturer of a polyurethane-coated silicone implant agreed to take the product off the market earlier this year after some studies indicated the coating may break down and release small amounts of a substance known as TDA, which can cause cancer in animals. Studies are now under way to determine if indeed the coating breaks down in the body and what risk of cancer, if any, the substance poses.
The Food and Drug Administration was granted authority to regulate medical devices, which includes breast implants as well as heart valves and IUDs, in 1976. But the regulatory process takes time.
In 1988, the FDA listed breast implants in a category that requires manufacturers to submit comprehensive safety and effectiveness data. Two years later, in April 1991, the FDA finally settled on the kind of safety and effectiveness data it wanted from manufacturers. The agency gave manufacturers 90 days to provide the information.
Six manufacturers submitted information; four companies' reports were accepted for full review and two were rejected because of incomplete information.
The FDA's General and Plastic Surgery Devices Panel held a hearing Nov. 13-14 to review the four accepted reports. The panel found the reports did not contain enough information to provide "reasonable assurance of the safety and effectiveness of the devices."
However, it voted unanimously to advise the FDA to keep implants on the market while additional data is gathered. The panel also recommended the FDA establish a national registry for women with implants to enable tracking of problems; require doctors to give patients informed consent forms to read and sign prior to surgery and create a timeline for studies on safety and effectiveness of the devices.
The FDA will decide in January whether to approve silicone gel-filled implants or to extend the deadline while more research on the safety of the devices is conducted.
Still to come is a review of saline-filled implants.