Silicone Breast Implants Available Under Tight Controls

by Food and Drug Administration (FDA)

The Food and Drug Administration decided last April to allow the continued use of silicone gel-filled breast implants, but only under limited conditions.

Any woman who needs implants for reconstruction after breast cancer surgery or for certain other medical conditions can get them, but the number of women who can have them for augmentation (breast enlargement) is limited.

Part of the reason for limiting the number of augmentation patients is that some of the risks of implants may be greater for these individuals, mostly because women who elect augmentation are generally younger and they have breast tissue. Younger women will be exposed to silicone for a longer time. Women with breast tissue should have mammograms to screen for breast cancer. Without special expertise, the potential for inadequate mammography can delay detection — and thus treatment of breast cancer — because implants can hide some breast tissue.

Whether for augmentation or reconstruction, the implants are available only through carefully controlled studies.

Announcing the decision April 16, FDA Commissioner David A. Kessler, M.D., said, "The central aim of FDA's decision is to gather information and restrict access of silicone gel breast implants to carefully controlled studies."

Since breast implants first came on the market 30 years ago, an estimated 1 million women in the United States have had these devices surgically inserted to enlarge or reshape their breasts, or for reconstruction following breast cancer surgery. Most are filled with a silicone gel; about 10 percent contain saline (salt water). Until recently, both gel-filled and saline implants were available to virtually any woman who wanted them.

In recent years, however, there has been an impassioned debate on the safety of silicone gel-filled breast implants and whether or not the devices should remain on the market. Despite the controversy, there was agreement among manufacturers, physicians, surgeons, consumer advocates, and women with implants on at least one point: Solid clinical research is needed to answer questions that loom large regarding the safety and long-term effects of these devices.

In accord with recommendations of an advisory panel convened by FDA last February, the agency set up a system ensuring that the devices will be available to women who elect breast reconstruction because of cancer, traumatic injury to the breast, or a disease or congenital disorder causing a severe breast abnormality.

"While this decision is meant to be compassionate toward these patients," said Kessler, "it is not to be interpreted as 'business as usual.' Our primary goal is to put in place a process to obtain adequate information about the safety of these devices."

Women desiring reconstruction can participate in "open availability" protocols. To be enrolled, the woman's physician will have to certify that saline implants are not a satisfactory alternative. These protocols will begin as soon as the manufacturers develop them and meet all FDA requirements for their conduct.

In addition, tightly controlled research, or "core" studies, will evaluate the known risks of the implants as well as their psychological benefits. Core studies will include a limited number of both reconstruction and augmentation patients, all of whom must meet specific criteria defined in the clinical protocol. Only enough women needed to answer the specific safety questions posed by the studies will be enrolled.

The implant manufacturers will sponsor both the core studies and the open-availability studies. FDA must approve the studies and protocols before they begin, and all patients will be required to give informed consent after being advised about possible risks. All patients will enroll in a patient registry, as well, so they will have access to information generated from all the studies.

The FDA decision also included a provision permitting women with an "urgent need" for implants to get them immediately. This included patients in the midst of the breast reconstruction process who had a temporary tissue expander in place and women who needed replacement for medical reasons such as implant ruptures, gel leakage, or severe hardening of the breast.

Of the women who received implants before the moratorium, 80 percent chose them for augmentation. Saline-filled implants are still available without restriction for both augmentation and reconstruction. Although the safety of this type of implant has not been proven, leakage or rupture would release only salt water, which is not harmful.

Nevertheless, like the silicone gel-filled devices, saline implants have a silicone rubber envelope and may not be entirely without risk. In addition, with leakage or rupture, saline implants deflate rapidly, requiring corrective surgery. FDA will soon require manufacturers of these implants to submit safety and effectiveness information for their products, just as was done for the silicone gel type.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.