Breast Implant Safety : Saline Implants

by Food and Drug Administration (FDA)

(Page 2 of 3)

Other Concerns

Brown also stresses that connective tissue diseases are not the only issue of concern, especially since they may affect a much smaller proportion of women with implants. The larger issue, she says, is the local complications that are clearly related to breast implants, such as rupture and migration of the silicone gel, capsular contracture, and infection.

"Of the two groups of women who consider getting implants — for breast reconstruction or for augmentation," Brown says, "the larger group wants them for cosmetic purposes. These are healthy women who may go out and get implants without a clear picture of what the possible risks are. They may end up going back in for surgery time and again and never be happy with the cosmetic effect."

In testimony before a congressional subcommittee in August 1995, FDA Commissioner David A. Kessler, M.D., stated that "Published studies to date suggest a rupture rate between 5 and 51 percent — an enormous range — and, unfortunately, we do not know with any confidence where within that range the real rupture rate lies." He also cited two studies that indicate the risk of rupture increases as the implants age.

Another concern — increased risk of breast cancer — has not been borne out by studies. "Several studies have indicated there is no increased risk of breast cancer in women with implants," Brown says. However, she adds, these women are not yet in the age group that is more prone to breast cancer, and it remains to be seen whether they will eventually have a higher incidence of breast cancer than women without implants. Long-term studies to look at this are under way.

Manufacturers' Studies

The events that led to removal of silicone implants from the market made it clear that prospective, or forward-looking, studies were also needed to answer important safety questions. Implant manufacturers agreed to conduct human trials in three phases: urgent need, adjunct, and core studies.

"The purpose of the first phase [urgent need] actually was simply to quickly provide implants to women who were already in the process of getting them for breast reconstruction or for another medical reason, and to bridge the time until the adjunct studies were begun," says Sahar M. Dawisha, M.D., a rheumatologist and medical officer who joined FDA's division of general and restorative devices in April 1993.

The women did, however, have to sign an informed consent form that summarized the risks and benefits of the implants. This form had not previously been required.

"The second phase, or adjunct, studies were intended to follow reconstruction patients for five years to assess short-term safety data, including rates of capsular contracture, rupture, and complications such as infection and hematoma [collection of blood that may cause swelling, pain and bruising]," Dawisha says. "These studies are open to all women wanting breast reconstruction with implants because of mastectomy, traumatic injury to the breast, or a disease or congenital disorder causing a severe breast abnormality. They do not include augmentation patients."

Mentor Corporation of Santa Barbara, Calif., began adjunct studies in 1992. According to Cathy Fox, clinical programs supervisor at Mentor, 14,803 patients are now enrolled.

The third phase, or core studies, Dawisha says, were intended to determine the full safety and effectiveness profile of the device, including rupture rates, quality-of-life benefits, extent of interference with mammography, and many more safety concerns — including rheumatologic assessments — that would need a large number of women. They were also to include augmentation patients. The sponsors, however, have not initiated these studies.

Saline Implants

Although many of the local complications of gel-filled implants are also associated with saline implants, the latter were permitted to remain on the market unrestricted for both reconstruction and augmentation. FDA considers saline-filled implants less risky, because although they have the same silicone rubber envelope as gel-filled implants, leakage or rupture would release only salt water, not silicone gel, into the body.

Nevertheless, FDA is requiring manufacturers to collect data on the saline implants as well, because the incidence of known risks (for example, deflation and capsular contracture) is not well defined. When the Medical Device Amendments were passed, it was determined that these devices would also eventually require premarket approval. In January 1993, FDA notified saline implant manufacturers that they would have to submit safety and effectiveness data for their products. In December 1994, the agency told them what type of safety and effectiveness data were needed, and delineated objectives and time frames for the trials. Saline implants will stay on the market while the studies are conducted, but the companies must report the laboratory, animal and clinical data in stages, and must provide written information on the known and possible risks of their products.

"Women considering saline implants should ask their doctor for a copy of the manufacturer's information sheet, a copy of the product insert sheet for the specific implant to be used, and a copy of the hospital informed consent form," says Barbara Stellar, FDA's breast implant information and outreach coordinator.

Stellar recommends women be given these documents at least a month before surgery is planned, if possible, so they can thoroughly discuss benefits and possible risks with surgeons, radiologists, and other women. These women should also ask their physicians about participating in the saline breast implant trials.

Brown hopes that further studies will more clearly define risks associated with all types of implants.

"We need to be able to tell women considering breast implants — whether for augmentation or reconstruction — the specific risks on which they can base their decision," she says. "It should be made clear that implants do not last forever, that they may break, and in what time period it is thought they might break. Most women have no idea implants break and there's very little information about rupture rates.

"The same is true for other complications, some of which may require further surgery or may cause the woman to be displeased with the cosmetic effect, which, of course, is the reason she got them," Brown says. "For a product that a person is putting in her body presumably for 20 years or more, we should have this information."

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.