Table of Contents
FDA Consumer magazine
July-August 2000
by Linda Bren
At the same time that Mattel's redesigned, smaller-busted Barbie doll was making its way onto the shelves of this nation's stores in 1998, a record number of the nation's women opted for a kind of surgery that would give them larger busts.
Breast augmentation has become the second most commonly performed cosmetic surgical procedure after liposuction, according to the American Society of Plastic Surgeons. In 1998 alone, more than 130,000 women in the United States underwent the procedure. This number grew to 191,000 in 1999--a 51 percent increase over the previous year and nearly a 500 percent increase since 1992.
Prior to 1992, two types of breast implants were available. Both had an outer silicone shell filled with either silicone gel or saline (sterile salt water). But since 1992, most of the breast implants have been of the saline variety because in that year, the Food and Drug Administration restricted the use of silicone gel-filled implants. This restriction was spurred by the concern that silicone gel leaking into the body could be harmful, and by the inability of the manufacturers to provide adequate safety data on their implants. FDA's decision eight years ago means that silicone-gel implants can only be used in controlled clinical studies for the purposes of reconstruction after mastectomy, correction of congenital deformities, or replacement of ruptured silicone-gel implants that were used for augmentation.
Saline-filled implants are believed to be safer than silicone because rupture or leakage will only release salt water--not silicone gel--into the body. Consequently, FDA has allowed these implants to remain on the market without evidence of safety until this year.
That evidence of safety was presented by McGhan Medical Corporation and Mentor Corporation, both of Santa Barbara, Calif., to an FDA advisory panel on March 1-3. On May 10, following the panel's recommendation, FDA approved saline-filled breast implants made by these two manufacturers. The products are approved for breast augmentation in women 18 years or older and for breast reconstruction in women of all ages.
Reasonable Assurance of Safety
Breast implants had been on the market for more than a decade in 1976, when FDA was charged with regulating them as medical devices. While allowing the continued use of these "grandfathered" implants, FDA made it clear that manufacturers would be required to show their products to be safe and effective at some point in time.
FDA's approval of McGhan's and Mentor's saline implants acknowledges that these manufacturers have provided "reasonable assurance of safety and effectiveness" of their products.
Yet, these products do have risks. Breast implants are artificial medical devices--and no medical device functions as well, lasts as long, nor is as safe as the biological body part it replaces.
Like their silicone counterparts, saline breast implants can rupture, ripple, harden, change shape, and shift position. They can also cause infection, pain, and loss of feeling in the nipple or tissue of the breast. And they can interfere with breast-feeding and the detection of breast cancer.
Benefits and Risks
During the FDA advisory panel meeting, some women with breast implants, particularly those who had them for reconstruction after breast cancer surgery, reported that they had experienced significant improvement in their quality of life. Despite the complications that occurred in many women in the Mentor and McGhan studies, the majority of those still in the studies after three years reported being satisfied with their implants. These studies included both augmentation and reconstruction patients.
Even though breast implant surgery is well-established, there can be complications. "The most commonly occurring local complications reported for saline-filled breast implants are capsular contracture, implant rupture or deflation, and the need for additional breast implant surgeries," says Sahar M. Dawisha, M.D., a medical officer in FDA's Center for Devices and Radiological Health who reviewed the study data submitted by Mentor and McGhan.
Because the implant is a foreign object, the body will typically form scar tissue around it. The tightening and squeezing of this scar tissue is called capsular contracture. This contracture may result in hardening of the breast tissue, rippling of the skin, and changes in breast shape. It also may cause pain, which, if severe, can require surgery to remove the scar tissue or replace the implant itself.
Breast implants have a limited life. A rupture can occur at any time. "I tell my patients that the implant is on loan," says Gregory O. Dick, M.D., a plastic and reconstructive surgeon and chief of surgery at Shady Grove Adventist Hospital in Rockville, Md. "They can enjoy it for 6 weeks or 6 years or 60 years."
Once the implant ruptures, surgery is required to remove or replace it. Surgery may also be necessary in the event of infection, shifting of the implant, or formation of calcium in the surrounding tissue.
Another potential complication from implant surgery is nerve damage, causing some women to experience a change in sensation or loss of feeling in their nipples and breast tissue. These symptoms may disappear eventually but can be permanent in some patients.
Additionally, says S. Lori Brown, Ph.D., an epidemiologist in FDA's Center for Devices and Radiological Health, "many women with implants are unable to breast-feed successfully." It is unclear whether insufficient milk production to breast-feed is due to damaged nerves or to other reasons, says Brown.
Making Cancer Harder to Detect
Breast implants can interfere with finding breast cancer during mammography. "The implant can hide breast tissue and, as a result, can hide lesions as well in the breast tissue," says Wendie Berg, M.D., director of breast imaging at the University of Maryland in Baltimore. In addition, extensive scarring and calcium deposits in tissue surrounding an implant can mimic cancer, Berg says, making them difficult to distinguish from tumors on a mammogram.
The process of taking a mammogram, which includes squeezing, or compressing, the breast, may increase the chance of rupture. But limiting the compression may compromise the quality of the picture.
When scheduling mammography, women with implants should ask for a comprehensive, or diagnostic, mammography instead of the regular screening mammography. They should request an x-ray technician who is experienced with mammography in women with breast implants. At the time of the appointment, women should inform the technician of the type of implant (saline or silicone) and its location (whether it is in front of or behind the chest muscle).
Making an Informed Decision
Women considering breast implant surgery need accurate information to help them make an informed decision. FDA requires breast implant manufacturers to provide printed information to help women with their decision, and has assisted manufacturers in developing this information. Women should ask their doctors for this "patient informed decision labeling" if they do not receive it.
For more information, request FDA's free consumer handbook, "Breast Implants, An Informational Update," by calling the agency's toll-free information line at 1-888-463-6332. (To get breast implant information, press 1, press 3, press 1, and then press 6.) The handbook, as well as copies of the Mentor and McGhan patient information on saline breast implants, is available at www.fda.gov/cdrh/breastimplants/.
Linda Bren is a staff writer for FDA Consumer.
--M.L.
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