Are Saline Implants Safe?
March 27, 2000 (Chantilly, Va.) -- Six months after the birth of her second daughter, Julia was trying on a swimsuit when she looked out the window. "I remember [seeing] all the young women on the beach, and thinking, 'I used to look like that,' " she recalled. "I decided right then and there that I was going to get implants."
It's a decision she now regrets.
The Dulles, Va., woman, who asked that her last name not be used, is contemplating a lawsuit against her surgeon and the company that made her implants: In the five years since her breast augmentation surgery, she has had to have her implants replaced twice.
Last month, she had them removed for good.
The breast tissue surrounding Julia's implants had become so sensitive that she could hardly touch her breasts. "The pain had gotten to be almost unbearable at times," she said. "I had gotten them to boost my self-esteem, but by the time I had them out I decided there was nothing sexy about me."
Women like Julia are watching Washington, D.C., these days following the Food and Drug Administration's (FDA) first formal review of saline implants.
Earlier this month, an FDA advisory panel recommended that two leading brands -- manufactured by McGhan Medical Corp. and Mentor Corp., both of Santa Clara, Calif. -- remain on the market as long as women are fully informed of the risks, including the possibility that their implants may rupture, leak, or cause an infection.
Among the panel's recommendations: that the FDA review the consent forms that women sign prior to surgery, and that implant makers provide more complete information about postsurgical complications such as reoperations to replace leaky or ruptured implants.
The FDA is expected to issue a final decision in mid-May. Most observers expect it to endorse the panel's recommendations.
A Legacy of Worry
Saline implants have been the only option for many women since 1992, when the FDA banned silicone implants based on concerns that they might be causing autoimmune disorders, such as lupus, arthritis, and body aches.
An Institute of Medicine report last year found no link between silicone implants and autoimmune problems; so did a study reported in the New England Journal of Medicine earlier this month. Yet the controversy over silicone has put pressure on the FDA to take a harder look at saline.