Saline Implants: FDA Hearing
March 27, 2000 (Chantilly, Va.) -- First, there was silicone.
In the 30 years after their introduction in 1962, silicone implants became the centerpiece of a legal and medical firestorm, culminating last November in a massive $3.2 billion settlement against the nation's leading maker of silicone implants, Dow Corning Corp.
Now the spotlight is on saline.
Saline, or saltwater-filled, implants currently are sold by the grace of a government loophole: They hit the market before the Food and Drug Administration's (FDA) began regulating medical devices in 1976.
The FDA has been under pressure for years to address saline implants. In early March, an FDA advisory panel held three days of hearings to consider whether two types of implants should be allowed to stay on the market.
The panel stopped short of declaring that saline implants were safe and effective -- legal and regulatory language that women's groups and lawyers have been eager to hear.
But according to a source close to the panel, it did recommend that the FDA do more to make sure women know about implant risks, including:
- Review the consent forms now given to women, usually by plastic surgeons prior to surgery, and recommend ways to improve them.
- Require implant makers to come up with a "protocol" that would ensure that women get complete and accurate information on health risks.
- Require implant makers to include more information about the number of women who require "revisions" after implant surgery -- essentially, second or even third operations to repair or replace damaged implants.
The panel also recommended more long-term studies on women who have received implants, as well as more testing to determine how and why implants rupture or leak.
To be sure, consumer demand for implants remains strong. In 1999, about 130,000 women received saline breast implants -- 80% of them for cosmetic purposes, not including reconstruction following cancer surgery or severe injury.
Ironically, the FDA has no plans at present to review silicone implants for safety and efficacy, despite a study published earlier this month in the New England Journal of Medicine that found no links between silicone implants and reports of autoimmune diseases such as arthritis and lupus.