Washington, April 9: Researchers have found a new reason for possible concern about the safety of silicone gel breast implants: high and potentially hazardous levels of the metal platinum in some women who had silicone implants in their bodies for many years.
With the US Food and Drug Administration (FDA) poised to allow silicone implants back on the market for unrestricted sale, two researchers reported this week in a journal of the American Chemical Society that they found high levels of platinum salts in the urine, hair and breast milk of 16 women with silicone gel implants.
The platinum, they concluded, was in a form that made it a potential source of severe allergic or toxic reactions. Their findings were immediately challenged by chemists associated with implant makers and are at odds with the long-time conclusions of the FDA, which has determined that the platinum used to make silicone gel implants is inactive and unable to cause harm.
Although the possibility that some silicone implants might release a harmful form of platinum has been debated since the early 1990s, the metal has not been at the centre of the long and contentious debate over the safety of the implants. And the possible health problems that could come from platinum ' severe allergies, asthma, nerve damage and reduced immune responses ' have not been the focus of the many lawsuits against implant makers.
The FDA deemed two applications to sell silicone gel implants to be “approvable” last year, although the agency has yet to give the final go-ahead to the companies ' Mentor Corp and Inamed Corp.
Some implants are used by women who have had mastectomies, but most of the more than 2,50,000 sold each year are for breast enhancement. That number is expected to rise if the more popular silicone implants are fully allowed back on the market along with saline-filled versions.
FDA spokeswoman Susan Cruzan said that the agency is “carefully reviewing the article, and we don’t know how long that will take.”
In their paper in Analytical Chemistry, considered a top journal of the field, researchers Ernest Lykissa and Susan Maharaj reported finding the highest platinum levels to date in women who had implants. They also wrote that for the first time, they found the platinum ' which had leached out of the implants ' in a transformed, oxidised state that makes it potentially more harmful.
“Implant manufacturers have said for years that their platinum is not harmful, and when the device is manufactured, they are correct,” said Lykissa, a forensic toxicologist with the firm ExperTox in Deer Park, Texas. “But in the body, we know that the implants degrade and the platinum can disperse and take on a more reactive form.”
Most of the women in the study, which was funded in part by a non-profit group that has argued to keep silicone implants off the market, had their enlargements implanted in the 1980s.
The study was quickly and aggressively attacked by other chemists, especially those with connections to breast implant makers.
Michael Brook, a chemist and silicone manufacturing expert, said the study contained some data and conclusions that were hard to accept.