US reviewing study of silicone breast implants

[Guest guest]

" If there's information out there that impacts the

review process, we plan on looking at it, " Dr.

Schultz, director of the FDA's Center for Devices and

Radiological Health, said when asked about the

platinum study.

http://news./s/nm/20060407/hl_nm/implants_dc_1

US reviewing study of silicone breast implants

Fri Apr 7, 5:37 PM ET

WASHINGTON (Reuters) - U.S. regulators are reviewing a

small study that reported high levels of platinum in

the hair, breast milk and other samples from women who

had silicone gel-filled breast implants, officials

said on Friday.

The findings represent the latest concern to be raised

about silicone breast implants, which were banned for

most women in 1992 amid a controversy over their

safety. Two makers are trying to return the implants

to general use.

Most questions have centered on the effects of leaking

silicone and not the platinum used in their

manufacturing.

In a report this week in the peer-reviewed journal

Analytical Chemistry, researchers said they studied

samples from 16 women who had implants for about 14

years on average and compared them with five women who

had no implants.

Platinum in nails, hair, urine and breast milk was

higher in women who had the silicone implants than

others who did not, the study said. Levels were 100

times higher in breast milk, and as much as 1,700

times higher in urine.

The study said the platinum was in a form that may be

harmful to human health.

" FDA will conduct a thorough review of this study, "

agency spokeswoman Cruzan said.

The study was conducted by researchers at the

Texas-based firm EperTox and the Center for Research

on Environmental Medicine.

A nonprofit group that provided funding for the study,

Chemically Associated Neurological Disorders, filed a

petition with the FDA asking it to delay a decision on

new silicone breast implants in light of the study.

The research " shows now that the platinum that is

being released is in a harmful reactive form. This is

important for women who may have leaking implants in

their body and also for young women who are

considering breast-feeding their children, " said

Keeling, the group's president.

Silicone implants made by Mentor Corp. and Inamed

Corp., which was acquired by Allergan Inc., have been

deemed " approvable " by the FDA if certain, undisclosed

conditions are met.

It was unclear how the new study would affect the

agency's ongoing review.

" If there's information out there that impacts the

review process, we plan on looking at it, " Dr.

Schultz, director of the FDA's Center for Devices and

Radiological Health, said when asked about the

platinum study.

Both companies dismissed the latest findings, saying

similar information was presented before the FDA made

its initial decision.

An earlier review of various research by the

Institutes of Medicine showed " platinum-related health

problems in women with breast implants do not

presently exist, " Mentor said in a statement.