Groups Seek Probe of FDA Breast Implant Review

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Groups Seek Probe of FDA Breast Implant Review

Thu Apr 21, 6:50 PM ET Health - Reuters

By Richwine and Heavey

WASHINGTON (Reuters) - Six women's groups on Thursday

called for a congressional probe into the U.S.

government's review of silicone breast implants,

citing an e-mail they said showed U.S. regulators

planned to approve the products regardless of any

advice from outside experts.

Reuters

Slideshow: FDA Debates Safety of Implants

(go to website to see)

Emotional Testimony on Breast Implants

(AP Video) - (go to website to see)

Rival companies Mentor Corp. and Inamed Corp. want the

Food and Drug Administration (FDA) to lift a

13-year-old ban on silicone implants for most women.

The groups, including the National Organization for

Women, want more study of implant risks before the

products are sold again. They objected to what they

said was an internal FDA e-mail with a summary

prepared for Acting FDA Commissioner Lester Crawford.

The e-mail was dated March 4, weeks before a panel of

outside experts met to review breast implant data.

The e-mail said the information in the summary came

from " an outsider who is interested in seeing us come

out okay on the b.i. (breast implant) issue. "

" Since the document is a biased summary of breast

implant research that clearly advocates for FDA

approval, this e-mail implies the FDA had a

pre-determined interest in approval even before the

FDA advisory panel met, " the groups said in a letter

to the Senate Health, Education, Labor and Pensions

Committee.

Reuters received a copy of the e-mail and the letter.

FDA spokeswoman Zawisza said the summary was

" not an FDA document, and it does not represent the

FDA's position. "

Earlier this month, the advisory panel voted 5-4

against Inamed's implants, while urging approval for

Mentor's implants by a 7-2 vote.

The FDA still is considering the applications and will

base its decision on whether data show safety and

effectiveness, Zawisza said.

The e-mail said the source of the implant information

had learned the issue likely would be raised at a

Senate hearing on Crawford's nomination to be

permanent FDA commissioner. The hearing was held March

17, with no mention of breast implants.

The e-mail shows that it was sent by Bond,

director of scientific policy in the FDA

commissioner's office, to Dr. Schultz, head of

the FDA's Center for Devices and Radiological Health.

It asks Schultz for feedback on the summary.

Neither Bond nor Schultz immediately responded to

e-mail and telephone requests for comment.

The Senate health committee is reviewing the letter,

according to Craig Orfield, a spokesman for Committee

Chairman Mike Enzi, a Wyoming Republican.

The groups that sent the letter to the Senate

committee include the National Organization for Women,

the Command Trust Network, In the Know, Our Bodies

Ourselves, the National Research Center for Women &

Families and the National Women's Health Network.