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FDA hears breast implant concerns.
2002 AUG 8 - (NewsRx.com & NewsRx.net) -- Two years after the U.S. government allowed continued use of saline-filled breast implants, a Food and Drug Administration (FDA) panel heard concerns in July 2002 about patients' further surgery and a lack of follow-up data.
The panel heard implants praised and condemned at the session, designed to collect information. No formal action was planned.
"I made the decision to have the surgery and have never regretted it," said Tammy Griffiths, who described herself as a mother of four from Texas. "I feel better about myself and more confident in my physical appearance."
Cheryl Valput added, "This was one of the best decisions that I have made in my life." Valput said she was from Ohio. Neither of the women at the hearing gave a hometown.
On the other side of the issue, Mary McDonough said she had had breast implants after she left the show "The Waltons," where she played the character Erin. "It's a decision I very much regret," she said, citing continuing health problems. "American women have been poorly served on the issue of breast implants."
The FDA approved the implants 2 years ago, setting a series of conditions, including a follow-up study.
But response rates were low despite efforts to contact women who took part in clinical trials of the implants prior to approval.
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- News wire article from: PTI - The Press Trust of India Ltd. August 7, 2007 700+ words
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- News wire article from: AScribe Medicine News Service August 7, 2007 700+ words
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- Newspaper article from: Cancer Weekly October 14, 1991 700+ words
...preserve their right to choose breast implants. The women - who all have chosen to...believe the same is true of breast implants. Women should be clearly and fully...only national survey of women with breast implants conducted to date, an...
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- Newspaper article from: Cancer Weekly February 3, 1992 700+ words
...annual report about breast implants. They also will be...manufacturers regarding breast implants. "This is a confidential...solely to benefit women with breast implants. We do not provide...provide assurance that a woman will be contacted...
Source: HighBeam Research, FDA hears breast implant concerns.