FDA Hears Breast Implant Concerns
FDA Hears Breast Implant Concerns
RANDOLPH E. SCHMID
Jul. 09, 2002
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GAITHERSBURG, Md. (AP) _ Two years after the government allowed continued use of saline-filled breast implants, a Food and Drug Administration panel heard concerns Tuesday 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 two 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.
Five years after their surgery, one study was able to contact just 5 percent of women who received implants for breast enlargement during preapproval trials. For women who got the implants for reconstruction after surgery the rate was higher, at 52 percent.
That study found a 20 percent chance of the women having another surgery in five years for the enlargement group and 43 percent for reconstruction patients.
The most common reason for the second surgery was cosmetic _ to change breast size, clear up scars or ease wrinkling. However, many of the procedures were for more serious reasons, including deflated or leaking implants or an infection.
Several witnesses stressed the right of women to choose implants and panel members seemed to agree, but were concerned about whether enough information was available.
``Clearly a woman has a right to choose,'' said Nancy A. Dubler of Alfred Einstein College of Medicine in New York. ``The problem is she has the right to choose between products that, by their own data, aren't terrific.''
Dr. Michael A. Choti of the Johns Hopkins school of Medicine in Baltimore said ``these products have problems ... there's clearly a mandate to improve.''
David L. DeMets of the University of Wisconsin, Madison, was highly critical of the lack of follow-up data and pressed the FDA and the companies that make the implants to work harder to collect data from patients.
Dr Robert L. McCauley of the University of Texas Medical Branch in Houston added that ``it's imperative that we push the envelope and get as much follow up as possible.''
Cliff Kline of Mentor Corp., an implant maker, said his firm is continuing such efforts and hopes to reach a 60 percent response level by 10 years after women's surgery.
Some panel members questioned why women who have the implants removed are then dropped from follow-up efforts.
Kline responded that they are no longer considered likely to suffer complications from the implants once they have been removed.
The session opened with speakers from the public and several women testified that having implants had improved their lives by giving them more confidence. Others complained of various medical problems, including leaking implants.
Samie Allen of the FDA told the panel that focus groups called for when the implants were approved have been completed and changes are being made to product labels to make them more understandable.