FDA Saline Hearings / March, 2000

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http://www.usatoday.com/life/health/plastic/lhpla006.htm

March 7, 2000

FDA panel unhappy with implant studies

By Rita Rubin, USA TODAY

GAITHERSBURG, Md. - Should saline breast implants remain on the market, or

should they go the way of silicone-gel implants?

ThatÂ’s the question now before the Food and Drug Administration, which is to

decide later this year.

Although saline implants have been on the U.S. market since the 1960s, many

women who have them only recently learned that the FDA has never determined

whether theyÂ’re safe and effective.

"ItÂ’s unbelievable that I am here to talk today about something that should

have been taken care of 30 years ago," said Ann Stansell, a New Mexico

breast cancer survivor who testified during a contentious three-day meeting

of an FDA saline implant advisory committee last week.

The meeting touched on issues as diverse as the nature of feminine

attractiveness and the validity of scientific research. In the end, the

committee recommended that the agency approve two implant makersÂ’

applications to stay on the market: Mentor and McGhan Medical, both of Santa

Barbara, Calif.

The advisory committee meeting marked the first time that saline implant

makers presented safety and effectiveness data to the FDA. Such implants

were on the market before May 1976, when Congress gave the FDA regulatory

authority over medical devices. Any devices sold before then were allowed to

remain on the market, with the caveat that the FDA eventually could ask

makers to demonstrate safety and effectiveness.

Although instructed to base their decision only on scientific data,

committee members heard from dozens of women about how saline - or

saltwater-filled implants changed their lives, for better or for worse. The

womenÂ’s testimony helped stretch the first day of the meeting to more than

13 hours.

"Just knowing that option was out there for me gave me hope," said

Gardner, a breast cancer survivor who had reconstruction of both breasts in

September at town University Medical Center in Washington, D.C. "I

feel happy, healthy and desirable again."

Then there was Ann Angus of Vancouver, British Columbia, who got saline

implants in 1995 at age 33 in an attempt to restore her pre-pregnancy

figure. Angus called that decision "the stupidest thing I ever did." Her

breasts became hard, painful and lumpy, she said, and her overall health

deteriorated. Angus told the committee that she had the implants removed 2

1/2 years after getting them.

Though the committee voted unanimously in favor of McGhanÂ’s application, and

all but one member voted in favor of MentorÂ’s, those decisions do not

represent a wholesale endorsement of the implants.

Committee members qualified their votes with lengthy lists of conditions

pointing out weaknesses in the manufacturersÂ’ data, especially the lack of

long-term follow-up and proof of the implantsÂ’ effectiveness, such as

whether women who had them were better off psychologically.

"The data were not that compelling," Maxine Brinkman, the committeeÂ’s

non-voting consumer representative, said in an interview after the meeting.

Brinkman, a nurse, works with breast cancer patients in Mason City, Iowa.

Since Kessler virtually banned silicone-gel implants in 1992 when he

was FDA commissioner, saline implants have been the only option for the

growing number of U.S. women who want to have their breasts enlarged. Breast

cancer patients can get silicone-gel implants only if they agree to

participate in clinical trials, so most choose saline.

Several committee members said the lack of alternatives made them more

willing to accept imperfect or less-than-promising data.

Li of the department of biomechanics and biomaterials at the

Hospital for Special Surgery in New York seemed especially concerned about

the implantsÂ’ high likelihood of rupturing. "ItÂ’s amazing that it seems to

be tolerated, that you just have to live with it," Li said.

Still, Li followed the lead of the three plastic surgeons on the panel and

voted for approval. "The devices have been around for a while," he noted in

an interview.

The manufacturersÂ’ studies were not good enough for a peer-reviewed

scientific journal, said committee member Brent Blumenstein, a

biostatistician with the American College of Surgeons Oncology Group.

"Accuracy is not manifest in the presentation of the data," Blumenstein said

in reference to McGhanÂ’s presentation, and he called MentorÂ’s data "kind of

smelly." Still, Blumenstein, like all but one panelist, voted to approve

both applications.

After each company presented its studies, FDA reviewers interpreted the

data. Sometimes it sounded as if the makers and the FDA staffers were

talking about different data.

For example, Bruce Cunningham, a University of Minnesota plastic surgeon and

Mentor consultant, said that a desire for larger implants was the main

reason breast augmentation patients had theirs removed. Minutes later, Sahar

Dawisha of the FDA said the majority of breast augmentation patients who had

their implants removed did so because of complications, not to increase

breast size.

Although Y-Me, a breast cancer advocacy group, has urged that saline

implants remain on the market, reconstruction patients fared far worse in

the manufacturersÂ’ studies than women who had augmentation. The reasons

werenÂ’t clear.

In an interview, Brinkman questioned how her colleagues could vote that

implants were "reasonably safe" for reconstruction patients. "It breaks my

heart," she says.

After three years of follow-up, only 27.5% of reconstruction patients and

57.4% of augmentation patients remained complication-free in the Mentor

study, FDA statistician Phyllis Silverman told the committee.

McGhanÂ’s patients did worse, with 25.6% of reconstruction patients and 43.3%

of augmentation patients remaining complication-free after three years of

follow-up, FDA staffer Telba Irony said.

Committee members debated whether the implants or the surgeons were to blame

for complications such as asymmetry and deflation.

Neither manufacturer had any information about the substantial number of

women who dropped out of the studies, an oversight that could have affected

the conclusions.

"It could be that the person didnÂ’t come back because she was feeling fine

and didnÂ’t see any reason to come back," Irony told the committee. "On the

other hand, maybe the patient was feeling bad and looked for help

elsewhere."

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537