Re: Fw: Tuesday's FDA hearing on breast implants

[Guest guest]

The ASAPS puts their spin on the FDA hearing

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ASAPS E-Bulletin

From the American Society for Aesthetic Plastic

Surgery

July 10, 2002

ASAPS and ASPS testified yesterday at the FDA Panel

Hearings on Saline-filled Breast Implants. Below is

our Joint Bulletin to members. One thing that should

be added to the points made below is that the McGhan

testimony validated Mentor’s data. The panel was

concerned that Mentor’s data was based on too small a

universe. McGhan’s results were virtually the same

based on more patients, and the panel was receptive to

that.

If you have any questions about the hearing, feel free

to call the Communications Office: 212.921.0500.

ASAPS and ASPS JOINT BULLETIN

On FDA Panel Hearings on Saline-filled Breast Implants

July 9, 2002

Gaithersburg, MD -- The American Society for Aesthetic

Plastic Surgery (ASAPS) and the American Society of

Plastic Surgeons (ASPS) presented testimony today on

saline-filled breast implants at the U.S. Food and

Drug Administration’s (FDA’s) public advisory

committee meeting of the General and Plastic Surgery

Devices Panel.

The purpose of the meeting was to update the panel

regarding the post-market conditions required of the

Mentor Corporation and McGhan Medical (now called

Inamed Aesthetics), when the FDA announced premarket

approval applications by these two companies in May

2000.

Perspectives-- pro and con -- were presented by

organizations and individual patients with implants

during the two-hour public comment period.

Organizations offering testimony included Y-Me

National Breast Cancer Organization, Women’s

Information Network Against Breast Cancer (WINABC),

National Women’s Health Network, and the National

Center for Policy Research for Women and Families.

V. Leroy Young, MD, testifying on behalf of ASPS/PSEF,

discussed the ASPS’ role of advocacy for patients and

the safety of implants, and PSEF initiatives including

the National Breast Implant Registry, the recently

formed International Breast Implant Registry, patient

information and informed consent, and sponsored

research. He also presented patient survey data on

complications, quality of life, breast pain, and

nursing following augmentation.

Laurie Casas, MD, provided the perspective of a female

plastic surgeon. Speaking on behalf of ASAPS, Dr.

Casas spoke about the continuing education offered to

plastic surgeons, and the psychological impact of

implants on patients’ quality of life. She emphasized

that the key to successful breast implant surgery is

full informed consent. Dr. Casas referenced the

multi-center prospective study recently funded by

ASERF on patient satisfaction following aesthetic

surgery.

Both Mentor and McGhan presented their postmarket

approval study data, and the FDA commented on the five

requirements that had been set forth. The panel was

critical of the quality of Mentor’s data and expressed

concern about the low percentage of patient follow-up

and the high rate of local complications, especially

device failure and reoperation (though it was

acknowledged that much reoperation is driven by

patient request for change in implant size). The panel

expressed concern that Mentor’s current data was

incomplete, and therefore unreliable, making complete

informed consent difficult. The data are considered

inadequate in large part because of incomplete

follow-up, which in some instances are as low as 60%

at five years. The panel was concerned that low

patient follow-up might indicate a high level of

dissatisfaction. However, most plastic surgeons

believe that satisfied patients do not see a reason

for continued office visits. Historically, long-term

follow-up in breast implant patients has been

difficult and at present no workable solution has been

found. Panel members stated support for data that

would be gathered through an independent breast

implant registry.

For McGhan, the panel was complimentary of its data

clarity and the high patient follow-up of over 80% at

five years. Concern was expressed at McGhan’s

reoperation rate, although most were driven by

patients’ requests. Finally, the FDA felt that McGhan

complied with three of the five requirements. The

other two are open and expected to be closed in the

near future.

Each of the manufacturers will be updating their

patient information materials based on feedback from

FDA-mandated focus groups.

Panel members offered generally supportive comments on

keeping implants available and that women should have

the right to choose surgery with breast implants. They

were not convinced, however, that women were well

informed about the risks and possibilities of further

surgery.

ASAPS and ASPS believe that the weight of current

scientific evidence supports the FDA’s approval and

continued oversight of these devices. Both

organizations support the FDA in its effort to ensure

patients receive safe and effective medical devices.

ASAPS and ASPS support a woman’s right to choose

implants for breast reconstruction or enlargement,

while emphasizing the importance of complete,

up-to-date and accurate information regarding the

potential risks and benefits of implant surgery. Both

organizations believe that informed consent is crucial

to successful breast implant surgery. Informed consent

results when patients are provided with all the facts

and information necessary to make an educated decision

to proceed with a medical treatment or surgical

procedure. Full informed consent is in the best

interests of both patients and physicians.

The FDA Medical Device Amendments were enacted in 1976

by Congress, giving the FDA the authority to regulate

medical devices such as breast implants, which were

already on the market. In 1988 the FDA classified all

breast implants as class III medical devices requiring

strict controls for safety and effectiveness. In May

2000 the FDA approved, with conditions, premarket

applications for saline-filled breast implants

manufactured by Mentor and McGhan. Today’s panel

meeting is a continuation of the ongoing regulatory

process of saline-filled breast implants.

A joint ASAPS and ASPS position statement for the

media is being posted on the ASAPS website

www.surgery.org and the ASPS website

www.plasticsurgery.org.

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