ONLY 5% follow-up on Mentor 'study' after 5 years!

[Guest guest]

EXCERPT: However, of the more than 1200 women in the Mentor study

of breast augmentation patients, only 60 (5 percent!) were analyzed

at the five-year follow-up. Physicians, researchers, and the

ethicist and consumer representative on the Advisory Panel said an

informed choice was impossible for Mentor patients because of the

low response rate.

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http://www.breastimplantinfo.org/what_know/bi092002.html

July 2002 Update On Saline Breast Implants: New 5-Year Studies

Available

By Zuckerman, Ph. D.

Saline breast implants were approved by the FDA in May 2000, even

though members of their Advisory Panel expressed shock about the

high rate of hardness, pain, additional surgery, and other local

complications. The FDA required the manufacturers to keep studying

their implants, and the latest results were made public at an FDA

meeting on July 9, 2002. After seeing the studies, the FDA's

Advisory Panel again expressed dismay because so many women

experienced serious complications, and because safety data are still

lacking.

The meeting was requested by the FDA Advisory panel that had

recommended FDA approval of saline implants in 2000, under the

condition that the companies, Mentor and Inamed (formerly McGhan),

conduct long-term safety studies. Both companies provided at least

three years of data on complications in 2000 and five years of data

on complications at the July 2002 meeting. However, of the more than

1200 women in the Mentor study of breast augmentation patients, only

60 (5 percent!) were analyzed at the five-year follow-up.

Physicians, researchers, and the ethicist and consumer

representative on the Advisory Panel said an informed choice was

impossible for Mentor patients because of the low response rate.

Study Problems

A study of 60 augmentation patients is not large enough to provide

useful safety data on breast implants, but the greater problem is

that when 95% of the women in a study drop out, nobody knows if

those who remain in the study are different than those who don't.

The concern is that women who dropped out of the study may have very

different medical problems than those who participated -- whether

they are healthier or more ill. Although Mentor subsequently

obtained some data for about half of the augmentation patients who

were supposed to be in their study, one member of the Advisory panel

criticized Mentor for its " mind boggling poor results. " I think that

was very kind. As a former faculty member, I can honestly say that

if an undergraduate student presented these data to me, I would have

flunked them. Approximately half the breast cancer reconstruction

patients in the Mentor study were analyzed after five years.

Although better than the breast augmentation study, this is still

considered a very poor response rate.

Health Problems, Cosmetic Problems, More Surgery, and Other

Complications

The study by Inamed (formerly called McGhan) was better designed,

but many of the women in the study had serious complications or

needed additional surgery. For example, during the first five years

of having implants, 45 percent of breast cancer reconstruction

patients required additional unplanned surgery, 28 percent had their

implants removed, 39 percent had breasts that did not match in

appearance, 36 percent had capsular contracture (hardness), 27

percent had implants that were visible or could be felt, and 25

percent had implants that created a wrinkling appearance, 18 percent

had implants that had moved to the wrong location, 18 percent had

breast pain, and 8 percent had implants that leaked or deflated. The

rates of 10 other complications such as infections, skin necrosis

(skin death) and implants extruding through the skin ranged from 3

percent to 7 percent each.

There are other reasons to be concerned about the safety of breast

implants. Four members of Congress recently asked the FDA about a

criminal investigation of Mentor. The FDA says they cannot discuss

any ongoing criminal investigations publicly. Two of the Congressmen

also asked the FDA to provide the Advisory Board with recent studies

conducted by the National Cancer Institute. One of these studies

showed an increased risk of cancer for women with saline or silicone

implants compared to other women, and the other showed an increase

risk of death from brain cancer or lung diseases among women with

saline or silicone implants, compared to other plastic surgery

patients. (Click here for previous press release) Why didn't the FDA

provide the data to their own Advisory Panel, or at least mention

the studies, since one of their own scientists helped conduct the

research?

What Next?

The bottom line: more than 250,000 women underwent implant surgery

last year, more than 200,000 of them to increase the size of their

healthy breasts. At the same time, 60,000 women had their implants

removed. The Mentor study is too poorly done to be published in a

medical journal, but the Inamed study should be published and made

widely available so that plastic surgeons and their patients will

know that serious complications are very common. Patient advocates

hope that the FDA will develop a booklet for plastic surgeons and

revise their consumer publications on breast implants to include the

Inamed study and the cancer studies. What happens to women who have

had breast augmentation or breast reconstruction for 15 or 20 years?

Almost 40 years after silicone breast implants were invented, we

still know very little about their long-term safety.

Zuckerman, Ph.D., is president of the National Center for

Policy Research (CPR) for Women & Families, a nonprofit research

center that provides health information about women, children, and

families.

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www.BreastImplantAwareness.org