Silicone Breast Implants Near Approval

[Guest guest]

Devices Have Not Been Studied Long-Term, Group Says By

Todd Zwillich

WebMD Medical News Reviewed By Louise Chang, MD

on Friday, February 03, 2006

More From WebMD

Silicone Breast Implants Near Approval

FDA Panel Sets Strict Conditions for Silicone

Implants

What's the Right Breast Cancer Treatment for You?

Feb. 3, 2006 -- A report issued Friday cautions

against the likely return of silicone breast implants

to the U.S. market, warning that companies have not

performed long-term safety studies in breast cancer

patients.

The FDA is expected to soon clear two companies'

silicone implants for U.S. sales after a nearly

14-year partial ban.

The implants are used for women seeking cosmetic

breast enhancement and breast cancer patients and

others needing reconstruction after mastectomies.

Concerns over ruptures and the possible health effects

of silicone leakage into the body had kept silicone

implants off the cosmetic surgery market.

Friday's report concludes that the companies have not

properly studied the implants' safety in women with

cancer.

" The main focus of this report is really the missing

data, the research that hasn't been done, " says

Zuckerman, PhD, president of the National Research

Center for Women and Families, which issued the

report.

Split Committee

Last April, an FDA advisory panel voted 5 to 4 to

reject Inamed's bid to sell silicone implants, citing

a lack of long-term safety data. The next day the

panel voted 7 to 2 to allow Mentor to sell its

implant, which appeared to be more durable and less

likely to rupture.

Inamed's study showed that 5% of women with the

implants experienced ruptures within three years of

surgery. Company projections concluded that 14% of the

implants could be expected to break after 10 years of

use, but patients were not actually followed for that

period of time.

Inamed officials say that they could not link any of

the ruptures in their study to serious health effects

and instead only found an increased likelihood of

local symptoms like pain and breast hardness around

broken implants.

But experts at the time criticized the company for not

conducting long-term safety trials. An FDA analysis

projected that as many as 93% of women could

experience ruptures after 10 years of use.

Safety Questions Linger

Thousands of women have blamed leaking silicone

implants for a variety of health problems, including

autoimmune diseases, connective tissue disorders, and

cancers.

Mentor implants showed a lower rupture rate, and a

small, nine-year study of women in Britain helped

convince experts to recommend approval under the

condition that the company monitor women closely after

surgery.

Inamed conducted a 2003 study of 250 women who got the

implants for post-mastectomy reconstruction. But

Friday's report complained that only a fraction of the

women were studied using mammography to pick up small

leakages that make up the vast majority of implant

ruptures.

" There's practically nothing on breast cancer

patients, and we think that's a terrible loss, "

Zuckerman says.

Last summer, the agency issued statements on

" approvable " letters to implant makers Inamed Corp.

and Mentor Corp. The letters require the companies to

meet certain, undisclosed conditions before marketing

is allowed.

Wood, PhD, former director of the FDA's office

of women's health, says companies have not studied the

implants for longer time periods or in an adequate

number of minority women.

" There is still such a lack of data in a very real and

concrete way, " she says. Wood resigned from the FDA in

August to protest the agency's failure to approve the

emergency contraceptive pill Plan B for

over-the-counter use.

Companies' Positions

Inamed did not respond to calls seeking comment. In

April, , MD, the company's executive

vice president for research and development, told the

advisory panel, " Our data has shown no systemic

illness, no connective tissue diseases over and above

what you would expect in the general population. "

In a statement, Mentor would not comment on the

conditions FDA has laid out for its products' approval

but says it " continues to work closely with the FDA to

address the conditions outlined in the FDA's

approvable letter. "

" Mentor believes the advisory panel evaluated the data

with rigor and made their recommendation of

" approvable " based on the scientific merit of the

studies included in the pre-market application, " the

company stated.

A 1999 Institute of Medicine study declared no

connection between the implants and systemic diseases,

though that same year former implant maker Dow Corning

agreed to pay $3.2 billion to settle claims that its

products sickened patients.

An FDA spokesperson says that the agency does not

comment on pending product applications.

-----------------------------------------------------------------

SOURCES: " Decisions in the Dark: The FDA, Breast

Cancer Survivors, and Silicone Implants. " National

Research Center for Women and Families, Feb. 3, 2006.

FDA Statements on " Approvable " letter to Mentor Corp,

July 28, 2005. FDA Statements on " Approvable " letter

to Inamed Corp, Sept. 21, 2005. Zuckerman, PhD,

president, National Research Center for Women and

Families. Wood, PhD, former director, FDA office

of women's health. , MD, vice

president, research and development, Inamed Corp. FDA.

Statement, Mentor Corp, Feb. 3, 2006.