Bacteria in Breast Implant? - Dr. Blais from evidence files

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DCC017001498

November 5, 1992 Toronto Sun

BACTERIA IN BREAST IMPLANTS?

MONTREAL (CP) - Ottawa chemist Pierre Blais and

colleagues at Laval University in Quebec City say they

have found large colonies of germs in surgically

removed breast implants.

" We found huge amounts of infectious materials in both

saline-filled and silicone-gel implants, " Blais said.

The implants were removed mostly from Canadian and

American women who were experiencing infection,

respiratory and immune-system problems and swelling

and fever, Blais said.

" A couple of implants were so contaminated with fungi

and other germs that they had turned coal black. "

Blais and his colleagues are using high-powered

microscopes to examine the germs.

But " in some cases, we could easily see signs of the

infected

materials without a microscope, " Blais said.

Some of the saline implants " have poorly designed

valves that

unfortunately can allow protein and plasma from the

woman to seep into the liquid. "

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November 5, 1992

Montreal Gazette

LAVAL TEAM FINDS GERMS FLOURISHING IN BREAST IMPLANTS

Devices studied after removal

Ottawa chemist Pierre Blais and colleagues at

University Laval in

Quebec City have found large colonies of germs in

surgically removed breast implants.

" We're finding huge amounts of infectious materials in

both

saline-filled and silicone-gel filled breast implants

that have been removed mostly from Canadian and

American women who are experiencing infections,

respiratory and immune-system problems, swelling and

fever, " Blais said in an interview this week.

" A couple of implants were so contaminated with fungi

and other germs that they had turned coal black, " he

said.

Blais and his colleagues are using high-powered

microscopes to examine the germs.

But " in some cases, we could easily see signs of the

infected

materials without a microscope, " Blais said.

" We're talking about grams of infected materials, not

tiny amounts. It includes bacteria exotic fungi some

of which grow like miniature mushrooms. "

All breast implants have been known to have a small

chance of causing infection. But this is the first

systematic investigation of infectious materials

trapped inside implants.

Some of the saline implants studied " have poorly

designed valves that unfortunately can allow protein

and plasma from the woman to seep into the liquid, "

Blais said.

" This may allow the germs to proliferate. And when

some of these

colonies get big enough, the germs could release

toxins that could affect body tissue and nerves. "

" The greatest danger to women with contaminated

implants is that the infectious material could spread

through the body if the implants leak or burst, " he

said.

" Once infection is in the body, the immune system

would be forced to react and it could trigger an

inflammatory process. "

So far the chemists have studied 20 sets of

saline-filled implants from various manufacturers. All

the implants had some germs.

" The variety and high degree of contamination suggest

that

manufacturing problems may be at fault, particularly

inadequate

sterilization, " Blais said.

But he said he had no proof that this was the case.

" Nor is there any way of knowing yet how many of the

several million sets of implants inserted in women in

North America, mostly in the last seven years, have

been contaminated by genus, " he said. " We've only

recently started looking at infection in implants and

so we don't know how widespread this problem is. "

Blais cautioned that women with implants shouldn't

jump to conclusions on the basis of early study

results because little is known yet about breast

implant contamination and the processes that might

cause harm.

Since 1983, doctors, patients and lawyers representing

women have been sending removed breast implants to

Blais and the Laval team, which is led by chemist

Guidoin, an implant expert. Blais and Guidoin

have data on 1,400 sets of implants showing how they

change or break down in the body.

Blais is to present evidence from the study of

contaminated implants at a breast implant conference

in Cleveland, Ohio, this weekend.

A moratorium on silicone gel-filled breast implants

began in the U. & and Canada last January after the

U.S. Food and Drug Administration reviewed safety data

on several products and found the data inadequate. The

implants are now available to women in the U.S. who

enroll in limited studies.

But saline-filled implants remain widely available in

the U.S. and Canada.

Norman , an implant expert at s Hopkins

University in

Baltimore, MD, told The Gazette yesterday that he has

reviewed the findings of implant contamination with

Blais at length, and the electron-microscope pictures

" show absolutely unacceptable levels of

contamination. "

, who has served on an FDA advisory committee

on breast

implants, and Blais's work is raising " root questions

about the lack of [government] regulation of something

as basic as proper

sterilization of implants. "

He said the fact that regulatory agencies in Canada

and the U.S.

neglected to establish registries of removed implants

so that they could be properly studied " now prevents

us from telling the public what the actual risk may

be. "

" Unfortunately, it's been common for plastic surgeons

and

manufacturers to dispose of removed implants, probably

because of

their concerns about possible lawsuits. " The FDA now

requires the

registration of women involved in breast-implant

tests.

said Blais and his colleagues are the only

ones who have been systematically studying removed

breast implants.

McGhan Medical Inc. of Santa Barbara, Calif, and

Mentor Corp. also of Santa Barbara, are the two

remaining makers of saline and silicone-gel implants

in the U.S. Several manufacturers withdrew from the

business last year following negative FDA assessments

of their products.

Dennis Condon, president of Mentor's surgical

division, said he won't comment on Blais and Guidoin's

findings until he sees their report.

At McGhan, recent sales of silicone-gel implants were

stopped after an FDA inspection last April found

lapses in sterilization as well as inadequate quality

control and record keeping said FDA spokesman

Cruzan.

Before McGhan can sell its silicone-gel implants for

test purposes, the company must convince the FDA that

it has made changes in the manufacturing plant. McGhan

sent a statement to the Gazette yesterday saying that

it will continue to work with the FDA to improve its

manufacturing process so that production of implants

may resume in the future.