Fwd: TOXIC BREASTS 2/2 (implants)

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Misty

Thu, 16 Oct 2003 02:41:26 +1300

TOXIC BREASTS 2/2 (implants)

 

http://www.redflagsweekly.com/toxicbreasts.html

 

According to investigations by the Human Resources and Inter-Governmental

Relations Subcommittee, headed by Manhattan Democrat Ted Weiss, the concerns

of FDA scientists about breast implants were blocked by higher-level agency

officials for fifteen years. The FDA's press office says that the agency had

more important regulatory priorities in mind, such as heart valves and AIDS

drugs. But an independent federal report on the workings of the agency,

conducted last May, places matters in much broader perspective. Various

congressional assessments of the FDA also paint a picture of an agency

severely cannibalized in the eighties by the Reagan administration's

deregulatory philosophy and stingy funding, an agency that increasingly

became more protective of business than of consumers. " FDA's inaction on

breast implants was typical, " says Weiss. " Unfortunately, the ruling

philosophy has been 'Let the buyer beware!' "

 

It was only in late 1987, after several women had filed personal-injury

suits against Natural-Y and more than ten thousand Mêmes had been put in,

that someone at Cooper Surgical began to take notice of the incomplete

information available on the Même's foam. In one court case, University of

Florida biochemist Chris Batich testified that he had demonstrated how the

foam could release cancer-causing TDA under harsh, chemical conditions.

After reviewing that testimony, Tom Powell, a Cooper Surgical

vice-president, called chemist Ed Griffiths, product manager at Scotfoam

Corporation, the foam's manufacturer. Griffiths confirmed that the product

could release at least a small amount of the chemical.

 

Griffiths had assumed that Cooper Surgical was using the foam for an

industrial application. " My eyes popped out when Powell explained his

company was buying the foam from a jobber in Los Angeles and using it as a

covering for a breast implant, " he recalls. " They had been using our foam

for many years, and it was the first time that I or anyone else at the

company had heard about it. " Griffiths then advised Powell that Scotfoam

didn't recommend such use in implants due to a lack of long-term data on the

foam's suitability and health effects. " I wanted him to know that we had no

expertise in determining the suitability of the foam in medical applications

and it was his - the end user's - responsibility. "

 

Cooper Surgical apparently got the message, although there was no

attempt to pull the Même from the market. In a series of letters exchanged

between the two companies, dated from January 11, 1988, to August 3, 1988,

the Même's manufacturer expressed the desire to conduct basic studies on the

foam, which would characterize its chemical stability. To that end, Scotfoam

provided Cooper Surgical with its formula and ingredient lists for the foam

under an " absolute secrecy agreement. "

 

By year's end, a new, eight-month animal study sponsored by Cooper

Surgical had been concluded at the Veterans Administration Medical Center in

Nashville, Tennessee. Its purpose was to determine what happened to

miniature polyurethane-coated breast implants at the site of implantation in

rats. In one test, pathologist Steven Woodward found that the foam size

decreased at least 50 percent in two to eight months. Woodward concluded

that the lost foam was strong evidence that the material broke down after

implantation. " The logical extension was more detailed site studies and a

look at the breakdown products [of the foam], " Woodward says now.

 

Cooper Surgical appeared interested in following up on Woodward's

findings. Documents show that the company initiated studies in 1988 to

examine the chemistry of the foam and its breakdown products. But in

December of that year, Cooper Surgical sold the Même production plant to

Surgitek, a subsidiary of Bristol-Myers Squibb-which decided not to fund the

studies after all. Jonathan Weisberg, a spokesman for Bristol-Myers, would

later say that further studies weren't warranted. Instead, Weisberg pointed

to another study, one of ten explanted Mêmes, that Bristol-Myers had

sponsored, which showed that the " lost " foam in Woodward's study was simply

entwined appropriately with tissue. After reviewing that data, Woodward

would stick by his own study.

 

Besides facing giant holes in its scientific database on the Même,

Surgitek was legally ordered to clean up unsanitary conditions in its newly

acquired manufacturing plant. Several months before the company acquired the

Même, the FDA, reacting to outside pressure, had launched an inspection of

the manufacturing facilities that had been expanded from a garage.

 

Over a sixteen-day period, beginning on July 11, 1988, FDA agents turned

up serious violations of the Federal Food, Drug, and Cosmetic Act, including

deficiencies in the process that was used to determine whether the implants

were sterile and the lack of an adequate quality-assurance program. The

company also had not been training its employees properly. Some were

observed blowing into each breast-implant shell for inflation during

inflation testing. Inspectors were unable to recover records both of the raw

materials used and the established specifications for the implants. But they

did find eleven recorded cases of medical problems associated with breast

implants, including the Même, which the company had never reported to the

FDA as required. The problems included infection, gel leakage, and

separation of the foam covering from the shell. Between that inspection and

the closing of the plant three years later, about 120,000 additional women

received the Même.

 

In June 1988, Sybil Niden Goldrich published a short article about her

experiences with breast implants in Ms. magazine described how, after her

final reconstructive surgery, was determined to find out why she had been a

" breast-implant failure. " Goldrich had called the FDA for information on

breast implants and was informed that every plastic surgeon was provided

with a concise manufacturer's warning listing potential complications from

and caveats about implants. It was up to the surgeon to properly inform his

patient about the pros and cons. She then obtained samples of implant

package inserts and was floored by the list of complications mentioned,

including leakage of gel, breast hardening, rupture of the implant's shell,

infection, blood clots, fluid accumulation, skin decay, and loss of nipple

sensation. " I naturally wondered, when I wrote the article, how many other

women were out there with breast implants, who had not been advised of the

potential risks, " she says.

 

Within weeks after her article was published, Goldrich began receiving

long-distance calls from women around the country who had thought they were

alone with their breast-implant problems. Almost all of the callers

mentioned how little information about the dangers of implants they had

received from their doctors. Then the FDA called. Faced with mounting

consumer complaints about breast implants in general, the agency had

scheduled a public meeting of its medical-device advisory panel for November

to help determine the types of safety and efficacy studies that

manufacturers of breast implants would be required to submit for review.

Would Goldrich attend to present a consumer's viewpoint?

 

By the time Goldrich arrived in Washington, breast implants were hot

news. Only days before the meeting, the Washington-based Public Citizen

Health Research Group released internal data from Dow Corning, showing that

injections of silicone caused malignant tumors in over 23 percent of rats

tested. The consumer group also released evidence that FDA scientists were

concerned about the manufacturer's experimental findings and that at least

one of the reviewers at the agency wanted an alert to be issued immediately

to the public, warning of the potential long-term cancer risk of breast

implants. One internal FDA memo had stated: " While there is no direct proof

that silicone causes cancers in humans, there is considerable reason to

suspect that it can do so. "

 

The FDA's advisory panel took note of the Dow Corning Corp.'s rat study

during its deliberations and concluded that the available data did not

warrant removal of breast implants from the market. But it did ask the FDA

to establish a national information program on the devices so as to assure

that patients received balanced information about the surgery. The

recommendation pleased Goldrich, who had used up most of her allotted

speaking time on that very subject.

 

 

 

..

 

SAFE UNSAFE

 

Breast implants and the Dalkon Shield IUD may be the most high-profile

examples of medical devices gone awry, but there are thousands of other

products in use that escape FDA safety checks. Over the last decade, the

agency has allowed manufacturers to use loopholes to avoid proper testing;

some have neglected to report side effects, including injury and death.

 

Underregulated medical devices include:

 

respirators for children

chin, cartilage, and testicular implants

kidney-dialyzing components

catheters that are placed in arteries

A federal survey of 112,000 households, released in February 1991,

revealed that defects or failure - resulting in pain, infection, bleeding,

and blood clots - were associated with a number of implanted devices; for

instance, cloudy vision was often associated with lens implants and

irregular heartbeat with pacemakers. Nearly 9 percent of the estimated total

of fifteen million implants used by Americans were replaced at least once.

 

The FDA assumes that most of these products are safe because they are

claimed by manufacturers to be " substantially equivalent " to older versions

of products. The agency relies on manufacturers' legal obligation to report

any excessive side effects to the FDA for evaluation, but companies often

don't comply. The Washington, D.C.- based Public Citizen Health Research

Group recently gained access to FDA files on inspections of thirty-five

manufacturers of medical devices between 1985 and 1988. The group discovered

that 7 deaths, 109 serious injuries, 265 malfunctions, and 41 other problems

had not been reported as required. The unreported casualties included 4

deaths and 4 serious injuries caused by failures of infant respirators, and

2 deaths, 1 serious injury, and 178 malfunctions associated with catheters

used during heart surgery. The FDA has taken no action against the companies

since this information came to light. - N.R.

 

..

 

 

 

Pierre Blais had realized that the Même's foam was actually intended for

industrial use back in 1989 as part of his job at Canada's Health Protection

Branch. After evaluating available data, Blais concluded there was a

possibility that " women with the Même faced a double cancer threat, one from

the silicone gel in the implant and another from its foam. " In January of

that year, he fired off a memo to David Johnson, a higher-level official,

warning that the Même was " unfit for implantation, " partly because its

chemical products could be released in the body. In a four-page technical

report, Blais termed the foam coating a " packaging and general-purpose

foam. " And he further questioned whether an expert on this type of material

" would consider, recommend, or approve the use of such a foam on a device

designed to be implanted permanently in a disease-prone area such as the

female breast. "

 

Johnson edited the documents, and Blais was ordered by his immediate

boss to eliminate all references to his certainty that the Même was unfit.

He complied, but wrote back in a memo, " In my opinion, the content of the

original documents is significantly altered. " Several days later, Blais was

ordered to destroy his original memos and technical report on the Même. The

following July, Blais was fired for his insistence that the Même be

withdrawn from the market-and for being the likely source of leaks to the

media. He was eventually rehired after filing a wrongful - termination suit,

but resigned in December 1989.

 

One month after his firing, Blais began work with a researcher at Laval

University in Quebec City. The research verified under conditions more

closely approximating those in the human body that the Même's foam could

release TDA. " It was becoming pretty clear that this foam was unstable, " he

says. Blais reported his progress to scientists, who, after the FDA advisory

panel met in December, conducted their own studies. That data, which

confirmed Blais's research, was made public one week before Surgitek

" voluntarily " withdrew the implant from the market. By that time a total of

200,000 women had the Même.

 

Bristol-Myers Squibb closed Surgitek's plastic-surgery unit last

September, but that was not an admission of guilt. Surgitek said that its

data on the safety and effectiveness of its other product line -

silicone-gel breast implants without foam - was deemed insufficient by the

FDA, and that, rather than appeal the decision, it was quitting the

breast-implant business. In its announcement, Bristol-Myers Squibb said that

it remained " committed to completing appropriate research to resolve all

outstanding scientific issues " associated with the Même.

 

Nearly a decade after the implant's introduction, discovering exactly

how much TDA is released by the Même's foam into the body has become a top

research priority. Last June, the FDA ordered Surgitek to find out how much

TDA might be in the blood, urine, and breast milk of women with the Même.

But a dispute over methodology in the studies means that there will likely

be a continuing controversy over the issue for years to come, no matter what

the findings show.

 

The issue of how to quantify the Même's cancer risk is not likely to be

settled very soon either. Surgitek claims, on the basis of a recent study it

sponsored, that, if there is a cancer risk associated with the Même, it is

insignificant, certainly no worse than about one in several million. That

would mean, at most, one woman would be affected. The FDA's official

worst-case scenario is that the figure may be one in twelve thousand but is

far more likely to be one in about a million-which would mean that between

one and seventeen women with breast implants are in danger. On that basis,

the agency is informing women with the Même that the risks associated with

the removal of the implant are likely to be far greater than any cancer

risk. But some FDA scientists, as well as Pierre Blais, argue that the

cancer risk may actually be between one in 50 and one in 200. According to

that estimate, between 1,000 and 4,000 women could contract cancer because

of their implants.

 

" The FDA is taking absolutely the most conservative stance possible and

is, for example, excluding from the risk analysis some early animal studies

that show implanted foam similar to the one used in the Même is a strong

chemical inducer of tumors, " Blais says. " Unfortunately in this case, it

appears that time will tell, and this is totally unacceptable. What a time

to begin addressing the scientific issues! Thousands of women are waiting

for more definitive answers. "

 

Meanwhile, there is little sign that manufacturers or plastic surgeons

feel remorseful about the current dilemma women face. Both Surgitek and Dow

Corning insist that what's carcinogenic to rodents is not necessarily

translatable to humans. Some doctors, like Hester and Sterling, blame the

media for stirring things up. " I might not have implanted quite so many

[Mêmes] had I known what I know now, " Sterling says, " but I want you to know

that my wife and daughters are still doing well. " Hester admits that " the

controversy will let us get more definitive about the TDA. " Even so, he

recently published an article that championed the idea of implanting two

sets of Mêmes-he called it " stacking " - to achieve a better effect in certain

patients.

 

As for the American Society of Plastic and Reconstructive Surgeons, the

group that referred to small breasts as a disease, it recently voted to

collect $1,050 from each of its thirty-seven hundred certified members to

finance a campaign to counter bad news about silicone-gel breast implants.

Garry Brody, a Los Angeles plastic surgeon and high-profile member of the

group, hints at what lies ahead in the controversy when he says, " The whole

process [of removing implants from the market] has destroyed the right [of

women] to choose. "

 

Back home in Los Angeles, Sybil Goldrich hopes she can answer that

challenge. She is concerned that the four-million-dollar publicity campaign

will convince consumer groups to rally around the principle of having access

to breast implants-even if they are not proven safe and effective. At the

FDA meeting that she attended recently in Washington, a number of women

spoke angrily against the idea of removing all implants from the market.

" The emotions were pretty high, " she says, " especially from those women

representing cancer groups. " And she adds, " This is something that I

understand, but I also don't believe that a breast-cancer patient would

knowingly accept a product that might be defective. " The FDA subsequently

decided to allow breast implants to remain on the market at current

availability levels, but will re-evaluate this decision after monitoring

recipients for the next year.

 

Goldrich recently wrote a letter to Dr. David Kessler, the FDA

commissioner, to say how wonderful it would have been if some of that vast

amount of money being collected by the plastic surgeons had been designated

for independent research to produce a safe and effective breast implant for

women who have had breast-cancer surgery.

 

She also suggested to Kessler that whatever decision is made about the

remaining breast implants on the market, it should be based on science and

science alone.

 

 

 

For additional information on breast implant issues, visit The Center For

Policy Research.

 

 

 

 

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