MyDNA: The implant dilemma

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http://www.mydna.com/resources/news/news_20060213_implant_dangers.htm

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The implant dilemma

Mon 13 Feb 2006 01:04 PM CST

WASHINGTON DC (myDNA News)

Winters was barely a teenager when she first thought of trying

to fix her breast " tubular deformities. "

At 30, after the birth of her first daughter, Winters went under the

knife. At first, everything was fine. But then, several years ago,

she developed itchy rashes, severe carpal tunnel syndrome and bouts

of fatigue and exhaustion. She assumed these symptoms were all

unrelated - perhaps a normal by-product of middle age or overworking.

" Every week, it seemed something worse was happening, " said Winters.

In February 2003, she " developed hives and went into anaphylactic

shock for no apparent reason. I was sure I was going to die, " she

said.

But then, later that fall, Winters got a magnetic resonance imaging

(MRI) test that showed a rupture in an implant. Her internist

confirmed that abnormal cells surrounding what was left of the

implant were the cause of her illness. And in April 2004, she

underwent surgery to have her implants removed.

Her experience is not unusual.

One out of every 10 women in the U.S. has joint aches, muscle pains,

memory issues and chronic fatigue syndrome associated with receiving

breast implants, according to Ed Melmed, M.D., a specialist plastic

surgeon from the Medical City Hospital in Dallas, Tex.

" There is no difference - racial or ethnic - among women between 20

and 75 years of age, " he said. And while things might seem fine

initially, nearly half of all implants will go bust in 10 year's

time - resulting in the creation of surrounding scar tissue. " It's

like a fly trapped into a spider's web, " Melmed said.

Melmed is worried that " while the manufacturers say their devices

are 100-percent safe, women come up with this 'missing-something-in-

life' syndrome. " This leads many, like Winters, to pursue explant

surgeries. Afterward, 70 percent of individuals report a

disappearance of symptoms.

A new report by the Washington, D.C.-based National Research Center

for Women and Families says that breast reconstruction patients

experience two to three times as many complications and additional

surgeries as augmentation patients.

The most frequent problems are capsular contracture (a hardening of

scar tissue surrounding the implant), which causes the breast to

feel hard, and later the rupture of the implant, which can lead to

infections, bruising and blood collection at the wound site.

The author of the report, Zuckerman, Ph.D., said that " women

are very sensitive to silicone implants. " " In our experience, it

seems that saline implants - given the chemical components in their

shells - can set off a reaction even more quickly than silicone gel

breast implants, " she said.

Common reactions, she said, included rashes and hair loss. Joint

pain, chronic fatigue and memory problems are also issues. " Women in

their 20s should not be experiencing those symptoms, " she added.

Zuckerman also chided the makers of breast implants, including

Inamed and Mentor, in the report: " After selling silicone breast

implants to tens of thousands of mastectomy patients in the last

five years, under the conditions that they participate in clinical

trials, implant manufacturer Inamed included only 80 such patients

in their longitudinal safety study submitted to the FDA (U.S. Food

and Drug Administration), and Mentor Corporation has not come up

with any useful information about rupture or silicone leakage for

reconstruction patients who have had their implants for more than

two years. "

" There was a significant increase in autoimmune reactions when

researchers compared women before getting implants to the same women

two years after getting implants. It was shocking that the changes

were statistically significant after such a short time, " she added.

Ilena Rosenthal, director of the San Diego-based Humantics

Foundation for Women, the largest breast implant support group in

the world, agreed.

" The so-called 'studies' that the silicone manufacturers and plastic

surgeons rely on are too small, too short and include eliminating

the data from the women who removed their implants for any reason.

This is madness, such as removing anyone from a lung cancer study

who coughed or showed any other symptoms, " she said.

The findings of the NRC research come on the heels of another

report, in January, when the 13-member Expert Advisory Panel on

Breast Implants recommended to the Canadian government agency,

Health Canada, that " a comprehensive breast implant registry would

enhance our understanding of the safety and efficacy of these

devices, improve our understanding of experiences with these

devices, increase our ability for conducting research on a large

representative sample of women and increase our knowledge of the

health care utilization implications. "

The panel recommended that implant manufacturers demonstrate that

leaked silicone provided an acceptable risk of hypersensitivity and

autoimmunity. At the same time, they also said " there is no current

scientific evidence to reliably support repeated - every one to two

years - breast MRIs for patients with breast implants. "

The assessment of silicone-filled breast implants, the panel

said, " should be at the discretion of the plastic surgeon, in

consultation with the patient, and preferably be based on new breast

symptoms or signs. "

" MRIs are not always accurate, but their accuracy is higher if the

proper breast coil MRI equipment is used and the person reading the

MRI is experienced in what to look for, " Zuckerman said.

Melmed advises getting an MRI once every seven to 10 years to check

for implant ruptures.

When it comes to prevention of problems, the report suggested that

patients who suffer from depression or eating disorders be fully

treated prior to surgery.

" It is obvious that women who seek any kind of plastic surgery

should be screened to make sure that their real problem isn't

depression or low self-esteem. Plastic surgeons say that they do

this, but in fact, they are not trained to screen for depression or

mental problems, don't know how to screen for mental problems, don't

really want to spend the time doing it, and there is not much

incentive. After all, they want these customers, " Zuckerman said.

Rosenthal agreed. " This is a multi-billion dollar industry. Plastic

surgeons can make millions annually by performing only a handful of

breast augmentations a week. Removal is even more expensive and

profitable for them. The 'guarantees' by the manufacturers cover

replacement only - and not removal - and disinformation abounds

because the manufacturers have pooled their public relations dollars

with those of the oil, food, chemical and pharmaceutical industries

to turn 'science' upside down, " she said.

" I remind women that there was no shortage of 'turn-on' of men for

women prior to breast implants! That healthy is 'sexy' ... energetic

is 'sexy' ... intelligence is 'sexy.' I tell them to fill their

hearts with love and appreciation of their health instead of a

foreign object which too frequently will cause them needless pain,

expense and loss of the breast tissue they have naturally, "

Rosenthal added.