Breast Implants – are they safe?

[Guest guest]

from KKJ ... thanks! (you're not going to like the quote about

saline tho ... I sure didn't.)

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Breast Implants – are they safe?

By Emerson Arehart

In Irondale, Alabama, a suburb of Birmingham, there is a federal

document storage facility that contains

the medical records of over 200,000 women. The women – 20 times as

many of them as there are residents in

Irondale – were all complainants in class action lawsuits against

three manufacturers of silicone gel breast

implants (Bristol-Myers Squibb, 3M, and Baxter). Their medical

records were collected during the litigation

process against these corporations, but there was a settlement and

the documents were not examined – and still

have not been.

A number of consumer advocacy groups have tried to gain access to

the Irondale documents to garner

statistical information on the safety of silicone gel breast

implants, but a federal judge has repeatedly denied it,

claiming judicial exclusion (federal judges have the ability to

prohibit access to documents at their discretion).

What secrets do those records contain?

Thousands of women across the United States have complained of minor

and major health problems that

they claim resulted from the silicone in breast implants. With an

increasing number of women getting saline

breast implants (which consist of a silicone shell filled with a

saline solution) and with a committee

recommending that the FDA allow the Mentor Corporation to put

silicone gel implants back on the market after

more than a decade, the issue is more inflammatory than ever.

The National Publication for Toxic Aware Consumers

Since 1995

Three hundred and fifty thousand women were implanted in 2004,

compared to 280,000 the year before,

and the number of women of all ages getting breast implants shows no

sign of slowing down, according to Kathy

ley-ston, Director of Toxic Discovery a National Consumer

Advocacy Group.

Some individuals and consumer groups (including ley-ston's)

are arguing, however, that breast

implants as we know them are far from safe. They argue that women

getting breast implants are not fully aware

of the myriad ramifications, which range from mild change in

sensation to – some claim – connective tissue

disease and other chronic health problems.

" These teenagers and young women that are going in for breast

implants need to realize that by the time

they're 40, they will look a lot worse than the flat-chested women

they now perceive themselves to be, " warned

Pam Dowd, an Idaho woman who, after becoming sick from silicone gel

implants, started the consumer group

Implant Veterans of Toxic Exposure.

" A significant percentage of women who have received breast

implants, especially silicone gel implants,

have faced serious health problems as a result, " said Geoff White, a

Reno, Nevada medical malpractice attorney

who has been involved in breast implant cases for almost 20 years.

" Why take the risk? "

The FDA does acknowledge that there are over 35 common complications

from breast implants, and

explains many of these in the FDA Breast Implant Consumer Handbook

(available online at

http://www.fda.gov/cdrh/breastimplants/).

One of the complications listed in the handbook is a condition

called capsular contracture. Capsular

contracture occurs when the scar tissue surrounding an implant

becomes hard and squeezes the implant, causing

pain and cosmetic deformity.

" I relate it to having a sliver in your hand, " White said. " If you

get a sliver in your hand, the area around

it will become bright red and sensitized, because the body is trying

to protect itself from the foreign substance

lodged in your hand. The silicone shell used in breast implants is a

foreign substance, and the tissue in the

breast reacts in the same way. Over time, this turns into a hard

capsule. "

Another common complication for all breast implants is rupture.

Implants can rupture silently, with no

symptoms, or spontaneously. When the silicone gel leaks it can cause

granulomas (buildups of hard tissue

around a foreign body) and can migrate to distant organs, according

to the FDA handbook.

" I was standing in my office and suddenly it felt like a snake

slithered across my chest, " ley-

ston said, referring to the spontaneous rupture of one of her

implants. " They've found silicone in my spinal

fluid which matches the material in my implants. "

One of the most common reasons for explantation (removal of

implants), according to the FDA, is

pain/sensation change. Women feel unusual sensations or pain in the

breast and nipples.

In addition, patients experience pain and cosmetic problems

resulting from improper positioning of an

implant, visibility of the implant or palpability of the implant

from outside the skin, and distortion of the implant

itself, such as rippling or wrinkling.

Although these complications, among others, are supposed to be

mentioned in the consent packets that

come with breast implants, some argue that plastic surgeons dismiss

the complications as few and far between.

" People are still getting snowed by plastic surgeons, " Dowd

said. " The forms say that there will likely be

ruptures and other problems – but these details are glossed over. "

Dr. Virden, a plastic surgeon who has been practicing in the

Reno area for 9 years, disagrees.

" There are no common complications, " he said. " If it [the

implantation procedure] wasn't safe, then the

FDA wouldn't let us do it. "

" There is a 4 percent chance of a capsular contracture which feels

tighter than the women would like, "

Virden said. The FDA website actually lists rates of capsular

contracture of type III or IV (breast looks or feels

abnormal) at 29 percent to 36 percent at five years after

implantation surgery. Virden acknowledged that

complications from surgery such as hematomas and seromas (collection

of blood and fluids inside a body cavity)

occur, but said they are extremely rare. The FDA does not have any

statistics on the occurrence of hematomas

and seromas.

Some women find that plastic surgeons' faith in the safety of breast

implants can be a bad thing.

" My plastic surgeon didn't go over any of the safety information

with me at all – he wasn't even in the

room when I was signing the consent forms, " said Kacey Long, a 22-

year-old Ennis, Texas woman who reacted

especially strongly to saline breast implants she received when she

was 19 years old. She said that if her doctor

had informed her of the potential risks and of the expense of

maintaining her implants, she would probably not

have had the procedure.

In addition to the accepted risks of complication, women should

realize that having breast implants is a

lifelong commitment – not a one-time fix, as the procedure seems to

be portrayed in the media.

" During [the television show] `The Swan,' they advertise for Mentor

brand implants, " Long said. " During

the show, you can't even get on their website because it's so busy.

It's really upsetting to me that so many

people are considering implants without knowing the risks. "

Virden defended himself against any claim that he was not giving his

patients the full picture.

" I recommend that my patients come in for a check every 10 years,

and have their implants replaced

every 15, " Virden said. " If there is a problem with one of the

implants, the manufacturer provides a warranty

which replaces both implants so the patient has implants which are

the same age. "

" I admire him for saying that they should be replaced every 10-15

years, " ley-ston said. " But

do his patients know what's involved in reimplantation? " With each

operation there is an increased risk of

complication, not to mention a lofty bill that many women with

implants are not expecting.

" I had no idea that you have to have implants replaced every 10

years, " Long said. " My plastic surgeon

told me the only additional surgery I would need would be if I

wanted to get a larger size or switch from saline to

silicone gel implants. Who wants all that surgery, and all the scars

that come with it? "

In many cases, there have been even more dire repercussions of

getting breast implants.

" I was a healthy 27-year-old woman when I was diagnosed with breast

cancer in 1975, " Dowd said. " It

took a radical double mastectomy [surgical removal of both breasts],

but after that I was back to being healthy. "

After five and a half years of good health, Dowd finally decided to

have silicone gel breast implants.

Less than 90 days after implantation surgery, one of Dowd's implants

ruptured, and she underwent a

second surgery to have it replaced. Less than two years later she

had to have another implant replaced. In

1987, one of Dowd's implants spontaneously ruptured, causing searing

pain and a trip to the emergency room.

Her doctor told her that her implant had ruptured, but that she

wasn't facing any real health risk from it.

" I was tired of surgery, so I waited another year before replacing

both implants, " Dowd said.

She received a new set of Mentor brand silicone gel breast implants

in 1988, and the otherwise-healthy

Idaho mother faced a number of health problems over the next seven

years.

" I had a constant cough until they were explanted, " Dowd

said. " Doctors treated me for asthma, but

when I had the implants taken out the problem went away and I was

told that I had never had asthma. "

Her breathing trouble went away upon removal of the Mentor implants,

but Dowd is far from healthy.

She attributes this largely to her breast implants.

" Silicone migrates through tissue; doctors have found silicone in

the back of my lungs which matches the

type of silicone found in my breast implants, " she said. Dowd has

been diagnosed with a number of health

conditions, including Peripheral Neuropathy (damage to the system

which transmits information from the brain to

the rest of the body) and Sjögren's syndrome (chronic arthritis

combined with other symptoms).

" The implants may seem great at first, " White said. " Eventually,

though, body processes will take their

toll on the implants and problems will start to occur. "

In addition to disfigurement and scarring, White says silicone

breast implants can cause autoimmune

diseases (diseases which affect the immune system), connective

tissue diseases (a grouping of symptoms

including symptoms similar to arthritis and lupus), fibromyalgia

(chronic pain in the muscles and bones), and

silicosis (inflammation and scarring of lung tissue) in susceptible

women.

White points to the case of Charlotte Mahlum vs. Dow Chemical in

1995 (he represented Mahlum). A

Washoe County, Nevada jury concluded that Dow Chemical, the parent

company of the manufacturer of

Mahlum's silicone implants, was liable to compensate the woman, an

Elko, Nevada resident. She was awarded

$14.2 million (which was later reduced to $4.2 million).

" The Nevada Supreme Court recognizes that silicone breast implants

caused diseases in her case, " White

said. " But she said to me, `I'd give it all up to have my health

back.' "

" What price vanity? " he asks.

Long knows that price first hand.

" I thought it would be fun, " Long said of getting breast

implants. " I never thought the implants would be

harmful to my health. I just wanted to even out my figure. "

From the beginning, she had problems.

" It took me a month to recover from the implantation surgery,

whereas it takes only a few days for most

women, " Long said. " Two or three months after surgery I started

having trouble moving my arm. I would have

to use my other hand to lift my arm over my head to reach things. "

Long started to feel tired all the time, and starting having sharp

muscle and joint pain at virtually every

point on her body.

" Each day brought a new symptom, " she said. " Doctors went out of

their way to tell me it wasn't the

implants. " After two years of having implants and two years of

debilitating pain, Long had her implants

removed.

" I felt better as soon as I woke up from surgery, " she said, " but I

am in no way healed. " Long, 22, is in

the process of qualifying for federal disability.

" I just wish that doctors would at least recognize the possibility

that breast implants can cause women to

be sick, " Long said. " Implant manufacturers literally buy the safety

data. "

" The companies pay for science, " agreed White. " They pay for the

studies, and then bend the results to

what they want. It's like the old saying, `liars figure and figures

lie.' They will do whatever they can to keep

their products on the market. "

Many plastic surgeons have a different view.

" The sad losers in this whole situation are the women who had their

[silicone gel] implants taken out

years ago when people were saying they were unsafe, " Virden

said. " Lawyers in this country have created this

problem, not [plastic surgeons]. The numbers just aren't there to

support their claims. Again, if the implants

weren't safe, we wouldn't be allowed to use them. "

But it will take more than the FDA's approval to convince White that

breast implants are safe.

" If my wife had breast cancer, I would ask her not to get breast

implants, " he said. " If she had to have

something, I would recommend saline – but only because it is the

lesser of two evils. "

So where does the truth lie? Some claim the truth can be found in

Irondale, Alabama.

" Manufacturers are fighting tooth and nail to prevent access to

those documents, " White said of the

evidence stored at the Multidistrict Litigation Depository in

Irondale. " They are fighting to protect that

information because they know that it would kill any remaining

claims that silicone breast implants are safe. "

" Day in and day out I see people who get their breasts reconstructed

by me with silicone implants, "

Virden said, " and they are so thankful that it feels close to what

they used to have, and they feel whole again –

it's been a wonderful experience. "

The court has restricted access to the Irondale documents on the

grounds of protecting individuals'

privacy. Attorneys for the women who have gotten sick from breast

implants claim that the documents could

incriminate breast implant manufactures – companies that contribute

$900 million to Congress, according to

ley-ston.

Perhaps the final question is: Who are the courts protecting?