ParfumGigi@aol.com

16 avril, 2005 10:13

Foster's Daily Democrat - Dover,NH,USA

... by Dr. Lawrence Gray, one of only 15 plastic surgeons nationwide and the only one in the

Northeast who is permitted to give women silicone breast implants. ... puke

This needs a response from every one of us ASAP! As he admits, He's never taken care Of an ill women from her breast implants!! Where has he been hiding at the bank depositing money$$ from all the implant surgery he performs without regard to the known side Effects he's well aware of..and I am certain fails to inform his patience's of totally grrr. another money hungry PS.. who's ditched his oath in favor of greed$$ He believes the ban was never necessary, what doesn't he understand about ill children and dead women from toxic faulty un approved medical devices? gigi/Karen

Dr. Lawrence Gray, at the Atlantic Plastic Surgery Center in Portsmouth, holds a saline implant in his left hand and a silicone implant in his right. Gray is one of the few doctors in the country who can use the silicone implants. (Beth Lorden/Photo)

Sunday, April 17, 2005

By ROBERT M. COOK

Staff Writer

PORTSMOUTH — The Food and Drug Administration’s scientific advisers recommended last week that a ban be lifted on silicone-gel breast implants after 13 years.

The news has been closely watched by Dr. Lawrence Gray, one of only 15 plastic surgeons nationwide and the only one in the Northeast who is permitted to give women silicone breast implants.

There is only so much that Gray, with the Atlantic Plastic Surgery Center in Portsmouth, can offer patients within the confines of three FDA approved studies that have allowed him to do silicone implants.

Gray said he performs about 150 or so silicone breast implant surgeries a year, thanks to the studies. He wishes he could make them more available to more women who want them.

Gray is one of many plastic surgeons who believe the ban was never necessary and he is not optimistic that the recommendations of its scientific advisers will be adopted by the FDA.

After three days of emotional debate, advisers said Mentor Corp. should be able to sell its gel implants — but only if it meets strict conditions.

Topping that list: ensuring women understand the devices may break inside their bodies; recommending that they get regular, and expensive, MRI exams to check for breaks; limiting implant insertion to specially trained plastic surgeons; and new studies to prove how long implants last.

Just a day earlier, the advisers narrowly rejected sale of rival manufacturer Inamed Corp.’s silicone implants, citing lingering questions about how long they last and what happens when silicone oozes into the breast.

The FDA isn’t bound by its advisers’ recommendations. Just 15 months ago the FDA overruled a recommendation to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage.

"Unfortunately, it’s a stupid issue with the FDA because it is a political issue, not a medical issue," Gray said.

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The FDA imposed its ban on most use of the implants in 1992 amid fears that leaking silicone was dangerous.

Today, gel implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But in addition to the risk of breakage, they can cause infection and painful, rocklike scar tissue.

Since 1992 when the ban was enacted, Gray said he has not seen a case of any patients who suffered leakage or medical issues from any of the silicone implants he has done.

"I have never taken care of a patient who was sick from implants," said Gray, who has been a plastic surgeon since 1985.

The FDA ban was influenced by thousands of complaints filed by women against implant companies when they suffered various side effects from surgery. But no conclusive link was ever established.

Within two years after the ban was imposed, 18,000 lawsuits were filed against manufacturers of breast implants. A global settlement fund of $4.2 billion was set up in 1994 to compensate women who had developed various medical conditions.

"I’m sure there could be a handful of people (who suffered problems from their surgeries), but it is probably more of a coincidence," Gray said. "I don’t question that the implants made in the 1970s and 1980s leaked more than they should have."

But Gray believes many of the lawsuits were filed by people who were out to make money more than to address a pressing problem with silicone implants.

Gray believes they are a superior product to saline implants, which are filled with saltwater. Saline implants are very soft and feel like a water balloon compared to silicone implants, which are much more solid.

He said half of his 250 patients who had to go with saline implants for cosmetic surgery would have chosen silicone implants.

The new generation of silicone implants have a much stronger shell and use a cohesive gell that could minimize leakage, Gray explained.

He said women would choose silicone over saline the same way people would choose a car that had leather seats instead of cloth seats.

Under the terms of the McGhan Medical Corporation and Mentor Corporation studies, Gray said he can do silicone implants for women who need reconstructive surgery following a mastectomy for breast cancer. He can also do the surgery for women who have birth defects or need breast reconstruction where saline implants are not adequate.

Under the terms of the Brazilian-based Silimed study, Gray said he can do silicone implants for a much wider range of women. Women who want breast augmentation, or enlargement, must be at least 18 years old. There is no age limit for primary reconstruction. Women who had prior surgery for primary augmentation or reconstruction are also eligible for silicone breast implants, according to the study.

Depending on the breast implant procedure involved, it can cost a patient anywhere from $5,400 to $8,000 to have their breasts enlarged at Gray’s Atlantic Plastic Surgery Center, according to Suzanne Foley, the practice’s administrator.

Under the terms of the three studies that allow Gray to offer silicone implants, each patient has to review and sign a lengthy consent form that clearly spells out the potential risks and complications.

They also have to pay a total of $650 over a 10-year period to have follow-up exams, tests and mammograms so their implants can be monitored, according to Dee Russo, the center’s clinical study coordinator. Each visit costs about $50.

Russo said some of the most common post-implant surgery complications are the risk of infection and bleeding, uneven breast pockets if the implant is not positioned properly behind the mammary gland, and pain and discomfort.

Contracture, a condition where the implant causes a thick, spherical scar tissue to form around the implant, is another problem.

A report of a study by the Institute of Medicine in Washington, D.C., noted that breast implants, saline or silicone, do not last forever and will need to be replaced at some point.

A study of women receiving reconstruction surgery over an average of six years showed that 16 percent of those with saline implants required replacements. About 18 percent of women who received silicone gell-filled implants over the same period had to have them replaced.

The study also reported that women with gel-filled silicone implants and those undergoing reconstructive surgery have a greater chance of complications than do women who have saline implants or implants for augmentation, or enlargement.

A study of 2,855 women with modern saline implants showed 18 percent of augmented women and 36 percent of those who had reconstruction surgery suffered complications within the first year.

The same study concluded that silicone implants do not cause disease or prevent women from breast feeding nor do they harm a developing fetus. In general, silicone is safe, the study reported.

Even if they can’t get silicone breast implants for cosmetic surgery, many women still are going with saline implants. Each year, the number of enlargement and reconstruction surgeries keeps rising.

About 264,000 breast enlargements and 63,000 breast reconstructions were performed in the United States last year.

From 1992 to 2004, the American Society of Plastic Surgeons reports that breast enlargements annually have increased from more than 32,600 to nearly 253,000. Over the same period, reconstructions have increased from more than 29,600 to more than 62,900.

According to the Institute of Medicine, more than 1.5 million women in the U.S. have silicone breast implants.

Dr. Kim Marble, a plastic surgeon in Exeter for nine years, said her practice has grown the past few years and her patients range in age from their mid-20s to women in their 50s. Typically, they all want the same thing — to look and feel better. She doesn’t treat anyone under 18.

The size of the implants she uses are as small as 120 cubic centimeters and as large as 800 cubic centimeters.

Her patients want them so they can have better proportion and fit better into their clothes.

She has also had patients who decided to have their silicone breast implants replaced with saline implants as a result of the media coverage about alleged medical problems.

"They feel more comfortable with not having them in their body," Marble said.

Like Gray, she said she has never had any patients complain about medical problems linked to their silicone implants. She has treated patients whose implants leaked, but nothing serious.

At Garrison Women’s Health Center in Dover, Dr. Pam Bertram said one of her biggest concerns continues to be the pressure that society exerts on young women to get cosmetic surgery to improve their breasts.

There are many times when young women in the mid-20s will talk with gynecologists and plastic surgeons at the center about having saline implants put into their breasts. She said the staff always explains the potential risks that could result from the surgery and tries to make the patient think about whether breast enlargement will really help their self-esteem.

As a doctor, all she can do is try to educate patients about the risks before they elect to have the surgery, Bertram said.

"I just hope that women think long and hard about those decisions and what those consequences are," Bertram said.

As far as which implants older women like more, Bertram said most of the center’s patients prefer silicone. In cases where patients replaced their silicone implants with saline implants, Bertram said many of them said they wish they kept their silicone implants.

She has never seen any women with silicone implants at the center who experienced medical problems.

Robert M. Cook can be reached by calling 742-4455, ext. 5396

Sunday, April 17, 2005

By ULRIKA G. GERTH

Staff Writer

DURHAM – In the opinion of one female University of New Hampshire student, anybody who is so crazy or so rich that she can afford a "boob job" should be able to get silicone gel implants.

"As long as the doctor informs you about any health risks it should be up to you," said Razieh Alavi, 20.

Silcone implants have been virtually banned since 1992, but advisers to the Food and Drug Administration surprised the agency this week with a recommendation to reintroduce them on the market.

On Thursday afternoon, a few 20-something women on campus gave their opinion on the issue while enjoying the sunlight.

Used to seeing voluptuous celebrities parade their enhanced chests on TV and in magazines, Alavi and her friends, Hannah Gray, 19, and Julie Nasser, 20, admitted they thought silicone implants were already available.

Learning about the government ban, they quickly decided women should decide for themselves whether they are willing to live with the risks.

"The less government intervention the better," said Alavi.

"If you take them off the ban, you’re giving women the right to make their own choice, and that’s good I guess," said Nasser.

Ashley Hyde, 21, and Dan Horr, 21, represented the other end of the issue, arguing there needs to be government control for safety’s sake.

"If the product is bad and there’s no regulation, that’s bad. If you know they’re putting in a safe product, that’s a good thing," said Horr.

The question resulted in an exchange between Sara, 20, and Ally, 20, who did not want to have their last names published.

"You should be able to get what you like," said Sara.

"No, I don’t agree," said Ally. "There’s health concern for that type of implant."

"Yeah, but there’s a health concern about liposuction and that’s being done. Everything has health implications," Sara replied, prompting Ally to retort:

"Your body could resist it and it could be really dangerous. Basically if there’s a real concern, the government must make it known. That’s what I think."

If the ban is lifted, Vanessa Labrecque, 20, a receptionist at Perfect Tan in Durham, said she hopes there will be an age limit.

"If you’re over 18 you should be able to get them, but under that would be ridiculous. But who really needs implants? Come on. No, thank you. It’s not something I’d ever do, but if you feel you need it, go right ahead."

"I just don’t believe in it," said Hyde. "This perfect image in our society I don’t agree with. People should be happy with what they have. But if somebody wants to have them done I don’t look down upon them."

But Alavi said although she would never consider breast implants, she will "definitely get Botox." (To smooth age wrinkles.)

"I have been tanning so much that in 10 years..." she explained.

"I don’t think I’d ever do anything," said Gray. "Now my parents would never let me and when I’m old I’ll be hideous anyway."

Thursday, April 14, 2005

By LAURAN NEERGAARD

AP Medical Writer

WASHINGTON (AP) — Silicone-gel breast implants, virtually banned for 13 years, would return to the market if the government heeds a surprising recommendation from its scientific advisers.

After three days of wrenchingly emotional debate, advisers to the Food and Drug Administration said Mentor Corp. should be able to sell its gel implants — but only if it meets strict conditions.

Topping that list: ensuring women understand the devices may silently break inside their bodies; recommending that they get regular, and expensive, MRI exams to check for those breaks; limiting implant insertion to specially trained plastic surgeons; and new studies to prove how long implants last.

Just a day earlier, the advisers narrowly rejected sale of rival manufacturer Inamed Corp.’s silicone implants, citing lingering questions about how long they last and what happens when silicone oozes into the breast, or beyond.

By a 7-2 vote, the FDA advisers said Mentor’s research was more compelling than its competitors’ that it was time to lift restrictions that, because of health concerns, limited gel implants to special research studies since 1992.

"Patients can determine whether or not for them it is worth it to have a device that might need to be replaced within a 10-year period of time," said Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center.

Mentor hasn’t proved they’ll last even 10 years, argued New York dermatologist Dr. Amy Newburger, who opposed lifting restrictions. Instead, it closely studied patients for just three years and didn’t settle concern about the consequences of silicone leaks.

"I don’t have the assurance that it’s safe," Newburger said. "My concern was, since hundreds of thousands of patients will be exposed to this, I felt that the urgency (to sell) was not warranted at this time."

The FDA isn’t bound by its advisers’ recommendations. Just 15 months ago the FDA overruled a recommendation to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage.

Still, the decision was sure to delight patients who contend silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.

"If I had the option today, I would choose silicone over saline," Arlene Nicole Cummings, a saline implant recipient who runs a Web site for women considering breast implants, told the FDA advisers. "Women, along with their surgeons, should be allowed to choose. ... We are neither ignorant nor shallow."

The decision was a blow to dozens of other women who told the panel of silicone oozing out of their bodies and of years of pain and other symptoms they blame on faulty implants.

"These conditions are unenforceable," said Sybil Goldrich, a breast cancer survivor who went through four sets of broken implants in the 1980s. "Who’s going to pay for that MRI?"

The advisers acted on "wishful thinking" instead of data, said Cynthia Pearson of the National Women’s Health Network. "How can you ask women to consent based on a lot of unknowns?"

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The FDA imposed its ban on most use of the implants in 1992 amid fears that leaking silicone was dangerous.

Today, gel implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But aside from the risk of breakage, they can cause infection and painful, rocklike scar tissue.

Mentor’s chief study tracked about 400 women for three years and found 1.4 percent suffered implant ruptures. It also cited 100 patients given Mentor implants by a British doctor, whose own tracking found 5 percent broke within about nine years of insertion.

FDA scientists said Mentor’s data was too limited to settle durability questions and that the British research was skewed because it included only volunteers and excluded patients at highest risk of implant rupture — those with serious scar tissue.

But the advisers found the data reassuring, saying it was supplemented by state-of-the-art mechanical testing that suggests the implants are strong.

The panel harshly criticized Inamed Corp., which had tracked about 900 patients for three or four years to find between 2 percent and 10 percent implant breakage.

The turnaround shocked Inamed Vice President Dan Cohen, who said the panel had made "bizarre and strange decisions" in demanding stricter data from one firm than the other. He said his company would pursue approval.

The two devices are different and Mentor’s studies were better, FDA adviser Stephen Li, a Florida medical device-testing expert, said to explain the differing views.

"We are holding it to higher standards than other implants," Li said. "This device has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard."

About 264,000 breast enlargements and 63,000 breast reconstructions were performed in the United States last year.