Chicago Tribune: Next generation of implants

[Guest guest]

Forwarded from Ilena:

Bravo to Dr. Zuckerman!http://www.chicagotribune.com/technology/chi-0406300048jun30,1,5727849.story?coll=chi-technology-hedNext generation of breast implants on horizonDoctors, patients clamor, but safety critics aboundBy SommerfeldThe Seattle TimesPublished June 30, 2004SEATTLE -- The quest for the perfect breast has come full circle. Even as checks from Dow Corning slip into mailboxes this month, finally settling thousands of silicone lawsuits, plastic surgeons and patients are clamoring for the latest breast-boosting technology--the next-generation silicone implant.Now, U.S. women who want larger breasts for purely cosmetic reasons can get only implants filled with saline. That hasn't hurt the breast business any: More

than a quarter-million women had breast-augmentation surgery last year. That's a nearly 700 percent increase since 1992, the year silicone implants were restricted for safety reasons and the first lawsuit against Dow Corning and other manufacturers was filed.Even the bikini-unfriendly Northwest isn't immune to the lure of artificial curves. Seattle plastic surgeon Dr. Phil Haeck said his office does at least 1,000 pairs of implants per year.Still, some women complain of sloshy results from the salt-water implants and pine for the fleshy feel of silicone gel. "This is cosmetic--patients expect perfection," Haeck said.Enter the "cohesive" silicone gel implant, so-called because the gel is thicker. These devices, yet to be approved by the Food and Drug Administration, were the darlings of a plastic surgeon's convention recently in Vancouver, Canada, where doctors with foreheads as free of

creases as their perfectly tailored suits poked, pinched and squeezed the rubber teardrops.They see cohesive implants as the best bet in their pursuit of a better bosom, promising the feel of silicone without the fear of leaks, the flaw that brought down their predecessors.That's yet to be proven. But despite nagging questions about health risks, some women are lining up to find out with their own bodies in clinical trials.The appeals for more natural-looking artificial curves are why Dr. Bradley Remington, a Kirkland, Wash., plastic surgeon who does about 100 breast augmentations a year, is helping test one of the new cohesive-silicone implants, the Contour Profile Gel. He has implanted five pairs so far, and said their maker, Mentor, will release more slots for an expanded clinical trial next month. He's eagerly awaiting his new allotment so he can attend to the handful of women

already on his waiting list.Remington stands the CPG upright in his palm, showing how the implant holds its shape like a Jell-O mold, unlike the saline version, which collapses into a rubber puddle in the other hand."The gel is more solid, like a gummy bear--it maintains its shape and stays where it's supposed to," he said. "This is the implant of the future." Zuckerman, president of the National Center for Policy Research for Women & Families, a vocal critic of breast implants, sees the zeal for the latest implants as a case of "wishful thinking over science.""The history of breast implants is full of `new and improveds' and riddled with failures," Zuckerman said, pointing to the polyurethane foam-coated implants in the 1980s, a so-called improvement meant to prevent scar tissue from forming. They were pulled from the market when the FDA raised concerns the foam could

break down into a carcinogen.And silicone gel is not off the hook, as far as she's concerned.Studies have disputed the link between silicone and autoimmune diseases. In 1999, the Institute of Medicine, an independent agency that advises the government, reviewed the research and concluded that implants don't cause diseases. Zuckerman doesn't buy the report. She cites studies that suggest links to brain cancer, suicide and fibromyalgia, and notes that scientists haven't ruled out the possibility that a subset of people are allergic to silicone.Still, the IOM report was no ringing endorsement. It warned that implants often leak and up to one-quarter of recipients need repeat surgery within five years.Many plastic surgeons, however, think that silicone's bad rap is undeserved. "I have no reservations whatsoever about using silicone for my patients," said Dr. Mark Jewell, a Eugene,

Ore., plastic surgeon and a top user of cohesive implants.In fact, Jewell and other surgeons pressed for a return of the original silicone sacs when implantmaker Inamed sought FDA approval last fall. Most of the FDA's experts believed the implants don't cause diseases, but the agency denied approval--for now, anyway--until the company can answer what happens over time when the devices leak silicone into the body.That's why surgeons are betting the new cohesives are the best shot to get silicone past the FDA. Early reports from doctors in the trial suggest the thicker shell and gummy-bear consistency lower the risk of ruptures and leaks.Smack in the center of the silicone buzz at the Vancouver meeting of the American Society for Aesthetic Plastic Surgery was Hani Zeini, executive vice president of Inamed Aesthetics. "When? When? That's all doctors keep asking me," he said, gesturing to

the surgeons hovering around the sample implants as impatiently as children who've already picked out their Christmas present in June.The company has two years of data on nearly 1,000 women who've received the Style 410 cohesive implant and will submit it for FDA approval by the end of the year, he said. Mentor is close on its heels with the CPG study.Both brands of cohesive implants are already used in Europe, South America and, on a limited basis, Canada. "If you look at worldwide sales outside of the U.S., more than 90 percent of implants sold are silicone. That's our future, Zeini said.But critics are vexed by his vision--even if these newfangled devices don't spill silicone into the body, they are expected to carry the same risks of local complications as saline and the old silicone version--namely, they can obscure mammograms; can cause infections, painfully hard scar tissue

and disfigurement; and frequently require repeat surgery.Plus, many young women may not realize they aren't buying a lifetime device. Odds are they'll need at least a couple more surgeries over the years to swap them out.After all, the whole point of this business is to come closer to perfection, a perspective neatly summed up in a banner ad at the plastic-surgery conference. The wall-size promotion for a European silicone maker featured a pretty, chesty blonde and issued the challenge: "Beauty is natural. Perfection is surgical."__________________________________________________

[Guest guest]

Don't you just love ?!!!

She is certainly one of our angels!

Lynda

At 01:27 PM 6/30/2004, you wrote:

>Forwarded from Ilena:

>

>Bravo to Dr. Zuckerman!

>

><http://www.chicagotribune.com/technology/chi-0406300048jun30,1,5727849.story?c\

oll=chi-technology-hed>http://www.chicagotribune.com/technology/chi-0406300048ju\

n30,1,5727849.story?coll=chi-technology-hed

>

>Next generation of breast implants on horizon

>Doctors, patients clamor, but safety critics abound

>

>By Sommerfeld

>The Seattle Times

>Published June 30, 2004

>

>SEATTLE -- The quest for the perfect breast has come full circle. Even

>as

>checks from Dow Corning slip into mailboxes this month, finally

>settling

>thousands of silicone lawsuits, plastic surgeons and patients are

>clamoring

>for the latest breast-boosting technology--the next-generation silicone

>implant.

>

>Now, U.S. women who want larger breasts for purely cosmetic reasons can

>get

>only implants filled with saline. That hasn't hurt the breast business

>any:

>More than a quarter-million women had breast-augmentation surgery last

>year.

>That's a nearly 700 percent increase since 1992, the year silicone

>implants

>were restricted for safety reasons and the first lawsuit against Dow

>Corning

>and other manufacturers was filed.

>

>Even the bikini-unfriendly Northwest isn't immune to the lure of

>artificial

>curves. Seattle plastic surgeon Dr. Phil Haeck said his office does at

>least

>1,000 pairs of implants per year.

>

>Still, some women complain of sloshy results from the salt-water

>implants

>and pine for the fleshy feel of silicone gel. " This is

>cosmetic--patients

>expect perfection, " Haeck said.

>

>Enter the " cohesive " silicone gel implant, so-called because the gel is

>thicker. These devices, yet to be approved by the Food and Drug

>Administration, were the darlings of a plastic surgeon's convention

>recently

>in Vancouver, Canada, where doctors with foreheads as fr ee of creases

>as

>their perfectly tailored suits poked, pinched and squeezed the rubber

>teardrops.

>

>They see cohesive implants as the best bet in their pursuit of a better

>bosom, promising the feel of silicone without the fear of leaks, the

>flaw

>that brought down their predecessors.

>

>That's yet to be proven. But despite nagging questions about health

>risks,

>some women are lining up to find out with their own bodies in clinical

>trials.

>

>The appeals for more natural-looking artificial curves are why Dr.

>Bradley

>Remington, a Kirkland, Wash., plastic surgeon who does about 100 breast

>augmentations a year, is helping test one of the new cohesive-silicone

>implants, the Contour Profile Gel. He has implanted five pairs so far,

>and

>said their maker, Mentor, will release more slots for an expanded

>clinical

>trial next month. He's eagerly awaiting his new allotment so he can

>attend

>to the handful of w omen already on his waiting list.

>

>Remington stands the CPG upright in his palm, showing how the implant

>holds

>its shape like a Jell-O mold, unlike the saline version, which

>collapses

>into a rubber puddle in the other hand.

>

> " The gel is more solid, like a gummy bear--it maintains its shape and

>stays

>where it's supposed to, " he said. " This is the implant of the future. "

>

> Zuckerman, president of the National Center for Policy Research

>for

>Women & Families, a vocal critic of breast implants, sees the zeal for

>the

>latest implants as a case of " wishful thinking over science. "

>

> " The history of breast implants is full of `new and improveds' and

>riddled

>with failures, " Zuckerman said, pointing to the polyurethane

>foam-coated

>implants in the 1980s, a so-called improvement meant to prevent scar

>tissue

>from forming. They were pulled from the market when the FDA raised

>concerns

>the foam could break down into a carcinogen.

>

>And silicone gel is not off the hook, as far as she's concerned.

>

>Studies have disputed the link between silicone and autoimmune

>diseases. In

>1999, the Institute of Medicine, an independent agency that advises the

>government, reviewed the research and concluded that implants don't

>cause

>diseases. Zuckerman doesn't buy the report. She cites studies that

>suggest

>links to brain cancer, suicide and fibromyalgia, and notes that

>scientists

>haven't ruled out the possibility that a subset of people are allergic

>to

>silicone.

>

>Still, the IOM report was no ringing endorsement. It warned that

>implants

>often leak and up to one-quarter of recipients need repeat surgery

>within

>five years.

>

>Many plastic surgeons, however, think that silicone's bad rap is

>undeserved.

> " I have no reservations whatsoever about using silicone for my

>patients, "

>said Dr. Mark Jewell, a Eugene, Ore., plastic surgeon and a top user of

>cohesive implants.

>

>In fact, Jewell and other surgeons pressed for a return of the original

>silicone sacs when implantmaker Inamed sought FDA approval last fall.

>Most

>of the FDA's experts believed the implants don't cause diseases, but

>the

>agency denied approval--for now, anyway--until the company can answer

>what

>happens over time when the devices leak silicone into the body.

>

>That's why surgeons are betting the new cohesives are the best shot to

>get

>silicone past the FDA. Early reports from doctors in the trial suggest

>the

>thicker shell and gummy-bear consistency lower the risk of ruptures and

>leaks.

>

>Smack in the center of the silicone buzz at the Vancouver meeting of

>the

>American Society for Aesthetic Plastic Surgery was Hani Zeini,

>executive

>vice president of Inamed Aesthetics. " When? When? That's all doctors

>keep

>asking me, " he said, gest uring to the surgeons hovering around the

>sample

>implants as impatiently as children who've already picked out their

>Christmas present in June.

>

>The company has two years of data on nearly 1,000 women who've received

>the

>Style 410 cohesive implant and will submit it for FDA approval by the

>end of

>the year, he said. Mentor is close on its heels with the CPG study.

>

>Both brands of cohesive implants are already used in Europe, South

>America

>and, on a limited basis, Canada. " If you look at worldwide sales

>outside of

>the U.S., more than 90 percent of implants sold are silicone. That's

>our

>future, Zeini said.

>

>But critics are vexed by his vision--even if these newfangled devices

>don't

>spill silicone into the body, they are expected to carry the same risks

>of

>local complications as saline and the old silicone version--namely,

>they can

>obscure mammograms; can cause infections, painfully hard scar ti ssue

>and

>disfigurement; and frequently require repeat surgery.

>

>Plus, many young women may not realize they aren't buying a lifetime

>device.

>Odds are they'll need at least a couple more surgeries over the years

>to

>swap them out.

>

>After all, the whole point of this business is to come closer to

>perfection,

>a perspective neatly summed up in a banner ad at the plastic-surgery

>conference. The wall-size promotion for a European silicone maker

>featured a

>pretty, chesty blonde and issued the challenge: " Beauty is natural.

>Perfection is surgical. "

>

>__________________________________________________

>