Re: L.A. Times: Silicone: Now a solid 'maybe' (????)

[Guest guest]

I know all of you are disheartened that silicone implants have been approved

but it's really clear from this article that your voices have been heard.

The FDA is suggesting that patients have an MRI three years following

surgery and every two years thereafter for life to check the implant's

integrity. If the FDA knew implants were safe, this wouldn't be happening.

Also, a doctor quoted in this article says that a broken implant can cause

inflammation. It is inflammation in our bodies that can cause fibro and a

whole host of other problems.

Of course women will have to bear the burden of cost for the MRI's and

repeat surgeries if necessary and insurance companies are steering clear of

getting involved. If I was told upfront that I needed these tests to be

sure my implants didn't rupture and that my insurance company wouldn't pay

for the tests and treatment if I became ill, I'd run for the hills. It is

very conceivable that one would have to pay tens of thousands of dollars

over their lifetime to keep their implants and comply with the FDA

suggestion.

This is a shallow victory for the implant manufacturers.

Kenda

> Silicone: Now a solid 'maybe' The breast implants' approval by the FDA was

> not fine-print free. Women must weigh the impact, and costs, of follow-up

> care.

> By Healy, Times Staff Writer

> November 27, 2006

>

> The days before Thanksgiving are typically quiet in the offices of plastic

> surgeons. But a long-awaited decision to approve silicone breast implants

> for women older than 22 prompted a flurry of excited calls and inquiries

> last week from prospective patients.

>

> The giddy welcome may not last. Even as the two U.S. manufacturers of

> silicone implants gleefully projected a surge in demand for their products,

> physicians began poring over the fine print of the Food and Drug

> Administration's recommendation and finding reasons for caution.

>

> Like a holiday hangover that sets in before the dishes are washed, the

> sobering details of the government's decision are making some doctors less

> than exuberant about the newly approved implants. As they begin to share

> their wariness with patients, some expect many women will stick with saline

> implants or wait for the FDA to give its blessing to a new generation of

> silicone implants sometime in the next two years.

>

> The agency's decision " does create a whole host of questions " for women

> considering silicone breast augmentation and for the doctors who perform

> those procedures, said Dr. Walter Erhardt, chairman of the American Society

> of Plastic Surgeons' public education committee.

>

> " Many women were waiting in the wings to see when [the] FDA would approve

> silicone, " said Brent Moelleken, a plastic surgeon with practices in Beverly

> Hills and Santa Barbara. Patients intent on getting silicone implants

> " really look on the bright side of the controversy, " he said. Although many

> prospective patients will inquire, " my recommendation to them may not be to

> have surgery " at this time, he added.

>

> Key among the questions that doctors are pondering is the cost of using the

> newly approved gel implants in the manner outlined as safe by the FDA in its

> Nov. 17 announcement. The agency recommends that each woman using the

> implants have her breasts checked by magnetic resonance imaging, or MRI,

> three years after her surgery and every two years thereafter " over a woman's

> lifetime " to check for any ruptures of the implant. If any break is detected

> in the seal of the device, " the implant should be removed and replaced, if

> needed, " the FDA added.

>

> Medical insurance doesn't cover cosmetic breast enhancement. Similarly, the

> cost of postoperative tracking and repeat surgery, the FDA notes, " may not

> be covered " by a woman's medical insurance and " may exceed the cost of her

> initial surgery. "

>

> Even if women can afford the original breast implant surgery, a subsequent

> surgery ‹ not to mention periodic MRIs ‹ may be out of their price range.

>

> *Cleared but questioned

>

> *The FDA's approval ‹ after 14 years of study ‹ had been expected to end the

> controversy around silicone gel implants.

>

> The devices were pulled from the general marketplace in 1992 amid concerns

> that they could rupture and endanger women, possibly contributing to

> autoimmune diseases. Although a link to health problems was never proved,

> long-term safety has remained an issue. In the meantime, the implants have

> remained available to cancer survivors and a wide range of women who agreed

> to enroll in studies of the implants' safety.

>

> But the new recommendations present patients and their plastic and aesthetic

> surgeons with additional uncertainties: Who will pay for the recommended MRI

> scans? What danger does the FDA foresee if patients, as expected, fail to

> get them? Does the FDA consider that a ruptured implant device ‹ even one

> that presents no discomfort or proven danger to the patient ‹ must

> necessarily be surgically removed and replaced? If so, whose financial

> responsibility would that be?

>

> " Do you think [insurance companies] are going to say, 'No problem, we want

> what's best for the patient?' " asks plastic surgeon Marcel s of Long

> Beach. " No. A lot of third-party payers have ruled out payment for any

> treatment ‹ including complications ‹ related to breast implants. "

>

> What to do if those MRI scans detect cracks or breaks in an implant " is

> another conundrum that's created by this [FDA] recommendation, " said

> Erhardt, of Albany, Ga. By calling for costly MRIs to detect silent ruptures

> and potential replacement surgery in such cases, the FDA is suggesting to

> patients and physicians that leakage may present safety concerns. " But we

> still don't have science that [a silent rupture] creates a harmful situation

> for the patients. And the FDA hasn't addressed that either, " Erhardt said.

>

> Plastic and aesthetic surgeons currently are divided on the question of

> whether " silent ruptures " ‹ breaks in a silicone implant that are not

> noticed by the patient ‹ need to be replaced for safety. Laurie Casas, a

> Chicago plastic surgeon, says she believes a broken implant could eventually

> cause inflammation and so " should be replaced, as you would any broken

> device. "

>

> Beverly Hills plastic surgeon Ellenbogen, whose view is widely

> shared among plastic surgeons, counters, " If it ain't broke, why fix it? Why

> submit a woman to that trauma? "

>

> Among young women, who are considered a key market for this so-called " third

> generation " of silicone devices, plastic surgeons predict the FDA's

> follow-up recommendations and the improving alternatives will temper

> enthusiasm. But they acknowledge that many women will get them anyway and

> simply ignore the FDA recommendations that come with them.

>

> " Most women want to put them in, go on with their lives and forget they got

> the surgery, " said Beverly Hills plastic surgeon Motykie. " That'll be a

> big question, whether they're going to want to be burdened with that

> follow-up. "

>

> The specialized MRI images required to detect the integrity of a breast

> implant typically cost between $1,500 and $1,800, said Zuckerman,

> director of the National Research Center for Women & Families, a nonprofit

> research and education organization in Washington, D.C. Costs at some

> centers can reach up to $4,000, and many women would have to travel long

> distances to get the recommended images, added Zuckerman, whose organization

> testified against the latest silicone implant approval.

>

> " These young girls are often going into debt that they can't really afford

> to get out of, and they're paying for something on installment that they can

> barely afford, " Zuckerman said. " I certainly think any woman who is not

> affluent would be crazy to choose silicone because of the additional cost. "

>

> *Saline improvements

>

> *Meanwhile, the look and feel of saline implants have been improved by a

> generation of surgeons who have had only that type of device to offer their

> patients. To overcome the wrinkles and folds that often mar the appearance

> of a saline implant in the breast, surgeons have begun to implant them under

> muscle and other breast tissue.

>

> At the same time, a newer and reportedly better generation of " highly

> cohesive " silicone devices is making its way through the FDA approval

> process. Although the silicone in the implants just approved is considered

> resistant to leakage and running if broken, the next generation ‹ often

> described as having a consistency similar to that of gummy candy ‹ is

> designed to be even more resistant.

>

> " Patients that really are interested in gel implants have done their

> homework " and know what advances lie ahead, said Erhardt, adding, " it will

> be interesting to see how many people will want to accept the old

> technology " approved after such exhaustive study by the FDA, when a new

> generation may be just a year or two down the road.

>

> ~~~~~~~~~~~~~

> www.BreastImplantAwareness.org

[Guest guest]

Kenda, their decision DOES have alot attached to it, doesn't it?

Let's consider it a victory! We shall prevail!

Love, Sunny

>

> I know all of you are disheartened that silicone implants have been

approved

> but it's really clear from this article that your voices have been

heard.

> The FDA is suggesting that patients have an MRI three years

following

> surgery and every two years thereafter for life to check the

implant's

> integrity. If the FDA knew implants were safe, this wouldn't be

happening.

> Also, a doctor quoted in this article says that a broken implant

can cause

> inflammation. It is inflammation in our bodies that can cause

fibro and a

> whole host of other problems.

>

> Of course women will have to bear the burden of cost for the MRI's

and

> repeat surgeries if necessary and insurance companies are steering

clear of

> getting involved. If I was told upfront that I needed these tests

to be

> sure my implants didn't rupture and that my insurance company

wouldn't pay

> for the tests and treatment if I became ill, I'd run for the

hills. It is

> very conceivable that one would have to pay tens of thousands of

dollars

> over their lifetime to keep their implants and comply with the FDA

> suggestion.

>

> This is a shallow victory for the implant manufacturers.

>

> Kenda

>

> > Silicone: Now a solid 'maybe' The breast implants' approval by

the FDA was

> > not fine-print free. Women must weigh the impact, and costs, of

follow-up

> > care.

> > By Healy, Times Staff Writer

> > November 27, 2006

> >

> > The days before Thanksgiving are typically quiet in the offices

of plastic

> > surgeons. But a long-awaited decision to approve silicone breast

implants

> > for women older than 22 prompted a flurry of excited calls and

inquiries

> > last week from prospective patients.

> >

> > The giddy welcome may not last. Even as the two U.S.

manufacturers of

> > silicone implants gleefully projected a surge in demand for their

products,

> > physicians began poring over the fine print of the Food and Drug

> > Administration's recommendation and finding reasons for caution.

> >

> > Like a holiday hangover that sets in before the dishes are

washed, the

> > sobering details of the government's decision are making some

doctors less

> > than exuberant about the newly approved implants. As they begin

to share

> > their wariness with patients, some expect many women will stick

with saline

> > implants or wait for the FDA to give its blessing to a new

generation of

> > silicone implants sometime in the next two years.

> >

> > The agency's decision " does create a whole host of questions " for

women

> > considering silicone breast augmentation and for the doctors who

perform

> > those procedures, said Dr. Walter Erhardt, chairman of the

American Society

> > of Plastic Surgeons' public education committee.

> >

> > " Many women were waiting in the wings to see when [the] FDA would

approve

> > silicone, " said Brent Moelleken, a plastic surgeon with practices

in Beverly

> > Hills and Santa Barbara. Patients intent on getting silicone

implants

> > " really look on the bright side of the controversy, " he said.

Although many

> > prospective patients will inquire, " my recommendation to them may

not be to

> > have surgery " at this time, he added.

> >

> > Key among the questions that doctors are pondering is the cost of

using the

> > newly approved gel implants in the manner outlined as safe by the

FDA in its

> > Nov. 17 announcement. The agency recommends that each woman using

the

> > implants have her breasts checked by magnetic resonance imaging,

or MRI,

> > three years after her surgery and every two years

thereafter " over a woman's

> > lifetime " to check for any ruptures of the implant. If any break

is detected

> > in the seal of the device, " the implant should be removed and

replaced, if

> > needed, " the FDA added.

> >

> > Medical insurance doesn't cover cosmetic breast enhancement.

Similarly, the

> > cost of postoperative tracking and repeat surgery, the FDA

notes, " may not

> > be covered " by a woman's medical insurance and " may exceed the

cost of her

> > initial surgery. "

> >

> > Even if women can afford the original breast implant surgery, a

subsequent

> > surgery ‹ not to mention periodic MRIs ‹ may be out of their

price range.

> >

> > *Cleared but questioned

> >

> > *The FDA's approval ‹ after 14 years of study ‹ had been expected

to end the

> > controversy around silicone gel implants.

> >

> > The devices were pulled from the general marketplace in 1992 amid

concerns

> > that they could rupture and endanger women, possibly contributing

to

> > autoimmune diseases. Although a link to health problems was never

proved,

> > long-term safety has remained an issue. In the meantime, the

implants have

> > remained available to cancer survivors and a wide range of women

who agreed

> > to enroll in studies of the implants' safety.

> >

> > But the new recommendations present patients and their plastic

and aesthetic

> > surgeons with additional uncertainties: Who will pay for the

recommended MRI

> > scans? What danger does the FDA foresee if patients, as expected,

fail to

> > get them? Does the FDA consider that a ruptured implant device ‹

even one

> > that presents no discomfort or proven danger to the patient ‹ must

> > necessarily be surgically removed and replaced? If so, whose

financial

> > responsibility would that be?

> >

> > " Do you think [insurance companies] are going to say, 'No

problem, we want

> > what's best for the patient?' " asks plastic surgeon Marcel

s of Long

> > Beach. " No. A lot of third-party payers have ruled out payment

for any

> > treatment ‹ including complications ‹ related to breast implants. "

> >

> > What to do if those MRI scans detect cracks or breaks in an

implant " is

> > another conundrum that's created by this [FDA] recommendation, "

said

> > Erhardt, of Albany, Ga. By calling for costly MRIs to detect

silent ruptures

> > and potential replacement surgery in such cases, the FDA is

suggesting to

> > patients and physicians that leakage may present safety

concerns. " But we

> > still don't have science that [a silent rupture] creates a

harmful situation

> > for the patients. And the FDA hasn't addressed that either, "

Erhardt said.

> >

> > Plastic and aesthetic surgeons currently are divided on the

question of

> > whether " silent ruptures " ‹ breaks in a silicone implant that are

not

> > noticed by the patient ‹ need to be replaced for safety. Laurie

Casas, a

> > Chicago plastic surgeon, says she believes a broken implant could

eventually

> > cause inflammation and so " should be replaced, as you would any

broken

> > device. "

> >

> > Beverly Hills plastic surgeon Ellenbogen, whose view is

widely

> > shared among plastic surgeons, counters, " If it ain't broke, why

fix it? Why

> > submit a woman to that trauma? "

> >

> > Among young women, who are considered a key market for this so-

called " third

> > generation " of silicone devices, plastic surgeons predict the

FDA's

> > follow-up recommendations and the improving alternatives will

temper

> > enthusiasm. But they acknowledge that many women will get them

anyway and

> > simply ignore the FDA recommendations that come with them.

> >

> > " Most women want to put them in, go on with their lives and

forget they got

> > the surgery, " said Beverly Hills plastic surgeon

Motykie. " That'll be a

> > big question, whether they're going to want to be burdened with

that

> > follow-up. "

> >

> > The specialized MRI images required to detect the integrity of a

breast

> > implant typically cost between $1,500 and $1,800, said

Zuckerman,

> > director of the National Research Center for Women & Families, a

nonprofit

> > research and education organization in Washington, D.C. Costs at

some

> > centers can reach up to $4,000, and many women would have to

travel long

> > distances to get the recommended images, added Zuckerman, whose

organization

> > testified against the latest silicone implant approval.

> >

> > " These young girls are often going into debt that they can't

really afford

> > to get out of, and they're paying for something on installment

that they can

> > barely afford, " Zuckerman said. " I certainly think any woman who

is not

> > affluent would be crazy to choose silicone because of the

additional cost. "

> >

> > *Saline improvements

> >

> > *Meanwhile, the look and feel of saline implants have been

improved by a

> > generation of surgeons who have had only that type of device to

offer their

> > patients. To overcome the wrinkles and folds that often mar the

appearance

> > of a saline implant in the breast, surgeons have begun to implant

them under

> > muscle and other breast tissue.

> >

> > At the same time, a newer and reportedly better generation

of " highly

> > cohesive " silicone devices is making its way through the FDA

approval

> > process. Although the silicone in the implants just approved is

considered

> > resistant to leakage and running if broken, the next generation ‹

often

> > described as having a consistency similar to that of gummy

candy ‹ is

> > designed to be even more resistant.

> >

> > " Patients that really are interested in gel implants have done

their

> > homework " and know what advances lie ahead, said Erhardt,

adding, " it will

> > be interesting to see how many people will want to accept the old

> > technology " approved after such exhaustive study by the FDA, when

a new

> > generation may be just a year or two down the road.

> >

> > ~~~~~~~~~~~~~

> > www.BreastImplantAwareness.org

>

[Guest guest]

I believe in seeing the bright side to everything, but... I do not see this as a

victory. The

" study " the FDA is requiring is only for 10 years, to exclude scleroderma -

which the FDA

has already stated they do not expect to find. If the FDA was serious about a

study, it

would be for 15 or 20 years. OR the FDA would require that manufacturers tell

women

that they must replace their implants every 10 years.

I do not see the FDA decision as any serious attempt at furthering research.

They also do

not require manufacturers to tell women they should follow up with MRIs - which

is the

" FDA recommendation " to detect rupture.

> >

> > I know all of you are disheartened that silicone implants have been

> approved

> > but it's really clear from this article that your voices have been

> heard.

> > The FDA is suggesting that patients have an MRI three years

> following

> > surgery and every two years thereafter for life to check the

> implant's

> > integrity. If the FDA knew implants were safe, this wouldn't be

> happening.

> > Also, a doctor quoted in this article says that a broken implant

> can cause

> > inflammation. It is inflammation in our bodies that can cause

> fibro and a

> > whole host of other problems.

> >

> > Of course women will have to bear the burden of cost for the MRI's

> and

> > repeat surgeries if necessary and insurance companies are steering

> clear of

> > getting involved. If I was told upfront that I needed these tests

> to be

> > sure my implants didn't rupture and that my insurance company

> wouldn't pay

> > for the tests and treatment if I became ill, I'd run for the

> hills. It is

> > very conceivable that one would have to pay tens of thousands of

> dollars

> > over their lifetime to keep their implants and comply with the FDA

> > suggestion.

> >

> > This is a shallow victory for the implant manufacturers.

> >

> > Kenda

> >

> > > Silicone: Now a solid 'maybe' The breast implants' approval by

> the FDA was

> > > not fine-print free. Women must weigh the impact, and costs, of

> follow-up

> > > care.

> > > By Healy, Times Staff Writer

> > > November 27, 2006

> > >

> > > The days before Thanksgiving are typically quiet in the offices

> of plastic

> > > surgeons. But a long-awaited decision to approve silicone breast

> implants

> > > for women older than 22 prompted a flurry of excited calls and

> inquiries

> > > last week from prospective patients.

> > >

> > > The giddy welcome may not last. Even as the two U.S.

> manufacturers of

> > > silicone implants gleefully projected a surge in demand for their

> products,

> > > physicians began poring over the fine print of the Food and Drug

> > > Administration's recommendation and finding reasons for caution.

> > >

> > > Like a holiday hangover that sets in before the dishes are

> washed, the

> > > sobering details of the government's decision are making some

> doctors less

> > > than exuberant about the newly approved implants. As they begin

> to share

> > > their wariness with patients, some expect many women will stick

> with saline

> > > implants or wait for the FDA to give its blessing to a new

> generation of

> > > silicone implants sometime in the next two years.

> > >

> > > The agency's decision " does create a whole host of questions " for

> women

> > > considering silicone breast augmentation and for the doctors who

> perform

> > > those procedures, said Dr. Walter Erhardt, chairman of the

> American Society

> > > of Plastic Surgeons' public education committee.

> > >

> > > " Many women were waiting in the wings to see when [the] FDA would

> approve

> > > silicone, " said Brent Moelleken, a plastic surgeon with practices

> in Beverly

> > > Hills and Santa Barbara. Patients intent on getting silicone

> implants

> > > " really look on the bright side of the controversy, " he said.

> Although many

> > > prospective patients will inquire, " my recommendation to them may

> not be to

> > > have surgery " at this time, he added.

> > >

> > > Key among the questions that doctors are pondering is the cost of

> using the

> > > newly approved gel implants in the manner outlined as safe by the

> FDA in its

> > > Nov. 17 announcement. The agency recommends that each woman using

> the

> > > implants have her breasts checked by magnetic resonance imaging,

> or MRI,

> > > three years after her surgery and every two years

> thereafter " over a woman's

> > > lifetime " to check for any ruptures of the implant. If any break

> is detected

> > > in the seal of the device, " the implant should be removed and

> replaced, if

> > > needed, " the FDA added.

> > >

> > > Medical insurance doesn't cover cosmetic breast enhancement.

> Similarly, the

> > > cost of postoperative tracking and repeat surgery, the FDA

> notes, " may not

> > > be covered " by a woman's medical insurance and " may exceed the

> cost of her

> > > initial surgery. "

> > >

> > > Even if women can afford the original breast implant surgery, a

> subsequent

> > > surgery ‹ not to mention periodic MRIs ‹ may be out of their

> price range.

> > >

> > > *Cleared but questioned

> > >

> > > *The FDA's approval ‹ after 14 years of study ‹ had been expected

> to end the

> > > controversy around silicone gel implants.

> > >

> > > The devices were pulled from the general marketplace in 1992 amid

> concerns

> > > that they could rupture and endanger women, possibly contributing

> to

> > > autoimmune diseases. Although a link to health problems was never

> proved,

> > > long-term safety has remained an issue. In the meantime, the

> implants have

> > > remained available to cancer survivors and a wide range of women

> who agreed

> > > to enroll in studies of the implants' safety.

> > >

> > > But the new recommendations present patients and their plastic

> and aesthetic

> > > surgeons with additional uncertainties: Who will pay for the

> recommended MRI

> > > scans? What danger does the FDA foresee if patients, as expected,

> fail to

> > > get them? Does the FDA consider that a ruptured implant device ‹

> even one

> > > that presents no discomfort or proven danger to the patient ‹ must

> > > necessarily be surgically removed and replaced? If so, whose

> financial

> > > responsibility would that be?

> > >

> > > " Do you think [insurance companies] are going to say, 'No

> problem, we want

> > > what's best for the patient?' " asks plastic surgeon Marcel

> s of Long

> > > Beach. " No. A lot of third-party payers have ruled out payment

> for any

> > > treatment ‹ including complications ‹ related to breast implants. "

> > >

> > > What to do if those MRI scans detect cracks or breaks in an

> implant " is

> > > another conundrum that's created by this [FDA] recommendation, "

> said

> > > Erhardt, of Albany, Ga. By calling for costly MRIs to detect

> silent ruptures

> > > and potential replacement surgery in such cases, the FDA is

> suggesting to

> > > patients and physicians that leakage may present safety

> concerns. " But we

> > > still don't have science that [a silent rupture] creates a

> harmful situation

> > > for the patients. And the FDA hasn't addressed that either, "

> Erhardt said.

> > >

> > > Plastic and aesthetic surgeons currently are divided on the

> question of

> > > whether " silent ruptures " ‹ breaks in a silicone implant that are

> not

> > > noticed by the patient ‹ need to be replaced for safety. Laurie

> Casas, a

> > > Chicago plastic surgeon, says she believes a broken implant could

> eventually

> > > cause inflammation and so " should be replaced, as you would any

> broken

> > > device. "

> > >

> > > Beverly Hills plastic surgeon Ellenbogen, whose view is

> widely

> > > shared among plastic surgeons, counters, " If it ain't broke, why

> fix it? Why

> > > submit a woman to that trauma? "

> > >

> > > Among young women, who are considered a key market for this so-

> called " third

> > > generation " of silicone devices, plastic surgeons predict the

> FDA's

> > > follow-up recommendations and the improving alternatives will

> temper

> > > enthusiasm. But they acknowledge that many women will get them

> anyway and

> > > simply ignore the FDA recommendations that come with them.

> > >

> > > " Most women want to put them in, go on with their lives and

> forget they got

> > > the surgery, " said Beverly Hills plastic surgeon

> Motykie. " That'll be a

> > > big question, whether they're going to want to be burdened with

> that

> > > follow-up. "

> > >

> > > The specialized MRI images required to detect the integrity of a

> breast

> > > implant typically cost between $1,500 and $1,800, said

> Zuckerman,

> > > director of the National Research Center for Women & Families, a

> nonprofit

> > > research and education organization in Washington, D.C. Costs at

> some

> > > centers can reach up to $4,000, and many women would have to

> travel long

> > > distances to get the recommended images, added Zuckerman, whose

> organization

> > > testified against the latest silicone implant approval.

> > >

> > > " These young girls are often going into debt that they can't

> really afford

> > > to get out of, and they're paying for something on installment

> that they can

> > > barely afford, " Zuckerman said. " I certainly think any woman who

> is not

> > > affluent would be crazy to choose silicone because of the

> additional cost. "

> > >

> > > *Saline improvements

> > >

> > > *Meanwhile, the look and feel of saline implants have been

> improved by a

> > > generation of surgeons who have had only that type of device to

> offer their

> > > patients. To overcome the wrinkles and folds that often mar the

> appearance

> > > of a saline implant in the breast, surgeons have begun to implant

> them under

> > > muscle and other breast tissue.

> > >

> > > At the same time, a newer and reportedly better generation

> of " highly

> > > cohesive " silicone devices is making its way through the FDA

> approval

> > > process. Although the silicone in the implants just approved is

> considered

> > > resistant to leakage and running if broken, the next generation ‹

> often

> > > described as having a consistency similar to that of gummy

> candy ‹ is

> > > designed to be even more resistant.

> > >

> > > " Patients that really are interested in gel implants have done

> their

> > > homework " and know what advances lie ahead, said Erhardt,

> adding, " it will

> > > be interesting to see how many people will want to accept the old

> > > technology " approved after such exhaustive study by the FDA, when

> a new

> > > generation may be just a year or two down the road.

> > >

> > > ~~~~~~~~~~~~~

> > > www.BreastImplantAwareness.org

> >

>

[Guest guest]

Molly,

Everyone's work is far from done but I do see it as a victory, along with

Sunny. The FDA is listening and is doing SOME research. It is too much to

expect that they would do anything more at this point -- it is our

government, after all. Implants make few women sick, that is a fact.

Because of this, implants are going to remain on the market.

Kenda

> I believe in seeing the bright side to everything, but... I do not see this as

> a victory. The

> " study " the FDA is requiring is only for 10 years, to exclude scleroderma -

> which the FDA

> has already stated they do not expect to find. If the FDA was serious about a

> study, it

> would be for 15 or 20 years. OR the FDA would require that manufacturers tell

> women

> that they must replace their implants every 10 years.

> I do not see the FDA decision as any serious attempt at furthering research.

> They also do

> not require manufacturers to tell women they should follow up with MRIs -

> which is the

> " FDA recommendation " to detect rupture.

>

>

>>>

>>> I know all of you are disheartened that silicone implants have been

>> approved

>>> but it's really clear from this article that your voices have been

>> heard.

>>> The FDA is suggesting that patients have an MRI three years

>> following

>>> surgery and every two years thereafter for life to check the

>> implant's

>>> integrity. If the FDA knew implants were safe, this wouldn't be

>> happening.

>>> Also, a doctor quoted in this article says that a broken implant

>> can cause

>>> inflammation. It is inflammation in our bodies that can cause

>> fibro and a

>>> whole host of other problems.

>>>

>>> Of course women will have to bear the burden of cost for the MRI's

>> and

>>> repeat surgeries if necessary and insurance companies are steering

>> clear of

>>> getting involved. If I was told upfront that I needed these tests

>> to be

>>> sure my implants didn't rupture and that my insurance company

>> wouldn't pay

>>> for the tests and treatment if I became ill, I'd run for the

>> hills. It is

>>> very conceivable that one would have to pay tens of thousands of

>> dollars

>>> over their lifetime to keep their implants and comply with the FDA

>>> suggestion.

>>>

>>> This is a shallow victory for the implant manufacturers.

>>>

>>> Kenda

>>>

>>>> Silicone: Now a solid 'maybe' The breast implants' approval by

>> the FDA was

>>>> not fine-print free. Women must weigh the impact, and costs, of

>> follow-up

>>>> care.

>>>> By Healy, Times Staff Writer

>>>> November 27, 2006

>>>>

>>>> The days before Thanksgiving are typically quiet in the offices

>> of plastic

>>>> surgeons. But a long-awaited decision to approve silicone breast

>> implants

>>>> for women older than 22 prompted a flurry of excited calls and

>> inquiries

>>>> last week from prospective patients.

>>>>

>>>> The giddy welcome may not last. Even as the two U.S.

>> manufacturers of

>>>> silicone implants gleefully projected a surge in demand for their

>> products,

>>>> physicians began poring over the fine print of the Food and Drug

>>>> Administration's recommendation and finding reasons for caution.

>>>>

>>>> Like a holiday hangover that sets in before the dishes are

>> washed, the

>>>> sobering details of the government's decision are making some

>> doctors less

>>>> than exuberant about the newly approved implants. As they begin

>> to share

>>>> their wariness with patients, some expect many women will stick

>> with saline

>>>> implants or wait for the FDA to give its blessing to a new

>> generation of

>>>> silicone implants sometime in the next two years.

>>>>

>>>> The agency's decision " does create a whole host of questions " for

>> women

>>>> considering silicone breast augmentation and for the doctors who

>> perform

>>>> those procedures, said Dr. Walter Erhardt, chairman of the

>> American Society

>>>> of Plastic Surgeons' public education committee.

>>>>

>>>> " Many women were waiting in the wings to see when [the] FDA would

>> approve

>>>> silicone, " said Brent Moelleken, a plastic surgeon with practices

>> in Beverly

>>>> Hills and Santa Barbara. Patients intent on getting silicone

>> implants

>>>> " really look on the bright side of the controversy, " he said.

>> Although many

>>>> prospective patients will inquire, " my recommendation to them may

>> not be to

>>>> have surgery " at this time, he added.

>>>>

>>>> Key among the questions that doctors are pondering is the cost of

>> using the

>>>> newly approved gel implants in the manner outlined as safe by the

>> FDA in its

>>>> Nov. 17 announcement. The agency recommends that each woman using

>> the

>>>> implants have her breasts checked by magnetic resonance imaging,

>> or MRI,

>>>> three years after her surgery and every two years

>> thereafter " over a woman's

>>>> lifetime " to check for any ruptures of the implant. If any break

>> is detected

>>>> in the seal of the device, " the implant should be removed and

>> replaced, if

>>>> needed, " the FDA added.

>>>>

>>>> Medical insurance doesn't cover cosmetic breast enhancement.

>> Similarly, the

>>>> cost of postoperative tracking and repeat surgery, the FDA

>> notes, " may not

>>>> be covered " by a woman's medical insurance and " may exceed the

>> cost of her

>>>> initial surgery. "

>>>>

>>>> Even if women can afford the original breast implant surgery, a

>> subsequent

>>>> surgery ‹ not to mention periodic MRIs ‹ may be out of their

>> price range.

>>>>

>>>> *Cleared but questioned

>>>>

>>>> *The FDA's approval ‹ after 14 years of study ‹ had been expected

>> to end the

>>>> controversy around silicone gel implants.

>>>>

>>>> The devices were pulled from the general marketplace in 1992 amid

>> concerns

>>>> that they could rupture and endanger women, possibly contributing

>> to

>>>> autoimmune diseases. Although a link to health problems was never

>> proved,

>>>> long-term safety has remained an issue. In the meantime, the

>> implants have

>>>> remained available to cancer survivors and a wide range of women

>> who agreed

>>>> to enroll in studies of the implants' safety.

>>>>

>>>> But the new recommendations present patients and their plastic

>> and aesthetic

>>>> surgeons with additional uncertainties: Who will pay for the

>> recommended MRI

>>>> scans? What danger does the FDA foresee if patients, as expected,

>> fail to

>>>> get them? Does the FDA consider that a ruptured implant device ‹

>> even one

>>>> that presents no discomfort or proven danger to the patient ‹ must

>>>> necessarily be surgically removed and replaced? If so, whose

>> financial

>>>> responsibility would that be?

>>>>

>>>> " Do you think [insurance companies] are going to say, 'No

>> problem, we want

>>>> what's best for the patient?' " asks plastic surgeon Marcel

>> s of Long

>>>> Beach. " No. A lot of third-party payers have ruled out payment

>> for any

>>>> treatment ‹ including complications ‹ related to breast implants. "

>>>>

>>>> What to do if those MRI scans detect cracks or breaks in an

>> implant " is

>>>> another conundrum that's created by this [FDA] recommendation, "

>> said

>>>> Erhardt, of Albany, Ga. By calling for costly MRIs to detect

>> silent ruptures

>>>> and potential replacement surgery in such cases, the FDA is

>> suggesting to

>>>> patients and physicians that leakage may present safety

>> concerns. " But we

>>>> still don't have science that [a silent rupture] creates a

>> harmful situation

>>>> for the patients. And the FDA hasn't addressed that either, "

>> Erhardt said.

>>>>

>>>> Plastic and aesthetic surgeons currently are divided on the

>> question of

>>>> whether " silent ruptures " ‹ breaks in a silicone implant that are

>> not

>>>> noticed by the patient ‹ need to be replaced for safety. Laurie

>> Casas, a

>>>> Chicago plastic surgeon, says she believes a broken implant could

>> eventually

>>>> cause inflammation and so " should be replaced, as you would any

>> broken

>>>> device. "

>>>>

>>>> Beverly Hills plastic surgeon Ellenbogen, whose view is

>> widely

>>>> shared among plastic surgeons, counters, " If it ain't broke, why

>> fix it? Why

>>>> submit a woman to that trauma? "

>>>>

>>>> Among young women, who are considered a key market for this so-

>> called " third

>>>> generation " of silicone devices, plastic surgeons predict the

>> FDA's

>>>> follow-up recommendations and the improving alternatives will

>> temper

>>>> enthusiasm. But they acknowledge that many women will get them

>> anyway and

>>>> simply ignore the FDA recommendations that come with them.

>>>>

>>>> " Most women want to put them in, go on with their lives and

>> forget they got

>>>> the surgery, " said Beverly Hills plastic surgeon

>> Motykie. " That'll be a

>>>> big question, whether they're going to want to be burdened with

>> that

>>>> follow-up. "

>>>>

>>>> The specialized MRI images required to detect the integrity of a

>> breast

>>>> implant typically cost between $1,500 and $1,800, said

>> Zuckerman,

>>>> director of the National Research Center for Women & Families, a

>> nonprofit

>>>> research and education organization in Washington, D.C. Costs at

>> some

>>>> centers can reach up to $4,000, and many women would have to

>> travel long

>>>> distances to get the recommended images, added Zuckerman, whose

>> organization

>>>> testified against the latest silicone implant approval.

>>>>

>>>> " These young girls are often going into debt that they can't

>> really afford

>>>> to get out of, and they're paying for something on installment

>> that they can

>>>> barely afford, " Zuckerman said. " I certainly think any woman who

>> is not

>>>> affluent would be crazy to choose silicone because of the

>> additional cost. "

>>>>

>>>> *Saline improvements

>>>>

>>>> *Meanwhile, the look and feel of saline implants have been

>> improved by a

>>>> generation of surgeons who have had only that type of device to

>> offer their

>>>> patients. To overcome the wrinkles and folds that often mar the

>> appearance

>>>> of a saline implant in the breast, surgeons have begun to implant

>> them under

>>>> muscle and other breast tissue.

>>>>

>>>> At the same time, a newer and reportedly better generation

>> of " highly

>>>> cohesive " silicone devices is making its way through the FDA

>> approval

>>>> process. Although the silicone in the implants just approved is

>> considered

>>>> resistant to leakage and running if broken, the next generation ‹

>> often

>>>> described as having a consistency similar to that of gummy

>> candy ‹ is

>>>> designed to be even more resistant.

>>>>

>>>> " Patients that really are interested in gel implants have done

>> their

>>>> homework " and know what advances lie ahead, said Erhardt,

>> adding, " it will

>>>> be interesting to see how many people will want to accept the old

>>>> technology " approved after such exhaustive study by the FDA, when

>> a new

>>>> generation may be just a year or two down the road.

>>>>

>>>> ~~~~~~~~~~~~~

>>>> www.BreastImplantAwareness.org

>>>

>>

>

>