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Dr. Pierre Blais on Saline Implants

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> SALINE-FILLED BREAST IMPLANTS - A CONTINUING AREA OF CONCERN

> P. Blais, INNOVAL, 496 Westminster Avenue, Ottawa, Ontario K2A 2V1

> Canada

>

> Introduction:

> Innoval has conducted studies on saline inflatable breast prostheses for

> nearly ten years, continuing work initiated by Canadian researchers in

> the early-eighties. Problems with these devices were discovered early

> and motivated proposals to amend the Canadian Medical Devices

> Regulations. The work was the object of publications which have not been

> widely disseminated.

> Control of commerce in breast implants has been difficult and costly.

> Early efforts are credited to the FDA in the mid-seventies culminating

> in recommendations for better mechanisms of approval and upgraded

> post-market follow-up as early as 1978. Saline inflatable breast

> implants were areas of concern then and remain central today. The need

> for mandatory filing of pre-market approval applications (PMA) and

> updated Notices of Completion of a Product Development Protocol (PDP)

> for this class of product is clearly demonstrated and urgent in the

> light of continuing performance shortfalls and alarming patterns of

> adverse reaction.

> Field reports on failures and adverse reactions from saline inflatable

> prostheses are not comprehensive. There is a history of under-reporting

> which has worsened significantly since 1990. Field report data do not

> realistically assess the extent or severity of complications. Promotion

> of the technology is at an all time high and shows no sign of abating.

> Published information on the realities of the technology is sparse and

> incomplete. There is suppression of information regarding untoward

> events and service failure of the items. Any committee engaged in review

> of safety and efficacy of saline inflatable prostheses will not have

> access to all data. Publicly mandated committees will not be able to

> derive informed conclusions and policies without access to implant

> retrieval programs and independent laboratory studies. Epidemiology

> studies are distorted by a background of natural morbidity involving the

> disease prone female breast. The situation is significantly worsened by

> heavy industry sponsorship of university research, lobbying and

> conflicts of interest with many key researchers and clinicians presented

> as independent intervenants.

> Amongst all commercially made saline inflatable prostheses, there is not

> one currently in use which could be construed as being substantially

> equivalent to a product made before May 28, 1976, the watershed date for

> U.S.F.D.A. medical device regulations. The products have undergone

> drastic changes at regular intervals as product design fashions,

> production machinery and raw material vendors changed. This view is

> confirmed in manufacturers' advertisements and promotional material to

> physicians and the public where the products are claimed to be novel and

> significantly improved from what was made previously. To date, there has

> been no perceptible change in the lackluster performance of the

> products.

>

> General Aspects of Saline-Filled Breast Implants:

> Breast implants are flexible plastic shells fitted with filling ports

> and filled with water-based fluids. They have been described in

> publications and patents for more than forty years. Commercially made

> items appeared during the sixties. Since then, more than eighteen

> manufacturers have made such products. About seven remain active.

> Current devices have not significantly evolved since the seventies and

> problems of product quality and durability remain. Adverse reactions

> continue unabated. Promotion and de-emphasis of risks are stronger than

> ever with new generations of users swelling an existing pool of injured

> users.

>

> Saline inflatable breast implants are widely promoted for cosmetic

> augmentation. In the early seventies, they represented less than 10% of

> the total breast prosthesis market. Many products were withdrawn in the

> eighties following pandemic failures and lawsuits. By 1984, the salines

> had nearly vanished. In 1992, the year when the FDA imposed a Moratorium

> on gel-filled breast implants, the number of new saline users in the

> U.S. increased by about 30,000 women. In 1997, new implantations were

> about 122,000. In 1998, about 132,000 women received saline implants for

> the first time. Worldwide, an increase of about 210,000 new users

> appeared in 1999, mostly in North America. The number of new implant

> users is growing at a compound rate of about 15% per year with Mexico,

> Latin America, Eastern Europe and the Far East reporting the most rapid

> rise.

> Less than 5% of new users are breast cancer patients, nearly unchanged

> for the last two decades. The dominant part of the user population

> consists of cosmetic surgery clients seeking to augment breast size.

> About 9-10% of current users are replacement patients who had earlier

> implants that failed and left them disfigured. This number is rising,

> reflecting maturation, failures and 'wear out' of poorly made saline

> inflatable devices inserted in the mid-nineties.

> The primary saline implant manufacturers are currently McGhan Medical

> Corporation (Inamed), Silimed S.A., Mentor H/S Corporation, NovaMed

> Inc., Poly Implant Protheses (PIP) S.A. and Progress Mankind Technology

> (PMT) GmbH. The U.S. is dominated by Mentor and McGhan who share the

> market. Secondary distributors include Hutchinson International and

> Sierra Medical Technologies Inc. There is an influx of unsanctioned

> foreign products imported and inserted in U.S. users at offshore clinics

> which advertise within the continental U.S.

> All salines use basically the same concepts, components and materials.

> Dominant suppliers of silicone intermediates include McGhan Nusil

> Corporation (Inamed), Applied Silicone Corporation (Rhodia) and Dow

> Corning Corporation. Stock parts for some valved devices are supplied as

> commodities from U.S.-based corporations.

>

> Lack of durability, fluid leakage, frequent replacements, adverse

> reactions and litigation have surrounded this technology from the

> outset. Late-nineties saline inflatable implants still have short

> service lives. They reflect antiquated designs and low quality. Many

> show serious fabrication defects. Implants that do not deflate

> noticeably at first become progressively less satisfactory with the

> onset of pain and deformity over time. Users inevitably must undergo

> more surgery with worsening cosmetic results and increased discomfort.

> In spite of rising problems of safety and durability, severe injury

> potential and large public health care costs, usage continues to rise,

> driven by misleading promotion.

Visit your family world website:

http://www.info-implants.com/IAS/index.html'>http://www.info-implants.com/IAS/index.html

http://www.info-implants.com/

http://www.info-implants.com/Sante/intro.html

http://www.info-implants.com/Canada/allan.html

http://www.info-implants.com/Walt/intro.html

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> SALINE-FILLED BREAST IMPLANTS - A CONTINUING AREA OF CONCERN

> P. Blais, INNOVAL, 496 Westminster Avenue, Ottawa, Ontario K2A 2V1

> Canada

>

> Introduction:

> Innoval has conducted studies on saline inflatable breast

prostheses for

> nearly ten years, continuing work initiated by Canadian

researchers in

> the early-eighties. Problems with these devices were discovered

early

> and motivated proposals to amend the Canadian Medical Devices

> Regulations. The work was the object of publications which have

not been

> widely disseminated.

> Control of commerce in breast implants has been difficult and

costly.

> Early efforts are credited to the FDA in the mid-seventies

culminating

> in recommendations for better mechanisms of approval and upgraded

> post-market follow-up as early as 1978. Saline inflatable breast

> implants were areas of concern then and remain central today. The

need

> for mandatory filing of pre-market approval applications (PMA) and

> updated Notices of Completion of a Product Development Protocol

(PDP)

> for this class of product is clearly demonstrated and urgent in the

> light of continuing performance shortfalls and alarming patterns of

> adverse reaction.

> Field reports on failures and adverse reactions from saline

inflatable

> prostheses are not comprehensive. There is a history of under-

reporting

> which has worsened significantly since 1990. Field report data do

not

> realistically assess the extent or severity of complications.

Promotion

> of the technology is at an all time high and shows no sign of

abating.

> Published information on the realities of the technology is sparse

and

> incomplete. There is suppression of information regarding untoward

> events and service failure of the items. Any committee engaged in

review

> of safety and efficacy of saline inflatable prostheses will not

have

> access to all data. Publicly mandated committees will not be able

to

> derive informed conclusions and policies without access to implant

> retrieval programs and independent laboratory studies. Epidemiology

> studies are distorted by a background of natural morbidity

involving the

> disease prone female breast. The situation is significantly

worsened by

> heavy industry sponsorship of university research, lobbying and

> conflicts of interest with many key researchers and clinicians

presented

> as independent intervenants.

> Amongst all commercially made saline inflatable prostheses, there

is not

> one currently in use which could be construed as being

substantially

> equivalent to a product made before May 28, 1976, the watershed

date for

> U.S.F.D.A. medical device regulations. The products have undergone

> drastic changes at regular intervals as product design fashions,

> production machinery and raw material vendors changed. This view is

> confirmed in manufacturers' advertisements and promotional

material to

> physicians and the public where the products are claimed to be

novel and

> significantly improved from what was made previously. To date,

there has

> been no perceptible change in the lackluster performance of the

> products.

>

> General Aspects of Saline-Filled Breast Implants:

> Breast implants are flexible plastic shells fitted with filling

ports

> and filled with water-based fluids. They have been described in

> publications and patents for more than forty years. Commercially

made

> items appeared during the sixties. Since then, more than eighteen

> manufacturers have made such products. About seven remain active.

> Current devices have not significantly evolved since the seventies

and

> problems of product quality and durability remain. Adverse

reactions

> continue unabated. Promotion and de-emphasis of risks are stronger

than

> ever with new generations of users swelling an existing pool of

injured

> users.

>

> Saline inflatable breast implants are widely promoted for cosmetic

> augmentation. In the early seventies, they represented less than

10% of

> the total breast prosthesis market. Many products were withdrawn

in the

> eighties following pandemic failures and lawsuits. By 1984, the

salines

> had nearly vanished. In 1992, the year when the FDA imposed a

Moratorium

> on gel-filled breast implants, the number of new saline users in

the

> U.S. increased by about 30,000 women. In 1997, new implantations

were

> about 122,000. In 1998, about 132,000 women received saline

implants for

> the first time. Worldwide, an increase of about 210,000 new users

> appeared in 1999, mostly in North America. The number of new

implant

> users is growing at a compound rate of about 15% per year with

Mexico,

> Latin America, Eastern Europe and the Far East reporting the most

rapid

> rise.

> Less than 5% of new users are breast cancer patients, nearly

unchanged

> for the last two decades. The dominant part of the user population

> consists of cosmetic surgery clients seeking to augment breast

size.

> About 9-10% of current users are replacement patients who had

earlier

> implants that failed and left them disfigured. This number is

rising,

> reflecting maturation, failures and 'wear out' of poorly made

saline

> inflatable devices inserted in the mid-nineties.

> The primary saline implant manufacturers are currently McGhan

Medical

> Corporation (Inamed), Silimed S.A., Mentor H/S Corporation, NovaMed

> Inc., Poly Implant Protheses (PIP) S.A. and Progress Mankind

Technology

> (PMT) GmbH. The U.S. is dominated by Mentor and McGhan who share

the

> market. Secondary distributors include Hutchinson International and

> Sierra Medical Technologies Inc. There is an influx of unsanctioned

> foreign products imported and inserted in U.S. users at offshore

clinics

> which advertise within the continental U.S.

> All salines use basically the same concepts, components and

materials.

> Dominant suppliers of silicone intermediates include McGhan Nusil

> Corporation (Inamed), Applied Silicone Corporation (Rhodia) and Dow

> Corning Corporation. Stock parts for some valved devices are

supplied as

> commodities from U.S.-based corporations.

>

> Lack of durability, fluid leakage, frequent replacements, adverse

> reactions and litigation have surrounded this technology from the

> outset. Late-nineties saline inflatable implants still have short

> service lives. They reflect antiquated designs and low quality.

Many

> show serious fabrication defects. Implants that do not deflate

> noticeably at first become progressively less satisfactory with the

> onset of pain and deformity over time. Users inevitably must

undergo

> more surgery with worsening cosmetic results and increased

discomfort.

> In spite of rising problems of safety and durability, severe injury

> potential and large public health care costs, usage continues to

rise,

> driven by misleading promotion.

Visit your family world website:

http://www.info-implants.com/IAS/index.html

http://www.info-implants.com/

http://www.info-implants.com/Sante/intro.html

http://www.info-implants.com/Canada/allan.html

http://www.info-implants.com/Walt/intro.html

--- End forwarded message ---

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