Fw: Mentor's Written statement for our Congressional hearing

[Guest guest]

Sent: Thursday, January 24, 2002 6:33 PM

Subject: Mentor's Written statement for our Congressional hearing

As most of you know, we were finally given a chance to speak in a congressional hearing on Nov. 15, 2001. The entire hearing transcript is posted on the House Commerce Committee web site.

Mentor corporation has submitted a written testimony to the hearing, objecting to our breast implant bill. I am including their statement in this email.

If after reading what Mentor says, if you feel inclined, please drop a note to Chairman Bilirakis and Congressman Roy Blunt, and briefly tell them why you support our bill (HR 1961). Please take a moment to do this!!!! Every voice counts!!!!!!! Please be professional and brief, these gentlemen have been a tremendous asset to our issue.

Congressman Roy Blunt: blunt@...

Chairman Bilirakis www.house.gov/bilirakis

This is what Mentor said:

Prepared Statement of Conway, President, Mentor Corporation

Dear Mr. Chairman, thank you for this opportunity to submit testimony on behalf of Mentor Corporation to the Committee on the safety and efficacy of breast implants. As a leading global medical device company, we address a wide variety of health-related needs, including incontinence, prostate cancer, impotence, and aesthetic and reconstructive surgery. Mentor Corporation manufactures breast implants for purposes of breast reconstruction and breast augmentation.

We share the Committee's concern that the best studies, information and facts be available to the public. We believe like the Committee that women have the right to know the risks and benefits of any medical procedure and device they might choose. Nevertheless, we have serious concerns about HR 1961 and do not believe that as currently drafted this legislation will achieve the Committee's goals.

The bill does not accurately reflect the history or status of breast implants in the United States. The findings are based largely on anecdote and poorly constructed and discredited studies and ignore the conclusions of the National Academy of Science's own Institute of Medicine study and other findings by several multidisciplinary panels of internationally-recognized scientists and physicians. Among the many findings, the IOM panel found that breast implants are safe and do not pose serious health risk for women. The studies also show that women can safely breast feed their babies, receive adequate breast care, including mammography and experience no greater risk for breast or other cancers than women without implants.

HR 1961 also ignores the federal regulations and requirements for breast implants. Premarket approval for saline implants requires rigorous research and study that does not stop with the approval of the product. We are required to conduct and submit reports on a 10-year-

post-approval study to assess the long-term clinical performance of this device. Continued approval of our product is also contingent on our compliance with the FDA statutes and regulations for medical devices including regular inspections and reports.

Finally, the legislation does not recognize the plethora of unbiased information currently available to breast implant patients, including our company's patient information booklet, which contains a discussion of the risks of breast implants and the materials widely available on the FDA's new breast implant web site.

We believe this testimony will provide the Committee with a more balanced perspective on the safety of breast implants by reviewing the status of past and ongoing research, the FDA's regulatory approval and oversight process for breast implants, and the unbiased information currently available to women considering implants.

the history of saline and silicone breast implants <SUP>1</SUP>

---------------------------------------------------------------------------

\1\ See ``Chronology of FDA Breast Implant Activities,'' attached.

---------------------------------------------------------------------------

There have been continued advances in the manufacture and regulation of breast implants over the last decade, including a greater scrutiny by the government and its scientific agencies, as well as by several multidisciplinary panels of internationally-recognized scientists and physicians. There are two general types of breast implants approved for marketing, saline-filled and silicone gel-filled, both of which our company offers to women meeting certain criteria. Saline-filled implants have an external silicone shell and are filled with sterile saline (salt water) by the doctor at the time of surgery. Silicone gel-filled implants have an external silicone shell but are pre-filled with silicone gel.

Saline Filled Implants

Saline implants have been available to women for more than 25 years. The FDA published a proposal in 1993 and a final rule in 1999, calling for safety and effectiveness data for saline-filled implants. Saline implants are available for breast reconstruction surgery and to women 18 years and older for breast augmentation.

The FDA granted premarket approval (PMA) for saline implants in May 2000 to Mentor, following their extensive review of the very large body of safety and efficacy data. Among our detailed submissions to the FDA--which involved more than 400 binders (approximately 750,000 pages)--were numerous preclinical studies, including chemical, toxicological, mechanical and manufacturing data. The submission also included results from clinical studies documenting the types and rates of local complications, as well as benefits, experienced by patients. These data are provided in both physician and patient labeling. The FDA also provides this information (including 3-year cumulative risk rates) on its public web sites.

Silicone Gel-Filled Implants

Silicone gel-filled implants are available for limited use. In 1992, the FDA approved our company's adjunct study for silicone gel-

filled implants for reconstruction and revision only. In 2000, the FDA approved our ``core gel'' study (or IDE study) for breast augmentation, reconstruction, and revision for a specified number of patients at a limited number of sites. Mentor first began manufacturing breast implants in 1984.

studies on the safety of breast implants

uc

Over the past decade, there has been very extensive further documentation of the safety and efficacy of breast implants that comes from a range of sources, including:

<bullet> Over 17 in-depth epidemiology studies (including many conducted by the leading medical and scientific institutions in this country) that have addressed long-term safety concerns such as potential immune effects or cancer

<bullet> Numerous clinical studies conducted by Mentor, including the saline prospective study, the adjunct study and most recently Mentor's core gel study

<bullet> Extensive preclinical studies conducted by Mentor using state-

of-the-art methods

<bullet> Clinical studies conducted by outside organizations

<bullet> A wealth of studies in peer-reviewed published literature

<bullet> Findings of scientific expert panels, including the Institute of Medicine, the National Science Panel and the International Review Group

Institute of Medicine Study on Silicone Implants <SUP>2</SUP>

---------------------------------------------------------------------------

\2\ See the Institute of Medicine ``Information for Women about the Safety of Silicone Breast Implants,'' attached.

---------------------------------------------------------------------------

Because of issues regarding the safety of silicone implants, Congress asked the Department of Health and Human Services in 1997 to sponsor a study on silicone breast implants. HHS appointed the Institute of Medicine, part of the National Academy of Sciences, to conduct an independent and unbiased review of all past and ongoing scientific research regarding the safety of silicone breast implants.

IOM established a thirteen-member committee of distinguished medical, scientific and academic experts to conduct this study of both augmentation and reconstruction patients. The committee set out to evaluate past and ongoing studies of the relationship, if any, between implants and systemic disease; evaluate the complications during or after implant surgery; assess the biologic and immunologic effects of silicone and other chemical components of breast implants; assess the impact of breast implants, if any, on the offspring of women with implants and on breastfeeding; and assess the accuracy of mammograms. The committee studied and reviewed thousands of published scientific reports, citing almost 1,200 references in the text of the report, 80% of which are from peer-reviewed literature. It also studied selected industry research reports on silicone breast implants and heard presentations from the public, including representatives of consumer groups, researchers, and women with silicone breast implants.

The committee's work resulted in a 440-page report (published in book form in 2000) with the following findings:

<bullet> There is no evidence that silicone implants are responsible for any major diseases of the whole body.

<bullet> There is no plausible evidence of a novel autoimmune disease caused by implants.

<bullet> There was no increase in either primary or recurrent breast cancer in women with breast implants. Some studies even suggest lower rates of breast cancer in implanted women.

<bullet> The major issues with implants are local, but not life-

threatening, complications. These include, implant removal, ruptures, deflations, capsulare contracture, disfigurement, infection and pain. (Note: Mentor's recently completed Saline-

Prospective Study already has, and its Core Gel Study currently underway will, provide detailed incidence rate data for these local complications.)

<bullet> There is no danger in breast-feeding.

<bullet> No studies of women with breast implants show increases in cancer deaths because of mammographic diagnostic delay.

<bullet> Implants are not lifetime devices; risks accumulate over time, and many women should expect to have more than one implant.

National Science Panel and International Review Group Studies on Silicone Implants

The National Science Panel, commissioned by the coordinating judge (Judge Pointer) for the federal breast implant litigation, and The International Review Group, commissioned by the British Minister of Health both in 1998, also reviewed, analyzed and critiqued the scientific literature pertaining to the possible link between silicone breast implants and connective tissue disease. The unanimous findings of both reports showed that breast implants constructed from or filled with silicone do not constitute any significant risk for connective tissue disease.

Adjunct and Core Gel Studies on Silicone Implants

Silicone gel-filled breast implants are currently available to women through an adjunct study and a ``core gel'' study, both of which are FDA-approved for our and at least one other company. These studies ensure that close attention is being given to the safety and efficacy of silicone gel-filled implants.

The adjunct study, FDA-approved in 1992, was developed to make silicone-gel filled breast implants available for reconstruction and revision patients to collect short-term complication data. Eligible women include those who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality and those who needed to have an existing implant replaced for medical reasons. Each woman in the adjunct study is required to have informed consent. Also Institutional Review Boards, composed of scientists, health professionals and community members who do not have a bias as to the outcome, oversee this study.

The core gel study is an IDE (investigational device exemption) study, which means it has been reviewed and approved by the FDA to ensure the data is meaningful and that patients are not exposed to unreasonable risks. This study was FDA-approved in 2000 for breast augmentation, reconstruction and revision for a specified number of patients at a limited number of sites. Generally, the IDE study data is used as the basis for a future PMA application to market the device for the clinical indications studied. Each woman who participates in an IDE study must give informed consent. Also an Institutional Review Board (IRB), composed of scientists, health professionals and community members who do not have a bias as to the outcome, oversee the study.

Saline Prospective Study

Our company's Saline Prospective Study, submitted to the FDA in 2000 as part of the PMA approval process, was a 36-month prospective study (with IRB oversight) that assessed all complications with breast implants as well as quality of life measures. It included both augmentation and reconstruction patients. Among the findings were:

<bullet> Risks were consistent with those reported in the medical literature for similar devices and indications.

<bullet> Augmentation patients have low risk.

<bullet> While reconstruction patients are at higher risk, they have greater potential emotional and physical benefits.

<bullet> Patients needing surgery on an existing implant experience similar or somewhat higher complication rates than surgery for primary implants.

<bullet> Despite some possible complications, patients report high levels of satisfaction and improved quality of life.

federal regulations and requirements for saline breast implants

The FDA has outlined rigorous conditions of approval for saline-

filled breast implants that we must comply with in order to ensure continued approval of the PMA. One such condition is a 10-year post-

approval study to assess the long-term clinical performance of the device. All patients enrolled in the Saline Prospective Study are asked to enroll in this post-approval study. Safety data must be collected annually out to 10 years. In addition, our company along with the other company with PMA approval must conduct a focus-group study to obtain immediate feedback on the patient brochure, ``Making an Informed Decision,'' for both augmentation and reconstruction patients. We must also conduct a retrieval study, which must collect visual examination, physical and histological data on removed implants to determine reason for failure. Mechanical testing (i.e., fatigue rupture and shelf-life) is also required to collect additional information.

Continued approval of our PMA is also contingent upon:

<bullet> Submission of annual post-approval reports

<bullet> Adverse reaction and device defect reporting

<bullet> Various other reporting requirements under the FDA Medical Device Reporting Regulation

In addition, the FDA conducts regular inspections at our company and manufacturing facilities to make sure that we are in compliance with applicable FDA statutes and regulations. The FDA provides reports of these inspections to us once the inspection is closed. In addition, the FDA routinely performs investigations of companies to examine allegations by individuals of possible wrongdoing. HR 1961 includes references to such an investigation. The FDA should be allowed to adequately perform an investigation without outside interference.

making informed decisions about breast implants

Our company believes that women have the right to complete and accurate information about the potential health risks and advantages of breast implants in order to make informed decisions. In the past five years, there has been a dramatic increase in the information available for women considering implants from a variety of sources, including:

<bullet> Patient information brochures created by our company that lay out among other information risks, contraindications, questions to ask a surgeon about reconstruction and augmentation and the FDA MedWatch contact to report problems.<SUP>3</SUP>

---------------------------------------------------------------------------

\3\ See Mentor's ``Saline-Filled Breast Implant Surgery: Making an Informed Decision,'' attached.

---------------------------------------------------------------------------

<bullet> FDA's Breast Implant Information Page (http://www.fda.gov/

cdrh/breastimplants) provides a breast implant customer handbook and other information that allows the customer to differentiate between breast implant labels and access information about possible complications, recent studies on breast implants.

<bullet> FDA's MedWatch (http://www.fda.gov/medwatch/index.html) or (1-

888-463-INFOFDA) is available if a patient feels she has experienced a serious problem(s) related to her breast implants, she should have her health care professional report the problem(s) to the FDA.

<bullet> Online copies of the IOM, NSP and IRG reports are available to the public and can be obtained on the following web sites:

<bullet> IOM: http://www.nap.edu/catalog/9618.html

<bullet> NSP: http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm

<bullet> IRG: http://www.silicone-review.gov.uk/

<bullet> Junk Science web site (http://www.junkscience.com/) provides an extensive list of links to informative, recent newspaper articles concerning the current medical status and social opinion of breast implants. Many of the stories highlight the fact vs. fiction/ myths vs. reality aspects of breast implants.

In conclusion, I thank the Committee for the opportunity to submit testimony in order to ensure that a balanced record exists on the safety of breast implants. In order to create a fair record of the history of breast implants, I ask the Chairman to include the following documents for the record:

<bullet> Chronology of FDA Breast Implant Activities

<bullet> Institute of Medicine ``Information for Women About the Safety of Silicone Breast Implants''

<bullet> Mentor's ``Saline-Filled Breast Implant Surgery: Making an Informed Decision''

Thank you.

_ Thank you.

[Guest guest]

----- Original Message -----

From: " ilena rose " <ilena@...>

<Recipient List Suppressed:>

Sent: Thursday, January 24, 2002 4:25 PM

Subject: Mentor's Written statement for our Congressional hearing

> Please post to your groups without my identifiers.

>

> As most of you know, we were finally given a chance to speak in a

> congressional hearing on Nov. 15, 2001. The entire hearing transcript is

> posted on the House Commerce Committee web site.

>

> Mentor corporation has submitted a written testimony to the hearing,

> objecting to our breast implant bill. I am including their statement in

> this email. If after reading what Mentor says, if you feel inclined,

> please drop a note to Chairman Bilirakis and Congressman Roy Blunt, and

> briefly tell them why you support our bill (HR 1961). Please take a

> moment to do this!!!! Every voice counts!!!!!!!

>

> Please be professional and brief, these gentlemen have been a tremendous

> asset to our issue.

>

> Congressman Roy Blunt: blunt@...

> Chairman Bilirakis www.house.gov/bilirakis

>

> This is what Mentor said:

>

> Prepared Statement of Conway, President, Mentor Corporation

>

> Dear Mr. Chairman, thank you for this opportunity to submit

> testimony on behalf of Mentor Corporation to the Committee on the

> safety and efficacy of breast implants. As a leading global medical

> device company, we address a wide variety of health-related needs,

> including incontinence, prostate cancer, impotence, and aesthetic and

> reconstructive surgery. Mentor Corporation manufactures breast implants

> for purposes of breast reconstruction and breast augmentation.

>

> We share the Committee's concern that the best studies, information

> and facts be available to the public. We believe like the Committee

> that women have the right to know the risks and benefits of any medical

> procedure and device they might choose. Nevertheless, we have serious

> concerns about HR 1961 and do not believe that as currently drafted

> this legislation will achieve the Committee's goals.

>

> The bill does not accurately reflect the history or status of

> breast implants in the United States. The findings are based largely on

> anecdote and poorly constructed and discredited studies and ignore the

> conclusions of the National Academy of Science's own Institute of

> Medicine study and other findings by several multidisciplinary panels

> of internationally-recognized scientists and physicians. Among the many

> findings, the IOM panel found that breast implants are safe and do not

> pose serious health risk for women. The studies also show that women

> can safely breast feed their babies, receive adequate breast care,

> including mammography and experience no greater risk for breast or

> other cancers than women without implants.

>

> HR 1961 also ignores the federal regulations and requirements for

> breast implants. Premarket approval for saline implants requires

> rigorous research and study that does not stop with the approval of the

> product. We are required to conduct and submit reports on a 10-year-

> post-approval study to assess the long-term clinical performance of

> this device. Continued approval of our product is also contingent on

> our compliance with the FDA statutes and regulations for medical

> devices including regular inspections and reports.

>

> Finally, the legislation does not recognize the plethora of

> unbiased information currently available to breast implant patients,

> including our company's patient information booklet, which contains a

> discussion of the risks of breast implants and the materials widely

> available on the FDA's new breast implant web site.

>

> We believe this testimony will provide the Committee with a more

> balanced perspective on the safety of breast implants by reviewing the

> status of past and ongoing research, the FDA's regulatory approval and

> oversight process for breast implants, and the unbiased information

> currently available to women considering implants.

>

> the history of saline and silicone breast implants <SUP>1</SUP>

> --------------------------------------------------------------------------

-

> \1\ See ``Chronology of FDA Breast Implant Activities,'' attached.

> --------------------------------------------------------------------------

-

> There have been continued advances in the manufacture and

> regulation of breast implants over the last decade, including a greater

> scrutiny by the government and its scientific agencies, as well as by

> several multidisciplinary panels of internationally-recognized

> scientists and physicians. There are two general types of breast

> implants approved for marketing, saline-filled and silicone gel-filled,

> both of which our company offers to women meeting certain criteria.

> Saline-filled implants have an external silicone shell and are filled

> with sterile saline (salt water) by the doctor at the time of surgery.

> Silicone gel-filled implants have an external silicone shell but are

> pre-filled with silicone gel.

>

> Saline Filled Implants

>

> Saline implants have been available to women for more than 25

> years. The FDA published a proposal in 1993 and a final rule in 1999,

> calling for safety and effectiveness data for saline-filled implants.

> Saline implants are available for breast reconstruction surgery and to

> women 18 years and older for breast augmentation.

>

> The FDA granted premarket approval (PMA) for saline implants in May

> 2000 to Mentor, following their extensive review of the very large body

> of safety and efficacy data. Among our detailed submissions to the

> FDA--which involved more than 400 binders (approximately 750,000

> pages)--were numerous preclinical studies, including chemical,

> toxicological, mechanical and manufacturing data. The submission also

> included results from clinical studies documenting the types and rates

> of local complications, as well as benefits, experienced by patients.

> These data are provided in both physician and patient labeling. The FDA

> also provides this information (including 3-year cumulative risk rates)

> on its public web sites.

>

> Silicone Gel-Filled Implants

>

> Silicone gel-filled implants are available for limited use. In

> 1992, the FDA approved our company's adjunct study for silicone gel-

> filled implants for reconstruction and revision only. In 2000, the FDA

> approved our ``core gel'' study (or IDE study) for breast augmentation,

> reconstruction, and revision for a specified number of patients at a

> limited number of sites. Mentor first began manufacturing breast

> implants in 1984.

> studies on the safety of breast implants

> uc

> Over the past decade, there has been very extensive further

> documentation of the safety and efficacy of breast implants that comes

> >from a range of sources, including:

> <bullet> Over 17 in-depth epidemiology studies (including many

> conducted by the leading medical and scientific institutions in

> this country) that have addressed long-term safety concerns

> such as potential immune effects or cancer

> <bullet> Numerous clinical studies conducted by Mentor, including the

> saline prospective study, the adjunct study and most recently

> Mentor's core gel study

> <bullet> Extensive preclinical studies conducted by Mentor using state-

> of-the-art methods

> <bullet> Clinical studies conducted by outside organizations

> <bullet> A wealth of studies in peer-reviewed published literature

> <bullet> Findings of scientific expert panels, including the Institute

> of Medicine, the National Science Panel and the International

> Review Group

> Institute of Medicine Study on Silicone Implants <SUP>2</SUP>

> --------------------------------------------------------------------------

-

> \2\ See the Institute of Medicine ``Information for Women about the

> Safety of Silicone Breast Implants,'' attached.

> --------------------------------------------------------------------------

-

> Because of issues regarding the safety of silicone implants,

> Congress asked the Department of Health and Human Services in 1997 to

> sponsor a study on silicone breast implants. HHS appointed the

> Institute of Medicine, part of the National Academy of Sciences, to

> conduct an independent and unbiased review of all past and ongoing

> scientific research regarding the safety of silicone breast implants.

> IOM established a thirteen-member committee of distinguished

> medical, scientific and academic experts to conduct this study of both

> augmentation and reconstruction patients. The committee set out to

> evaluate past and ongoing studies of the relationship, if any, between

> implants and systemic disease; evaluate the complications during or

> after implant surgery; assess the biologic and immunologic effects of

> silicone and other chemical components of breast implants; assess the

> impact of breast implants, if any, on the offspring of women with

> implants and on breastfeeding; and assess the accuracy of mammograms.

> The committee studied and reviewed thousands of published scientific

> reports, citing almost 1,200 references in the text of the report, 80%

> of which are from peer-reviewed literature. It also studied selected

> industry research reports on silicone breast implants and heard

> presentations from the public, including representatives of consumer

> groups, researchers, and women with silicone breast implants.

> The committee's work resulted in a 440-page report (published in

> book form in 2000) with the following findings:

> <bullet> There is no evidence that silicone implants are responsible

> for any major diseases of the whole body.

> <bullet> There is no plausible evidence of a novel autoimmune disease

> caused by implants.

> <bullet> There was no increase in either primary or recurrent breast

> cancer in women with breast implants. Some studies even suggest

> lower rates of breast cancer in implanted women.

> <bullet> The major issues with implants are local, but not life-

> threatening, complications. These include, implant removal,

> ruptures, deflations, capsulare contracture, disfigurement,

> infection and pain. (Note: Mentor's recently completed Saline-

> Prospective Study already has, and its Core Gel Study currently

> underway will, provide detailed incidence rate data for these

> local complications.)

> <bullet> There is no danger in breast-feeding.

> <bullet> No studies of women with breast implants show increases in

> cancer deaths because of mammographic diagnostic delay.

> <bullet> Implants are not lifetime devices; risks accumulate over time,

> and many women should expect to have more than one implant.

> National Science Panel and International Review Group Studies on

> Silicone Implants

> The National Science Panel, commissioned by the coordinating judge

> (Judge Pointer) for the federal breast implant litigation, and The

> International Review Group, commissioned by the British Minister of

> Health both in 1998, also reviewed, analyzed and critiqued the

> scientific literature pertaining to the possible link between silicone

> breast implants and connective tissue disease. The unanimous findings

> of both reports showed that breast implants constructed from or filled

> with silicone do not constitute any significant risk for connective

> tissue disease.

> Adjunct and Core Gel Studies on Silicone Implants

> Silicone gel-filled breast implants are currently available to

> women through an adjunct study and a ``core gel'' study, both of which

> are FDA-approved for our and at least one other company. These studies

> ensure that close attention is being given to the safety and efficacy

> of silicone gel-filled implants.

> The adjunct study, FDA-approved in 1992, was developed to make

> silicone-gel filled breast implants available for reconstruction and

> revision patients to collect short-term complication data. Eligible

> women include those who have had breast cancer surgery, a severe injury

> to the breast, a birth defect that affects the breast, or a medical

> condition causing a severe breast abnormality and those who needed to

> have an existing implant replaced for medical reasons. Each woman in

> the adjunct study is required to have informed consent. Also

> Institutional Review Boards, composed of scientists, health

> professionals and community members who do not have a bias as to the

> outcome, oversee this study.

> The core gel study is an IDE (investigational device exemption)

> study, which means it has been reviewed and approved by the FDA to

> ensure the data is meaningful and that patients are not exposed to

> unreasonable risks. This study was FDA-approved in 2000 for breast

> augmentation, reconstruction and revision for a specified number of

> patients at a limited number of sites. Generally, the IDE study data is

> used as the basis for a future PMA application to market the device for

> the clinical indications studied. Each woman who participates in an IDE

> study must give informed consent. Also an Institutional Review Board

> (IRB), composed of scientists, health professionals and community

> members who do not have a bias as to the outcome, oversee the study.

> Saline Prospective Study

> Our company's Saline Prospective Study, submitted to the FDA in

> 2000 as part of the PMA approval process, was a 36-month prospective

> study (with IRB oversight) that assessed all complications with breast

> implants as well as quality of life measures. It included both

> augmentation and reconstruction patients. Among the findings were:

> <bullet> Risks were consistent with those reported in the medical

> literature for similar devices and indications.

> <bullet> Augmentation patients have low risk.

> <bullet> While reconstruction patients are at higher risk, they have

> greater potential emotional and physical benefits.

> <bullet> Patients needing surgery on an existing implant experience

> similar or somewhat higher complication rates than surgery for

> primary implants.

> <bullet> Despite some possible complications, patients report high

> levels of satisfaction and improved quality of life.

> federal regulations and requirements for saline breast implants

> The FDA has outlined rigorous conditions of approval for saline-

> filled breast implants that we must comply with in order to ensure

> continued approval of the PMA. One such condition is a 10-year post-

> approval study to assess the long-term clinical performance of the

> device. All patients enrolled in the Saline Prospective Study are asked

> to enroll in this post-approval study. Safety data must be collected

> annually out to 10 years. In addition, our company along with the other

> company with PMA approval must conduct a focus-group study to obtain

> immediate feedback on the patient brochure, ``Making an Informed

> Decision,'' for both augmentation and reconstruction patients. We must

> also conduct a retrieval study, which must collect visual examination,

> physical and histological data on removed implants to determine reason

> for failure. Mechanical testing (i.e., fatigue rupture and shelf-life)

> is also required to collect additional information.

> Continued approval of our PMA is also contingent upon:

> <bullet> Submission of annual post-approval reports

> <bullet> Adverse reaction and device defect reporting

> <bullet> Various other reporting requirements under the FDA Medical

> Device Reporting Regulation

> In addition, the FDA conducts regular inspections at our company

> and manufacturing facilities to make sure that we are in compliance

> with applicable FDA statutes and regulations. The FDA provides reports

> of these inspections to us once the inspection is closed. In addition,

> the FDA routinely performs investigations of companies to examine

> allegations by individuals of possible wrongdoing. HR 1961 includes

> references to such an investigation. The FDA should be allowed to

> adequately perform an investigation without outside interference.

> making informed decisions about breast implants

> Our company believes that women have the right to complete and

> accurate information about the potential health risks and advantages of

> breast implants in order to make informed decisions. In the past five

> years, there has been a dramatic increase in the information available

> for women considering implants from a variety of sources, including:

> <bullet> Patient information brochures created by our company that lay

> out among other information risks, contraindications, questions

> to ask a surgeon about reconstruction and augmentation and the

> FDA MedWatch contact to report problems.<SUP>3</SUP>

> --------------------------------------------------------------------------

-

> \3\ See Mentor's ``Saline-Filled Breast Implant Surgery: Making an

> Informed Decision,'' attached.

> --------------------------------------------------------------------------

-

> <bullet> FDA's Breast Implant Information Page (http://www.fda.gov/

> cdrh/breastimplants) provides a breast implant customer

> handbook and other information that allows the customer to

> differentiate between breast implant labels and access

> information about possible complications, recent studies on

> breast implants.

> <bullet> FDA's MedWatch (http://www.fda.gov/medwatch/index.html) or (1-

> 888-463-INFOFDA) is available if a patient feels she has

> experienced a serious problem(s) related to her breast

> implants, she should have her health care professional report

> the problem(s) to the FDA.

> <bullet> Online copies of the IOM, NSP and IRG reports are available to

> the public and can be obtained on the following web sites:

> <bullet> IOM: http://www.nap.edu/catalog/9618.html

> <bullet> NSP: http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm

> <bullet> IRG: http://www.silicone-review.gov.uk/

> <bullet> Junk Science web site (http://www.junkscience.com/) provides

> an extensive list of links to informative, recent newspaper

> articles concerning the current medical status and social

> opinion of breast implants. Many of the stories highlight the

> fact vs. fiction/ myths vs. reality aspects of breast implants.

> In conclusion, I thank the Committee for the opportunity to submit

> testimony in order to ensure that a balanced record exists on the

> safety of breast implants. In order to create a fair record of the

> history of breast implants, I ask the Chairman to include the following

> documents for the record:

> <bullet> Chronology of FDA Breast Implant Activities

> <bullet> Institute of Medicine ``Information for Women About the Safety

> of Silicone Breast Implants''

> <bullet> Mentor's ``Saline-Filled Breast Implant Surgery: Making an

> Informed Decision''

> Thank you.

> _ Thank you.

>

>

>