Guest guest Posted October 6, 2002 Report Share Posted October 6, 2002 ----- Original Message ----- From: Zuckerman Undisclosed-Recipient:;@... Sent: Friday, October 04, 2002 9:22 PM Subject: Implants in the news! Dear Friends, Here are two excellent letters to the editor in the Washington Post. I have already thanked Pearson for her letter; for more than a dozen years she has urged Congress and the FDA to study the health risks of implants. The article about medical device legislation and the Mentor criminal investigation may also be of interest. I think the column by Jacey Eckhart is a good way of getting young women to think twice about implants. Sincerely, Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006202 223-4000www.center4policy.org Remember CPR when you give to United Way or CFC, by designating #9884! The Washington Post October 02, 2002 "Breast Implants Under the Microscope" The Sept. 22 front-page article "Popularity of Breast Implants Rising" barely mentioned an important health problem: the effects of implants on mammography. When these women reach the age of needing mammographic examinations, they must have eight views altogether, two on each side with the implant in place and two on each side with the implant pushed back, thus doubling the radiation for each examination. Even in the best of situations, physicians may not see all of the breast tissue. If scar tissue forms around the implant, the pushed-back views may be impossible to obtain. An infrequent but potential complication is rupture of the implants during mammographic compression, an essential part of the examination. In addition, the physical examination and even ultrasound examination of these breasts can be challenging. Newer techniques such as computer-aided diagnosis, which physicians use on all mammograms, also is limited by the amount of tissue that can be seen. Women should be told about these problems before they have breast implant surgery. PETER S. DUNNER Potomac * The article on breast implants did not point out the flaws in the Food and Drug Administration's approach to implants. The FDA points to the importance of breast implants for patients who want reconstruction after breast cancer and implies that this need justifies weaker regulations and the approval of flawed products. But the numbers show that only about one in four implant patients is using implants for reconstruction, and that proportion will get smaller in years to come. For the past decade, most women who are diagnosed with breast cancer have been eligible for lumpectomy -- removing the cancer but not the entire breast. And, of those who must have or choose to have a mastectomy, some are choosing other forms of reconstruction that use the body's own tissue rather than implants. Approving flawed products for use by many women because of the needs of a small and increasingly smaller group of women, many of whom have other options, is not good public policy. The tragedy is that if the FDA had established more stringent standards for breast implants, the implants being sold today would be safer and there would be fewer complications. CYNTHIA A. PEARSON Executive Director National Women's Health Network Washington Congressional Quarterly Daily Monitor October 1, 2002 "Expediting Medical Device Approval on Committee Agenda" BY Goldreich, CQ Staff Writer The House Energy and Commerce Committee is expected to approve a bipartisan bill (HR 3580) Wednesday aimed at speeding up approvals of new medical devices by assessing industry user fees to increase funding for regulators. The medical device fee bill represents a triumph for the industry, which has been lobbying for years to speed up the Food and Drug Administration's safety and review process. The bill would codify a deal negotiated between medical products manufacturers and the Bush administration earlier this year to collect user fees from companies seeking FDA approvals. Reauthorization of a similar program for drug makers sailed through Congress earlier this year, but consumer advocates have criticized the user fee system, saying it makes the FDA a captive of the companies it regulates. The bill covers devices ranging from breast implants to heart defibrillators and has been stalled by concerns from some Democrats that it cedes too much to industry. The bill, sponsored by C. Greenwood, R-Pa., and G. Eshoo, D-Calif., would boost FDA funding for its review process by about $40 million for fiscal 2003, with $25 million coming from user fees. Funding would increase by $225 million over five years. When the administration and industry representatives reached agreement on user fees in May, Pamela G. , president of the medical device trade group AdvaMed, said the assurance of dedicated funding "will help ensure that patients gain timely access to innovative medical technologies." Some patient and consumer groups oppose the bill; Public Citizen and allied groups in the Patient and Consumer Coalition have denounced it as a "rollback" of public safety. The bill has been the industry's top priority but lobbyists failed in their goal of winning authority for the FDA to hand off to independent private contractors the responsibility to review and recommend approval for many new medical devices. The bill would allow private inspectors to assume some of the FDA's manufacturing inspection duties. The bill has had strong support from Energy and Commerce Chairman Tauzin, R-La., and Senate Health, Education, Labor and Pensions Committee Chairman M. Kennedy, D-Mass. - Physician assistance. Also on the agenda is a bill (HR 4634), the National Capital Area Physician Emergency Assistance Act, which would waive legal and licensing barriers to physicians who provide medical assistance in the national capital region during a public health emergency such as a terrorist attack. The measure, sponsored by Constance A. Morella, R-Md., would allow physicians licensed in land, Virginia or the District of Columbia to treat people in any of the three during the emergency. It also would shield them from liability for "any act or omission" in treating victims of the emergency unless they were guilty of "willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious, flagrant indifference to the rights or safety of others." The Dallas Morning News October 1, 2002 "FDA ends inquiry on maker of implants; Agency won't say if firm with Irving facility cleared of allegations" BY JIM MORRIS WASHINGTON - The Food and Drug Administration has concluded its four-year criminal investigation of Mentor Corp., which manufactures breast implants at a factory in Irving, an agency spokeswoman confirmed Monday. FDA spokeswoman Sharon Snider would not say whether the closing of the inquiry meant that Mentor had been cleared of wrongdoing. However, the agency announced no action against the company. In allegations lodged first with the FDA's Dallas office, employees and former employees had accused Mentor of failing to record some patient complaints and allowing potentially contaminated products to enter the market. Mentor officials denied the allegations, although they promised in 1998 to improve manufacturing validation procedures, designed to ensure product uniformity. The FDA's Office of Criminal Investigations opened its investigation that summer. A Mentor spokeswoman said Monday that company officials would have no comment on the end of the investigation because "they have not received any official notification from FDA." In a letter last week to FDA Commissioner Lester M. Crawford, Rep. Jim Greenwood, R-Pa., asked the agency to provide the House subcommittee he chairs with all records relating to the Mentor investigation. The FDA had rebuffed earlier congressional requests for information on grounds that the investigation was still open. Mr. Greenwood could not be reached for comment. He told the Reuters news service last week that the FDA had cleared Mentor of charges that it falsified records, and that the House Energy and Commerce Committee's subcommittee on oversight and investigations would examine how the agency had conducted its inquiry. In his letter, Mr. Greenwood gave the FDA until Oct. 9 to provide the pertinent materials. "The fact that the criminal investigation has been closed could mean the beginning - not the end - of some kind of public scrutiny," said Dr. Zuckerman, president of the National Center for Policy Research for Women & Families, a Washington-based advocacy group that has questioned the safety of implants. "It's been the concern for more than a year that [FDA officials] weren't actually doing anything but were keeping the investigation open so they didn't have to make information available to the public or Congress." California-based Mentor began making saline- and silicone-filled breast implants at the Irving factory in 1994. The Virginian-Pilot (Norfolk, Va.) October 1, 2002 "STAYING ABREAST OF LATEST TRENDS IN AUGMENTATION" BY JACEY ECKHART I SAW A GUY on of those courtroom TV shows sue his former paramour for the $6,000 he spent on her breast implants. The way he acted you would have thought she had slunk away with his stereo in the back of the car instead of her breasts in her own bra. He detailed for the judge just how he had scrimped and saved for the operation. He almost cried. But what exactly was he hoping to win - Restitution? Repossession? Unsupervised visitation? I don't get it. Then again, I don't get the whole implant thing. Apparently, I am the only one who doesn't. According to the American Society of Plastic Surgeons, the popularity and social acceptability of breast implants has risen to unprecedented levels. More than 206,000 women had breast augmentations last year, up from only 33,000 just 10 years ago. And the $669 million industry projects another 10 percent increase this year. That's some weird, wild stuff. Even weirder than the plaintiff on TV. I can see why a woman might spend $36 on a water bra to enhance an especially clingy sweater. Or after a certain age how she might buy a swimsuit with enough underwire to fence Oklahoma. But am I so obtuse to not understand why anyone would go under general anesthesia unless it were to get a new kidney? Maybe I'm just not taking the time to dance naked in the yard often enough. Add that to my list of things to do. Until then, though, I'm holding out for something better. I'm putting off the surgery until they develop a breast implant that includes a fat burning device to enable the wearer to eat a brownie sundae every day. With extra whipped cream. I'm waiting for the kind that includes a personal floatation device that guarantees I will survive a class 5 hurricane. I'm waiting for one with a plastic turkey timer that promises to pop up if I've got breast cancer. Or the kind that spins - and comes with sprinkles. Until then, thanks, I'll go au naturel. Because I don't like hospitals. In the most recent data presented to the FDA, it was shown that almost a quarter of saline breast implants will require another operation within five years. Few implants are expected to last more than 10 years. Then when you read about women who have suffered hardening, leakage, deflation, inflammation, infection.... Oh, yeah, I'm feeling much sexier now. But maybe when it comes to breast augmentation I'm not the one who doesn't get it. Maybe the women who actually pay for the honor and privilege of being bustier are merely advertising their own cluelessness. We have one girlfriend we call The Voice. She is not large-breasted and boasts that she hasn't owned a bra in years. But, mercy, she's got the Voice. A mix between Bacall and Dulce de Leche, her response to 'paper-or-plastic' has bag boys following her across the parking lot on their knees. And she mocks them. It's not pretty. But it does prove the Voice's theory that everyone has got a certain sexiness about them. Thick hair. Icy eyes. Devilish sense of humor. Remarkable imagination. A certain lazy willingness of nature that makes other people think longingly of afternoon naps. Something in the creation of your average human insists that we all have something that makes at least one other person consider our nibbly toes. Generous breasts are merely the most obvious of these. "Besides," says the Voice. "Large-breasted women look so much older than smaller-breasted women, don't you think?". The other night my daughter handed me a book she had checked out of the library that quoted comedian Denis Leary's bit about how he likes all breasts, big and small. "I love the ones that are shaped like golf balls, I love the ones that are shaped like teardrops. I like the melons and the pears, the footballs and the ferns. I love the ones shaped like LBJ's head. I love them all, as long as they're real." I laughed. "When you get right down to it," I told her. "I think most men feel that way about breasts." "Yeah," she said. "Me, too." Reach Jacey Eckhart via e-mail at jaceyeckhart@...; read previous columns at www.pilotonline.com/opinion Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 7, 2002 Report Share Posted October 7, 2002 ----- Original Message ----- From: Zuckerman Undisclosed-Recipient:; Sent: Friday, October 04, 2002 10:22 PM Subject: Implants in the news! Dear Friends, Here are two excellent letters to the editor in the Washington Post. I have already thanked Pearson for her letter; for more than a dozen years she has urged Congress and the FDA to study the health risks of implants. The article about medical device legislation and the Mentor criminal investigation may also be of interest. I think the column by Jacey Eckhart is a good way of getting young women to think twice about implants. Sincerely, Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006202 223-4000www.center4policy.org Remember CPR when you give to United Way or CFC, by designating #9884! The Washington Post October 02, 2002 "Breast Implants Under the Microscope" The Sept. 22 front-page article "Popularity of Breast Implants Rising" barely mentioned an important health problem: the effects of implants on mammography. When these women reach the age of needing mammographic examinations, they must have eight views altogether, two on each side with the implant in place and two on each side with the implant pushed back, thus doubling the radiation for each examination. Even in the best of situations, physicians may not see all of the breast tissue. If scar tissue forms around the implant, the pushed-back views may be impossible to obtain. An infrequent but potential complication is rupture of the implants during mammographic compression, an essential part of the examination. In addition, the physical examination and even ultrasound examination of these breasts can be challenging. Newer techniques such as computer-aided diagnosis, which physicians use on all mammograms, also is limited by the amount of tissue that can be seen. Women should be told about these problems before they have breast implant surgery. PETER S. DUNNER Potomac * The article on breast implants did not point out the flaws in the Food and Drug Administration's approach to implants. The FDA points to the importance of breast implants for patients who want reconstruction after breast cancer and implies that this need justifies weaker regulations and the approval of flawed products. But the numbers show that only about one in four implant patients is using implants for reconstruction, and that proportion will get smaller in years to come. For the past decade, most women who are diagnosed with breast cancer have been eligible for lumpectomy -- removing the cancer but not the entire breast. And, of those who must have or choose to have a mastectomy, some are choosing other forms of reconstruction that use the body's own tissue rather than implants. Approving flawed products for use by many women because of the needs of a small and increasingly smaller group of women, many of whom have other options, is not good public policy. The tragedy is that if the FDA had established more stringent standards for breast implants, the implants being sold today would be safer and there would be fewer complications. CYNTHIA A. PEARSON Executive Director National Women's Health Network Washington Congressional Quarterly Daily Monitor October 1, 2002 "Expediting Medical Device Approval on Committee Agenda" BY Goldreich, CQ Staff Writer The House Energy and Commerce Committee is expected to approve a bipartisan bill (HR 3580) Wednesday aimed at speeding up approvals of new medical devices by assessing industry user fees to increase funding for regulators. The medical device fee bill represents a triumph for the industry, which has been lobbying for years to speed up the Food and Drug Administration's safety and review process. The bill would codify a deal negotiated between medical products manufacturers and the Bush administration earlier this year to collect user fees from companies seeking FDA approvals. Reauthorization of a similar program for drug makers sailed through Congress earlier this year, but consumer advocates have criticized the user fee system, saying it makes the FDA a captive of the companies it regulates. The bill covers devices ranging from breast implants to heart defibrillators and has been stalled by concerns from some Democrats that it cedes too much to industry. The bill, sponsored by C. Greenwood, R-Pa., and G. Eshoo, D-Calif., would boost FDA funding for its review process by about $40 million for fiscal 2003, with $25 million coming from user fees. Funding would increase by $225 million over five years. When the administration and industry representatives reached agreement on user fees in May, Pamela G. , president of the medical device trade group AdvaMed, said the assurance of dedicated funding "will help ensure that patients gain timely access to innovative medical technologies." Some patient and consumer groups oppose the bill; Public Citizen and allied groups in the Patient and Consumer Coalition have denounced it as a "rollback" of public safety. The bill has been the industry's top priority but lobbyists failed in their goal of winning authority for the FDA to hand off to independent private contractors the responsibility to review and recommend approval for many new medical devices. The bill would allow private inspectors to assume some of the FDA's manufacturing inspection duties. The bill has had strong support from Energy and Commerce Chairman Tauzin, R-La., and Senate Health, Education, Labor and Pensions Committee Chairman M. Kennedy, D-Mass. - Physician assistance. Also on the agenda is a bill (HR 4634), the National Capital Area Physician Emergency Assistance Act, which would waive legal and licensing barriers to physicians who provide medical assistance in the national capital region during a public health emergency such as a terrorist attack. The measure, sponsored by Constance A. Morella, R-Md., would allow physicians licensed in land, Virginia or the District of Columbia to treat people in any of the three during the emergency. It also would shield them from liability for "any act or omission" in treating victims of the emergency unless they were guilty of "willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious, flagrant indifference to the rights or safety of others." The Dallas Morning News October 1, 2002 "FDA ends inquiry on maker of implants; Agency won't say if firm with Irving facility cleared of allegations" BY JIM MORRIS WASHINGTON - The Food and Drug Administration has concluded its four-year criminal investigation of Mentor Corp., which manufactures breast implants at a factory in Irving, an agency spokeswoman confirmed Monday. FDA spokeswoman Sharon Snider would not say whether the closing of the inquiry meant that Mentor had been cleared of wrongdoing. However, the agency announced no action against the company. In allegations lodged first with the FDA's Dallas office, employees and former employees had accused Mentor of failing to record some patient complaints and allowing potentially contaminated products to enter the market. Mentor officials denied the allegations, although they promised in 1998 to improve manufacturing validation procedures, designed to ensure product uniformity. The FDA's Office of Criminal Investigations opened its investigation that summer. A Mentor spokeswoman said Monday that company officials would have no comment on the end of the investigation because "they have not received any official notification from FDA." In a letter last week to FDA Commissioner Lester M. Crawford, Rep. Jim Greenwood, R-Pa., asked the agency to provide the House subcommittee he chairs with all records relating to the Mentor investigation. The FDA had rebuffed earlier congressional requests for information on grounds that the investigation was still open. Mr. Greenwood could not be reached for comment. He told the Reuters news service last week that the FDA had cleared Mentor of charges that it falsified records, and that the House Energy and Commerce Committee's subcommittee on oversight and investigations would examine how the agency had conducted its inquiry. In his letter, Mr. Greenwood gave the FDA until Oct. 9 to provide the pertinent materials. "The fact that the criminal investigation has been closed could mean the beginning - not the end - of some kind of public scrutiny," said Dr. Zuckerman, president of the National Center for Policy Research for Women & Families, a Washington-based advocacy group that has questioned the safety of implants. "It's been the concern for more than a year that [FDA officials] weren't actually doing anything but were keeping the investigation open so they didn't have to make information available to the public or Congress." California-based Mentor began making saline- and silicone-filled breast implants at the Irving factory in 1994. The Virginian-Pilot (Norfolk, Va.) October 1, 2002 "STAYING ABREAST OF LATEST TRENDS IN AUGMENTATION" BY JACEY ECKHART I SAW A GUY on of those courtroom TV shows sue his former paramour for the $6,000 he spent on her breast implants. The way he acted you would have thought she had slunk away with his stereo in the back of the car instead of her breasts in her own bra. He detailed for the judge just how he had scrimped and saved for the operation. He almost cried. But what exactly was he hoping to win - Restitution? Repossession? Unsupervised visitation? I don't get it. Then again, I don't get the whole implant thing. Apparently, I am the only one who doesn't. According to the American Society of Plastic Surgeons, the popularity and social acceptability of breast implants has risen to unprecedented levels. More than 206,000 women had breast augmentations last year, up from only 33,000 just 10 years ago. And the $669 million industry projects another 10 percent increase this year. That's some weird, wild stuff. Even weirder than the plaintiff on TV. I can see why a woman might spend $36 on a water bra to enhance an especially clingy sweater. Or after a certain age how she might buy a swimsuit with enough underwire to fence Oklahoma. But am I so obtuse to not understand why anyone would go under general anesthesia unless it were to get a new kidney? Maybe I'm just not taking the time to dance naked in the yard often enough. Add that to my list of things to do. Until then, though, I'm holding out for something better. I'm putting off the surgery until they develop a breast implant that includes a fat burning device to enable the wearer to eat a brownie sundae every day. With extra whipped cream. I'm waiting for the kind that includes a personal floatation device that guarantees I will survive a class 5 hurricane. I'm waiting for one with a plastic turkey timer that promises to pop up if I've got breast cancer. Or the kind that spins - and comes with sprinkles. Until then, thanks, I'll go au naturel. Because I don't like hospitals. In the most recent data presented to the FDA, it was shown that almost a quarter of saline breast implants will require another operation within five years. Few implants are expected to last more than 10 years. Then when you read about women who have suffered hardening, leakage, deflation, inflammation, infection.... Oh, yeah, I'm feeling much sexier now. But maybe when it comes to breast augmentation I'm not the one who doesn't get it. Maybe the women who actually pay for the honor and privilege of being bustier are merely advertising their own cluelessness. We have one girlfriend we call The Voice. She is not large-breasted and boasts that she hasn't owned a bra in years. But, mercy, she's got the Voice. A mix between Bacall and Dulce de Leche, her response to 'paper-or-plastic' has bag boys following her across the parking lot on their knees. And she mocks them. It's not pretty. But it does prove the Voice's theory that everyone has got a certain sexiness about them. Thick hair. Icy eyes. Devilish sense of humor. Remarkable imagination. A certain lazy willingness of nature that makes other people think longingly of afternoon naps. Something in the creation of your average human insists that we all have something that makes at least one other person consider our nibbly toes. Generous breasts are merely the most obvious of these. "Besides," says the Voice. "Large-breasted women look so much older than smaller-breasted women, don't you think?". The other night my daughter handed me a book she had checked out of the library that quoted comedian Denis Leary's bit about how he likes all breasts, big and small. "I love the ones that are shaped like golf balls, I love the ones that are shaped like teardrops. I like the melons and the pears, the footballs and the ferns. I love the ones shaped like LBJ's head. I love them all, as long as they're real." I laughed. "When you get right down to it," I told her. "I think most men feel that way about breasts." "Yeah," she said. "Me, too." Reach Jacey Eckhart via e-mail at jaceyeckhart@...; read previous columns at www.pilotonline.com/opinion Quote Link to comment Share on other sites More sharing options...
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