Guest guest Posted October 7, 2002 Report Share Posted October 7, 2002 ----- Original Message ----- From: " Kathi " <pureheart@...> Sent: Sunday, October 06, 2002 7:22 AM 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. > President > National Center for Policy Research (CPR) for Women & Families > 1901 Pennsylvania Avenue, NW > Suite 901 > Washington, DC 20006 > 202 223-4000 > www.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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