Archive for the ‘Breast Implants’ Category

August 9, 2007

Another Study Links Breast Implants to Higher Suicide Rate

From Reuters:

Women who get cosmetic breast implants are nearly three times as likely to commit suicide as other women, U.S. researchers reported Wednesday.

The study, published in the Annals of Plastic Surgery, reinforces several others that have shown women who have breast enlargements have higher suicide risks.

The study looked at the death certificates of 3,527 Swedish women who had cosmetic breast implant surgery between 1965 and 1993 to to analyze the causes of death among women with breast implants.

“The increased risk of suicide was not apparent until 10 years after implantation,” the researchers wrote.

One of the researches involved in the study, Loren Lipworth of the Vanderbilt University Medical Center, told Reuters that “she believes that some women who get implants may have psychiatric problems to start with, perhaps linked with lower self-esteem or body image disorders.”

The study found no increase in the risk of death from cancer, including breast cancer, but there was an increased risk of death from drug or alcohol abuse.

“Thus, at least 38 deaths (22 percent of all deaths) in this implant cohort were associated with suicide, psychological disorders and/or drug and alcohol abuse/dependence,” the researchers wrote.

The study’s abstract is available here; registration required for the full text.

In 2006, a study published in The American Journal of Epidemiology found that women with implants had a suicide rate 73 percent higher than that of the general population.


June 8, 2007

Double Dose: “Free” Breast Implants, Oliver North on Women’s Liberation in Iraq and More Breast Cancer Studies

The Kid’s All Right — But Those Grandparents …: Writing about the birth of Samuel David Cheney, the son of Mary Cheney and Heather Poe, Robert-Jay Green, executive director of the Rockway Institute, a national center for LGBT research and public policy, looks at recent studies that show children of lesbian and gay parents are just as emotionally well-adjusted as children who grow up within a traditional mom-and-dad family structure.

No comment, however, on the dysfunctional and maladjusted White House PR machine, which left both mommies out of the official new-baby photograph, instead releasing a photo of the grandparents — Dick and Liz Cheney — with the infant. Props to Eugene Robinson at the Washington Post who wrote, “I can’t bring myself to wield Mary Cheney’s newborn son as a weapon in the culture wars, but it’s tempting.”

Website Pays for Breast Implants: Well, not the website exactly, although that’s the title of this NBC story — the payments actually come from men who can go through women’s online profiles and choose who to donate to. “It works similar to any other social networking Web site like Facebook or Myspace. A guy signs up and a girl signs up they each create their own profile. They got their own bio. They got photos and basically you start trying to meet people on the Web site,” Jason Grunstra, founder of MyFreeImpants.com, said. After-photos are optional. Eck.

Plus: Bigger is not better.

Liberating Iraqi Women: Andrea Lynch at RH Reality Check has a great post on an article penned by “veteran feminist Lt. Col. Oliver North,” who argues that “if Speaker of the House Nancy Pelosi were really interested in promoting women’s rights, she would be vigorously promoting the U.S. occupation of Iraq, since ‘the principal protectors of Muslim women today [are] the Armed Forces of the United States.’”

North asserts: “Thanks to young Americans wearing flak jackets and helmets, hundreds of schools have been built for Muslim girls, millions of women have the right to vote, scores of female health care clinics have been opened, and hundreds of thousands of women now work, have their own bank accounts, use cell-phones — even serve in elected office.” But this New York Times story paints a less-rosy picture.

Good News, Bad News: Ann at Feministing neatly sums up the House’s attitude toward family planning programs and abstinence-only education.

Ethnic Plastic Surgery: Describing Washington’s Cultura Medical Spa, which bills itself as “a place where it’s appropriate to treat people based on the color of their skin,” Sandra G. Boodman of the Washington Post writes: “Two-thirds of the center’s patients are nonwhite, many of them black women who in increasing numbers are seeking such procedures as nose jobs and laser hair removal that until recently were largely the province of well-heeled white women. Many of these patients, doctors say, are also seeking treatments that seek to enhance — not obscure — their racial or ethnic characteristics.”

Show Us the Money: Susan E. Reed argues in a New York Times op-ed that “Congress should pass legislation mandating that all workplaces create this kind of transparency by requiring companies to post salaries. It makes sense, especially in light of the court’s decision last week requiring employees to file pay discrimination complaints under Title VII of the Civil Rights Act within 180 days of the last pay adjustment.”

The 5-4 decision came in a case involving a female supervisor at a Goodyear Tire plant in Gadsden, Ala., who was paid less than any of her male colleagues but didn’t learn about the difference until late in her almost 20-year career.

Life as a Feminist: The Asbury Park Press recently profiled former area resident Mary Vasiliades, a 76-year-old novelist, playwright and former journalist who is featured in Barbara’s Love’s “Feminists Who Changed America 1963-1975.” Vasiliades was part of a group of women who sneaked onto the Statue of Liberty on Aug. 10, 1970 and unfurled a banner that read, “Women of the World Unite.”

Love said of Vasiliades: “She organized groups and events all over New York City so it was impossible not to know her. She was everywhere. Mary fit the same criteria that all women needed to be mentioned in the book: She was a change-maker. She did things that affected the landscape of the country for women and girls.”

“Feminists Who Changed America” chronicles the achievements of more than 2,000 feminist pioneers, including many of the original founders of the Boston Women’s Health Book Collective.

Woman Sues eHarmony for Discrimination: “A Northern California woman sued the online dating service eHarmony on Thursday, alleging it discriminates against gays, lesbians and bisexuals,” according to the AP. “The lawsuit claims that by only offering to find a compatible match for men seeking women or women seeking men, the company was violating state law barring discrimination on the basis of sexual orientation.”

Sexual Harassment Training: Sexual harassment training does not invite lawsuits, according to a study by Caren M. Goldberg, a management professor at American University’s Kogod School of Business. “Some organizations have avoided implementing sexual harassment training programs for fear that providing it might increase lawsuits from otherwise unaware victims,” Goldberg said. “But if an employer is sued, proof that sexual harassment training was offered may be one the best defenses. This study indicates that the presumed downside is much ado about nothing.”

Study Finds Less Radiation Effective on Breast Cancer: “Less radiation may be just as good as the standard dose in treating women with early breast cancer, according to a study presented Sunday in Chicago at the world’s biggest cancer meeting,” writes Judy Peres in the Chicago Tribune. “The British study, the biggest to look at the question, found that fewer, larger doses of radiation were as effective at preventing recurrence and did not cause any more side effects. If the results are borne out by similar ongoing studies in the U.S., they could offer a welcome alternative to many American women who now must take six to seven weeks out of their lives to undergo post-surgical radiation.”

Other research presented at the 43rd Annual American Society of Clinical Oncology meeting:

- According to researchers at The University of Texas M. D. Anderson Cancer Center, breast cancer survival rates for black women have not improved and the difference in life expectancy between white and black women continues to widen.

- According to researchers at Loyola University Health System, a 21-gene test of a patient’s breast cancer tumor — known as the The Oncotype DX™ Recurrence Score — may change doctor and patient treatment decisions, including the need for chemotherapy.


May 25, 2007

Breast Implants and MRIs: The Doctors Debate

You might think a story about doctors objecting to FDA guidelines concerning patients with silicone breast implants would appear in a newspaper’s health or national news section. Not so at The New York Times, where “Implants Are Back, and So Is Debate” ran in Thursday’s Fashion & Style section.

Considering that breast augmentation is now the most popular cosmetic surgery, perhaps it’s not that much of a surprise. Still, it’s frustrating to see such an important health issue mixed in with features on prize couture and whether men should wear shorts to work in the summer.

Let’s not kid ourselves: breast implants are a health issue. After 15 years of being off the market, the FDA is once again allowing silicone breast implants — “provided that manufacturers instruct doctors to advise patients they will need biannual M.R.I.’s to check for ruptures and should remove the implants if a rupture is detected,” writes Natasha Singer.

Unlike saline implants, which release saltwater into the body upon deflation, silicone implants “may break without a person knowing, and the material is not absorbed; the gel may remain in the breast area, contained by a wall of scar tissue, or it could migrate and cause problems such as painful lumpy nodules, doctors said.”

The problem is that many cosmetic surgeons are balking at the new testing requirements — even going so far as to suggest they will not follow them. They don’t appear to be objecting on medical grounds, however. Dr. Scott L. Spear, chairman of plastic surgery at Georgetown University Hospital, simply says, “They bring a lot of red tape and expense.”

And I guess that begs the question: Is a woman’s health worth all that hassle?

You know there’s something wrong when you end up looking to the corporate makers of the silicone implants — rather than medical professionals — for refuge. But there they are — both Mentor Corporation and Allergan, Inc. — not only supporting the FDA initiative but also embracing strict product labeling and offering training for doctors to cut through all that “red tape.” Of course, agreeing to MRIs was probably necessary for FDA approval.

Silicone implants are supposed to be more lifelike that the safer saline alternative. As a result, some surgeons are presuming that some women might just want to take the risk. Many other surgeons, however, see the important of the testing:

“The guidelines are critically important because we really don’t yet know how best to follow-up with these patients, what tests they should get and how often,” said Dr. Michael H. Rosenberg, a plastic surgeon in Mount Kisco, N.Y., who is enrolling women who get silicone implants in a study that will monitor them using M.R.I.’s and ultrasound. “I don’t think it is unreasonable to come up with a standard method to determine the rate of problems with implants.”

Or as Judy Norsigian, executive director of Our Bodies Ourselves, wrote to The New York Times in response to this article: “Plastic surgeons now opposing this basic safeguard demonstrate both chutzpah and callous disregard for the health and well-being of women. Could it be that they don’t want women to find out that their implants don’t last as long as promised?”

And let’s be honest: at a cost of $1,000 to $2,200, MRIs are pricey — and unlikely to be covered by insurance. That cost, on top of the implants, makes some women wonder if it’s worth it.

“If you added up all the M.R.I.’s you would need over the years, I figured the cost of the tests would soon outstrip what you paid for the actual augmentation with silicone,” Michelle C. Meyer, a bank teller in Waseca, Minn., who got saline implants last week, told the NYT.

Some doctors contend silicone is benign, so they don’t see what all the fuss is about. “In my opinion, a rupture is not going to hurt anyone,” said Dr. Richard Ellenbogen, a plastic surgeon in West Hollywood who told the NYT he has put in thousands of implants and has never seen major problems. He added that “radiologists are going to make a lot of money paying off their $800,000 machines.”

Norsigian responds to that allegation as well:

Any plastic surgeon who says that he or she has put in thousands of implants and has never seen major problems is either not paying attention, or has so lost the trust of a patient with a bad outcome, that she has gone elsewhere to deal with her problem.

Many women tell us that their plastic surgeons insist that implants are not causing their health problems, but when the implants are removed the women are miraculously better. The hundreds of women we have heard from over the years (plus the thousands more that have contacted our colleagues) should not be made even more invisible by ignoring their very real experiences.

Meanwhile, Dr. Joseph M. Gryskiewicz, a plastic surgeon in Edina, Minn., and chairman of the emerging trends task force of the American Society for Aesthetic Plastic Surgery, is developing an alternative diagnostic tool called Novalert — “a dime-size radio-frequency identification tag that fits on the back of an implant and emits a signal if it senses leaking silicone.”

Beeping breasts? Now that won’t cause any alarm.


February 6, 2007

Silicone’s Safety Tested on Women

“Women are essentially the experimental lab rats into whom the so-called new and improved ‘fifth generation’ of silicone will be implanted,” asserts Judy Norsigian, executive director of Our Bodies Ourselves, and Dr. Edward Melmed, a plastic surgeon based in Dallas.

Their op-ed, which appeared in Friday’s Boston Globe, addresses the dangers of silicone breast implants, which the FDA approved in November after a 14-year hiatus, despite lingering concerns about the effect on women’s health and the acknowledgement that the implants will break, most within 10 years.

On top of that, replacement is generally more expensive than the initial surgery and there is an even higher rate of complications. Indeed, the cost from the onset is quite astounding — as is the government’s set of recommendations for women who opt for silicone breast implants. From the op-ed:

In terms of cost, silicone implants are about $1,000 more expensive than saline implants — and this represents just the beginning. The FDA has made it clear that patients will need a breast MRI after three years, and every year after that for the rest of their lives. An MRI for [correction: both breasts] ranges from $1,600 to $5,000. In addition, follow-up surgery to replace a leaking implant is usually more expensive than the initial procedure.

Most troubling is that the FDA endorsement was made without adequate safety assessments. The medical community still does not have a clear picture of how many women have become sick due to a leaking implant. There are also no well-designed studies examining the effect of leaking silicone on breast milk. And there is a significant, unanswered question about the existence of platinum in the breast milk of women with silicone implants — some believing that platinum is dangerous. We should have understood the effects of platinum before approving the product.

Perhaps the greatest indicator that the FDA has proceeded too quickly is that, according to its latest ruling, silicone manufacturers must conduct [correction: two studies of at least 40,000 implant recipients each] over the next 10 years to determine the long-term safety and efficacy of the implants. Should this kind of study not be conducted before giving the green light, not after? Should we not understand the long-term risks before sending a product to market?

This story in the Philadelphia Inquirer, meanwhile, notes that demand for silicone implants is growing — and the trend is toward even bigger implants, with more women now choosing a D cup instead of a C cup. Marie McCullough writes:

In 2005, about 360,000 American women — nine times more than when the FDA restricted implants in 1992 – paid an average $5,000 (more like $6,000 to $10,000 in the Philadelphia area) to get better bosoms. That’s all out of pocket, because health insurance doesn’t cover it.

Year after year, the demand increases, data from the American Society of Plastic Surgeons show.

All told, an estimated 3.7 million U.S. women have gotten bigger breasts — more than the population of Connecticut. Most of them went under the knife after 1992, even though the majority had to get cosmetically inferior saline implants, which were also the subject of safety questions.

The Inquirer also includes statistics from studies that the FDA required of two breast implant manufacturers, Allergan and Mentor:

Allergan, for example, found that 41 percent of first-time implant patients had at least one significant complication within four years, including 23 percent who needed another operation to fix breast hardening, pain, swelling, scarring, asymmetry, rupture or other problems. For patients replacing an implant, the complication rates were even higher – 57 percent.

Mentor had lower reoperation rates – but only three years of data.

“Women tend to accept this sobering reality as the price of what they perceive as beauty,” McCullough adds. And the woman quoted in the story support this. One plastic surgeon says his patients know the risks but “either they’re infinitely optimistic and think, ‘It won’t happen to me,’ or they’re realistic and say, ‘I’ll deal with it when it happens.’”

But this “sobering reality” continues to trouble women’s health activists who have been down this road before.

Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, has called the implants “the most defective medical device ever approved by the F.D.A.”

“The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety,’” he told The New York Times last November.

Edward Melmed, the plastic surgeon co-wrote the Boston Globe op-ed with Norsigian, used to perform cosmetic breast augmentation, but he doesn’t anymore. As he explained last month, Melmed reevaluated his pro-silicone position in the early 1990s.

“Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants. But I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed,” Melmed wrote previously. “Last year, I completed a review of the last 500 gel implant removals I performed, and found that more than half the women had similar symptoms, ranging from mild to debilitating.”

As we said, astounding.


January 26, 2007

Friday Double Dose: Breast Cancer Foundation Turns 25, HDTV Reveals Real Flaws, Vegan Cupcakes and More

Susan G. Komen Breast Cancer Foundation Turns 25: It now has a new name and a new advertising campaign. The AP’s Jamie Stengle writes:

In the 25 years since, the foundation has grown from a small gathering of women in Brinker’s living room to a world-renowned operation that will have invested roughly $1 billion in community outreach and research by year’s end.

The Dallas-based organization has 200 employees, more than 100,000 active volunteers and 125 affiliates. Its annual Race for the Cure has grown from 800 women who ran for charity in Dallas to about 1.5 million participants in 120 races worldwide. The foundation has funded work in more than 47 countries.

The non-profit is celebrating its 25th year with a new name — Susan G. Komen for the Cure, an edgy new advertising campaign that includes T-shirts reading: “If you’re going to stare at my breasts, you could at least donate a dollar to save them,” sales of pink promise rings and a pledge to raise another $1 billion in the next 10 years.

Thoughts?

U.S. Mammogram Rate Drops: “The share of women 40 and older who said they had a mammogram in the previous two years slipped from 76.4 percent to 74.6 percent between 2000 and 2005, according to a study released by the Centers for Disease Control and Prevention,” reports the AP. “The CDC and other researchers said possible explanations for the drop include a shortage of mammography screening centers and specialists, and a lack of health insurance among patients.”

Ten Questions For Ellen Goodman: Goodman on Bush, feminism and being a grandmother.

Monday Night Feminism: New discussion series kicks off with a great title and challenging subjects.

Newsflash, Hollywood — No Means No: A very good post about where “Studio 60″ went wrong.

HDTV = More Plastic Surgery?: Some porn actors aren’t thrilled about their “real” appearance. “Jesse Jane, one of the industry’s biggest stars, plans to go under the knife next month to deal with one side effect of high-definition,” reports The New York Times. “The images are so clear that Ms. Jane’s breast implants, from an operation six years ago, can be seen bulging oddly on screen. ‘I’m having my breasts redone because of HD,’ she said.”

Willful Ignorance: “Teens who are merely told ‘Just don’t do it’ are lacking more than an anatomy lesson or information on contraceptive choices,” argues Courtney Martin in The American Prospect. “They are also missing out on essential communication skills and life-saving knowledge about sex and power.”

Pregnancy Buzz: A Google search on the BMJ study that found moderate caffeine intake does not increase the risk of premature or underweight births turned up quite the mix of headlines. To wit: “Moderate cups of coffee can do no harm to your unborn baby”; “Caffeine’s impact on pregnancy uncertain”; “Caffeine Has ‘No Effect’ on Pregnancy”; “Some Coffee OK Late in Pregnancy?” — Good luck with that.

More on Low-Dose Birth Control: “New birth-control pills that are less effective in preventing pregnancy than the original contraceptives of the 1960s still could win federal approval if they promise other benefits, under a recommendation by health advisers,” reports AP.

Vegan Ethics Frosted with Hedonism: I do love a vegan cupcake


January 19, 2007

A Plastic Surgeon Sees Trouble Ahead

Apologies for not posting yesterday due to technical trouble. Here’s Thursday’s post with a double dose to follow shortly.

Edward Melmed, a Dallas surgeon, has written one of the most convincing essays I’ve come across about the dangers of silicone breast implants. His recent op-ed in the Los Angeles Times opens with the subject line of an e-mail he and thousands of other surgeons received in November from a breast implant manufacturer: “Let’s toast this monumental occasion.”

The reason for such joy? The FDA decided to allow silicone breast implants, which were banned in 1992, back on the market.

Melmed said he’s one plastic surgeon who isn’t pouring champagne. After three decades of enlarging women’s breasts, Melmed reevaluated his pro-silicone position in the early 1990s when women started coming to him complaining of hardened and painful breasts. Here’s his experience:

In the last 14 years, I have removed implants from almost 1,000 women. I have found roughly 50% of their implants have ruptured within 10 years, and more than 70% have ruptured within 15 years. We are still not sure of all the places where the micro-droplets of silicone end up, though I have found it in lymph nodes. [...]

Most plastic surgeons vehemently deny any connection between health complaints and leaking silicone implants. But I have seen a disturbing number of patients with symptoms, including fatigue, short-term memory loss, joint and muscle pains, skin rashes, disturbed sleep patterns, depression and hair loss, that clear up when implants are removed.

Last year, I completed a review of the last 500 gel implant removals I performed, and found that more than half the women had similar symptoms, ranging from mild to debilitating. According to the manufacturers’ own literature, one in four women has additional surgery within the first year. Many women have multiple surgeries.

“Women deciding to have these implants need to be prepared to have additional surgery,” cautioned Dr. Daniel Schultz, head of the Center for Devices and Radiological Health at the FDA.

The FDA is requiring manufacturers to spend 10 years studying 80,000 women who receive the implants. Apparently our government’s policy has become, “Approve now, test later.” At current implantation rates, these devices will be in the bodies of 5% of U.S. women within a decade. As I now see it, grossly outsized artificial breasts are a deformity that flouts medical standards and even the plastic surgeons society’s own definition of “cosmetic” — all too often encouraged by the media, which celebrates these water balloons for self-esteem.

Though I do approve of the use of implants for breast reconstruction, when there is no other option, I no longer perform cosmetic breast augmentation. But let’s raise a glass of bubbly for the manufacturers and the plastic surgeons. This will be a happy and prosperous year, for them.

Plus: Need more background? Our Bodies, Ourselves has quite a bit of information about silicone implants.


December 29, 2006

Friday Double Dose: More House Work = Less Breast Cancer, The Role of Beauty Queens and a Flexible Wish for the New Year

I’m traveling this week, so here’s a shortened version of the “double dose.” Have a Happy, Healthy New Year!

Wish for the New Year: Increased use of flex time.

Housework Cuts Breast Cancer Risk: Yes, that’s the actual headline, but the real point of the study, as reported by the BBC, is that “moderate forms of physical activity” may be more useful in reducing breast cancer risk than “less frequent but more intense recreational physical activity.” So of course housework is the recommended activity — as it was in 2004.

Living Longer, Saving Less: The Los Angeles Times this week reported on scientists searching for the key to longevity and women having less financial security as they get older.

Silicone Over Saline?: With the recent FDA approval of silicone implants, more women are likely to choose silicone, despite lingering health concerns.

What Are Beauty Queens For, Anyway?: Just asking.

When Nature Calls, Women in House Hike: Add to the New Year’s wish list: a women’s bathroom off the House chamber. Margaret Talev writes:

The members-only House men’s room, with its shoeshine stand, fireplace and television tuned to floor proceedings, is nestled a few paces from the House chamber, beside the speaker’s lounge, flanked by Capitol police. How convenient.

Reaching the women’s equivalent entails traversing a hall where tourists gather, or entering the minority leader’s office, navigating a corridor that winds past secretarial desks and punching in a keypad code to ensure restricted access.

When Speaker-elect Nancy Pelosi, D-Calif., takes the gavel, she may revisit, along with the Iraq war and raising the minimum wage, the question of potty parity.


November 17, 2006

FDA Approves Silicone Breast Implants — With Mention of Additional Surgery

In 1992, the FDA banned the cosmetic use of silicone breast implants, according to the Washington Post, “after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was ‘inadequate information to demonstrate that breast implants were safe and effective.’”

Fourteen years later, they’re ba-aack.

Manufacturers weren’t taken by surprise — Mentor Corporation already unveiled a website for its MemoryGel silicone implants.

Stephanie Saul writes in The New York Times (which also published a pop-up timeline showing the on-again, off-again history of silicone implants):

The federal agency approved implants manufactured by two California companies, Mentor and Allergan, for breast reconstruction and cosmetic breast augmentation, but limited cosmetic use of the implants to women ages 22 and older.

The decision appeared to end a controversy over the safety of silicone implants that lasted more than two decades and resulted in thousands of lawsuits by women who claimed the implants leaked and caused a number of diseases, including cancer and rheumatoid arthritis. The dispute led to the bankruptcy of the manufacturer Dow Corning, a federal moratorium on the use of the implants, and, finally, findings by both the Institute of Medicine and the Food and Drug Administration that the devices do not cause major illnesses.

Because the implants made of silicone gel are softer than the saline implants currently available, plastic surgeons said they would quickly become preferred among the more than 300,000 women in this country who have breast implants each year.

Critics of the decision lambasted it and said that longstanding safety concerns had not been resolved. But supporters of the implants, including leading surgeons, applauded it. “For us, it’s a triumph of science,” said Dr. Richard A. D’Amico of Engelwood, N.J., president-elect of the American Society of Plastic Surgeons. “We’ve always felt that the science would bear out the use of the implants.”

If only for a while.

Dr. Daniel G. Schultz, director of the FDA’s Center for Devices and Radiological Health, said that while the FDA had determined the implants were safe, the possibility remains that the implants will rupture and women will need additional surgery. One study found that 69 percent of women experienced a ruptured implant, according to the NYT.

“Women should know that breast implants are not lifetime devices,” Schultz told reporters during a telephone briefing. “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery.” He also mentioned the possibility of “silent ruptures,” which can occur without a woman’s knowledge.

Which makes the remarks of Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, seem quite sane. He called the implants “the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’”

Amy Allina, program director at the National Women’s Health Network, told the NYT that knowing how long the implants would last — and if leaking silicone causes health problems — are basic safety questions manufacturers had failed to answer.

In a statement posted on the website of the National Research Center for Women and Families, President Diana Zuckerman said:

It’s important for women to know that the FDA has not determined that silicone gel breast implants are safe – only that they are “reasonably safe.” What does that mean? In this case, it means that if a woman lives for 25 years after getting these implants, she will need to remove them at least once, probably twice, and possibly more than that. If she doesn’t, the implants are likely to break inside her body, and possibly leak silicone into her breasts, lungs, and other organs.

What do we know about the risks? Most women with silicone gel breast implants experienced at least one complication within the first three years of getting implants, including breasts that were hard or painful, oddly shaped, or had lost sensation, or the need for additional surgery to fix implant problems. The additional surgery is often very expensive, and almost never covered by health insurance.

Plus: Oh, Canada — Across the border, Canadian health officials came to a similar decision to allow silicone implants just three weeks ago.


October 19, 2006

Whistleblower Calls Attention to Safety Issue with Silicone Breast Implants Under FDA Review

The consumer advocacy group Public Citizen last week called for a criminal investigation into why Mentor Corp. didn’t send all its data about safety issues with new silicone breast implants to the Food and Drug Administration. David Brown of the Washington Post writes:

In a letter to the FDA’s administrator, Public Citizen said it learned of test results — some new, some reinterpreted — from a scientist at implant maker Mentor Corp. who says he could not persuade his bosses to forward the data to the regulatory agency.

The scientist had worked for 15 years for Mentor, which is based in Santa Barbara, Calif. He was let go earlier this year in a company reorganization, although he thinks his protests to superiors were part of the reason.

The FDA is in the late stage of reviewing applications by two companies to sell once more silicone breast implants for general use. Last year, the agency gave preliminary approval for the devices on condition that Mentor and a competitor, Inamed (now part of another company, Allergan), complete required tests.

Currently, most breast implants used in the United States are filled with saline solution — salt water. Silicone implants can be used only under limited conditions, generally in FDA-approved studies at specified hospitals.

Many implants are used by women who have had a mastectomy for breast cancer, but most of the 250,000 sold each year are for breast enhancement. That number is expected to rise if the more popular silicone implants are allowed back on the market.

Seriously, Tara Reid should be ordered to do PSAs.

But I digress. For the record, Mentor released a statement that read in part: “During July, representatives from FDA visited our Santa Barbara facility. They asked questions and reviewed documents specific to our preclinical testing. To our knowledge, all questions were answered to the satisfaction of FDA.”

But Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a letter to FDA Acting Commissioner Andrew von Eschenbach: “This new information is compelling enough to warrant a reassessment of FDA’s position. At the very least it should clearly stop any FDA final approval of either device until the withheld data has been submitted, evaluated by the FDA staff, and made available to the public. This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation into the Mentor’s failure to promptly send the agency all new information bearing on the safety of silicone gel implants.”

Public Citizen’s letter to the FDA and the whistleblower’s letter to the FDA are available here.

Our Bodies Ourselves, the National Women’s Health Network, and the National Research Center for Women & Families urge people to write to the FDA and insist that silicone gel implants not be approved for general use until serious safety concerns have been addressed.


September 26, 2006

Breast Implants Linked to Higher Suicide Rates; Nose Jobs Big in Iran

Add to the health debate over breast implants a study pointing to a higher rate of suicide among women who get implants for cosmetic reasons.

The authors of the study published in The American Journal of Epidemiology examined the records of women who obtained breast implants in Ontario and Quebec between 1974 and 1989.

“During that time, 480 of the women died,” Eric Nagourney writes in The New York Times. “When the researchers looked into the causes of death, they found that the women with implants had a suicide rate 73 percent higher than that of the general population.”

The researchers didn’t find any evidence directly linking implants to mortality, and instead pointed to earlier research that focused on a higher rate of self-esteem problems. “[The women] are also more likely to have undergone therapy or to have been admitted to a psychiatric hospital,” writes Nagourney.

Meanwhile, the Chicago Tribune reports on the growth of cosmetic surgery in Iran — where nose bandages are considered a rite of passage. Christine Spolar writes:

Plastic surgery is commonplace in countries such as Lebanon and Syria, but patients in Iran exude a remarkable enthusiasm about their decision. Bandages are worn openly and youngsters routinely discuss the benefits of looking like Nicole Kidman and Angelina Jolie.

Rhinoplasty has become a common reward for passing college entrance exams. Some even undergo surgery two or three times — at a fraction of the cost of Western procedures — to perfect their profiles framed by the ever-present hijabs, or scarves, they must wear.

The sculpting doesn’t stop there. Chins are filled out in outpatient procedures. Older women are flocking in for eye-, breast- and face-lifts, surgeons say, and even men are being persuaded to make a few changes. Some doctors estimate teenage boys make up 10 percent of all nose-job patients.

Makrokh Amirshahi, a 36-year-old mother of a teenage daughter, told the Trib: “In the old days, when we didn’t have to wear the scarf, women paid attention to their hair. Now they cover the head and all they have is the face to make beautiful.”