Archive for the ‘Breast Implants’ Category

September 2, 2008

Re-Framing Empowerment: Allergan, Breast Implants and a New, Improved You

What’s the most empowering action you’ve taken recently? Did you ask for a raise? Stand up for a cause? Run for president?

If you answered “Got breast implants!” well, Allergan’s marketing is working.

Allergan is a global pharmaceutical company perhaps best known for producing Botox. In late 2005, Allergan merged with Inamed, maker of silicone breast implants — just before silicone breast implants received FDA approval.

Earlier this summer, Orange County Register columnist Colin Stewart, who is admittedly no fan of elective cosmetic surgery but who remains “dazzled by the ways Allergan makes the idea” of “injecting, slicing and rearranging body parts” seem appealing, devoted a column to Allergan’s marketing scheme, which is all about empowering you:

In its new breast-implant campaign, for example, Allergan’s marketers imply that implants are artful, like designer clothing. Even though implants are basically plastic bags filled with silicone or saline solution, Allergan portrays them as sources of power, freedom, individuality and self-confidence.

That’s a big change from last year, when Allergan bought Santa Barbara-based Inamed and its breast implants for $3.2 billion. Then, the implants were labeled “Style 68,” “Style 101,” etc.

The old labels were cold and clinical, so Allergan is giving them a new identity that sounds natural, feminine and artful. In a new marketing campaign, they’re the “Natrelle collection of breast implants.”

Breast implants can seem crudely sexual, but Allergan combats that impression too, ingeniously presenting them almost as a feminist issue. The company says it’s “empowering” women with information about their options.

The tag line for the Natrelle collection: “To each her own.”

Studies of breast-implant users reveal that women “aren’t getting them to attract men, but to feel greater confidence in their femininity,” says Robert Grant, president of the Allergan Medical division.

Presumably, women whose natural attributes have Natrelle enhancements will gain self-confidence from each masculine head that turns when they walk past.

“Nearly 400,000 women did something fabulous for themselves last year,” is Allergan’s message about Inamed’s breast implants. But to Grant that number isn’t fabulous enough.

“The $3.2 billion price for Inamed isn’t worth it for us” at that rate, Grant says. “We can grow (the rate of annual implants) to in excess of one million procedures.”

How else is Allergan making a show of empowering women? Let’s consider the research. Last November, a review of studies on the safety of breast implants appeared in the journal Annals of Plastic Surgery. The authors concluded that “the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis.”

In fact, the only caution the authors registered concerned the observed higher incidence of suicide among with women with implants. On this point, they recommended future studies “to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors.”

But if that sounds, well, mostly reassuring, there’s more.

After the study was published, Diane Zuckerman, president of the National Research Center for Women & Families notified health activists that the journal article’s four authors all have financial ties to the breast implant industry. The lead author, Joseph McLaughlin, has been a consultant to Inamed/Allergan.

“In fact, McLaughlin is an author of almost every study on breast implants of the last 10 years, all funded by Dow, all concluding that implants are safe,” wrote Zuckerman. “With a couple of exceptions, the only studies he hasn’t co-authored are ones by NCI and FDA, which found significant increases in several illnesses among women with implants.”

“This isn’t a new study, it’s a review of all the old studies that McLaughlin co-authored. So, he’s summarizing his own work (without admitting it is his) and once again concluding that implants are safe.”

Makes you want to replace the guards at the hen house, no?

Despite the increasing popularity of breast implants — breast augmentation was the most popular plastic surgery procedure in 2007, with close to 350,000 procedures done — the safety debate rarely breaks through the marketing noise.

But thoughtful and personal critiques are carried out each day in blogs like Beauty and the Breast, which covers the impact of breast implants, and in documentaries such as “Absolutely Safe,” which has a terrific website filled with resources, including a section on the data debate.

Another documentary, “America the Beautiful,” which opened (or will be opening) in some theaters this summer, looks at the obsession with plastic surgery in general — and how surgeries can go horribly wrong.

And who knows — perhaps “empowerment” will be reclaimed in the future to mean making choices and taking risks that truly improve, not harm, our well-being. Then again, the FDA could approve the lip implants


May 17, 2008

Double Dose: The New Film Genre: Fertility Films; D.C. Sets Up a Place to Pump; The Business of Bacteria; Culture Affects How Teen Girls See Harassment …

When Chick Flicks Get Knocked Up: “Eventually, your female friends — the ones who married late and retained youthful obsessions with Yo La Tengo and graphic art books until forty — may shock you by having children,” writes Alissa Quart at Mother Jones. “This year, at least, they have cinematic alter egos; those millennium Mary Tyler Moores Sarah Jessica Parker and Helen Hunt have left their cosmos and canned laughter behind and gotten knocked up onscreen too. In the process, they have created a new genre: The Fertility Film. But are the new fertility film stars actually feminists?” (via Feministing)

Silicone Gel Implants May Lose Approval: From our enlightened neighbor to the north … “Health Canada may have to reverse its controversial 2006 decision to allow women to get silicone gel-filled breast implants if it proceeds with a plan to declare key chemicals found in them to be toxic, experts say,” reports The Ottawa Citizen. (via Beauty and the Breast)

South Carolina Supreme Court Overturns Conviction: “A South Carolina woman convicted of homicide by child abuse after her stillborn baby tested positive for cocaine should get a new trial because of several mistakes her attorneys made, the state Supreme Court ruled Monday,” reports the Associated Press. “Attorneys for Regina McKnight did not introduce the baby’s autopsy report into evidence and failed to rebut the prosecution’s medical expert, the court said in the unanimous decision.”

Prosecutors have 15 days to decide whether to appeal. From the Myrtle Beach Online:

Attorneys for the National Advocates for Pregnant Women and the S.C. Civil Liberties Union became involved in McKnight’s case when she asked for post-conviction relief.

“The groups got involved because there is complete consensus that prosecuting pregnant women is bad for mothers and babies,” said Lynn Paltrow, with the National Advocates for Pregnant Women. “Regina McKnight was convicted on junk science and was not fairly represented at trial.”

A Place to Pump: “Washington area women have hooked up electric or manual versions in parked cars, restrooms, a telephone booth and the basement storage room of the National Zoo visitors center, where a box of panda costumes doubled this spring as a table on which one woman set her pump, bottles and other equipment,” writes Rebecca Adams at the Washington Post.

“Not perhaps what the D.C. Council had in mind when it passed a law in December requiring employers to provide female workers a private, clean space, outside a restroom, to express milk. The Child’s Right to Nurse Act also gives a woman the right to breast-feed, covered or not, in any place, public or private, where she has a right to be.”

Maternal Exposure to Persistent Organic Pollutants Linked to Urologic Conditions in Boys: This release from the American Urological Association summarizes studies that confirm existing hypotheses that maternal exposure to endocrine-disrupting chemicals – including total polychlorinated biphenyls (PCBs, such as Arochlor) and organochlorinated pesticides (such as dichlorodiphenyl-trichloroethane, or DDT) may contribute to an increased incidences of congenital anomalies.

Mammograms Coupled with Ultrasounds: Deborah Katz of U.S. News & World Report looks at new research on combining mammography and ultrasounds, which may be better for finding cancers in some women, but it also greatly increases the rate of false-positive results. Plus: Check out our analysis on routine mammograms for premenopausal women.

The Business of Bacteria: The L.A. Times reports on the popularity of probioitics, live "friendly" bacteria that is showing up in more foods, like Dannon’s Activia yogurt. “Companies claim that the daily consumption of probiotics can provide consumers with benefits such as a boost to the immune system and relief from intestinal distress — and researchers think that certain probiotic strains hold promise in a number of areas,” writes Brendan Borrell. “But how significant these benefits are is a matter of debate. And it can be tough to decipher which products offer verifiable health claims and which are piggybacking on the hype of the booming industry.

Doctors Start to Say “I’m Sorry” Long Before “See You in Court”: The New York Times reports on a change in hospital policy: full disclosure when a doctor makes a mistake. Kevin Sack writes:

For decades, malpractice lawyers and insurers have counseled doctors and hospitals to “deny and defend.” Many still warn clients that any admission of fault, or even expression of regret, is likely to invite litigation and imperil careers.

But with providers choking on malpractice costs and consumers demanding action against medical errors, a handful of prominent academic medical centers, like Johns Hopkins and Stanford, are trying a disarming approach.

By promptly disclosing medical errors and offering earnest apologies and fair compensation, they hope to restore integrity to dealings with patients, make it easier to learn from mistakes and dilute anger that often fuels lawsuits.

Malpractice lawyers say that what often transforms a reasonable patient into an indignant plaintiff is less an error than its concealment, and the victim’s concern that it will happen again.

Culture Affects How Teen Girls See Harassment: “Teenage girls of all ethnic and socioeconomic backgrounds still experience sexism and sexual harassment – but cultural factors may control whether they perceive sexism as an environmental problem or as evidence of their own shortcomings,” according to this release from the University of Kentucky summarizing a study of 600 girls, ages 12 to 18, in California and Georgia.

Ninety percent of the girls reported experiencing at least one incident of sexual harassment, the researchers from University of Kentucky and University of California Santa Cruz found.

Specifically, 67 percent of girls reported receiving unwanted romantic attention, 62 percent were exposed to demeaning gender-related comments, 58 percent were teased because of their appearance, 52 percent received unwanted physical contact and 25 percent were bullied or threatened with harm by a male. 52 percent of girls also reported receiving discouraging gender-based comments on the math, science and computer abilities, usually from male peers, and 76 percent of girls reported sexist comments on their athletic abilities, again
predominantly from male peers.

The researchers found that girls have different levels of understanding of sexism and sexual harassment, which may affect reporting data. Older girls and those from a lower socioeconomic background reported more sexism than did their peers. Latin and Asian American girls reported less sexual harassment than did girls of other ethnic groups. Girls who had been exposed to feminist ideas, either through the media or an adult such as a mother or teacher, were more likely to identify and report sexist behavior than were girls who had no information about feminism. Girls who reported feeling pressure from their parents to conform to gender stereotypes were also more likely to perceive sexism. Girls who felt atypical for their gender and/or were unhappy with stereotypical gender roles were most likely to report sexism and harassment.

The study appears in the May/June issue of Child Development.


April 19, 2008

Double Dose: Academics’ Ethics; Blogging About Disablism; “My Beautiful Mommy” Bombs with Bloggers, Scores on Publicity; Plastic Surgery on TV; Contraceptives in Middle School; Breast Cancer Rates Drop – for White Women; and More

Ethics Worth More Than Financial Payments: “With little fanfare, a small number of prominent academic scientists have made a decision that was until recently all but unheard of. They decided to stop accepting payments from food, drug and medical device companies,” reports The New York Times.

No longer will they be paid for speaking at meetings or for sitting on advisory boards. They may still work with companies. It is important, they say, for knowledgeable scientists to help companies draw up and interpret studies. But the work will be pro bono.

The scientists say their decisions were private and made with mixed emotions. In at least one case, the choice resulted in significant financial sacrifice. While the investigators say they do not want to appear superior to their colleagues, they also express relief. At last, they say, when they offer a heartfelt and scientifically reasoned opinion, no one will silently put an asterisk next to their name.

Blogging Against Disablism Day: Coming May 1. Last year, more than 170 people took part. Diary of a Goldfish has the details: “You can write on any subject, specific or general, personal, social or political. In the previous two BADDs, folks have written about all manner of subjects, from discrimination in education and employment, through health care, parenting, family life and relationships, as well as the interaction of disablism with racism and sexism.”

Plus: Tips on language.

“My Beautiful Mommy”: “Oh I just can’t think of enough bad things to say about this book but for starters…” begins Lucinda Marshall’s critique of a new children’s book written by a plastic surgeon to help kids age 4-7 get with the whole “mommy makeover” (tummy tuck and breast augmentation). It’s emblematic of reactions read ’round the web (though EW surprisingly feels the need to ask, “a practical solution for a well-defined demo, or pure evil?” Hmmm. Let me think.)

The book got a lot of attention this week after this Newsweek story came out. Making Light has good info on how a self-published vanity-press book made major league headlines … including a mention on Wait, Wait …. Don’t Tell Me” this morning.

Plastic Surgery on TV: When Botox, face lifts and reconstructive surgery gets in the way of acting, is it appropriate for a critic to call it out? Mary McNamara at the L.A. Times writes:

People should be free to look as they choose, and this town is tough on women — don’t talk to me about Judi Dench and Helen Mirren, they’re British. Would an American woman ever get away with anything approaching Nicolas Cage’s hair or James Spader’s increasing portliness? Of course not.

But television is a visual art, and if people are going to significantly alter the way they look in ways not directly connected with the roles they are playing, it can affect not only their performance but the whole tone of the show.

So you tell me, what is a critic supposed to say when part of the problem with a show is that the leading lady’s face seems incapable of movement or her eyes appear to be moving toward the sides of her head or her lips just look weird?

Plus: Maureen Ryan on women keeping it real: “In future, I’ll not only attempt to acknowledge when a plastic face impedes the enjoyment of a show, but I’ll also make it my business to congratulate the women who look like they’ve lived, for hanging on to what’s made them distinctive individuals.”

Remember the Controversy Over Contraceptives in Portland, Maine?: “For all the firestorm surrounding the decision to make prescription contraceptives available at King Middle School, only one girl has used the service in the six months since the program began, officials say,” reports the AP.

As of Thursday, the only student to obtain a prescription for contraceptives was a 14-year-old girl, the city reported in response to a Freedom of Access request from The Associated Press.

“If it helps one student who otherwise might be in a position of being at risk, then it’s worth it,” said Lisa Belanger, who oversees Portland’s student health centers.

Falling Breast Cancer Rates Prevalent Only Among White Women: “New research shows a sharp drop in U.S. breast cancer cases in recent years was limited to white women, possibly because they abandoned hormone replacement therapy in greater numbers than minority groups,” reports Reuters.

White women had been more likely to use hormone therapy, and were also the most likely to abandon the drugs after U.S. regulators warned about the cancer link in 2003, according to Dr. Dezheng Huo of the University of Chicago and the study’s lead investigator.

“The sharp reductions seen in Caucasians aged 50 to 69 years were not seen among other ethnic groups,” Hou told the American Association for Cancer Research.

The researchers said the decline has been mainly among women older than 50 with estrogen-receptor positive cancer.

Why We’re Fatter: This Slate article isn’t new — in fact, it was published in 2006 — but it was just brought to my attention and it’s definitely an interesting read. Writer Sydney Spiesel reviews five of the 10 explanations for obesity identified in a study by David Allison and Scott Keith of the University of Alabama at Birmingham.

“In all likelihood, the rise in obesity results from a combination of several of these factors, each making its own contribution and perhaps interacting with other causes in some yet-more-complicated way,” writes Spiesel.

History As Appetizing As Tater Tots: I admit I fall hard for history texts that bring in the social and cultural implications, which is why I’m putting this on my summer reading list: “School Lunch Politics: The Surprising History of America’s Favorite Welfare Program” (Princeton University Press, 2008) by Susan Levine, a University of Illinois at Chicago professor of history.

“The National School Lunch Program has outlasted almost every other 20th century federal welfare initiative and holds a uniquely prominent place in popular imagination,” Levine said in this UIC release. “It suggests the central role food policy plays in shaping American health, welfare and equality.”

Levine, by the way, is also the author of “Degrees of Equality: The American Association of University Women and the Challenge of Twentieth Century Feminism,” and “Labor’s True Woman: Carpet Weavers, Industrialization and Labor Reform in the Gilded Age.”

Strategic Spending on Organic Foods: With the price of organic foods rising, here’s some good advice for shoppers who want to prioritize spending on those organic fruits and vegetables that have a high pesticide residue when grown conventionally. Check out the The Environmental Working Group’s list of 43 fruits and vegetables tested for pesticide residue.


April 12, 2008

Double Dose: Breast Implants and Illnesses; Lawsuit Over Ortho Evra Birth Control Patch; Abortion Has Left the Classroom; Aging and Quality of Life; Mothers Movement Online; Digital Mammograms Lead to More Call-Backs; Razor Blades and Inner Goddeses

Dumb Quote of the Week: “Eighteen is certainly an age where we’re putting men and women in uniform on a battlefield … I think they can decide if they want larger breasts.” — Dr. Alan Gold, a Great Neck, N.Y., plastic surgeon, as quoted in this Newsday story on breast implants.

The story notes that “according to the American Society for Aesthetic Plastic Surgery, the number of women 18 and younger who have had breast enlargements has risen nearly 500 percent over the last decade, a sharper climb than the 300 percent increase in breast augmentations among all age groups,” but it doesn’t cover the health risks except to note the recent death of Stephanie Kuleba, 18, of South Florida, who died of what may have been a rare genetic reaction to general anesthesia given during breast-augmentation surgery.

It does, however, include this important point:

Traci Levy, an assistant professor who teaches courses in feminism and gender studies at Adelphi University, said the growing perception that it’s a common procedure, along with ads for plastic surgery, may contribute to its popularity.

“To say that you need to have a very expensive surgical procedure with real health risks in order to be considered beautiful, I think, is a problematic image,” she said.

Plus: Kacey, who got breast implants when she was 19 and tells her story at ImplantsOut.com, blogged recently at Beauty and the Breast about the illnesses she experienced (and is still experiencing) that she believes are linked to her implants.

Kacey was a recent guest on Fox’s “The Morning Show with Mike and Juliet,” and she wrote that another guest — an 18-year-old who wants breast implants — commented off-stage, “They’re just breast implants. It’s just like getting your hair cut!”

“I just got my hair cut – no scalpels, drains, anesthesia, surgeons or nurses necessary,” writes Kacey. “I will never wonder if my hair cut will cause joint pain. Can anyone say the same about breast implants?”

Aging Among the Haves and Have-Nots: “Seniors are living longer, healthier and more financially secure than past generations, according to a federal report released by several government agencies last month. But large disparities separate the quality of life for seniors of different genders, ethnicities, education levels and incomes,” reports the Ventura County Star, which headlines the story with this statistic: 71,500,000 Americans will be 65 and older in 2030, compared with 37 million people in 2006.

Plus: Read more on The Older Americans 2008 study, released by the National Institute on Aging.

Behind a Legal Shield: Here’s an extremely frustrating legal story concerning the Ortho Evra birth control patch, as reported by The New York Times:

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

Naturally, the Bush administration backs this doctrine. Read the whole story. And here’s a powerful op-ed on FDA oversight.

Abortion Has Left the Classroom: RH Reality Check has an excellent package of stories on the shortage of abortion doctors, all written by members of Medical Students for Choice.

“As recently as six or seven years ago, abortion was included in my medical school’s curriculum, but no longer,” writes Louisa Pyle, adding:

Medical school is, in many ways, a language school. Someone told me once that a medical student learns over 20,000 new words in their first two years of school, and in addition to the new vocabulary, I soon became capable of saying things over dinner that one should never say. “Rectum” no longer induces giggles and “vagina” is boring, not sexy or empowering. And yet, the word “abortion” is still said with a pause, a nod, a little quieter than the rest of the sentence. I’m happy when we talk about it at all: for me, the problem is the deafening silence. That a procedure more common than an appendectomy would never be named: In the halls of science and healthcare, that to me is an abomination.

Nicole Wolverston writes about the work of Medical Students for Choice. Jalan Washington, who is also a member of Advocates for Youth, writes about her frustration since starting medical school “with the lack of widespread action to address many of the educational, social, and economic determinants of health.”

“Hearing bleak statistics about Black and Latino health is a commonplace, routinely accepted, and unquestioned part of the American medical landscape. Very seldom do our discussions then proceed to the ways in which health care providers and the medical infrastructure directly contribute to these trends,” she writes.

Mothers Movement Online: The most recent issue of Mothers Movement Online is the pregnancy and childbirth issue. Included among the engaging and informative essays is an interview with OBOS executive director Judy Norsigian.

MMO Editor Judith Stadtman Tucker (read her editor’s notes) is a contributor to the new OBOS book on pregnancy and birth, specifically the section on advocating for the workplace rights of pregnant and parenting women.

In Shift to Digital, More Repeat Mammogram: As doctors learn to interpret digital mammograms, they are more likely to request second tests, reports The New York Times. Denise Grady writes:

At many centers, these nerve-racking calls are on the rise, at least temporarily — the price of progress as more and more radiologists switch from traditional X-ray film to digital mammograms, in which the X-ray images are displayed on a computer monitor.

Problems can arise during the transition period, while doctors learn to interpret digital mammograms and compare them to patients’ previous X-ray films. Comparing past and present to look for changes is an essential part of reading mammograms. But the digital and film versions can sometimes be hard to reconcile, and radiologists who are retraining their eyes and minds may be more likely to play it safe by requesting additional X-rays — and sometimes ultrasound exams and even biopsies — in women who turn out not to have breast cancer.

Over at Well, Tara Parker Pope put up pictures showing the difference between a normal digital mammogram and a normal mammogram from traditional X-ray film.

Plus: Here’s a brief but important post from the L.A. Times health blog on how MRIs may affect breast cancer treatment decisions.

Estrogen Linked to Benign Breast Lumps: “Add another risk to hormone therapy after menopause: Benign breast lumps,” reports the AP. A new study published in the Journal of the National Cancer Institute re-examines data from the Women’s Health Initiative pertaining to women who took estrogen only (women who had hysterectomies) instead of the estrogen-progestin combination hormone therapy.

Those estrogen-only users doubled their chances of getting non-cancerous breast lumps. That’s a concern not only because of the extra biopsies and worry those lumps cause, but because a particular type — called benign proliferative breast disease — is suspected of being a first step toward developing cancer 10 years or so later.

Razor Blades and Inner Goddesses – Get the Connection?: I missed this story about the latest in razor blade technology when it first came out, but it’s worth noting if only for the silly take on how shaving razors are marketed to women. The piece looks at the new advertising campaign around the Gillette Venus Embrace, which turns users into deities. (Any readers feeling transformed? Do tell.)

“Now we’ve given women the permission to reveal her own goddess,” said Gro Frivoll, who has worked on the Venus account at BBDO for eight years. “Every woman can be the goddess of something, because this allows you to be your most feminine self.”

Ack. Read on and the message is less, um, smooth:

When Gillette pitches razors to men, it tends to emphasize technological innovations. But on the women’s side, “we focus more on the emotional end benefits,” Ms. Frivoll said. ‘Men want to know, What am I paying more for? If a man were paying $25 for lipstick, it would have to have more than the Chanel name on it.”


March 11, 2008

Documentary Examines Breast Implant Safety

absolutely_safe.jpg

Boston University will screen “Absolutely Safe,” a documentary examining breast implant safety and the role of beauty, on Friday, March 28.

A Q&A with the director, Carol Ciancutti-Leyva, will follow.

From the film’s synopsis:

At a time when more women than ever are getting breast implants, fewer voices than ever seem to be asking “Why?” And fewer still are asking “Are they safe?” ABSOLUTELY SAFE takes an open-minded, personal approach to the controversy over breast implant safety. Ultimately, ABSOLUTELY SAFE is the story of everyday women who find themselves and their breasts in the tangled and confusing intersection of health, money, science, and beauty.

OBOS Executive Director Judy Norsigian has high praise for the documentary, calling it “the perfect antidote to ads and TV shows that now routinely mislead women into thinking that these devices have been proven to be safe.” You can read reviews here.

And check out the rest of the website, which is among the best film websites I’ve seen in terms of presentation and issue information. The implant controversy is covered in-depth, and there are numerous resources and links for more background identified in each section.

The free film screening at BU starts at 6:30 p.m. and takes place in Sargent College Room 101, 635 Commonwealth Avenue. It’s sponsored by Every Person Counts.

“Absolutely Safe” has been shown on college campuses and in cities around the country. If you’re interested in organizing a screening, contact info AT absolutelysafe.com.


October 4, 2007

Marketing the Mommy Makeover

Marketing is truly an amazing thing.

Only in recent years have mothers been made to feel ashamed if they don’t have stick-thin figures with buoyant breasts within weeks of giving birth. And now there’s a whole industry working off that new guilt, targeting women with a smorgasbord of surgery options packaged as the quick-and-easy path to the perfect body.

Plastic surgeons have figured out a new way to sell a full-body tune-up: Start by calling it the “Mommy Makeover.” Offer a trifecta of procedures — breast lift (maybe implants to go along it), tummy tuck and liposuction — with a price tag starting around $10,000. Cue terms like “positive self image” and “embrace the feeling of being a woman.”

That’s what the website of Dr. David A. Stoker does. And Stoker leaves no question about his opinion of women’s postpregnancy bodies: “The severe physical trauma of pregnancy, childbirth and breast-feeding can have profound negative effects that cause women to lose their hourglass figures,” Stoker tells the New York Times.

“Twenty years ago, a woman did not think she could do something about it and she covered up with discreet clothing,” he adds. “But now women don’t have to go on feeling self-conscious or resentful about their appearance.”

Of course what this really amounts to is a thinly-veiled critique of women’s bodies that don’t fit a very particular ideal. NYT writer Natasha Singer does a good job of contextualizing this critique, starting with some OBOS history:

In 1970, “Our Bodies, Ourselves,” the seminal guide to women’s health, described the cosmetic changes that can happen during and after pregnancy simply as phenomena. But now narrowing beauty norms are recasting the transformations of motherhood as stigma.

These unforgiving standards are the offspring of pop culture and technology, a union that treats biological changes as if they were as optional as hair color. Gossip magazines excoriate celebrity moms who don’t immediately lose their “baby weight.” Even Cookie, a luxury parenting magazine, recently ran an article that described postpregnancy breasts as “the ultimate indignity” and promoted implant surgery; a photo of droopy water-filled balloons accompanied the article.

Many women struggle with the impact of aging and pregnancy on their bodies. But the marketing of the “mommy makeover” seeks to pathologize the postpartum body, characterizing pregnancy and childbirth as maladies with disfiguring aftereffects that can be repaired with the help of scalpels and cannulae.

“The message is that, after having children, women’s bodies change for the worse,” said Diana Zuckerman, the president of the National Research Center for Women and Families, a nonprofit group in Washington. If marketing could turn the postpregnancy body “into a socially unacceptable thing, think of how big your audience would be and how many surgeries you could sell them,” she said.

Or as Judy Norsigian, executive director of Our Bodies Ourselves, tells the Times, “Some women go back to a pretty flat stomach and some don’t, some go back to their pre-baby weight and some don’t. The question is, does that need to be treated with a surgical makeover?”

The story concludes with what I thought was a great quote:

On the blog StrollerDerby, Karen Murphy, a mother of four, lambasted mommy surgery.

“Those badges of motherhood have turned into badges of shame and, if you’re the one caught without a tummy tuck, then you won’t get invited to the party,” she wrote. “It peeves me no end that something as drastic as surgery, as this blatant nonacceptance of one’s own body in whatever shape it happens to be in, has become so pervasive.”

Read Murphy’s full blog post, though, and you’ll see her feelings toward the surgery are a little more complicated. While her ambivalence and frustration is totally understandable, I think the Times, by not quoting Murphy more fully, over-simplifies the point.

A side note: The caption accompanying the photo at the top of the story says Sharlotte Birkland “had postpregnancy surgery in March.” Yet according to the story, she’s 39 and has a 20-year-old son. Wouldn’t her case be, well, just plastic surgery?

The American Society of Plastic Surgeons, notes the Times, “reported a rise in cosmetic surgery among women of child-bearing age (not all of whom are necessarily mothers). Last year, doctors nationwide performed more than 325,000 ‘mommy makeover procedures’ on women ages 20 to 39, up 11 percent from 2005, the group said.”

So it seems a little tricky to break out how many “mommy makeovers” are being done vs. how many women in the “mommy demographic” are now opting for multiple procedures.

Plus: The Times, in a separate short piece, looks at vaginal rejuvenation surgeries, such as labioplasty and vaginoplasty, which were recently criticized by the American College of Obstetricians and Gynecologists for providing no benefits and leading to complications such as infection, scarring and pain during sex.

“These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented,” ACOG said in the journal Obstetrics and Gynecology.


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.