Category Archives: We Are Quoted

The Rising Trend of Breast Implants in America

We Are Quoted
BBC Persian: April 3, 2013.

With 330,631 breast augmentation procedures performed in the United States in 2012 alone, America is now officially the global leader in this branch of cosmetic surgery and breast implants are now the second most popular plastic surgery in the world. […]

Florence Williams, author of BREASTS: A Natural and Unnatural History: “I think the plastic surgery industry has been masterful at marketing implants and augmentation as very benign procedures It sort of in line with other procedures women get Botox, hair colouring, this is marketed as yet another way improve you image.” […]

Diana Zuckerman, Ph.D. President, National Research Centre for Women & Families Cancer Prevention and Treatment Fund: “Self-esteem is not like having a bad hair day and a good hair day. People feel better about themselves on a good hair day than a bad hair day, but it doesn’t change their self-esteem; it doesn’t change how they really feel about themselves. And so the objective studies that have been done of cosmetic surgery–and this is true for breast implants and other surgeries–show that usually men and women who have cosmetic surgery feel better about the body part that was fixed. If their nose was changed they like their nose better, if their ears don’t stick out they like their ears better. If their breasts are larger they might feel sexier and think their breasts look nicer but it doesn’t actually change that sort of basic feeling of who they are.” […]

Mental health specialists believe anyone considering aesthetic procedure should make sure that they are doing so for the right reasons. If they are looking for a procedure because they feel society wants them to look a certain way or someone is pressuring them to have it done – it is unlikely that the operation will improve their quality of life. If however, they want to do it for themselves to feel younger when they look in the mirror, and if they have weighed in all the risks involved, then they will have a much more positive outcome — both mentally and physically.

 To view the segment (in Farsi) click here.

Women’s Health Advocates Question FDA About Missing Safety Data on Silicone Breast Implants

We Are Quoted, ,
Matthew Perrone, Associated Press: January 5, 2012.

[…] FDA concluded last summer that the silicone-gel implants are basically safe as long as women understand they come with complications. More than one in five women who get implants for breast enhancement will need to have them replaced within five years, the agency’s report concluded.

In August, an outside panel of physicians affirmed the FDA’s decision that the devices should remain available for both breast enhancement and reconstruction.

But the National Research Center for Women and Families says the FDA did not present information that showed women reported lower emotional, mental and physical well-being after implantation. Additionally, the group questions why figures presented by the FDA appear to show implant complications declining over time. The implants are known to fail over time.

“This shows problems with the data, since the complication rates are reported to be cumulative and should therefore stay the same or increase over time,” states Diana Zuckerman, the group’s president, in a letter to the head of FDA’s medical device division.

Most of the FDA’s data on the safety and effectiveness of breast implants comes from long-term studies conducted by the two U.S. manufacturers of the devices, Allergan Inc. of Irvine, Calif., and Mentor, a unit of Johnson & Johnson, based in New Brunswick, N.J.

When the FDA reviewed the initial applications for the devices in 2005, women using Allergan’s implants scored lower on nine out of 12 quality-of-life measures, including mental, social and general health. Women did report higher scores on measures of sexual attractiveness-body esteem.

Women implanted with J&J’s implants also scored worse on measures of physical and mental health. In the 11-page letter, Zuckerman questions why that information was not presented at FDA’s public meeting in August.

“Breast implants are widely advertised and promoted as a way to increase women’s self-esteem and positive feelings about themselves,” said Zuckerman, in an interview with the Associated Press. “But the implant companies’ own data, which the FDA made public in 2005 but ignored last year, shows the opposite.” […]

Breast implants are known to rupture and break down over time. But Zuckerman points out in her letter that the company data seem to defy this trend, with complication rates falling over time.

For instance, Allergan’s reported rate of swelling among patients fell from 23 percent in 2005 to 9 percent reported in 2011. Rates of scarring similarly fell from 8 percent to 4 percent.

“This again raises questions about the accuracy of reporting, and whether patients with complications were excluded from the 10-year sample,” writes Zuckerman. […]

 

Read the original article here.

FDA: Breast Implant Safety Studies Will Continue

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 Brenda Goodman, WebMD: August 31, 2011.

After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue.

“The current post-approval studies will continue,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health, in remarks after the meeting. “The FDA is committed to seeing them completed and making sure the follow-up rates improve.”

The safety studies in question, of nearly 100,000 women with breast implants, which the FDA said were the largest ever required of manufacturers after their devices were marketed to the public, have lost track of up to 79% of the women they enrolled just three years into planned 10-year efforts.

As a result, FDA epidemiologists testified yesterday, the studies had lost the ability to find rare complications, including connective tissue diseases, that they were designed to look for. […]

Consumer advocates, like Dana Casciotti, PhD, the public health research director at the Cancer Prevention and Treatment Fund, said annual, 27-page questionnaires women were asked to complete should be shortened and simplified.

“I’ve seen copies of these questionnaires, and they are much too long” and technical, she said.

Read the original article here.

F.D.A. Affirms Safety of Breast Implants

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Gardener Harris, The New York Times: August 31, 2011.

WASHINGTON — After two days of discussion and testimony about silicone breast implants, a top government health official said he had heard nothing to shake his faith in the safety of the widely used implants.

The official, Dr. William Maisel, chief scientist for the Food and Drug Administration’s Center for Devices, said silicone breast implants were safe. […]

Some patients and women’s groups who testified at the meeting disagreed.

Diana Zuckerman, president of the National Center for Health Research, a research and education group, told an expert panel that the two companies that manufacture silicone breast implants — Johnson & Johnson and Allergan — had done a poor job of studying patients who got the implants, as the F.D.A. required them to do.

“And without proper data, we still don’t know how safe or effective they are and whether there are certain patients at risk for extremely negative outcomes,” Ms. Zuckerman said. […]

There was some criticism of the 27-page research form that patients who participate in the study are required to complete and whether it could be shortened. Nearly all expressed hope that a registry could be created that would follow all breast implant patients, but such registries are expensive to maintain and complicated to create. […]

Read the original article here.

FDA explores possible link between breast implants, cancer

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Andrew Zajac, The Los Angeles Times: January 26, 2011.

The Food and Drug Administration announced Wednesday that it has begun investigating the possible connection between breast implants and an increased risk of a rare form of cancer.

Though the number of women who may develop the disease is small, there is apparently no way to identify those who are likely to develop it — making it a source of potential concern to all women with the implants.

Among women who do not have implants, the cancer — anaplastic large cell lymphoma, or ALCL — develops in the breast tissue of about 3 out of 100 million women nationwide. [..]

“It raises a red flag about what other immune disease could be occurring that are not obvious,” said Diana Zuckerman, president of the National Research Center for Women & Families.

The FDA based its announcement on a review of scientific literature between 1997 and last May, which reported 34 cases of ALCL in women with breast implants, as well as other information from international regulatory agencies, scientific experts and implant manufacturers, which turned up additional cases. […]

Read the original article here.

Plastic Surgery for Teens

We Are Quoted, , ,
Valerie Ulene, The Los Angeles Times: Jan 12, 2009.

The American Society of Plastic Surgeons estimates that more than 330,000 adolescents — most of them female — underwent cosmetic procedures in 2007. The most popular surgical procedures were nose jobs, breast augmentation, ear reshaping and liposuction.

Of course American teens want to undergo these procedures: They face tremendous pressure to be attractive, and they’re constantly bombarded with images of beautiful men and women who are held up as the norm.

“We’ve made a decision about what beauty looks like in this country, and everybody — teens in particular — wants to fit the mold,” says Diana Zuckerman, president of the National Research Center for Women and Families, a nonprofit organization that works to improve the health of women and children.

But, in general, cosmetic surgery may not be appropriate for adolescents. After all, altering the way you look before you’re even done developing physically seems almost ridiculous.

Many plastic surgeons argue that cosmetic procedures aren’t just about improving appearances; they make the case that surgery can improve teenagers’ self-esteem too. […]

“Although patients who have undergone a cosmetic procedure often do feel better about that particular body part, there’s really no data to suggest that it improves their overall body image or self-esteem,” Zuckerman says. […]

Teens need to be mature enough to understand what the surgery can and cannot do for them. A nose job may eliminate a bump and liposuction might slim their hips, but these procedures won’t eliminate problems in their lives.

Read the original article here.

 

Some Hidden Choices in Breast Reconstruction

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Natasha Singer, New York Times: December 23, 2008

For many cancer patients undergoing mastectomies, reconstructive breast surgery can seem like a first step to reclaiming their bodies.

But even as promising new operations are gaining traction at academic medical centers, plastic surgeons often fail to tell patients about them. One reason is that not all surgeons have trained to perform the latest procedures. Another reason is money: some complex surgeries are less profitable for doctors and hospitals, so they have less of an incentive to offer them, doctors say.

“It is clear that many reconstruction patients are not being given the full picture of their options,” said Diana Zuckerman, the president of the National Research Center for Women and Families, a nonprofit group in Washington. […]

Implant surgery is the most popular reconstruction method in the United States. Often performed immediately after a mastectomy, it initially involves the least surgery usually a short procedure to insert a temporary balloon-like device called an expander and the shortest recovery time.

But implants come with the likelihood of future operations. Within four years of implant reconstruction, more than one third of reconstruction patients in clinical studies had undergone a second operation, primarily to fix problems like ruptures and infections, and a few for cosmetic reasons, according to studies submitted by implant makers to the Food and Drug Administration. (Reconstructive patients are more likely to develop complications after implant surgery than cosmetic patients with healthy breast tissue.)

“Patients should not necessarily accept the first thing they hear as the end-all, because that is not necessarily the full story,” Dr. Allen said.

[…]

Read the original article here.

Women’s Health: A Red-Flag Warning

We Are Quoted, ,
Seattle Post-Intelligencer: January 12, 2007

We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.

Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. […]

We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Health Research at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:

 Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.

 Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.

 You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.

 By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA. […]

Read the original article here.

Silicone: Now a Solid ‘Maybe’

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Melissa Healy, The Los Angeles Times: November 27, 2006.

The days before Thanksgiving are typically quiet in the offices of plastic surgeons. But a long-awaited decision to approve silicone breast implants for women older than 22 prompted a flurry of excited calls and inquiries last week from prospective patients. […]

The agency’s decision “does create a whole host of questions” for women considering silicone breast augmentation and for the doctors who perform those procedures, said Dr. Walter Erhardt, chairman of the American Society of Plastic Surgeons’ public education committee. […]

Cleared but questioned

The FDA’s approval — after 14 years of study — had been expected to end the controversy around silicone gel implants.

The devices were pulled from the general marketplace in 1992 amid concerns that they could rupture and endanger women, possibly contributing to autoimmune diseases. Although a link to health problems was never proved, long-term safety has remained an issue. In the meantime, the implants have remained available to cancer survivors and a wide range of women who agreed to enroll in studies of the implants’ safety.

But the new recommendations present patients and their plastic and aesthetic surgeons with additional uncertainties: Who will pay for the recommended MRI scans? What danger does the FDA foresee if patients, as expected, fail to get them? Does the FDA consider that a ruptured implant device — even one that presents no discomfort or proven danger to the patient — must necessarily be surgically removed and replaced? If so, whose financial responsibility would that be?

“Do you think [insurance companies] are going to say, ‘No problem, we want what’s best for the patient?’ ” asks plastic surgeon Marcel Daniels of Long Beach. “No. A lot of third-party payers have ruled out payment for any treatment — including complications — related to breast implants.”

What to do if those MRI scans detect cracks or breaks in an implant “is another conundrum that’s created by this [FDA] recommendation,” said Erhardt, of Albany, Ga. By calling for costly MRIs to detect silent ruptures and potential replacement surgery in such cases, the FDA is suggesting to patients and physicians that leakage may present safety concerns. “But we still don’t have science that [a silent rupture] creates a harmful situation for the patients. And the FDA hasn’t addressed that either,” Erhardt said. […]

The specialized MRI images required to detect the integrity of a breast implant typically cost between $1,500 and $1,800, said Diana Zuckerman, director of the National Research Center for Women & Families, a nonprofit research and education organization in Washington, D.C. Costs at some centers can reach up to $4,000, and many women would have to travel long distances to get the recommended images, added Zuckerman, whose organization testified against the latest silicone implant approval.

“These young girls are often going into debt that they can’t really afford to get out of, and they’re paying for something on installment that they can barely afford,” Zuckerman said. “I certainly think any woman who is not affluent would be crazy to choose silicone because of the additional cost.” […]

Read the original article here

FDA Ends Ban on Silicone Implants

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David Brown and Christopher Lee, The Seattle Times: November 18, 2006.

The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

The FDA is requiring that manufacturers tell women that the implants “are not lifetime devices” and that most recipients will need at least one additional surgery to remove or replace their implants. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government. […]

Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 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.” A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices. […]

Diana Zuckerman, president of the National Research Center for Women and Families, said the approval was the product of corporate lobbying rather than good science.

Zuckerman, a former Capitol Hill staffer who has worked on breast implant safety issues for more than 15 years, said too little is known about the long-term health risks of the implants. She said what is known indicates that some women will experience joint pain, chronic fatigue and leakage. […]

Read the original article here.