Tag Archives: breast implants

F.D.A. Affirms Safety of Breast Implants

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.

Plastic Surgery for Teens

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.

 

Women’s Health: A Red-Flag Warning

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. […]

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Silicone Implants Generate Renewed Debate

Colette Bouchez, HealthDay: August 21 2002.

As federal health officials ready for hearings on whether silicone breast implants should be allowed back on the U.S. market, a 2002 study offers evidence of a reduced rate of implant rupture. The study, conducted by a group of Danish researchers, used magnetic resonance imaging (MRI) to study implant rupture rates in some 300 women for a period of three years. From that data, the researchers extrapolated a rupture rate of 15 percent to 17 percent 10 years after the women received the implants. […]

Diana Zuckerman, a former member of the National Cancer Institute advisory committee on breast implants, says the study offers a gross underestimate of the implant rupture problem.

“If it were truly 15 percent at 10 years, that would be an improvement, but I do not believe for a minute that it is 15 percent. It’s an estimate based on an assumption that I don’t believe this study supports,” says Zuckerman, executive director of the National Center for Policy Research for Women and Families.

Zuckerman notes the research, published in an issue of the Archives of Surgery, only studied women for three years. And without specific 10-year data, there’s no real way to accurately project the rate of rupture across an entire decade, she says.

A study published in 2000 by the U.S. Food and Drug Administration (FDA) found a silicone implant rupture rate as high as 55 percent, with up to 69 percent of all women likely to experience a rupture in at least one breast. […]

“Up until two years ago there were no specific studies done on the health problems of women whose implants ruptured. And when this research was finally conducted, in one study by the FDA and two by the NCI (National Cancer Institute), there was a significant increase in certain health problems in the women with the ruptured implants,” Zuckerman says.

Zuckerman says the findings from the NCI studies were even more troubling. In this research, doctors compared women who had breast implants to other plastic surgery patients, and found the implant group (most of whom had silicone gel implants) were more than twice as likely to die from brain cancer, and three times as likely to die of lung cancer.

“If I were a woman contemplating silicone breast implants, this would sure scare me,” Zuckerman says. […]

Read the original article here.