Tag Archives: breast implants

Breast Implant Illness: Two Metro Women Say Implants Caused Years of Complications

Ben Oldach, WHO TV: May 21, 2018.

Breast implants are the most popular form of plastic surgery in the United States. Katie Krug’s followed a botched breast reduction.

“There were quite a few people that asked me when I was in a bathing suit if I had open heart surgery, so it was something that I was really self-conscious about,” said Krug. […]

“About a year later is when I started noticing some really small symptoms. I was tired a lot more, started having some brain fog, started being really sensitive to smells, and then it just seemed like every year it got worse,” said Krug. […]

Both women say they went to doctors who couldn’t figure out what was wrong, all while new symptoms were developing. […] and after doing some research found a Facebook group of 35,000 women, all claiming similar symptoms.

The women in the group believe they are suffering or had suffered from something being called breast implant illness, although experts say it’s a symptomatic reaction rather than an actual disease. […]

Miller and Krug consulted with a local plastic surgeon who performs explants and had theirs removed. They say they immediately started feeling better. […]

Read the original article here.

25 Reasons Not to Get Breast Implants

Dr. Nalini Chilkov, The Huffington Post: Dec 7, 2017

Last week the FDA reported that breast implants put women’s lives in danger. The big news last week was that a small number of women can get a very rare type of cancer (ALCL: anaplastic large cell lymphoma). It confirmed that death is a possible side effect of breast implants. […]

According to Diana Zuckerman, Ph.D., Elizabeth Nagelin-Anderson, M.A.
and Elizabeth Santoro, R.N., M.P.H.: In 2008, more than 300,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, and almost 80,000 breast cancer patients had reconstruction after mastectomy, often with implants. The popularity of breast augmentation has more than tripled since 1997, when there were just over 101,000 of these procedures. More than 40,000 implant removal procedures were also reported in 2008. […]

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year. Silicone-7 migrated outside of the breast capsule for 21 percent of the women, even though most women were unaware that this had happened.

Don’t forget the financial burden and increased health insurance costs that go with multiple surgeries and medical complications. In some cases the surgery to remove implants can be like a mastectomy, complete removal of the breast tissue and sometimes the muscle underneath.

Read the original article here.

 

A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

Denise Grady, The New York Times: May 14, 2017.

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest. […]

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants.  […]

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling […] An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease. […]

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston. […]

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants. […]

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy. […]

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit. […]

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted […]

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Can Breast Implants Cause Cancer? WJLA Investigates


“You have cancer — again.”

“What? Breast cancer?”

“No … a new one.”

So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she survived breast cancer seven years earlier.

Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.

“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”

The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.

But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants. […]

When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL. […]

7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:

“It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.

Read the original article here.

Can Having Breast Implants Lead to Suicide? 7 On Your Side Investigates

Kimberly Suiters, WJLA ABC7: November 7, 2016.

Three-hundred thousand women will get breast implants this year, making it the number one cosmetic surgery in the U.S. Research shows the typical breast implant patient has high self-esteem and good mental health, higher and better than the general population. According to implant manufacturers, satisfaction rates top the 83-97 percentile range, excellent results for any kind of surgery. So why would some women with breast implants have a higher rate of suicide than women who don’t have them?

“Maybe just a coincidence,” Dr. Scott Spear, a well-known plastic surgeon in Washington, D.C., told 7 On Your Side. “There may be an association between breast implants and suicide, but it’s probably a loose association.”

That’s not the way Diana Zuckerman, PhD, president of the National Research Center for Women and Families, sees it. Not at all.

“When you look at suicide and implants, the women with breast implants are more likely to kill themselves.”

How much more likely? Anywhere from two to 12 times. Zuckerman wrote about that conclusion after evaluating seven studies on the topic.

“Some surgeons believe if a woman with implants kills herself, she must’ve had something wrong to begin with; that she got implants because of low self-esteem, depression, to feel better. But women with implants are more likely to kill themselves than with other (plastic) surgeries. Why would a mastectomy patient be 10 times as likely to kill herself as a mastectomy patient who doesn’t have implants?”

Zuckerman doesn’t know that answer definitively, but she is convinced there is something physiological or mental that causes women with implants to have a diminished view of themselves.

The number of women who get to that tragic point is small. According to the CDC: 9.8 women per 100,000 will commit suicide. And middle-aged women, in general, had the largest increase in suicide in the last 15 years, up 63 percent.

Dr. Zuckerman said women going through menopause are one of the highest risk groups. Their bodies have changed after giving birth, and they may be lured in by “Mommy Makeover” marketing.

“But according to research,” she said, “it’s a bad time. A dangerous time.”

[…]

Read the original article here.

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. […]

Read the original article here.

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 new 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 new research, published in a recent 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.