Tag Archives: FDA

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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FDA Agrees with WHO, Links Breast Implants to Rare Cancer. How Worried Should Women Be?

Rita Ruben, Forbes: March 22, 2017.

The Food and Drug Administration has received nine reports of women dying of a rare blood cancer years after getting breast implants, according to information the agency released Tuesday.

The FDA says it now agrees with the World Health Organization that such cases are linked to the breast implants and not some unfortunate coincidence. As of Feb. 1, the FDA says, it had received a total of 359 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The FDA reports suggest that implants with a textured surface are more likely to be associated with the cancer than smooth implants—of the 231 reports that contained information about the implant’s surface, 203 were reported to be textured implants, while 28 were reported to be smooth. The Australian Therapeutic Goods Administration (TGA) analyzed 46 confirmed cases of BIA-ALCL, including three deaths, and none of the cases occurred in women with smooth implants.

BIA-ALCL on average is diagnosed about a decade after implant surgery, according to the WHO. The first reported case of a woman with breast implants developing ALCL was published in a 1997 letter to the journal Plastic & Reconstructive Surgery. While that case was a woman with saline-filled implants, the FDA says the filling, be it saline (salt water) or silicone, doesn’t seem to make much of a difference, although no well-designed studies have yet been conducted to settle that issue.

BIA-ALCL is rare, but just how rare isn’t clear. As the FDA notes, it medical device reports can’t answer that question, because they don’t represent all cases, and the denominator—the total number of women who’ve received breast implants—isn’t known.

ALCL is more common in the breasts of women who’ve had implants than in those who don’t have implants, in whom the cancer almost never develops in the breast. A U.S. studypublished in January concluded that over their lifetime, 3.3 women out of every 100,000 with textured breast implants will develop BIA-ALCL. But the TGA estimates that the disease is more common, affecting 1 in 10,000 to 1 in 1,000 women with breast implants (that agency says it has received no reports of BIA-ALCL in women with smooth implants).

“There is no reason to think it is less likely to develop in women in the U.S., and given the dramatic increase in diagnoses in recent years, it is clear that it was under-diagnosed and under-reported for many years,” Diana Zuckerman, a health advocate who has long questioned the safety of breast implants, told me.  Zuckerman serves as president of both the National Center for Health Research and the Cancer Prevention and Treatment Fund, nonprofits based in Washington, D.C.

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

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. […]

 

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FDA: Breast Implant Safety Studies Will Continue

 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.

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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. […]

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FDA explores possible link between breast implants, cancer

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. […]

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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: Now a Solid ‘Maybe’

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.” […]

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FDA Ends Ban on Silicone Implants

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. […]

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Silicone Implants Backed by FDA Panel

Marc Kaufman, Washington Post: April 14, 2005.

A Food and Drug Administration advisory panel recommended yesterday that silicone gel breast implants made by Mentor Corp. be allowed back on the market for wider use — a surprise decision that came a day after the same panel rejected the application of a rival company.

Mentor officials were delighted by the panel vote.

In explaining their decision, several panel members said they were more impressed by Mentor’s data on how and why implants rupture and by the lower rupture rate of its implants. While Inamed reported a yearly ruptue rate of about 1.4 percent, the yearly Mentor rate was 0.2 percent — a figure that had been questioned by FDA reviewers.

The panel decision was sharply questioned by Inamed officials, who had been criticized the day before for not having sufficiently long-term data.

“Inamed views today’s panel decision as curious and inconsistent with the decision reached by the panel yesterday on Inamed’s [application] — we look forward to working with Dr. [Lester M.] Crawford and FDA staff on addressing these inconsistencies,” Inamed president and chief executive Nicholas L. Teti said in a statement.

About 260,000 American women had their breasts enlarged with implants last year, and an additional 60,000 had received them after surgery for breast cancer.

Because of health concerns, the FDA in recent years has allowed silicone gel implants to be used only in women who had mastectomies and in some who take part in clinical trials; all others received implants filled with a saline solution. Many women say the silicone gel looks and feels more natural, and it is widely used in other parts of the world.

The panel’s decision was also criticized by some public interest groups, which have long argued that the potential dangers of silicone gel implants remain insufficiently studied.

“I think this was a triumph of wishful thinking which overruled the lack of science,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families. “Because of all the conditions, it’s far from a done deal regarding the FDA. It’s not helpful to women to have a product approved on the basis of two years of safety data.”

[…]

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