Category Archives: We Are Quoted

How Safe Are Breast Implants, Really?

Rebecca Nelson, Elemental by Medium: September 3, 2019.


When Jamee Cook got breast implants at 21, she hoped to feel more confident about her body. Instead, the implants nearly ruined her life.

Just three years after her surgery, Cook, who is now 42, started having a slew of medical problems: fatigue, fevers, sinus infections, memory problems, and trouble concentrating. She felt like she constantly had the flu and could barely muster the energy to take care of her three kids. Because of her health problems, she had to quit her job as a paramedic. Four years ago, she finally saved up enough money to get her implants removed due to the complications and discovered her symptoms subsided. “I felt like I did a turnaround,” she says. She had finally gotten her life back.

Cook is not an outlier among women with breast implants. The safety of breast implants has long been a topic of debate in the medical community. After a safety scare in the 1990s, silicone implants were banned for more than a decade before the U.S. Food and Drug Administration (FDA) allowed them back on the market in 2006. But a growing body of evidence suggests that these newer breast implants aren’t as safe as this generation of women has been led to believe. The FDA requested in July that the implant manufacturer Allergan recall their textured implants, citing a link to a rare cancer called breast implant-associated anaplastic large cell lymphoma. And an online movement of thousands of women who say their implants have made them sick is calling more attention to other long-term complications.

Breast implants first came on the market in the U.S. in the 1960s. They are classified as medical devices by the FDA and an estimated 10 million women around the world have them currently. While the vast majority of those women don’t have issues, there’s increasing evidence that implants are associated with serious risks. But the available data on their safety is of poor quality, and doctors, researchers, and patients disagree about what some of the risks actually are — making it all the more difficult for women to determine them before making a decision.

The medical community has long downplayed the potential complications of implants, says Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., who has studied implants. “There are many, many plastic surgeons whose entire livelihood depends on doing breast augmentation surgery. If they were to tell every patient what all the risks are, they’d have fewer patients.”

Here’s what’s known for sure: Nearly 600 cases of breast implant-related anaplastic large cell lymphoma, a cancer of the immune system, have been reported to the FDA. As of July, 33 people died from it. Textured implants made by Allergan were linked to the cancer, and recalled globally that month. While the FDA says there’s generally a low risk of people with breast implants developing cancer from them, the agency said in a statement at the time that “we believe all individuals who are considering a breast implant of any type be informed of the risk.”

“Of the millions of women with breast implants, we know that complications occur in at least 1% of patients,” says FDA spokeswoman Stephanie Caccomo. “We believe, though, that all women should be aware of the potential risks and complications of breast implants, which are not lifetime devices.”

People who consider implants may be unaware that they are viewed as temporary devices to be removed or replaced at a later date. According to the FDA, the longer people have the implants, the higher their risk for complications. “The life of breast implants varies by person and can’t be predicted,” reads a FAQ about breast implants on the agency’s website. “That means everyone with breast implants will face additional surgeries — but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience.”

[…]

Read the full story here.

What’s behind the surge of prescriptions for risky, expensive medications? Millions from drugmakers.

John Fauber, Milwaukee Journal Sentinel: August 8, 2019.


In 2011, a group of influential dermatologists, most of whom had financial ties to drug companies, issued a set of national guidelines for treating psoriasis.

It said a class of immune-suppressing drugs could be used to clear up mild skin issues before weddings or other special events.

The problem: The recommendation went against the approved uses for the drugs, which carry stringent safety warnings from the U.S. Food and Drug Administration.

In 2012, AbbVie created a “Nurse Ambassador” program that paid nurses around the country to make home visits to patients who had been prescribed Humira, its rheumatoid arthritis and psoriasis drug.

The wrinkle: The nurses were instructed not to mention the risks of the drug, which include potentially deadly infections, according to a lawsuit filed by California regulators.

In 2014, Pfizer paid for a study of its rheumatoid arthritis drug Xeljanz — one authored by 12 experts, all with financial ties to the company. Xeljanz came out on top.

The twist: It was not compared to the treatment experts consider the most effective.

All three efforts were part of a massive drug company push to boost the sale of expensive, immune-suppressing drugs to treat autoimmune conditions such as psoriasis and rheumatoid arthritis.

The drugs, many of which are biological medicines, called biologics, were introduced two decades ago and have hit $45 billion in sales, despite escalating prices and mounting reports of serious side effects.

“There are a lot of different playbooks on drugs,” said Diana Zuckerman, president of the Washington, D.C.-based National Center for Health Research, a public health advocacy group. “The industry knows how to sell a product.”

AbbVie’s nurse program is the focus of an insurance fraud lawsuit filed last year by the California Department of Insurance. It alleges the company paid kickbacks to doctors to prescribe the drug and sent the nurses into homes “to keep patients on a dangerous drug at any cost.”

The lawsuit, which claims more than $1.2 billion in insurance fraud, alleges the nurses were trained to hide Humira’s serious cancer and infection risks — allegations AbbVie denies.

The nurse program offers a unique spin on what past Milwaukee Journal Sentinel investigations have found to be a pattern of drug company money touching every step of the process.

Upbeat TV commercials and magazine ads that tout the benefits of the drugs.

Treatment guidelines that call for doctors to prescribe them — written by doctors with financial ties to drug companies.

Favorable studies underwritten by drug companies — often conducted by researchers who double as speakers and consultants to the companies.

Biologic drugs are cultured from animal cells and introduced by injection or IV.

The drugs are often effective and can lead to significant improvement in symptoms, even remission. But they also leave patients susceptible to a growing number of infections and other serious side effects.

Of the 21 biologic drugs that have won FDA approval, 13 — 62% — have received the agency’s most stringent warning, known as a “black box.” In the majority of those, the warnings were added when serious risks and side effects began showing up after the drugs were on the market.

Earlier this year, a Milwaukee Journal Sentinel investigation found more than 1 million “adverse events” were reported to the FDA in people using the drugs since 2004, including nearly 500,000 that were deemed serious.

There were 34,000 reported deaths.

While the FDA database has limitations, including a lack of verification of the reports and the possibility that other drugs could also have been used, it is the largest publicly available data set of reactions associated with prescription drugs.

If anything, experts say, it undercounts the potentially dangerous incidents.

Zuckerman, the head of the public health advocacy group, said part of the drug company strategy is to get the FDA to approve more and more products — or to get existing drugs approved to treat more and more conditions. 

That creates a confused marketplace.

“The doctors are left with 20 different products and no idea which one is best for which patient,” she said.

Rising competition, rising costs

Led by top-selling Humira, biologic drugs have become some of the biggest moneymakers for the U.S. pharmaceutical industry.

Prescriptions for them were on pace to exceed more than 6 million in 2018, up from about 4 million in 2013, according to data from the pharmaceutical market research firm IQVIA. That represents a 50% increase.

Humira prescriptions were set to top 3 million, an increase of more than 60%.

Meanwhile, biologic drugs were expected to tally $45 billion in sales, with Humira on pace to hit $18 billion alone — an increase of more than 150% since 2013.

The list price on the drugs can exceed $40,000 a year, though rebates and discounts can reduce the amount paid by insurance companies and individuals.

There are now more than 20 biologic drugs on the market, in addition to other, traditional treatments for the conditions.

Yet prices seem to defy the laws of supply and demand.

February 2019 paper in the journal JAMA Internal Medicine looked at three of the most popular biologic drugs in a class known as tumor necrosis factor inhibitors: Humira, Enbrel and Remicade.

Before 2009, they were the only such drugs approved to treat rheumatoid arthritis.

In the years that followed, the FDA approved three more drugs — increasing competition. The study authors expected costs would still rise 34% from 2009 to 2016, due to inflation and other factors. Instead, costs went up 144%.

[…]

California alleges insurance fraud

In September 2018, the California insurance commissioner’s office laid out its case of financial impropriety against AbbVie, providing a window into the push to boost sales of Humira.

A similar lawsuit was filed in federal court in Illinois.

That lawsuit alleges AbbVie officials “bragged at national sales meetings about how the Ambassador Program resurrected the otherwise plateauing sales of Humira and attributed a sharp and specific rise in sales directly to the Ambassador Program.”

Both cases are pending. AbbVie denies wrongdoing.

[…]

The California lawsuit alleges the program began as a pilot effort in 2012, developed a presence in California in 2013 and soon became “wildly successful in this state and others.”

Through the program, doctors allegedly got kickbacks in the form of cash, meals, drinks, gifts, trips, even patient referrals.

One court document indicates the national program reached 179,000 patients.

“Kickbacks and more sophisticated schemes, like those alleged in the AbbVie case, are significant drivers in the out-of-control cost of prescription drugs that harm consumers,” California Insurance Commissioner Ricardo Lara said in a statement to the Journal Sentinel.

His office estimates private insurers in California alone paid out $1.2 billion in Humira claims from 2013 to 2018, making it potentially the largest insurance fraud case in the department’s history.

[…]

Major marketing push

In 2018, Humira topped all drugs for ad spending, at $483 million, according to data from the firm Kantar Media, which tracks cross-media ad spending.

Xeljanz, a non-biologic that competes in the same market, was third at $256 million. Cosentyx, a biologic, was eighth at $180 million.

The totals include all ad spending, aside from social media, but TV commercials are clearly at the center of marketing efforts — particularly on cable news networks.

During a five-day span in mid-March, a total of 21 commercials for autoimmune system drugs — most of them biologics — were aired during cable news shows on CNN, Fox and MSNBC between 6 and 9 p.m., according to a Journal Sentinel analysis.

[…]

Rita Redberg, editor of the journal JAMA Internal Medicine, said she is struck by how many of the drugs are advertised on TV.

“It is clear (the drugs) are not selling on the merits alone, otherwise they wouldn’t need all the advertising,” said Redberg, a professor of medicine at the University of California, San Francisco.

Drug companies and treatment guidelines

Doctors frequently turn to treatment guidelines when it comes to determining how to care for patients. The guidelines, which serve as national standards for treating various diseases, often are used by front-line doctors who see patients and write prescriptions.

They are frequently issued by medical societies and related groups.

Where do the groups get their money?

Often from companies marketing the drugs.

[…]

Consider the 2011 guidelines for treating psoriasis and psoriatic arthritis issued by the American Academy of Dermatology.

Those guidelines said that if a person with a milder case of the disease has an important upcoming event, such as a wedding or graduation, it is OK to use biologic and other drugs.

However, the FDA has only approved biologic drugs for more serious cases, what is known as moderate to severe psoriasis.

The guideline-writing committee was made up of 15 experts, 12 of whom — including the chairman — had financial ties to companies that make biologic drugs.

At the time the guidelines were issued, committee chairman Alan Menter disclosed he received money from three companies that make biologic drugs for psoriasis, but did not list the amounts.

A check of the federal government’s Open Payments database showed that in 2013 he received about $90,000 from those companies. He continued to work with the companies, receiving more than $300,000 between 2014 and 2017.

[…]

Meanwhile, the American Academy of Dermatology has received millions of dollars in funding in recent years from companies that manufacture biologic drugs, based on giving levels the group lists on its website and other records. AbbVie, the maker of Humira, alone gave more than $2 million in grants and donations to the academy between 2013 and 2017.

[…]

Less expensive option not recommended

Financial conflicts were also at play in 2015 treatment guidelines for rheumatoid arthritis from the American College of Rheumatology.

Rheumatoid arthritis causes inflammation, leading to swelling, pain, stiffness and potential damage to the joints. The condition affects more than 1 million Americans.

Experts generally agree that the best first-line treatment for the condition is the generic drug methotrexate, which is normally is taken by mouth. If that fails, a biologic can be added.

But there are other options, such as adding two generic and less expensive non-biologic drugs — what is known as “triple therapy.” A 2013 paper in the New England Journal of Medicine showed that approach to be just as effective as adding the biologic Enbrel.

The effectiveness may be equal, but there is a dramatic difference in cost.

“Triple therapy” costs less than $4,000 a year, while taking a biologic drug costs about $43,000, according to an analysis provided to the Journal Sentinel by Alvaro San-Juan-Rodriguez, a research fellow at the University of Pittsburgh School of Pharmacy.

When the American College of Rheumatology issued its treatment guidelines in 2015, it did not factor in the difference in cost, which would have put biologics at a disadvantage.

The guidelines simply said either approach could be used.

Nine of the 26 members of the committee had financial relationships with companies that either made or were developing biologic drugs at the time, a Journal Sentinel analysis found.

[…]

Study ignores most effective treatment

The influence of drug company money is increasing among experts who author papers about drugs used to treat rheumatoid arthritis, according to a May 2019 paper in the journal Rheumatology.

The paper found conflicts of interest among authors in 54% of studies in 2002 and 2003. That increased to 65% for the second period examined, 2010 and 2011.

A Journal Sentinel examination of rheumatoid arthritis studies and financial disclosure forms found an especially conflicted 2014 study of the Pfizer drug Xeljanz.

All 12 authors had financial ties to the company, including eight who were employed by Pfizer, which funded the study.

What’s more, the study compared Xeljanz to the drug methotrexate alone — not the more effective treatment of methotrexate plus a low-dose steroid. The study concluded Xeljanz was better.

Other studies of rheumatoid arthritis drugs have taken the same approach.

Pfizer spokesman Steven Danehy noted the study authors are recognized experts in the field and work with many pharmaceutical companies. He added: “Further, the New England Journal of Medicine works with an editorial team that employs rigorous editorial, peer and statistical processes to evaluate manuscripts for scientific accuracy.”

Critics question why Xeljanz was tested against a “second-best treatment” — and whether patients in the trial knew what they were getting.

“Comparing the new treatment to a treatment that we already know is not good enough proves nothing,” said John Kirwan, an emeritus professor of rheumatic diseases at the University of Bristol in the U.K.

“You can’t help thinking that the company designed their study this way just to make their new treatment look good.”

 

Read the original article here.

Kris Pickel, CBS 5 Investigates up for national Emmy for breast implants illness stories

News Staff, Arizona Family: July 31, 2019.


PHOENIX (3TV/CBS 5) – Arizona’s Family anchor Kris Pickel is nominated for a national News and Documentary Emmy Award for her ongoing investigative reports into breast implant illness.

“We are honored that CBS 5 Investigates is helping create a national conversation on breast implant illness,” Pickel said. “For decades, sick women have been ignored or portrayed as imagining their symptoms. We listened and investigated their claims.”

Pickel and the CBS 5 Investigates team —  Edward Ayala, Morgan Loew, and Gilbert Zermeno — first tackled this complicated and controversial story in 2017. Pickel interviewed former Playboy Playmate of the Year, Karen McDougal about her decision to explant – or in other words, to have her breast implants removed.

McDougal talked about health issues she battled for more than 10 years, explaining how she came to believe that her implants were to blame for those problems.

It was an emotional interview. McDougal shared how she felt when she hit rock bottom.

“I couldn’t get out of bed,” McDougal told Pickel. “The noise sensitivity was so bad. I couldn’t even tolerate my own voice because it hurt me so bad. The migraines were excruciating. I literally thought I was dying. All I could do was lie in bed.”

Finding more questions than answers, Pickel didn’t stop with McDougal’s experience, deciding to dig deeper into what woman had come to call breast implant illness. Despite being told – repeatedly – by implant manufacturers, doctors, and even the Food and Drug Administration that breast implants were perfectly safe, Pickel suspected there was a bigger story. As part of her extensive research, she asked to join a private Facebook group for women like McDougal, women who suffered severe health issues that they attributed to their implants.

Pickel contacted Nicole Daruda, the woman who started the Facebook group. Pickel was granted access, and within days, dozens of women reached out to her. They wanted their extremely personal stories heard, and they wanted Pickel to be the one to tell them.

“Kris Pickel and I have interviewed countless women, and Kris has talked to hundreds more about how their implants have impacted their lives, women who were told their symptoms were simply ‘in their head,'” Ayala said. “When they were not being heard, we became their voice. These women, tens of thousands of them came together, helping each other in an effort to effect change; we simply delivered their message.”

The responses from women who saw Pickel’s stories – some of whom were already painfully familiar with breast implant illness and others who were hearing about it for the first time — were overwhelmingly positive. And appreciative.

“I’m writing to let you know how your reporting has changed my life in a way I thought was lost to me,” one woman wrote to Pickel. “I was broke to my core. … Your thorough reporting brought me answers as well as new paths I could start researching. This is life changing (sic) ….”

That’s how many with breast implant illness have described Pickel’s and Ayala’s work – life-changing.

“I sincerely owe my life to you and your report,” wrote another woman. “I can’t thank you enough for what you did for me ….”

“You’ve probably saved my life,” a third woman wrote to Pickel.

Like any journalist, Pickel did her due diligence, learning everything she could about breast implants — from how they’re classified as medical devices by the U.S. Food and Drug Administration, to FDA reports on the safety of implants and acknowledgment of breast implant-associated anaplastic cell lymphoma.

“Having my desk right next to Kris, I’ve learned a few things during the course of this investigation,” CBS 5 anchor Sean McLaughlin said. “Kris never took ‘no’ for an answer. She would methodically chase down every person by phone, email, by whatever means necessary. From an East Coast time zone text before sunrise to tenderly responding to a frightened woman via social media at midnight, Kris was on it no matter the hour. No breast implant manufacturer or federal agency employee escaped from her blizzard of concise, razor-sharp questions that were gleaned from hundreds of hours spent poring through thousands of government documents.”

Armed with information culled from FDA reports and studies, Pickel went to one of the foremost experts on women’s health safety and effectiveness of medical products like implants, Dr. Diana Zuckerman of the National Center for Health Research in Washington, D.C. Zuckerman explained some of the problems with those very studies, giving Pickel some critical context, including the fact that many early studies were “funded by implant manufacturers or plastic surgery medical societies.”

“Having surgeons whose entire livelihood, or almost entire livelihood, is based on breast surgery, with breast implants, can’t possibly be objective,” said Zuckerman, who has long advocated for policy changes to protect patients from potentially dangerous medical devices.

[…]

See the original story here.

Why Everyone Is Talking About Breast Implant Safety Right Now

Michelle Stacey, Allure: July 29, 2019.


Candyce Kirbyson wanted a bit more. At 105 pounds, she had A-cup breasts. So at 32, the Seattle-area mom decided to get implants. But she got a lot more. A laundry list of ailments, in fact. Hives and muscle weakness. Numbness and tingling in her arms and legs. Insomnia and chronic sinusitis. At various points in Kirbyson’s 14-year slog through doctor’s offices, MRIs, and emergency-room visits, it was suggested (among many other potential diagnoses) that she had “mold toxicity,” sometimes known as “sick-building syndrome.”

Kirbyson wondered if it had to do with her new office. “I was on and off antibiotics that would work for a while, and then my hives and inflammation would come back,” she says. “I sometimes felt like I was getting early Alzheimer’s, like my brain wasn’t working. I tried integrative medicine, functional medicine, ENTs. Nobody could figure out what was going on, and doctors said it was all in my head. I felt like I was dying.”

Never once did Kirbyson suspect the implants as the source of her sickness since she didn’t have pain in her breasts and not one doctor had ever raised the possibility.

Then late last year, she read an article that led her to a Facebook group that described similar symptoms. “I started crying my eyes out, because everything I was reading was what had happened to me,” she says. Kirbyson consulted a local plastic surgeon who was mentioned in the group and had her implants removed in January.

Slowly, her symptoms are diminishing. “My energy is back, my brain fog is lifting, the tingling and hives are happening less,” she says. “I’m 500 percent sure that my whole system broke after I got implants.”

An alarming conclusion, particularly since breast augmentation is the most popular plastic surgery. There were almost 314,000 procedures in the U.S. in 2018, up 4 percent from the previous year. In a 2011 report, the Food and Drug Administration estimated that between 5 and 10 million women worldwide have breast implants. Admittedly, fears about potential dangers have surrounded implants since their inception in 1961. But past concerns were that they would rupture and leak.

The new fear factor: Could simply letting these things exist in your body be ruinous? Claims like Kirbyson’s — that breast implants have triggered inexplicable chronic illness — are growing, and new reports show a direct line from implants to a rare lymphoma. In March, the FDA held a public advisory committee meeting on breast implants to discuss these issues. Sides were taken, and tensions ran high.

One of the speakers, Diana Zuckerman, the president of the National Center for Health Research, who has been a voice in the debate for decades, says: “I was struck by how often the answer to a question was ‘We don’t know.’ We don’t know which implants are better or worse, or how often people get sick. Women deserve to know what their odds are of getting sick because of their breast implants, and we can’t answer that question.”

Doctors and the FDA concede that there is still much to learn, says Grant Stevens, the president of the American Society for Aesthetic Plastic Surgery (ASAPS) and a clinical professor of plastic surgery at the Keck School of Medicine of USC. But after 35 years of performing breast implants on more than 10,000 patients, he’s convinced that the vast majority have few problems with the devices.

Women suffering from what they call breast implant illness (BII) beg to differ. Though not a disease, BII has recently gained credibility. So much so that the FDA has incorporated the patient-coined term into its website among cautions about implants, citing “systemic symptoms” as one potential risk, although “what causes them are poorly understood.”

In the run-up to its March meeting, the FDA listed examples of the top reported BII markers: fatigue, brain fog, rash, joint pain, and memory loss (amid an exhaustive 87-item list of other possible issues, including “ear ringing” and “throat-clearing”).

“BII is not a diagnosis,” says Stevens. “It’s a collection of symptoms — about 22 of which I have myself at any given time. [But] I’ve looked into the eyes of women who say they’re going through it, and I know they’re not making it up. They’ve seen a bunch of doctors; they’re frustrated; they’re scared.”

There have been no formal studies on BII to mollify those fears. (The first of its kind is starting now, funded by the Aesthetic Surgery Education and Research Foundation, according to Stevens.) It’s difficult to track symptoms that are so subjective and wide-ranging, and Laurie A. Casas, the former president of ASAPS’s Aesthetic Surgery Education and Research Foundation and a clinical professor of plastic surgery at the University of Chicago Medicine, says many manufacturers have “had trouble getting” follow-up reports on patients who use their implants — an FDA requirement.

In March, the agency issued warning letters to two companies, Mentor and Sientra, for falling far short. In a statement to Allure, Mentor admits they “continue to encounter challenges,” due to the low percentage of U.S. patients who use their textured implants. Sientra told us that many of its patients have family and work obligations that preclude them from follow-ups, but says it’s committed to helping bridge that gap by compensating patients and doctors.

“I think some companies did a lousy job,” says New Jersey–based plastic surgeon Caroline Glicksman. “You tend not to hear from patients who are doing fine. These manufacturers should incentivize women who take time and spend money to show up for follow-ups every year.” One company that did that, Ideal, was able to track nearly 95 percent of its patients for five years by offering a balloon payment at the end of the study, potentially granting each woman $5,000 to $8,000.

The recent establishment of several breast implant “registries” could also help to assess long-term safety. “Ideally, we want to track every implant in every patient over the lifetime of the implant,” says Casas. “These studies should have a control group of women of the same age that do not have implants. That way we can understand the incidence of these symptoms in women of the same age who have and do not have implants.”

That raises the question: Could it be that breast implants aren’t for everyone? Many doctors are intrigued by the potential of using genetic tests to determine whether someone might have inflammatory or allergic “markers” that would indicate they’re a bad fit for the devices, says Casas. That’s a possibility the FDA is now entertaining, saying in a statement: “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. They develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”

That small number of patients is radicalized. The Breast Implant Illness and Healing Facebook group, for one, has grown from a few hundred members to more than 70,000 in the past three years. Its message — your breast implants are making you sick — is powerful. But that power can be a double-edged sword, says Nashville-based plastic surgeon Melinda Haws. “Many women have turned to social media for support and information when their doctors were unsympathetic,” she says. “Unfortunately, the support groups, in many cases, have become more trusted than the plastic surgeons. If I’ve got a pain in my knee, I can search the Internet for the cause. But I still have to see an orthopedic surgeon.”

BII’s symptoms can make many patients feel helpless and unnecessarily guilty, since it’s an elective surgery. “Many women have described to me the negative impacts on their family and their jobs that they believe have come from this procedure,” says Haws, adding that such worries can compound and worsen insomnia and anxiety.

For patients like Kirbyson, advice from the BII group was transformational. However, for Celeste Greene*, it presented a red herring. Greene got her first implants at age 21. They were saline and lasted six good years, until they began to feel hard and she traded them for silicone implants. She soon developed some symptoms similar to Kirbyson’s, went through full-panel tests with no conclusive diagnosis, and three years later, found solace and enlightenment in the same Facebook group.

Within about nine months of finding the group, she had her implants removed. As she recovered, Greene felt markedly better. Fast-forward a few months, and all of her symptoms returned. It took another year, a divorce, and finding out that her estrogen was abnormally low (“My endocrinologist said it was like that of a 60-year-old woman!”) for Greene, now 36, to get a complete picture. She is now positive that job stress, studying for board exams to keep that job, an abusive marriage, and hormone irregularities were collectively the “perfect storm” that caused her malaise. “It was an expensive lesson.”

[…]

 

See the original story here.

Breast Implants Linked to Rare Cancer Are Recalled Worldwide

Denise Grady, The New York Times: July 24, 2019.


Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and Drug Administration, and will also be recalled globally, the agency announced on Wednesday.

The F.D.A. decision, based on an increasing number of cases and deaths from the implant-associated cancer, lags far behind action in Europe, where the Allergan devices were effectively banned late last year.

Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.

[…]

F.D.A. officials said they were continuing to monitor the incidence of lymphoma linked to other types of implants and would take action against them if needed.

They also said they were considering changes to the labeling of breast implants, like adding a black-box warning to draw attention to the risks, and requiring doctors and patients considering the surgery to go over a checklist to help women understand the benefits and risks of the devices.

The contents of the implant, silicone or saline, are not a factor in the lymphoma. The covering or shell of the implant, which can be either smooth or textured, is the key. Textured implants, which have a slightly roughened surface that adheres to tissue and helps hold the device in place, have been singled out as the cause of the lymphoma.

Why the texturing leads to cancer in some patients is not known. Some people may be genetically predisposed to have an inflammatory reaction to the texturing that can gradually lead to cancer, Dr. Clemens, the plastic surgeon, said. Some researchers also suspect that bacteria trapped in crevices in the roughened surface might somehow lead to the lymphoma.

Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products.

Allergan’s textured implants account for only about 5 percent of the implants used in the United States, but have been much more common in Europe, where they have already been recalled by many countries. Worldwide, 38 countries have banned textured implants, Dr. Clemens said.

Allergan said on Wednesday that it was halting sales of the textured implants worldwide.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” said Diana Zuckerman, president of the National Center for Health Research, who has studied implants.

She added that the recall would reduce the risk but not eliminate it, because some women with other types of implants also had the lymphoma.

See the full story here.

Allergan Breast Implants Linked To Cancer Recalled After FDA Request

Lauren Dunn, NBC News: July 24, 2019.


Following a request from the Food and Drug Administration, Allergan is recalling its textured breast implants worldwide, the company said Wednesday.

The move comes after 38 countries already recalled the implant because of the higher risk of anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system.

[…]

The recall is “a very important step” toward reducing this type of lymphoma, women’s health advocate Diana Zuckerman said.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman, president of the National Center for Health Research, said in a statement. “This recall will reduce that risk but it won’t eliminate it, because not all women with BIA-ALCL had these specific types of implants.”

Last November, NBC News, along with its partner, the International Consortium of Investigative Journalists, found that BIA-ALCL is an emerging risk for women with textured implants.

In March, the FDA said BIA-ALCL is most likely caused by textured breast implants, which have a suede-like coating. But the agency stopped short of taking the implants off the market, noting it wanted to continue studying the disease and tracking cases. It’s estimated that of the 400,000 women in the United States who get breast implants each year, about 1 in 10 has textured implants.

 

Read the full story here.

Allergan Recalls Textured Breast Implants Globally Due to Cancer Links

Sasha Chavkin, IJIC: July 24, 2019.


Allergan will recall its Biocell textured breast implants worldwide after United States health authorities requested that it remove them from the market due to their association with a rare cancer of the immune system.

The announcement, which reflects the most sweeping recognition to date of the serious health risks associated with breast implants, comes after the U.S. Food and Drug Administration obtained new data showing that Allergan implants were linked to most known cases of the cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Amy Abernethy, in a statement issued by the agency.

The company said the recalled implants, both saline and silicone, would no longer be distributed or sold in any market where they are currently available.

[…]

President of the National Center for Health Research Diana Zuckerman, who has called for stricter oversight of breast implants, said Allergan’s recall was a step in the right direction but did not eliminate the risks of BIA-ALCL.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman said.

“This recall will reduce that risk but it won’t eliminate it, because the FDA has stated that not all women with BIA-ALCL had these specific types of implants.”

In its press conference, the FDA said that it was considering additional measures to protect patient safety.

The agency said it would soon announce updated labeling standards for breast implants, and that these might include a black box safety warning, which is reserved for products that pose the most serious health risks.

The FDA also said it might require a patient checklist, a document that briefly states the key health risks from breast implants which patients would sign before undergoing surgery. The agency is not recommending that women who currently have Allergan Biocell implants get their implants removed, unless they experience signs or symptoms of BIA-ALCL.

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Allergan Recalls Textured Breast Implants Linked to Rare Cancer

Laurie McGinley, Washington Post: July 24, 2019.


Allergan announced a worldwide recall of textured breast implants Wednesday after the Food and Drug Administration found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them off the U.S. market.

The Dublin-based company said it is recalling Biocell textured breast implants and tissue expanders from all markets in which they are sold. The devices had already been banned or recalled in several countries.

The FDA said the new data shows that 573 cases worldwide have linked the rare cancer to the implants since the agency began tracking the issue in 2011. The vast majority of those cases involve Allergan products. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Of those fatalities, authorities identified the implant manufacturer in 13 cases — and it was Allergan in all but one.

In February, the last time the FDA had updated its numbers on implant-associated illness, it reported 457 cases and nine deaths worldwide.

The agency said Wednesday that the latest data indicates the risk of such disease is six times greater with Allergan Biocell textured implants than with other types of textured implants sold in the United States.

The FDA’s new stance against the Biocell product is a reversal of its posture a few months ago, when it said there was insufficient evidence to try to remove the devices from the market.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said on a news call the agency changed its position partly after seeing the sharp increase in reported deaths.

Allergan pulled the products off the European market last year. Canada banned them in May after finding an increased risk of cancer.

[…]

Diana Zuckerman, president of the National Center for Health Research, a nonprofit organization, welcomed the FDA’s decision to press Allergan to recall the implants. “We are very glad they have done it,” she said. “I think they could have done it months ago and I hope a lot of women have not been getting these implants in the meantime.”

The FDA said that in most cases, the rare lymphoma linked to the implants is found in scar tissue and fluid near the devices, but that sometimes it can spread throughout the body. The condition can be life-threatening if it isn’t diagnosed and treated promptly, the agency said. Most patients are treated successfully by surgery to remove the implant and scar tissue but some may require chemotherapy or radiation.

Scientists are not sure why certain textured implants might be linked to the rare cancer. “We don’t know what it is that might increase the risk,” said Binita Ashar, director of the FDA’s office of surgical and infection control devices.

The agency said its data on the rising incidence of illnesses and deaths related to the implants came from medical device reports and searches of medical literature.

See the full article here.

Allergan Recalls Textured Breast Implant Tied to Rare Cancer

Matthew Perrone, AP for ABC Action News; July 24, 2019


WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer.

The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems.

WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer.

The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems.

[…]

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

Read the full story here.

FDA Will Not Ban Textured Breast Implants at this Time

Lauren Dunn, NBC News: May 3, 2019.


Almost one month after an emotional hearing on breast implant safety, the Food and Drug Administration announced it would not ban textured breast implants, which have been linked to a type of lymphoma.

Allergan’s textured implants have already been yanked off the market over safety concerns in 38 countries, including France and most recently Canada. But the FDA said Thursday there isn’t enough evidence to warrant a ban in the United States.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug, and Cosmetic Act,” the agency said Thursday.

The implants, which have a rough, sandpaper-like surface, are linked to breast implant associated-anaplastic large cell lymphoma or BIA-ALCL, a cancer of the immune system that can be deadly if it’s not treated early enough. In the United States, 457 women have been diagnosed with the disease. Worldwide, 17 have died.

“This disease is still so grossly underestimated and we will continue to see more deaths and diagnosed women,” Michelle Forney, who was diagnosed with BIA-ALCL last year, said. “However, not banning textured implants because it doesn’t meet a banning standard from a legislative act gives me more concern that our country cannot protect us or our children from other cancer-causing devices.“

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning — the FDA’s strictest caution.

Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

“We are considering these actions to help to ensure that all women who consider breast implants have the information they need to have thoughtful and balanced discussions with their health care professional about both the benefits and risks of breast implants based on clear information reflecting the most current understanding of these issues,” the FDA said in a statement.

Critics fear the moves don’t go far enough to protect women.

 

See the original story here.