All posts by CPTFadmin

Teens Are Being Hospitalized With Lung Damage From Vaping At An Alarming Rate

Emily Reily, Yahoo! Entertainment: August 14, 2019.


A surprising number of teens are suffering from lung damage, and it appears to stem from vaping.

Young Adults Getting Lung Damage

Several cases of severe lung damage were reported in Wisconsin last month, and it’s got medical professionals talking.

“It’s mind-boggling. I’ve never heard of a smoker ending up in the hospital in their teens,” says Dr. Diana Zuckerman, president of the National Center for Health Research.

We Have Evidence Now

And we have real, concrete examples of lung damage in young people.

A teen who said he vaped one Juul pod every two days for a year eventually suffered a collapsed lung.

“He didn’t have the symptoms that might have warned him that something was wrong — until something was really terribly wrong,” added Zuckerman.

[…]

Studies Confirm E-Cigs Are a Bad Idea

The journal “Pediatrics” published a study last year on e-cigarettes, noting that there is a slew of toxic chemicals in them. Some of those chemicals are linked to cancer.

“It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke,” adds Zuckerman.

Read the original story here.

Teens are being hospitalized for lung damage after vaping — “It’s mind-boggling,” doctor says

Caitlin O’Kane, CBS News: August 13, 2019.


In Wisconsin, at least a dozen people have recently been hospitalized and treated for severe lung damage. The first cases were reported last month, and the number has been growing. All of these patients are young — between their teenage years and 30s — and all of them appear to have been harmed by vaping.

Wisconsin’s Department of Health Services confirmed 12 cases and is investigating 13 others, including older patients up to their 50s who are experiencing lug damage as a result of vaping, according to The Milwaukee Journal Sentinel.

The hospitalization of at least a dozen young people raises the question: How have e-cigarettes caused so much damage, when they haven’t even been around for that long?

“It’s mind-boggling,” Dr. Diana Zuckerman, president of the National Center for Health Research, told CBS News. “The vast majority of people who smoke started as children or as young teens, and yet you don’t hear about people getting lung cancer until their 40s, 50s, 60s,” she said. “Think about that compared to what’s happening to these kids now. I’ve never heard of a smoker ending up in the hospital in their teens.”

Zuckerman pointed to one specific case: a college freshman from Florida whose lung collapsed. In an interview with The Daily Mail, the teen admitted to vaping about one JUUL pod every two days for a year. 

“Really, a collapsed lung on an 18-year-old after one year? That’s mind-boggling,” Zuckerman said.  “He didn’t have the symptoms that might have warned him that something was wrong — until something was really terribly wrong.”

The big problem she sees with Juul and other e-cigarettes and vapes: “We don’t know yet what the symptoms might be,” Zuckerman said.

It took doctors years to fully understand all of the risks associated with smoking cigarettes, including cancer, Zuckerman said. When it comes to vaping, it is too early on for doctors to know all the potential long-term health consequences. However, there is growing evidence of short-term risks and lung damage, according to Zuckerman.

“Lung damage is what we’re most focused on right now, but there’s so much more going on,” she said. “There are chemicals in Juul and e-cigs and we’re not exactly sure what the impact is going to be because we haven’t seen it before.”

[…]

While there are many unanswered questions about vaping that may be revealed over time, one thing is starting to become clear to Zuckerman: “It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke.”

Juul’s popularity with teens is a particular concern because the rash of lung problems appears to be affecting young people more than any other age group. “The same amount of vaping for a child that weighs, say, 100 pounds, is a bigger issue than for somebody who weighs 200 pounds,” Zuckerman said.

See the original 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.

Insurance Coverage Information for Breast Implant Removal

The original reason for getting your breast implants matters to health insurance companies (as well as Medicare and Medicaid).  If your implants were put in after a mastectomy and your doctor believes that removing your implants is “medically necessary,” then your health insurance is legally obligated to cover your breast implant removal under the Women’s Health and Cancer Rights Act of 1998 (WHCRA).

If the original reason for getting breast implants was for augmentation of healthy breasts, then some health insurance companies will cover your explant surgery if they consider the services to be “medically necessary.”

What are “Medically Necessary” Services?

Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness. Although you or your doctor may believe a service is medically necessary, insurance companies don’t always agree.

Most insurance companies will not cover any cosmetic procedures and some will not cover complications from previous cosmetic procedures.  However, many companies consider removal of breast implants medically necessary for patients with any of these conditions:

Unfortunately, insurance companies usually won’t cover the cost of breast implant removal for autoimmune or connective tissue diseases or other systemic complications. If you have any of the conditions listed in the bullets above, you should focus on those in your insurance claim because insurance companies are more likely to cover these symptoms.

How do I know whether my insurance company will cover the cost of removal?

To find out if your insurance company is likely to cover removal, you will need to look at your specific policy language. You can usually find this language in a document called “Evidence of Coverage” (EOC), this is also sometimes called a “Benefits Booklet.” It is a document (typically about 100 pages) that describes in detail the healthcare benefits covered by your health plan, including procedures that your insurance company will and will not cover.

You can access an electronic copy of your EOC through your online account on your insurance company’s website. You can also call the member services number on the back of your insurance card and ask an insurance representative for a copy of this document.

What Do I Look For?

Once you have your policy, look for language about breast implant removal.  If you don’t see any language about breast implant removal, search for language on complications from cosmetic surgery. If you cannot find any specific language about breast implant removal, you should also look to see what your insurance company’s definition of “medically necessary” is. It is also important to check whether your insurance plan requires pre-authorization for any surgeries.

If you’re using an electronic copy, you don’t need to read the entire document. You can easily find terms using the “Control+F” keys on your keyboard. That will provide a “search box” that will search for any words you enter. Just enter the word “breast” or “cosmetic” or “medically” in the search box. If you are unable to find what you need in the lengthy document, call your member services line and ask for assistance to locate the correct pages.

File for Pre-Authorization

Most insurance companies will require that you get pre-authorization (also called prior approval or pre-certification) before the surgery. This means your insurance company reviews your relevant information and determines whether surgery is medically necessary. Then, the insurance company will let you know if it is likely to cover your surgery. However, that pre-authorization isn’t a promise that your surgery will be covered.

The easiest way to get pre-authorization is to have your plastic surgeon sign and submit a letter that lists your symptoms and explains why removal is medically necessary based on your insurance policy language. (Usually one or more of health problems listed on the bullets earlier in this article). Your surgeon should also enclose any medical documentation that provides proof of your symptoms.

It is best if your plastic surgeon signs this letter to send with your insurance claim. However, if your surgeon is unwilling to sign the letter, another doctor involved with your care, such as your primary care provider, can sign. You can find templates for these letters here. If your doctor agrees to sign the letter, but won’t submit it to your insurance company, you will need to submit the letter before your surgery to ensure you receive pre-authorization.

NOTE: If you don’t get pre-authorization when it was required, the insurance company isn’t required to cover the surgery, even if it considers the procedure to be medically necessary.

After Your Surgery: Filing a Reimbursement Claim

If your surgeon is in your insurance company network, he/she should file a claim on your behalf. If not, you will have to pay upfront for the surgery and file the reimbursement claim with your insurance company. Even if you see a surgeon who doesn’t take insurance, you should still file a pre-authorization claim with your insurance company. If you didn’t seek pre-authorization before your surgery, you can still file a reimbursement claim.

In your reimbursement claim, you will need to submit your pre- and post-operative reports, along with a letter from the surgeon stating that the procedure was medically necessary.

You can learn more about getting private insurance to cover your explant surgery, including how to appeal a denial, here on our breast implant information website. 

What if I have Medicare?

Medicare usually covers breast implant (saline or silicone) removal for any of these conditions:

  • Painful capsular contracture with disfigurement
  • Implant rupture
  • Infection
  • Implant extrusion (coming through the skin)
  • Interference with the diagnosis of breast cancer
  • Siliconoma or granuloma (silicone-filled lumps under the skin)
  • Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system)

Medicare coverage can differ depending on the state where you live. You can check the specific Medicare policies on breast implants removal in your state here.

You can learn more about getting Medicare to cover your explant surgery here on our breast implant information website. 

You can learn more about getting Medicaid to cover your explant surgery here on our breast implant information website. 

What do I Need to Know about Breast Implant Removal Surgery?

See our article here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff

How to Read a Drug Label

Michelle Llamas, DrugWatch: July 31, 2019 Update.


Consumers should always read drug labels to make sure they are taking a medication correctly and safely as well as to learn about possible side effects. Unfortunately, these labels can be challenging for the average person to digest.

If you struggle to make sense of the information on your drug labels, you are not alone.

“Several studies have shown that patients often have difficulty in reading and understanding medication labels, which may lead to medication errors such as taking the wrong medication or the wrong dose,” said Mireille Hobeika, who received her doctorate in pharmacy from the University of Saint Joseph in West Hartford, Connecticut.

Understanding drug labels is even more important for people with chronic illnesses and seniors. They have the greatest risk of medication errors or interactions because they tend to take multiple medications.

There are two kinds of drug labels: over-the counter drug labels — also called Drug Facts — and prescription drug labels, which include many pages of safety information, such as pharmacy information sheets, medication guides and prescribing information.

Before you start taking a new medication, review the drug label with your doctor and pharmacist and let them know of any health conditions you have and any medications and supplements you take.[…] Diana Zuckerman, president of the National Center for Health Research, recommends patients consider the following questions and tips when reading clinical trial data on drug labels.

  • Were patients in the study like you in terms of age, sex and race? Look for at least 30 patients like you in the study. It might not provide you the most relevant data if people in the study aren’t similar enough to you.
  • Were patients in the study like you in terms of medical diagnosis? For example, if it’s a cancer drug, did the study involve people with your type of cancer? The same goes for drugs that treat other diseases. Data might be less relevant to you if you are not represented by patients in the study.
  • Is the drug tested in people who failed at other treatments? The FDA approves some higher risk drugs for people with no other treatment options.

Medication Guides

If a drug has an FDA-approved medication guide, pharmacists are supposed to give it to patients with their prescription, but this doesn’t always happen. And not all drugs have them.

The FDA requires manufacturers to write medication guides in easy-to-understand language for patients. You can find these medication guides on the drug manufacturer’s website or on DailyMed.

The blood thinner Coumadin, also known under the generic name warfarin, has a medication guide. Similar to the Drug Facts on an OTC label, the medication guide tells patients the most important prescription drug information in simple language.

INFORMATION IN A MEDICATION GUIDE

  1. What is the most important information I should know about the drug? The most serious risks, side effects and symptoms you should look for are detailed here.
  2. What is the drug? Here you can find the condition or symptoms the drug treats.
  3. Who should not take the drug? This section describes diseases or health conditions that may worsen with use of the drug. It also addresses people who may be allergic to the drug.
  4. Before taking the drug. If you have diseases or health conditions listed in this section, talk to your doctor before taking the medication.
  5. How should I take the drug? This section explains the special instructions on how to take the drug. It reminds people to take the drug only as directed by their doctor.
  6. What are the possible side effects of the drug? This section includes side effects information and brief explanations about each side effect. Sometimes it includes information on tests your provider may run or symptoms to watch for.
  7. How should I store the drug? Information on how to store the drug is included here. Some drugs are sensitive to heat or cold and some may need refrigeration.
  8. What are the ingredients in the drug? Check this section for the active and inactive ingredients. Tell your provider if you are allergic to any ingredients in the drug.

Is Side Effect Information Always Accurate?

Side effect information on drug labels usually comes from clinical trial data collected before a manufacturer sells the drug. Sometimes the label will get an update based on side effect reports the FDA receives after the drug has been on the market. This information is called postmarketing data.

“If side effects are known, they should always be included on the label, but some side effects aren’t known until years after a product goes on the market,” Zuckerman said.

Drug manufactures can face lawsuits if they know about a side effect but fail to warn consumers and doctors.

“Back when I took Levaquin in 2006, there were no black box warnings on fluoroquinolones,” said Brummert, who suffered multiple ruptured tendons after taking the antibiotic. “The first warning came in 2008 for tendon ruptures, and that black box only stated that people over 60 were at risk. Adverse reactions I have suffered that are still not included in the warnings are autonomic and central nervous system dysfunction and neurodegenerative disorders.”

Brummert said she discovered the FDA had admitted to these side effects in a hidden document obtained through a Freedom of Information Act request.

What Should You Do If You Don’t Understand a Label?

If you have tried reading a drug label and don’t understand it, don’t be afraid to ask for help. Your health care provider and pharmacist are there to assist you.

“Before leaving the doctors’ office, patients should make sure they are well informed about the name of the drug and why they are taking it, the medical conditions this drug treats, how many times per day should they take it, how long will it take this drug to work, when should they stop taking it, are there any side effects that they should know about and any situations where they should not be taking the drug,” Hobeika said.

If you leave your health care provider’s office without the information you need to take your medicine safely and effectively, the pharmacy from where you pick up your medication can help. Your pharmacist can answer questions about OTC and prescription medications.Hobeika recommends having all prescriptions filled at the same pharmacy, so the pharmacist has a record of them. She also suggests doing the following before you leave the pharmacy:

  • Check the label to make sure your name is on it. If it isn’t, talk to the pharmacist.
  • Check the label to make sure you can read and understand the name of the medicine, directions and colored warning stickers on the package. If the letters are too small to read, ask your pharmacist to print it in a larger type.
  • Are the directions on the package the same as those you and your provider discussed? If not, tell the pharmacist.
  • Ask if there are special instructions on how to store the medicine. Should it be kept in the refrigerator or a dry place?
  • Ask if there is anything you shouldn’t eat or drink while taking the medicine.
  • Ask if it’s safe to take the drug with other prescriptions or OTC medicines you’re taking.

Read the full article 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.

Read the full story here.