Joce Sterman and Alex Brauer, WJLA: September 16, 2019.

WASHINGTON (SBG) – We’ve all heard of recalls on cars and dangerous toys, but a global recall of a device that’s surgically implanted inside your body has thousands of women on alert. The recall of Allergan’s textured BIOCELL breast implants was prompted by a government analysis that showed an increased risk of cancer. Still, women who have them are generally being told not to have them removed from their chests.

For the last two months, Raylene Hollrah’s email and phone have been blowing up, with hundreds of women contacting her non-profit, dedicated to raising awareness about the emerging cancer. It’s called Breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL.

The fear women are dealing with comes following the August global recall of Allergan’s BIOCELL textured implants due to the increased the risk of lymphoma, a cancer of the immune system that Raylene now knows all too well.

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.”

[…]

Caitlin O’Kane, CBS News: August 22, 2019.

Vaping, even temporarily, can affect the blood vessels in healthy people — even if the vape pod does not contain nicotine, according to a new study published in the journal Radiology this week.

Researchers from the University of Pennsylvania School of Medicine studied 31 volunteers, all of whom were healthy, non-smoking adults with an average age of about 24 years old.

The participants were monitored as they each took 16 three-second inhalations from a disposable e-cigarette. The researchers used an ePuffer with flavored e-cigarette liquid but no nicotine in it. A research coordinator made sure sure the participants did not cough or swallow the vapor.

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.

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.