Category Archives: News Stories & Editorials

E-cigarettes affect a person’s blood vessels after just one use, study finds

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.

The researchers then conducted MRI scans on the participants and found a reduction in blood flow in the femoral artery in their legs. This change occurred after just one vaping experience.

The findings suggest vaping impaired function of the endothelium, or inner lining of blood vessels, a press release on the study explained.

“These products are advertised as not harmful, and many e-cigarette users are convinced that they are just inhaling water vapor,” Alessandra Caporale, Ph.D., a post-doctoral researcher and lead author of the study, said in a statement. “But the solvents, flavorings and additives in the liquid base, after vaporization, expose users to multiple insults to the respiratory tract and blood vessels.”

[…]

“Lung damage is what we’re most focused on right now, but there’s so much more going on,” Dr. Diana Zuckerman, president of the National Center for Health Research, recently told CBS News. “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.”

A study published in the journal Pediatrics last year found a number of different toxic chemicals in e-cigarettes, including one linked to several types of cancer. Some of the chemicals turned up even when teens used non-nicotine products like fruit-flavored vapes.

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.

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.

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.

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 Photo by: Matt McGlashen 

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.

More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

Sydney Lupkin and Christina Jewett, KHN; May 30, 2019


UNITED STATES – NOVEMBER 9 – The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)

The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018.

The newly acknowledged reports were detailed in an executive summary for FDA advisers. The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out of its lowest-risk category — reserved for simple devices like tongue depressors and bandages — to a higher grade that may require testing and additional oversight. Surgical staplers are used to cut and seal vessels and tissues inside the body.

When the FDA initially announced the meeting in March, it acknowledged in a letter to doctorsthat “many more device malfunction reports” were reported to the agency than it had publicly disclosed. The FDA executive summary published this week shows that the total reports more than doubled when the agency took nonpublic reports into account, totaling nearly 110,000 malfunctions or injuries from 2011 through 2018.

“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing legal case.

Surgical staplers have a unique ability to harm patients if they malfunction. Often used in minimally invasive surgeries, they are meant to both cut tissue and vessels and then quickly seal them. Patients have been gravely harmed when staplers have failed to fire or seal tissue, suffering from massive bleeding or infections if stomachs or intestines aren’t sealed properly.

The nonpublic reports were sent to the FDA as “alternative summary” reports, the topic of a recent Kaiser Health News investigation that focused on the agency accepting millions of hidden reports related to medical devices — including for surgical staplers.

The agency had previously acknowledged that in 2016, even as it posted fewer than 100 stapler-related injuries in a public database called MAUDE, it accepted nearly 10,000 reports into its little-known internal alternative summary reporting database. (The data in the FDA’s executive summary contains reports for staplers and staples, which experts have said were just different names for the same problem.)

Tuschman said he was stunned that there were more hidden reports than public ones in the executive summary. “The first question should be ‘Why?’ Why would they have the right to submit to a hidden database?”

Leading surgical stapler makers include divisions of Medtronic and Johnson & Johnson. Medtronic has said the FDA granted it exemptions for stapler-related malfunctions; Johnson & Johnson said it has not. (Ethicon is the name of its subsidiary medical devices company.)

On Thursday, the advisory panel recommended switching surgical staplers to a higher-risk classification with additional safety requirements, according to meeting attendee Jack Mitchell, director of health policy for the nonprofit National Center for Health Research. FDA spokeswoman Stephanie Caccomo declined to confirm this, citing a media office policy against telling reporters what happens at advisory committee meetings, which are open to the public.

“Every surgeon that I have ever worked with has had stapler failures,” said Dr. Doug Kwazneski, a Michigan surgeon who authored a survey in 2013 about “unacknowledged” stapler problems after searching the FDA’s public database of device incidents and coming up empty-handed.

“Going into something without data is dangerous,” Kwazneski said. “If the information exists, we should have access to it.”

More than 400 deaths have been reported since 2011 in the FDA’s public MAUDE database; fatalities can’t be reported to the alternative summary reporting database. Deaths were associated with Ethicon and Covidien products.

In recent communications about stapler safety to doctors, the FDA has advised against using the staplers on large blood vessels.

Kwazneski said surgical staplers are a time-saving tool, which lessens the risk of anesthesia complications during surgery, for example. But it’s important for physicians to remember they can fail.

Diana Zuckerman, president of the National Center for Health Research, said that alternative summary reports are “a well-kept secret” and that any reports related to their existence were “done in a way that was not understood as a repository for hundreds of thousands of serious adverse event reports.” […]

See the original story here.

How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say

Nicole Carr, WSBTV; May 20, 2019



Jonesboro resident Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life.

In 2013 she was implanted with a defibrillator to help with her congestive heart failure. She went to the doctor for checkups every six months. Robinson thought her device would keep her healthy for years. But last month the hospital called to tell her that device’s battery was failing. Robinson rushed to the emergency room.

“I was scared they wasn’t going to get to me in time,” Geraldine said.

The next day doctors replaced her device. The reason for the surgery noted on her patient information card was, recall.

Channel 2’s Nicole Carr searched the FDA recall database and found Robinson’s device had been recalled two years earlier. The manufacturer’s suggested course of action was to monitor the device.

While Robinson said she had no idea her device was recalled, her hospital said she was mailed a letter to notify her. Robinson said she never got that letter.

Diana Zuckerman, president of The National Center for Health Research, said she wasn’t surprised that Robinson’s recalled device remained implanted for years.

“This is the doctor having to say to the patient, ‘This implant in your body has been recalled but we don’t think you should have it removed unless you’re having obvious problems with it,” Zuckerman said.

Zuckerman was also said Robinson is most likely not alone in her confusion, and often patients don’t learn their device is recalled.

“Perhaps the patient has moved and the doctor or even the hospital doesn’t know where that patient is anymore,” Zuckerman said.

Linda Radach, an implant recipient herself, said she believes the recall process needs an overhaul.

“The FDA is very, very slow to use their authority to issue a recall instead requiring warning letters and requiring post market surveillance studies. Most of which are never completed,” Radach said.

According the FDA website they hardly every issue a recall, instead trusting manufacturers to self-report. An FDA spokeswoman said recalls are not the only way they get dangerous products off the market.

There are several patient resources available for medical device recipients, including questions to ask your doctor about the approval process.

Radach said a 2006 metal on metal hip replacement failed leaving dangerous cobalt chromium debris in her system.

“I’ve now had six total hip replacements,” Radach said. She said her issues were never reported to the FDA by her doctors and her device was never recalled. She did her own research and found her device had been approved for market three years after it was put in her body. “That alarmed me enough to realize this was much, much bigger than just me.”

Radach told Channel 2 Action News many of the parts that made up her implant were cleared through the 510k process which rarely requires clinical trials on human patients. The process has been in place since 1976.

Zuckerman said the 501K process it’s not enough.

“All those companies have to do is prove that their new device is substantially equivalent to a device that’s already on the market,” Zuckerman said.

In 2011 Zuckerman co-authored a report that found from 2005 until 2009, 113 recalls were class one. Only 21 of those recalls went through clinical trials. She said things haven’t improved.

“Instead of saying ‘let’s be more stringent and require clinical trials for more implants,’ they’re doing exactly the opposite,” Zuckerman said. […]

See the original story here.

FDA Ending Controversial ‘Alternative Summary Reporting’ Program

Thomas Dworetzky, DOTMed News: May 8, 2019.


Following the groundbreaking Kaiser Health News report exposing the scope of the little-known FDA “alternative summary reporting” program that let medical device makers “conceal millions of reports of harm and malfunctions from the general public,” the agency has now stated that it will be shutting the program down, according to KHN.

FDA cited the decision in a statement about its “new efforts to protect women’s health and help to ensure the safety of breast implants,” especially textured implants, which have been linked to a type of cancer and which the agency now plans to leave on the market as it “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,” Amy Abernethy, M.D., Ph.D., FDA’s principal deputy commissioner, and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. But the announcement also addressed the way in which adverse breast implant events were reported with “alternative summary reporting,” stating that “the FDA has ended all summary reporting of breast implant medical device reports.”

The statement then addressed the controversial alternative reporting issue for devices beyond the implants, as well.

“This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks,” the agency stated, continuing, “this program was established in 1997 to more efficiently review adverse events for well-established risks, but was not allowed for patient deaths and unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL. Alternative summary reports were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE) [the FDA public-facing database of device safety reports].

The Kaiser report exposed that the 20-year-old program had 1.1 million reportskept from both public and professional review since 2016.

Former FDA official Dr. S. Lori Brown told KHN that this ending was a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown told the investigative news group.

In March, the revelations in the KHN report prompted concern for healthcare professionals.

“The FDA absolutely should be making all of this information available,” Diana Zuckerman, president of the National Center for Health Research, told the news agency. 

The numbers of these “alternative summary reporting” (ASR) exemptions, Zuckerman added “takes my breath away,” KHN reported at the time. 

Former FDA chief Dr. Scott Gottlieb confessed to the news agency at the time that he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.”[…]

See the original 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.