National Consumers League statement on FDA action regarding CBD

November 29, 2019

Leading consumer advocate urges ‘buyer beware’ as busiest shopping season of the year gets underway

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—Sally Greenberg, executive director of the National Consumers League and a convening partner of Consumers for Safe CBD, today released the following statement in response to FDA’s recent action regarding CBD:

“The decision by the FDA to send 15 new warning letters and remind consumers of potential harm caused by untested and illegal CBD is a step forward in keeping millions of Americans safe. While regular communication from the FDA is helpful, it’s critical that we pursue tangible actions that will lead to broad awareness and prevent the sale of harmful CBD products in a marketplace that is growing by the day. This includes enforcing existing regulations regarding labeling and ingredients, as well as setting safe concentration levels. We cannot wake up a year from now and wish that we had done something when there are practical and achievable solutions right in front of us. Our recent polling shows that 83 percent of registered voters support regulating CBD. We need the gold standard that the FDA provides now more than ever.

“Today marks the start of the busiest shopping season of the year. As consumers head to stores and browse the Internet for deals, we are urging buyer beware when it comes to CBD products. The risk of not getting what you pay for and, even worse, putting one’s own health in jeopardy is far too great. Until the FDA steps in with its stamp of approval, we have no choice but to warn consumers to avoid unregulated CBD products and encourage family and friends to do the same.

“The National Consumers League and Consumers for Safe CBD will continue to work with advocates, policymakers and other stakeholders to ensure that we keep people safe, provide a much-needed sense of clarity and put the interests of the consumer first.”

Learn more about the CBD Myths and Facts HERE.

Learn more about what could be in CBD products HERE.

See what others are saying about CBD HERE.

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About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

CBD is not the cure for whatever ails you

Unless you’ve been living under a rock, you’ve surely seen the dozens of ‘miraculous’ CBD products available today. Health food stores, pet supply stores, gas stations, and even your neighborhood pharmacy and grocery stores are carrying a plethora of CBD-infused products. CBD is included in everything from lotions and oils, beauty products, pet treats, and “tampons.” You can buy CBD-infused workout clothing and even take CBD yoga classes.

CBD, or cannabidiol, is a compound found in cannabis and derived from the hemp plant. After the passage of the Farm Bill, CBD is now legal and CBD products are marketed as having little or no THC, the primary psychoactive element in marijuana. However, under the bill, these products may lawfully contain as much as 0.3 percent THC, which is enough to produce intoxication or a positive result on a drug test, which has led to many workers unwittingly losing their jobs.

Sales of products containing CBD have exploded in recent years. In 2018, Americans purchased $500 million in products containing CBD. By 2022, that amount is expected to more than triple to reach $1.8 billion nationwide.

Consumers, take note! Illegal marketing of these products include unsubstantiated health claims as innocuous as offering “a higher sense of well-being” to the extreme claims of therapeutic benefits such as treating Alzheimer’s and Parkinson’s disease, schizophrenia, or AIDS. 

Our concern is that most CBD products on the shelves today fail to meet the safety standards we have come to expect:

  • Most have not been scientifically tested for safety and efficacy.
  • CBD product labels aren’t accurate in lists of ingredients and potency.
  • The purity and potency of ingredients in most CBD products have not been verified by reliable third parties.

Without these safeguards, consumers may be using these products or offering them to their children and pets with blindfolds on.

Exaggerated claims of unproven benefits are nothing new, but with the legalization of CBD, there’s a new explosion of untested products that demand attention from regulators. CBD could be key to the development of many new treatments and therapies. One indication is the success of the first FDA-approved drug containing CBD in controlling two types of rare, childhood-onset seizures. However, without better regulation and enforcement, unsafe dosages of CBD and the use of adulterated products make for a minefield of consumer caveat emptor.

Clinical studies have demonstrated potential risks of CBD, including liver toxicity, fatigue, and harmful interactions with other drugs. The Food and Drug Administration (FDA) has recently begun to take action. In October, it issued a strongly worded advisory discouraging pregnant and breastfeeding mothers from using CBD products. It also recently warned a Florida company that was illegally selling unapproved products containing CBD online with unsubstantiated claims that the products treat teething pain and earaches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), among other conditions or diseases. We welcome that action by the FDA, and we want to see it doing more.

Advocates recognize the dangers for consumers and we are mobilizing. Earlier this month, National Consumers League (NCL) staff presented at a roundtable discussion of consumers and other partners about FDA’s authority to protect consumers via product testing and regulation of product marketing. The discussion allowed further sharing of information and identified opportunities to bring commonsense changes to the marketplace.

Consumers need access to good information about CBD, how to understand concentration levels in products, and the products’ risks. The FDA should take a more active role as a regulatory agency overseeing products that make health benefit claims. Our regulators should help consumers understand the difference between FDA-approved medicines and consumer products, including a definition of a safe level of CBD.

We welcome the potential that CBD has to offer new therapies and treatments, but the products in the marketplace must be safe and proven effective with hard science. NCL is committed to doing its part to help protect and educate consumers.

AAOA and National Consumers League Raise Awareness About Prescription Opioid Abuse Safety

October 16, 2019

Media contact: press@againstopioidabuse.org or National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Alexandria, VA—Allied Against Opioid Abuse (AAOA) and the National Consumers League (NCL) released a new suite of resources to help educate consumers about prescription opioid safety. The AAOA-NCL Consumer Toolkit provides materials to help reinforce the need for patients, caregivers, parents and others to understand their rights, risks and responsibilities associated with prescription opioid use.

Education plays a crucial role in helping consumers understand the importance of safely using, storing and disposing of prescription opioids,” said Sally Greenberg, Executive Director, NCL. “We are pleased to partner with AAOA on this important set of resources, which will provide individuals with actionable steps that they can take to keep prescription opioids secure and prevent misuse and abuse of these medicines among family and friends.”  

The AAOA-NCL Consumer Toolkit addresses common questions that patients may have about their rights, risks and responsibilities associated with prescription opioids, and highlights facts about opioid medications to fill a knowledge gap and prevent misuse before it occurs. The toolkit includes the following resources:

AAOA has taken a leading role in sharing information and fostering communication between patients, consumers and the medical community to help reduce prescription opioid abuse,” said John Parker, Senior Vice President of Communications for the Healthcare Distribution Alliance, the founding member of AAOA. “By leveraging NCL’s expertise, our goal is to communicate directly with consumers about the important role everyone has to play in ensuring the appropriate use, storage and disposal of prescription opioids.”  

In August, the AAOA-HealthyWomen Toolkit was released to help educate women, in their role as consumers and caregivers, about what they can do to prevent the misuse and abuse of prescription opioids in the home. To learn more about AAOA’s resources, including a series of videos that raise awareness about prescription opioid safety, visit www.AgainstOpioidAbuse.org/Act.

For press inquiries, contact press@againstopioidabuse.org

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About Allied Against Opioid Abuse
Allied Against Opioid Abuse is a national education and awareness initiative to help prevent abuse and misuse of prescription opioids. Founded by the Healthcare Distribution Alliance, the initiative is a collaborative effort with diverse partners across the pharmaceutical supply chain, as well as organizations that are experts in public health and healthcare, including Alliance for Aging Research, American Pharmacists Association, American Physical Therapy Association, BeMedWise, Caregiver Action Network, Gerontological Society of America, Healthcare Leadership Council, HealthyWomen, Men’s Health Network, Mental Health America, National Alliance of State Pharmacy Associations, National Association of Directors of Nursing Administration, National Association of States United for Aging and Disabilities, National Community Pharmacists Association, National Consumers League, National Transitions of Care Coalition, Pharmacy Technician Certification Board, and the PA Foundation. Our goal is to contribute to solving the opioid crisis in a meaningful way by educating patients about their rights, risks and responsibilities. To learn more, visit www.AgainstOpioidAbuse.org or follow us on Twitter: @AAOA_Tweets.

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Calling an end to the health and humanitarian crisis at the border

Nissa ShaffiFlorence Kelley, first general secretary of the National Consumers League (NCL), was a pioneer in progressive social reform during a time in our nation’s history that was defined by mass immigration and egregious health violations. 120 years later, we bear witness once again to the unconscionable transgressions occurring in migrant detention centers across the border with regards to immigrant rights and access to health care. 

At this very moment, people who are exercising their legal right to seek asylum, according to international and U.S. law, are being systemically dehumanized. The atrocities occurring at our border completely tarnish the social protections that NCL has historically fought to solidify.

On July 10, the House Oversight Committee held a hearing to examine the humanitarian crisis at the border. The investigation followed the release of a July 2 report by the Office of Inspector General (OIG) detailing the dangerous and unsanitary conditions migrant detainees are experiencing at Custom and Border Patrol (CBP) and Immigration Customs Enforcement (ICE) facilities.

Images of children sprawled across cold concrete floors in overcrowded holding cells, wrapped in nothing but flimsy mylar blankets, prompted members of Congress, immigration lawyers, and physicians to visit various migrant detention centers throughout Texas to witness the matter firsthand.

Visitors noted a stench that could be detected immediately upon entry into the facilities, which was attributed to detainees being sardined into holding cells, in conditions that have been classified as inhumane and in violation of international law. A majority of detainees have been denied access to basic toiletries like soap and toothbrushes to help them maintain their hygiene. Additionally, individuals have not been able to shower in weeks, are sleep deprived, and are housed in frigid temperatures in rooms that have been given the apt moniker of the “ICE Box.” Many migrants have claimed that they were wearing the same soiled clothes that they wore during their long passage into the country.

These facilities were not designed to house migrants for prolonged detainment. Regulations prohibit the detention of detainees for longer than 72 hours, yet OIG reported that migrants had been held indefinitely, some even as long as several weeks. The unsanitary conditions prevalent in the detention centers have resulted in outbreaks of the flu, lice, shingles, scabies, and chickenpox. The processing centers in the facilities are housed beyond infrastructural capacity, leading border officials to take desperate measures to hold detainees in cages and under overpasses. These dangerous conditions will inevitably advance the spread of disease, endangering the lives of detainees as well as the general public who will come into contact with CBP and ICE agents.

These facilities are privatized, for-profit migrant detention centers that function outside the purview of federal oversight and accountability. Shareholder interests call for incentivized cuts to medical staffing, which as a result, has led to cruel and negligent practices that have encouraged the spread of disease, the proliferation of trauma, and the violation of human rights.

NCL calls on Congress to address the harrowing health and human rights violations taking place at our borders. NCL strongly advocates for a principled, comprehensive immigration reform that treats all immigrants with respect and dignity, no matter their legal status in the United States. NCL’s immigration policy advocates to:

  • keep families together;
  • ensure a humane pathway to citizenship and builds upon the success of Deferred Action for Childhood Arrivals (DACA) to incorporate young immigrants into mainstream society; and
  • ensure effective enforcement that protects our borders, fosters commerce, and promotes the safe and legitimate movement of people and goods at our ports of entry.

To learn about NCL’s immigration policy, click here.

The National Consumers League calls on lawmakers to work together to enact humane immigration policy reform that genuinely encompasses the promise of American values. Congress must act swiftly and in the best interest of migrants detained to collectively bring an end to this humanitarian crisis.

No more surprises: Congress and patients alike sick of surprise billing

headshot of NCL Health Policy intern Alexa

By NCL Health Policy intern Alexa Beeson

This July, the House Energy and Commerce’s Health Subcommittee passed the No Surprises Act (H.R. 3630) to protect patients from surprise billing. The Senate Health, Education, Labor and Pensions Committee also passed its companion to address surprise billing, the Lower Health Care Costs Act (S.1895). These bills were being considered after a press conference at which President Trump called for reform in surprise billing.

Stakeholder witnesses at the House hearing this June on H.R. 3630 included patient, provider, and insurance payer groups. Reimbursement models were discussed at length, but the unifying theme was that patients should be held harmless in surprise billing situations.

Surprise billing happens mostly in a small subsect of out-of-network providers; the patient has no idea about who’s in or out of network. Some professionals are out-of-network technicians subcontracted by an in-network facility, such as a last-minute anesthesiologist switch for a surgery, or any other non-disclosed provider. To get reimbursed for their services, providers send a bill to the patient for whatever wasn’t covered by the insurance company.

Surprise billing also occurred among patients who should receive reduced prices for care. Johns Hopkins Hospital filed suit on more than 2,400 patients in the last decade, collecting the equivalent of 0.03 percent of its operating revenue. Some of these patients were never told about their right to charity care, and many who qualify never received a discounted rate. These bill collections are inconsequential for Johns Hopkins but could bankrupt a patient.

Legislation to address balance or surprise bills will protect patients, ensuring they will only have to pay in-network rates for out-of-network emergency care. This will help patients avoid bills that can set them back, sometimes, hundreds of thousands of dollars. Although surprise bills only come from a small portion of providers, 1 in 7 insured adults will receive a surprise medical bill from an in-network hospital. The Kaiser Family Foundation found that 70 percent of such patients were not aware that the provider was out-of-network when they received the care.

Panelist Sonji Wilkes, a patient advocate, presented testimony about her struggle with a surprise bill sent after the birth of her son, who was diagnosed with hemophilia. That child was treated by a charitable out-of-network hematologist who did not charge them for her services. However, the NICU that observed the boy was subcontracted to a third-party provider. This meant that the NICU was out-of-network. The Wilkes were sent a $50,000 bill by the hospital that still haunts them 15 years later.

Thomas Nickels, the executive vice president of the American Hospitals Association, claimed that fixed reimbursement rates, such as a median benchmark or percentage of the Medicaid reimbursement value, would disincentivize insurers from maintaining adequate provider networks. Nickels supported the Alternative Dispute Resolutions method, which involves baseball-style arbitration where providers and payers settle on reimbursement value on a case-by-case basis.

Jeanette Thornton, a senior vice president at America’s Health Insurance Plans, argued that the New York model of baseball-style arbitration would create immense clerical burden, resulting in lost time and greater administrative costs. She argued the arbitration reimbursement model would raise costs for patients in the end. Instead, she advocated for the government-dictated fixed reimbursement rates.

Both versions of the bill call for a benchmark to resolve payments between insurance plans and out-of-network providers. This benchmark says health plans would reimburse providers with the median in-network rate already contracted within specific geographic areas. The House bill contains binding arbitration as a fallback in case either the provider or payer decide the payment was an unfair price.

The National Consumers League supports Congress’ tackling of this issue of surprise or balance billing. NCL has taken no position on how these bills are settled between the payer and provider, as long as patients are protected from outrageously expensive bills they can never hope to pay and were never anticipating. In addition, medical debt is the greatest contributor to consumers declaring bankruptcy, and balance billing is a contributor to that troubling consumer issue. The bottom line is that a bill for medical services should never cause bankruptcy, and a patient should never have to choose between medical treatment and food or housing. We are hopeful this issue will be resolved during this Congressional session.

Alexa is a student at Washington University in St. Louis where she studies Classics and Anthropology and concentrates in global health and the environment. She expects to graduate in May of 2020

NCL continues to advocate for breastfeeding mothers

headshot of NCL Health Policy intern Alexa

By NCL Health Policy intern Alexa Beeson

This July, Dutch airline KLM found itself in the middle of a breastfeeding snafu: “public decency” vs. “natural practice.” A mother wrote about the airline with a Facebook post describing how a KLM flight attendant asked her to cover up if she wanted to continue nursing her baby. The new mom said that, while contacting KLM to file a complaint, she was told that she should “be respectful of people of other cultures.”

Other moms went on Twitter to ask KLM about its official breastfeeding policy. KLM responded with: “Breastfeeding is permitted at KLM flights. However, to ensure that all our passengers of all backgrounds feel comfortable on board, we may request a mother to cover herself while breastfeeding, should other passengers be offended by this.” The National Consumers League is disappointed.

New moms should be encouraged, supported, and protected to breastfeed. It has so many health benefits for mom and baby including the prevention of allergies in babies and the reduced risk of developing certain forms of cancer in moms.

A few years back, NCL posted a Breastfeeding Mothers’ Bill of Rights, that included the following:

  • A mother should have the right to breastfeed her child in any public or private establishment where they both are legally present, without harassment or discrimination of any kind,
  • No establishment should enact a rule that prevents breastfeeding a child, and
  • Breastfeeding mothers should not be told to only do so in a discreet manner.

Breastfeeding is a safe, healthy, and natural act, through which mothers provide nourishment to their children. NCL stands with mothers wishing to express milk whenever needed, regardless of the presence of their child. In no way should breastfeeding ever be considered lewd, immoral, or indecent–you are feeding your baby! That has nothing to do with sex.

Memo to KLM: check with your lawyers. Both the United States and the Netherlands protect public breastfeeding. All 50 states have laws that allow breastfeeding in public or exempt breastfeeding from public decency laws. In the Netherlands, there are no specific laws regarding public breastfeeding, but it is widely socially accepted. Why then, on a flight from San Francisco to Amsterdam, should KLM be able to prevent a woman from breastfeeding?

Reading replies to this tweet is a happy reminder that people do, in fact, support a woman’s right to breastfeed in public. Many people were upset that KLM considered breastfeeding an offensive act. Others satirically asked whether KLM would force an adult to cover his head if his eating “offended” another passenger. A few people questioned why a woman needs permission from an airline to feed her child. KLM themselves called breastfeeding “the most natural thing in the world,” yet still uphold their policy of having the right to discourage mothers from breastfeeding.

No mother should never feel uncomfortable or judged by another while feeding her child or expressing milk. KLM’s policy shows they would rather cater to someone who is “offended” by the most basic act of feeding one’s child; that is wrong. KLM–you must do better! And all airlines should publish affirmative policies supporting breastfeeding. Women and their babies need our support.

Alexa is a student at Washington University in St. Louis where she studies Classics and Anthropology and concentrates in global health and the environment. She expects to graduate in May of 2020

NCL statement on White House pathway for drug importation

August 2, 2019

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—As the nation’s pioneer consumer organization, the National Consumers League (NCL) strongly supports consumer access to safe, effective, and affordable prescription drugs. The recent announcement by the White House to open a pathway for importation of drugs from outside of the United States seems unworkable and poses safety and purity challenges.

Six years ago, the U.S. government enacted a safe system to “track and trace” drugs sold to U.S. consumers through the Drug Supply Chain Security Act. The law required, that by 2023, all drugs sold to U.S. consumers must have both a product identifier and a unique package code to allow Food and Drug Administration (FDA) and any buyer in the supply chain to obtain a comprehensive history of where the drug was manufactured and packaged. This secure supply chain system best ensures consumers are receiving medications that are not counterfeit or substandard.

“The recent announcement by the White House ignores the Drug Supply Chain Security Act and undermines the security of the U.S. pharmaceutical supply chain,” said Sally Greenberg, NCL executive director. “This new pathway for importation could easily lead to counterfeit or substandard drugs finding their way to consumer’s medicine cabinets, thus putting patient health and safety at risk.”

In addition to the safety risks posed by this new policy announcement, there are no guarantees that it will save consumers money. The proposal opens the door for states, pharmacies, and distributors to obtain the medications outside of U.S. borders, but it does not require that any cost savings from obtaining those “lower-priced” medications be passed on to consumers. So, even if safety concerns could be addressed, it is not clear that there will be any direct cost savings benefit to consumers.

The threat to public health is real. Counterfeit medications may contain the wrong active ingredient, the wrong amount of the active ingredient, no active ingredient, harmful ingredients, or even poisons such as mercury, road tar, or antifreeze. Counterfeit medications made with deadly ingredients have been found in more than 40 states across America, posing a significant public health threat.

“Allowing importation will only serve to exacerbate the challenge of preventing counterfeit drugs from reaching American patients,” said Greenberg.

NCL continues to advocate for more responsible strategies to ensure the affordability and accessibility of safe and effective prescription drugs.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Oral argument for ACA case will determine the fate of millions

Nissa ShaffiOn Tuesday, July 9, the U.S. Court of Appeals for the 5th Circuit will hear oral arguments that will determine whether or not the Affordable Care Act (ACA) may be overturned. Throughout the course of its life, the ACA has been under the specter of possible repeal. While there have been piecemeal attempts to strike down the legislation over time, none have been as concerning as the most recent Texas v. United States case, which argues that since the individual mandate is no longer enforced, ACA  would be unconstitutional.

The individual mandate requires that most people maintain a minimum level of health insurance or be subject a financial penalty. In 2017 however, the Tax Cuts and Jobs Act (TCJA), set the individual mandate to $0 as of 2019. As a result of this ruling, the Texas v. United States case was filed by 20 Republican state attorneys general and governors. The plaintiffs argue that the ruling rendered the individual mandate futile, as it no longer produces revenue for the federal government, and since Congress declared the individual mandate to be “essential” when enacting the ACA, this would now make the entire law invalid.

In an ideal situation, the court would maintain the ACA as it exists today, absent the individual mandate. If the ACA is repealed along with the protections that come with it, close to 20 million people would lose their health coverage. Those affected will include mostly low-income adults and children with chronic or pre-existing conditions, dependent adult children ages 26 and younger, Medicare and Medicaid enrollees, employer and employee groups, and more.

Repealing the ACA would jeopardize Medicaid expansion, further burdening uncompensated care and provider reimbursement. In addition, repealing the ACA would increase health care costs among the uninsured by $50.2 billion, result in more than 9 million people losing federal subsidies to purchase health insurance via the marketplace, and would endanger consumers’ ability to obtain essential health benefits.

California’s Attorney General, Xavier Beccerra, is leading a coalition of 21 Democratic attorneys general who have intervened to defend the ACA. Advocates interested in joining these efforts can contact izzy@xavierbecerra.com – please do so and sign the petition by July 14. In addition, organizations can participate in the TXvUS Tweetstorm to express their concerns regarding this case, using the hashtags #TXvUS and #WhatsAtStake, on July 9th at 2 pm EST/ 11 am PST.

NCL is a zealous supporter of the ACA and notes that it is still the law of the land. We are following the developments of this case closely and will continue to fight for access to affordable healthcare for all Americans. For more information on developments of this case, please click here.

FDA acts to protect women’s health

Nissa Shaffi

Last April, the U.S. Food and Drug Administration (FDA) issued a ban on all sales of pelvic surgical mesh products after determining that the manufacturers, Boston Scientific and Coloplast, failed to “demonstrate [a] reasonable assurance of safety and effectiveness.”

The ban comes on the heels of a 2016 reclassification of the product by the FDA, resulting in a class III (high-risk) designation. As a result, the manufacturers were required to undergo meticulous review and obtain premarket approval by the FDA in order to continue sales of their products in the United States.

A surgical mesh is a medical device used to treat urogynecological or pelvic organ issues. Most commonly, surgical mesh has been used to treat pelvic organ prolapse (POP). POP is a type of pelvic floor disorder that occurs when the muscles and tissues supporting pelvic organs become weakened–often resulting in urinary incontinence typically seen as a result of childbirth or advanced age.

A transvaginal surgical mesh is intended to provide additional support to the pelvic floor muscles to reinforce a weakened vaginal wall for treatment of POP. A urethral sling surgical mesh is supposed to provide support to the urethra or bladder to address urinary incontinence. Surgical mesh comes in two forms: synthetic and animal derived. Synthetic surgical mesh remains in the body indefinitely and acts as a permanent implant. Animal derived mesh, made from the intestine or skin of pig or cow, are absorbable and lose durability over time.

The most frequent complications from these devices include vaginal scarring, mesh erosion, increased risk of infection, and painful urination. Nearly 10 million women worldwide have received mesh implants, with about 10 to 15 percent of these women suffering from complications. Following the ban, there are currently no FDA-approved pelvic surgical mesh products available for sale in the United States.

The FDA advises that women who have already received a transvaginal mesh for the surgical repair of POP should continue their routine follow-up care with their provider and need not take any additional action if they are satisfied with their procedure. Patients should notify their provider if they experience any adverse reactions, such as bleeding or pain, following the procedure.

Given the grave injury these devices have caused in women patients, the National Consumers League questions how they ever received FDA approval in the first place. Nevertheless, banning the devices now is better than keeping them on the market. We must expect better from our healthcare regulators. Thankfully, we now have stronger safety standards that have brought an immediate halt to the sale of these unsafe medical devices.

To read the FDA’s full report on transvaginal mesh, click here.

NCL Health Policy Intern Alexa Beeson contributed to this blog.