What Drug & Medical Device Labels Don’t Say

Hidden Harms

Drugs and medical devices save lives every day, but they can also lead to serious pain or injury—and even death. In some cases, these dangerous side effects happen with surprising frequency.

Select a Drug or Device

Do You Know Your Risk?

We’ve examined data from tens of thousands of adverse event reports and hundreds of clinical trials and studies to highlight the risks of some of the more troublesome drugs and medical devices. We then compared them to everyday risks—such as delayed flights and dog bites—to put them in context. The results presented below may surprise you. Explore the risks now.

Select a drug or medical device

Essure's Hidden Harm Essure Risks vs Everyday Risks

Problems

  • Unintended Pregnancy
  • Chronic Pelvic Pain
Essure is a tubal ligation device intended to permanently prevent pregnancy. It is implanted in a woman's fallopian tube, blocking eggs from entering the uterus. Bayer stopped selling the birth control device in the U.S. at the end of 2018.

2 out of 20 users are expected to become pregnant after Essure permanent sterilization.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for an Essure user to develop chronic pelvic pain than for a shark attack victim to die.

It is more likely for an Essure permanent sterilization device user to become pregnant than it is for a tax return to be audited.

It is more likely for an Essure user to develop chronic pelvic pain than for a shark attack victim to die.

20 out of 500 Essure recipients develop chronic pelvic pain.
16 out of 500 shark attack victims do not survive the attack.

It is more likely for an Essure permanent sterilization device user to become pregnant than it is for a tax return to be audited.

48 out of 500 Essure recipients are projected to become pregnant within ten years.
31 out of 500 tax returns are officially or unofficially audited.

Testosterone's Hidden Harm Testosterone Risks vs Everyday Risks

Problems

  • Heart Attack
  • Cardiovascular Event
Testosterone replacement therapy is used to treat low testosterone (low-T) in men, though some men also take testosterone supplements for off-label uses.

4 out of 20 men who take testosterone suffer a heart attack, arrhythmia or another cardiovascular event.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for a male testosterone user to suffer a heart attack (within 90 days) than for a person to have a strawberry allergy.

It is more likely for a male testosterone user over the age of 65 to suffer a cardiovascular event than for an Amazon package to arrive late.

It is more likely for a male testosterone user to suffer a heart attack (within 90 days) than for a person to have a strawberry allergy.

3 out of 500 testosterone users over the age of 65 has a heart attack within 90 days.
2 out of 500 people have a strawberry allergy.

It is more likely for a male testosterone user over the age of 65 to suffer a cardiovascular event than for an Amazon package to arrive late.

108 out of 500 men who take testosterone suffer a cardiovascular event (heart attack, arrhythmia, congestive heart failure, stroke).
50 out of 100 Amazon packages arrive late.

Concerta's Hidden Harm Concerta Risks vs Everyday Risks

Problems

  • New Onset Tic
  • Anorexia
Concerta or methylphenidate is an attention deficit/hyperactivity disorder (ADHD) drug often given to children.

2 out of 20 children who take Concerta long-term develop a new physical tic.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for children taking Concerta to develop clinical loss of appetite (anorexia) than to have a strawberry allergy.

It is more likely for children taking Concerta long term to develop a physical tic than it is for a tax return to be audited.

It is more likely for children taking Concerta to develop clinical loss of appetite (anorexia) than to have a strawberry allergy.

5 out of 500 children who take Concerta experience loss of appetite classified as anorexia.
2 out of 500 people have a strawberry allergy.

It is more likely for children taking Concerta long term to develop a physical tic than it is for a tax return to be audited.

45 out of 500 children who take Concerta long term develop a new physical tic.
31 out of 500 tax returns are officially or unofficially audited.

Blood Thinners' Hidden Harm Blood Thinners Risks vs Everyday Risks

Problems

  • Life-Threatening Bleed
  • Major Bleed
Pradaxa is an anti-coagulant or blood-thinner. It helps prevent blood clots and reduce the risk of stroke.

1 out of 40 Pradaxa patients experience a life-threatening bleed.

Select a side effect
⇤ Less likely More likely ⇥

A Pradaxa user has as great a risk of experiencing a life-threatening bleed as they do of dying from the flu.

It is more likely for a Pradaxa patient to experience a major bleed than for a shark attack to be fatal.

A Pradaxa user has as great a risk of experiencing a life-threatening bleed as they do of dying from the flu.

8 out of 500 Pradaxa patients experience a life-threatening bleed while taking the drug.
8 out of 500 Americans die from the flu.

It is more likely for a Pradaxa patient to experience a major bleed than for a shark attack to be fatal.

33 out of 500 Pradaxa patients experienced a major bleed while taking the drug.
16 out of 500 shark attack victims do not survive the attack.

Hernia Mesh's Hidden Harm Hernia Mesh Risks vs Everyday Risks

Problems

  • Surgical Site Infection
  • Hernia Recurrence
Hernia mesh is a common implantable medical device used to treat hernias. Because they have been used for so long, many of the devices on the market today went through a fast-track FDA approval process.

4 out of 20 patients developed a surgical site infection after intraperitoneal hernia repair with C-Qur hernia mesh.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for a Physiomesh hernia repair patient to experience hernia recurrence than it is for an Amazon package to arrive late.

It is more likely for a C-Qur hernia mesh repair to become infected than it is for an Amazon package to arrive late.

It is more likely for a Physiomesh hernia repair patient to experience hernia recurrence than it is for an Amazon package to arrive late.

60 out of 500 patients undergoing intraperitoneal hernia repair with Physiomesh experience hernia recurrence.
50 out of 500 Amazon packages arrive late.

It is more likely for a C-Qur hernia mesh repair to become infected than it is for an Amazon package to arrive late.

95 out of 500 patients receiving ventral hernia repair with intraperitoneal C-QUR V-Patch Mesh develop a surgical site infection.
50 out of 500 Amazon packages arrive late.

Hip Replacements' Hidden Harm Hip Replacements Risks vs Everyday Risks

Problems

  • Allergic Reaction to Metal Debris
  • Implant Loosening
Artificial hips can help with stiffness, arthritis, pain, or other joint discomfort. Different types of hip implants can be used to replace part or all of the ball-and-socket joint.

2 out of 20 Recap M2A Magnum Cup hip implants have to be removed due to loosening within 5.5 years.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for a M2A Magnum hip replacement to create an allergic reaction to metal debris than for an Amazon package to arrive late.

It is more likely for a Recap M2A Magnum Cup hip implant to loosen enough to require revision than for a tax return to be audited.

It is more likely for a M2A Magnum hip replacement to create an allergic reaction to metal debris than for an Amazon package to arrive late.

69 out of 500 M2A Magnum total hip replacements cause allergic reactions to metal debris (metallosis) within 6 years.
50 out of 500 Amazon packages arrive late.

It is more likely for a Recap M2A Magnum Cup hip implant to loosen enough to require revision than for a tax return to be audited.

38 out of 500 Recap M2A Magnum Cup hip implants have to be removed due to loosening within 5.5 years.
31 out of 500 tax returns are officially or unofficially audited.

IVC Filters' Hidden Harm IVC Filters Risks vs Everyday Risks

Problems

  • Vein Puncture
  • Sudden Death
Inferior vena cava (IVC) filters prevent dangerous clots from traveling to the heart, lungs and brain. They protect patients who are unable to take anti-clotting drugs. Physicians implant them in a large blood vessel, where they can remain permanently.

16 out of 20 Celect IVC Filters puncture a vein within 90 days of implantation.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for an IVC filter to puncture a vein than for a flight to be delayed.

It is more likely for a Bard Recovery IVC filter recipient to die suddenly than it is for a shark attack victim to die.

It is more likely for an IVC filter to puncture a vein than for a flight to be delayed.

400 out of 500 Celect inferior vena cava filters puncture a vein within 90 days.
142 out of 500 flights are delayed.

It is more likely for a Bard Recovery IVC filter recipient to die suddenly than it is for a shark attack victim to die.

18 out of 500 patients receiving Bard Recovery inferior vena cava filters dies suddenly.
16 out of 500 shark attack victims do not survive the attack.

Heartburn Drugs' Hidden Harm Heartburn Drugs Risks vs Everyday Risks

Problems

  • Hip Fracture
  • Chronic Kidney Disease
Proton-pump inhibitors like Nexium, Prilosec and Prevacid are used to treat acid reflux (heartburn, GERD, etc.) and stomach ulcers.

1 out of 250 patients who take a proton-pump inhibitor will experience a hip fracture.

Select a side effect
⇤ Less likely More likely ⇥

A patient using a proton pump inhibitor long-term is just as likely to experience a hip fracture as they are to have a strawberry allergy.

It is more likely for a person to develop chronic kidney disease after a year of proton pump inhibitor use than for a person to have a peanut allergy.

A patient using a proton pump inhibitor long-term is just as likely to experience a hip fracture as they are to have a strawberry allergy.

2 out of 500 proton pump inhibitor users experience a hip fracture.
2 out of 500 people have a strawberry allergy.

It is more likely for a person to develop chronic kidney disease after a year of proton pump inhibitor use than for a person to have a peanut allergy.

13 out of 500 people who use proton pump inhibitors for a year develop chronic kidney disease.
11 out of 500 people have a peanut allergy.

Pelvic Mesh's Hidden Harm Pelvic Mesh Risks vs Everyday Risks

Problems

  • Prolapse Recurrence
  • Reoperation
Pelvic mesh is used to treat pelvic organ prolapse and stress urinary incontinence in women. It is surgically implanted in the pelvis or abdomen.

3 out of 20 women who get pelvic mesh need additional operations due to failure, complications or incontinence.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for a pelvic mesh recipient to experience prolapse recurrence than it is for a tax return to be officially or unofficially audited.

It is more likely for a transvaginal mesh recipient to need additional operations than it is for an Amazon package to arrive late.

It is more likely for a pelvic mesh recipient to experience prolapse recurrence than it is for a tax return to be officially or unofficially audited.

36 out of 500 Prolift transvaginal mesh recipients experience prolapse recurrence.
31 out of 500 tax returns are officially or unofficially audited.

It is more likely for a transvaginal mesh recipient to need additional operations than it is for an Amazon package to arrive late.

73 out of 500 Prolift pelvic mesh recipients need additional operations due to failure, complications or incontinence.
50 out of 500 Amazon packages arrive late.

Gout Medication's Hidden Harm Gout Medication Risks vs Everyday Risks

Problems

  • Fatal Heart Attack
  • Death
Uloric is a gout medication used to treat severe arthritis flare-ups. Doctors prescribe Uloric when other gout drugs such as allopurinol cause adverse reactions or do not work.

1 out of 20 people who take Uloric die of a heart attack.

Select a side effect
⇤ Less likely More likely ⇥

It is more likely for a Uloric patient to die of a heart attack than for a shark attack victim to die.

It is more likely for a Uloric patient to die from any cause than it is for a tax return to be officially or unofficially audited.

It is more likely for a Uloric patient to die of a heart attack than for a shark attack victim to die.

22 out of 500 people who take Uloric die of a heart attack.
16 out of 500 shark attack victims do not survive the attack.

It is more likely for a Uloric patient to die from any cause than it is for a tax return to be officially or unofficially audited.

38 out of 500 people who take Uloric long-term die (from any cause).
31 out of 500 tax returns are officially or unofficially audited.

What We Learned About Hidden Harms

What we found was surprising, even for those of us who read daily reports about dangerous drugs, faulty medical devices and defective consumer products. Some of these risks were unknown, while others had warnings buried so deep in prescription labels that almost nobody would read them. Those who did likely could not understand the warnings, because they’re written in medical jargon that thwarts even many experienced doctors.

Accountability & Action

Every year, thousands of people who are hurt by drugs and medical devices file lawsuits against the companies who hid their harmful effects from the public. It’s time to bring these hidden harms to light and hold the manufacturers, marketers and distributors accountable for their failure to disclose problems with their products. If you know someone who has suffered, share this page with them and tell them to get help today.

What Should I Do If I’ve Been Harmed by a Drug or Device?

Report a Dangerous Product

Alert the authorities to problems you’ve experienced with a harmful consumer product.

Report Adverse Events

Tell the FDA about serious drug or device side effects.

Research Your Rights

Investigate your options for legal recourse after using a harmful drug or device.

Get a Free Case Review

Have an experienced lawyer evaluate your case for no charge.

Methodology

How We Created Hidden Harms

Drug and Medical Device Harms

To uncover the real-world impact of Hidden Harms, we needed to gather several pieces of information from reliable sources:

  1. Complete list of side effects for each drug or medical device
  2. The number of patients experiencing each side effect
  3. The time period in which the side effects were monitored
  4. The total number of patients who used the drug or medical device in that time period

We started this process by pulling records from the FDA’s Adverse Event Reporting System (FAERS) and the Manufacturer and User Facility Device Experience database (MAUDE). These databases could theoretically provide the first three pieces of information listed above, though MAUDE, in particular, would require a substantial amount of effort.

For drugs, we found the total number of prescriptions in a given time period using the ClinCalc Drug Stats database. We found the corresponding information for medical devices from public manufacturer filings where possible. When this information was excluded from public filings, we used information provided by a manufacturer representative to a reputable news outlet.  In cases where none of these methods provided reliable information, we searched PubMed for studies of the specific drug or device in question.

We did not combine data from multiple studies to create average or conglomerate incidence for any adverse event. Each risk statement in the Data Explorer comes from a single clinical trial, study or database. In the case of pregnancy after Essure sterilization, we did include one data point from a mathematical modeling manuscript. It was the only study to quantitatively assess this risk in a time frame relevant to that of the implant, and the authors used information from 13 separate studies to do so.

For each side effect, we found at least two data points. If they were substantially different, we chose to include data from whichever study had more of the following qualities:

  1. Higher Sample Size
  2. Longer Follow-Up
  3. Real-World Data

In our opinion, these qualities represent information more likely to reflect the experience of the average person using these drugs or devices.

Within the timeframe of our investigation, news broke that MAUDE was missing millions of reports due to an extensively exploited reporting loophole. This loophole affected several of the devices in our investigation. Though the FDA has recently made these reports public, they lack the depth of information available from typical MAUDE database entries. Nonetheless, we analyzed data from more than 50,000 MAUDE reports. In every case, MAUDE reports underestimated the frequency of side effects in comparison to clinical and post-market studies.

Everyday Risks

For estimating the frequency of everyday risks, we used data from trustworthy sources, including:

  1. Government Reports
  2. Published Studies
  3. Reputable News Outlets

In some cases, everyday health risks were reported as risk for a specified duration of time. We standardized these data points to lifetime risk by dividing the yearly risk by the average United States life expectancy for the year in which the risk was initially determined. We determined average United States life expectancy from the Centers for Disease Control’s National Center for Health Statistics reports.

Comparing Risks

Our goal in creating Hidden Harms is to raise awareness of the risks buried in (or missing from) drug and device labels by providing easy-to-understand, relatable information. We believe the key to achieving this goal is ensuring that people can see how drug and device risks compare to risks they or someone they know have personally experienced.

That being said, it is nearly impossible to calculate the true lifetime frequency of drug and medical device problems from studies lasting only a couple of years. In most cases, the chance of injury or failure changes over time. Some problems occur more frequently at the start of a drug’s use or implantation of a device. Others do not occur for years but become more common the longer the drug or device is used.

With this in mind, we did not standardize drug and device risks to lifetime risk as we did with everyday risks. Doing so would have misrepresented the frequency of almost every malfunction and side effect we studied. Instead, we chose to include the risk time period in the Compare the Risks portion of the Risk Explorer.

In this way, we accurately represent the real-world frequency of drug and medical device problems while providing relatable context in the form of everyday lifetime risks.

Sources