Protect Yourself Against Risks Posed by Dangerous Medical Devices

Last year, a joint investigation into Phillips, a major manufacturer of breathing machines, discovered that the company withheld information about potential health risks associated with its products for 11 years despite being aware of the dangers. 

The company kept warnings and over 3,700 complaints about the potential harm caused by foam used in its continuous positive airway pressure (CPAP) devices secret while its profits continued to rise.

The foam used to dampen the CPAP machine’s noise was breaking down, contaminating the machines and causing potentially “toxic and carcinogenic” material to enter into users’ noses, mouths, throats, and lungs.

The company did not launch a formal investigation of the problem until 2019 — nine years after the first wave of complaints and three years after the first known tests by the company found that the foam was deteriorating.

Sadly, this scenario is more common than you might think. 

Most medical implants have never been tested for safety, and unsuspecting Americans are paying the price. It’s no surprise—yet still shocking—to see that injuries, complications, or deaths due to faulty medical devices have increased by over 500 percent in the last decade.  

If you’re one of the tens of millions of Americans who rely on this kind of equipment to keep you alive, what can you do to protect yourself against the risks posed by dangerous medical devices? 

First, Educate Yourself on the Realities of the Industry

Recently, a group of U.S. senators called for a thorough investigation into the oversight practices of the FDA regarding medical devices. Their request for an inquiry comes in the wake of concerns raised by the recall of certain Continuous Positive Airway Pressure (CPAP) machines due to potential health risks and the alleged failure of the FDA to keep Americans safe from these faulty devices.

  • In addition to the Philips investigation, the FDA recently recalled all 20 million CPAP masks, branded AirFit or AirTouch, made by the manufacturer ResMed. The FDA has categorized this recall as a Class 1, meaning it is the most serious type of recall and could cause injury or death. 
  • Last Week Tonight tackled the medical device industry’s big money-makers and even more significant problems with regulation.
  • If you use any medical device, make sure it hasn’t been recalled. Check the FDA website for recalls by year or search their database. Everything is accessible by searching the device’s name. 

Second, Take These Steps to Guard Against Risks

These four tips from Consumer Reports can help protect you or your loved ones from the risk of defective medical devices. 

  1. Consider the alternatives – If your doctor suggests an implant, ask what will happen if you don’t get it. Sometimes, patients aren’t adequately informed about options. In some cases surgery isn’t needed but others may not have a choice.
     
  2. Research the device – Aside from checking the FDA for safety warnings, complaints, and recalls, search elsewhere for patient forums and other information about the device online.
     
  3. Write down the details – Ask for your device’s brand name, model, and serial number (if applicable) so that if you learn of a warning or safety recall, you’ll know whether yours is one of the problem models.
     
  4. Don’t panic – If you discover problems with your device, don’t assume it has to be removed. Contact your doctor and learn to recognize possible adverse side effects in your case.

Third, Know When to Get Legal Help

One of the problems the Senators uncovered in the Philips investigation is that the FDA’s current oversight practices may be inadequate in addressing emerging risks and ensuring timely responses to safety concerns. One of the key issues raised by the senators is the FDA’s reliance on manufacturers to self-report safety issues with their products. In the case of Phillips, the company did not self-report thousands of complaints about their breathing machines.

“Even when Philips Respironics conducted an internal health hazard evaluation, which confirmed that inhaling the chemicals from the sound abatement foam could cause ‘permanent impairment,’ it did nothing, while patients suffered,” the senators wrote. “That is unacceptable.”

The CPAP recall serves as a focal point for examining these issues, shedding light on potential gaps in the FDA’s regulatory processes and the need for reforms to enhance the safety of all Americans who use medical devices. 

If you have unknowingly been the victim of a faulty medical device and you wish to discuss the specifics of your case in a free consultation with an experienced personal injury lawyer, please contact us today.