Are You Using a Dangerous or Faulty Medical Device?

Tens of millions of Americans rely on medical devices and implants to improve their quality of life. It’s an underlying assumption that those same devices have been tested for safety and effectiveness. 

Consumer Reports says that’s typically not the case. “For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration (FDA) a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue.”

As a result, most medical implants have never been tested for safety, and unsuspecting Americans are paying the price. Injuries, complications, or deaths due to faulty medical devices have increased by over 500 percent in the last decade.  

So, it begs the question, are you using a dangerous or faulty medical device? And if you were, how would you even know? 

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.

Senators Call for Probe of FDA After CPAP Failures

Last year, a joint investigation into Phillips, a major manufacturer of breathing machines, discovered that the company withheld over 3,700 complaints about potential health risks associated with its products for 11 years despite being aware of the dangers. The company kept warnings and 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 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.

Due to this investigation, a group of U.S. Senators have urged the Government Accountability Office (GAO) to conduct a detailed probe into the FDA’s handling of the CPAP recall and its broader regulatory oversight of medical devices. This bipartisan effort reflects growing apprehensions among policymakers regarding the effectiveness of the FDA’s regulatory mechanisms in ensuring the safety and efficacy of medical devices. 

Protect Yourself with These Four Tips

One of the problems the Senators uncovered in the investigation is that the FDA’s current oversight practices may be inadequate in addressing emerging risks and ensuring timely responses to safety concerns. While the investigation plays out, these four tips from Consumer Reports can help protect your 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 the options. For example, women who received transvaginal mesh for prolapse repair may not have needed surgery. But people ill enough to require an implantable defibrillator for their heart may not have a choice.
  2. Research the device – The Food and Drug Administration’s website,, contains information on device safety warnings, complaints, and recalls, all accessible by searching the device’s name. Also, 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.

Medical Device Recall Spotlights Missteps by the FDA

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 Tucson personal injury lawyer, please contact us today.