The healthcare industry has grown leaps and bounds thanks to the constantly innovating medical technology and machinery. These medical devices are integral to modern healthcare, enabling diagnosis, treatment, and monitoring of conditions. However, these devices are man-made, and despite rigorous testing and development, they are sometimes susceptible to failure.
When medical devices fail, they can cause serious patient harm, leading to urgent recalls. Several major recalls in medical history have resulted from medical device failures from some of the industry’s biggest brands. Here are some of the high-profile cases of medical device failures that shook the industry and impacted countless lives.
Bard PowerPort Recall
This is a high-profile case that has affected thousands of patients. Victims have filed a Bard Power Port lawsuit alleging that the manufacturer marketed the defective device without providing adequate warnings or making necessary changes. According to these lawsuits, the manufacturer should have recalled the device for its tendency to cause serious complications or injury due to catheter failure. It caused fatal repercussions like blood clots and infections.
TorHoerman Law notes that the FDA announced a recall for Bard Power Port in March 2020. However, the recall was canceled in May 2022 through the 510(k) process. It is a pre-market submission made to the FDA to demonstrate that the device is as safe and effective as a legally marketed device.
The lawsuit alleges that Bard continued to market the device as safe without addressing the problems for which it was recalled. The company tried to shift the blame to physicians, saying that device fractures were caused by improper placement. As of now, there are over 232 pending lawsuits against Bard.
Allergan Breast Implants Recall
After the agency’s extensive research, the FDA recalled Allergan breast implants in the U.S. in July 2019. While the implants were recalled, the FDA initially advised against removal for those who already have them. However, new findings have revealed that the regulatory authority is reconsidering the decision and might advise users to get them removed.
The Allergan breast implants have been linked with anaplastic large-cell lymphoma. For the uninitiated, the breast-implant-associated ALCL is a type of non-Hodgkin lymphoma that presents itself in the form of scar tissues around the breast implants. In more advanced cases, it can cause lymph nodes in the chest wall and armpits. Allergan voluntarily recalled the Biocell textured implants, considering the severe health implications.
GE Healthcare Body Scanners Recall
The FDA labeled the recall of GE Healthcare body scanners as Class I, which is the most serious kind. The recalled devices included Nuclear Medicine 600/800 Series systems, which are body imaging platforms. The company recalled around 700 devices in the U.S. from December 2022 to the present.
These nuclear medicine systems were used to create body images to help healthcare professionals assess organ function and detect and diagnose diseases like cancer. However, these medical devices came with a faulty ball screw that mitigates the fall of the suspended mass of the detector. This could result in the 550kg mass of the detector potentially falling and crushing the patient.
Philips Respironics Ventilators Recall
Imagine being on a ventilator for respiratory issues and the same device pumping toxic particles into your airways. This is precisely what happened with Philps, leading to a recall of its respiratory devices, including CPAP and BiPAP ventilators, in June 2021. According to a report, the FDA has received around 116,000 complaints, including 561 fatalities.
These devices, used for sleep apnea therapy and more, contained sound abatement foam. This substance tends to degrade over time and enter the patient’s airways. After the recall in 2019, Philips Respironics exited the market and continues to be out of the industry to this day. Recently, Philips announced that it has settled all personal injury claims filed in the U.S. for $1.1 billion.
These medical device failure cases underscore the importance of medical device safety and the devastating consequences when they fail. The common threads in these failures are design flaws, material issues, and inadequate testing. Regulatory bodies like the FDA play an essential role in overseeing device safety.
However, the challenge is to balance rapid innovation with rigorous oversight. Having said that, technology has immense potential to improve healthcare. But it must be developed and deployed with utmost care and vigilance. As we move forward in the future, continued innovations in the field of medical technologies must prioritize patient well-being above everything else.