Improperly tested and manufactured medical devices cause thousands of severe injuries and fatalities each year. Loose regulations that allow for selective reporting exacerbate the risk and put patient lives at risk. Patients who have suffered adverse events due to defective devices can pursue compensation via a Reno defective medical device lawyer.
From 2002 to 2013, there were 578 recalls from six manufacturers of hip replacement devices. Stryker had the most with 231, and DuPey had the second greatest number with 150. Devices manufactured by these companies can cause severe pain and suffering that can have a considerably negative impact on a patient’s quality of life.
One of the most dangerous devices in recent years have been power morcellators used to remove uterine fibroids or to conduct hysterectomies. These tools cut up tissue and are designed to reduce recovery time. However, their function and operating method spreads tissue throughout the area. This can lead to the spread of pathogens and cancerous cells.
These metal cages are inserted into veins where they trap blood clots before they travel into the lungs. They have a high failure rate, and it’s estimated that they cause upwards of 1,000 serious adverse events each year. These can include migration and perforation of organs.
Products such as Essure manufactured by Bayer are intended to prevent unwanted pregnancies. Unfortunately, they don’t always work as intended. In the case of Essure, the metal coils inserted into the fallopian tubes can cause organ perforation, severe pain, and can even lead to the development of autoimmune diseases. In 2015, the FDA received more than 5,000 reports of adverse events related to Essure devices.
510(k) Leaves Patients Exposed
The FDA approves many medical devices through a program that requires they merely show that there is a substantially equivalent device available within the marketplace. This makes it easier for companies to receive approval for products that may have serious design flaws. Changes to the program would make it easier for injured patients and their Reno defective medical device lawyer to track the record of adverse events.
The loophole has prompted Congressman Mike Fitzpatrick (R-Pennsylvania) to seek a legislative remedy. He has introduced the Medical Device Guardian’s Act. If passed, the legislation would require physicians to report all adverse events related to a medical device.This would make it easier to track and remove dangerous devices from the market.