Technology has helped and enabled pharmaceutical companies to formulate drugs and design better medical devices that can replace, support or enhance, missing or damaged biological structures that will restore or improve a person’s condition. Not all medical devices work as effectively or as safely as these were intended to, however, as some are found to be causing more harm than relief after these are used or implanted.
Many different kinds of medical devices that have already been introduced and used in patients; some of these, however, have been proven defective, causing only harmful effects. A few of these include the transvaginal mesh (including Johnson & Johnson vaginal mesh kit and Alloderm mesh), the Stryker ABG II Modular-Neck Hip Implant System, Stryker Rejuvenate modular-neck stems, Depuy hip implant, Zimmer NexGen knee replacements, and the automated external defibrillator (AED) heart device.
The U.S. Food and Drug Administration (FDA) is the agency that approves whether a medical device can be used to treat patients. Once a device has been approved, this same agency then turns to medical device reporting (MDR), its post-market surveillance tool, to monitor a device’s performance, discover potential safety issues and consider the device’s benefits and risks. MDR is mandatory for importers, manufacturers and device user facilities (such as an outpatient treatment or diagnostic facility, a nursing home, an ambulatory surgical facility or a hospital) and voluntary for consumers, caregivers, patients, doctors and other health care professionals. Besides problems and serious adverse effects linked to medical devices, the FDA also encourages voluntary reporters to share information on any therapeutic failure, poor quality issue, or erroneous use of these devices – all for the purpose of improving and ensuring overall safety of patients.
According to the law firm Russo, Russo & Slania, P.C., “Medical devices are commonly used by doctors and surgeons to treat patients. While many medical devices work as expected and successfully treat patients, others have been proven to be defective and result in serious health issues.
Defective medical devices can cause serious medical issues for patients. Some of these dangerous medical devices include: contraceptive devices, defibrillators, stents and implants. Defective medical devices lawyers understand the physical pain and financial stress of those who have suffered from defective medical devices. Fortunately, however, you (and other victims) may be able to pursue recourse through the court. The medical expenses associated with recovery, as well as lost wages and other costs can quickly result in a significant financial burden; in this case, through the court you may be able to fight for financial restitution.