Defective Medical Devices: Putting Patients More at Harm’s Way

Dec 12, 2016 by

Devices and tools that make replacement, support or enhancement of missing or damaged biological structures, to restore or improve a patient’s condition, faster, easier and safer is probably the greatest benefit of modern technology in medicine. Unfortunately, not all medical devices are safe as they are effective as some are found to cause harm than the relief these were intended to provide.

Hundreds of different kinds of medical devices have already been introduced and used in patients. Many of these, though, have been proven defective and the causes of harmful effects. A few of these defective medical devices, based on complaints reported and filed with the U.S. Food and Drug Administration (FDA) include the transvaginal mesh (including Johnson & Johnson vaginal mesh kit and Alloderm mesh), the automated external defibrillator (AED) heart device, the Stryker ABG II Modular-Neck Hip Implant System, the Stryker Rejuvenate modular-neck stems, and the Depuy hip implant, Zimmer NexGen knee replacements.

After the FDA approves the use of a medical device for treatment of patients, it turns to its post-market surveillance tool, the Medical Device Reporting (MDR), to monitor the devices’ performance, discover potential safety issues and consider the device’s benefits and risks. MDR, which contains the mandatory requirement of reporting to the FDA certain device-related adverse events and product problems, is a mandatory regulation for importers, manufacturers and device user facilities (such as a diagnostic or outpatient treatment facility, an ambulatory surgical facility, a nursing home or a hospital); reporting of adverse events and product problems, however, is voluntary for consumers, caregivers, patients, doctors and other health care professionals. Furthermore, the FDA 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 their overall safety.

With regard to mandatory reporting, the following are required:

  1. For device manufacturers: they are obligated to report any incidence of device malfunction or any incidence of serious injury or death (due to use of a certain device) as soon as they learn of it.
  2. For importers: if their (imported) device malfunctions,they must submit a report to the product’s manufacturer. If the device, however, has caused or contributed to a death or serious injury, then the report should be forwarded to both the device’s manufacturer and the FDA.
  3. For device user facilities: any death that is suspected to be due to the use of a device should be reported by the facility (which has become aware of this incidence) to both manufacturer and the FDA; where serious injury is concerned, the report must be forwarded to the manufacturer; however, if the manufacturer is not known, then the report will have to be submitted to the FDA.

The FDA receives hundreds of medical device failure reports every year; these, however, make up just a small percentage of the many different medical mistakes, which lead to patient harm or death, committed in the U.S. According to Tucson personal injury lawyers of Russo, Russo & Slania, P.C.,the physical pain and financial stress suffered by those who have been harmed by defective medical devices should not have been, had these devices’ manufacturers only made sure that their products are safe.

Victims of the negligent acts of others should not be made to bear the financial burden resulting from the additional costly medical procedures required to treat new serious health issues they are made to suffer. With help from personal injury lawyers, victims may pursue a legal action that may enable them to seek financial restitution for medical expenses associated with recovery, as well as lost wages and other costs.

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