High-Risk Medical Devices Sold Without Proof of Safety

The safety of certain medical devices, such as pacemakers and heart valves, is under serious scrutiny. These high-risk devices may lead to serious injury or death in patients, and government investigators found that lax review by the Food and Drug Administration is putting the public’s health even more at risk.

The Government Accountability Office recently faulted the FDA for approving the sale of several high-risk devices without conducting a close scientific review. Patients ultimately suffer the harm of this oversight because these devices are more likely to completely fail or malfunction.

The watchdog agency found that at least two dozen sensitive medical devices were allowed on the market without being properly tested, including metal hip joints, external defibrillators, and electrodes for pacemakers.

The now-recalled artificial hip sold by Johnson & Johnson is one example of a failed safety device that jeopardized the health of tens of thousands of Americans. The FDA approved the A.S.R., or Articular Surface Replacement, for sale without conducting clinical trials. The faulty hip began shedding metal particles and disinigregating in patients, leaving some of them crippled.

Medical devices are intended to prolong a patient’s life, not further endanger it. Medical malpractice attorneys at Pintas & Mullins Law Firm Law Firm continue to advocate on behalf of all patients harmed by these defective devices.

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