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How Much Does the FDA Do in Approving Medical Devices?

Medical Malpractice

Many people assume that the medical devices used in their surgical procedures have been rigorously tested when receiving approval by the FDA. This would make sense, considering the important role these devices play in the success of your procedure. Unfortunately, this is rarely the case. In reality, most medical devices have only undergone minimal testing, if any, before being approved for use in surgical procedures.

As a result, you may be a guinea pig for a new device recently approved. It is very scary to think that the medical professionals performing your procedure may not know whether the devices they are using are safe.

Consumer Reports has noted that the typical approval process for a new medical device involves the filing of some paperwork with the FDA accompanied by a fee of approximately $4,000. Missing from this process is the extensive documentation, through clinical studies, demonstrating the safety of these devices.

This relaxed approval process has resulted in serious injuries to patients who have received a variety of defective medical devices, including:

  • Metal-on-metal hip implant devices
  • Transvaginal mesh
  • Heart defibrillator leads
  • Heart stents
  • Specialty catheters
  • Knee implants

If you have suffered an injury caused by the use of a defective medical device, you may be entitled to receive compensation for your damages. New York product liability lawyer Marc Albert will fight aggressively to make sure the negligent medical device manufacturer is held accountable for your injuries.

Over the past 15 years, Mr. Albert has earned a reputation as one of the premier personal injury attorneys in the New York City area. He has developed a strong track record of success and helped many of his clients receive multimillion-dollar verdicts and settlements.

Please contact the Law Offices of Marc S. Albert today to schedule your free defective medical device consultation. Mr. Albert serves clients throughout the New York City metropolitan area from his offices in Queens, Manhattan, and Long Island.