Medtronic Receives FDA Warning Over Manufacturing Violations

0
1119

Medtronic Receives FDA Warning Over Manufacturing ViolationsOverview: Medtronic is once again being questioned over its business practices, as the U.S. Food and Drug Administration (FDA) warns the company of its failure to establish and follow guidelines for receiving complaints. Medtronic has already undergone controversy over its artificial bone graft product, Infuse.

 

 

 

  • The FDA sends Medtronic a warning letter about its inadequate procedures for receiving and analyzing complaints
  • This is not the first time Medtronic has been questioned about the integrity of its procedures; the company has been under increased scrutiny over Infuse
  • Medtronic Infuse is an artificial bone graft product that has been linked to life-threatening complications when used in off-label procedures; Medtronic has been accused of paying doctors to hide side effects

Product: Medtronic Infuse Bone Graft

Manufacturer: Medtronic, Inc.

Side Effects & Complications

  • Cancer
  • Difficulty breathing, swallowing
  • Uncontrolled bone growth
  • Nerve injury
  • Male sterility
  • Retrograde ejaculation

FDA Warning Letter

According to Reuters, Medtronic received a warning letter from the FDA dated July 17th . In general, the agency told Medtronic that it lacks adequate procedures for receiving and evaluating complaints and asked the company to amend the violations. Failure to comply with this request could result in further regulatory action, said the FDA. Reuters reports that Medtronic replied to the warning letter with a description of the actions it intends to take, but the FDA found their response insufficient. According to Wall Street Journal, Medtronic does not expect the warning to significantly impact its financial earnings. Chief Financial Officer Gary Ellis said in on conference call that “We are working with the FDA to quickly resolve the issues,”

Medtronic Infuse

This is not the first time Medtronic is being scrutinized over its business practices. In recent years, the company has been under multiple investigations over Infuse, a product used to stimulate bone growth in the spine. The device has raised a number of safety concerns, particularly when used in off-label procedures. In 2008, the FDA warned that using Infuse off-label in the cervical spine could lead to life-threatening complications including swelling of the neck and throat.

Last June, a prominent spine publication questioned the integrity of Medtronic-funded research, suggesting that the medical device maker bribed researchers to purposely omit complications of Infuse, such as male sterility.