Less than a week before a major hearing on breast implant safety, the FDA issued two warning letters to implant manufacturers, citing their failure to do proper safety studies.
, the FDA issued two warning letters to implant manufacturers, citing their failure to do proper safety studies.warned that certain implants could be pulled off the market if the companies didn’t fulfill the agency’s requirements, which ask that manufacturers continue safety studies even after the devices are approved.
According to the letters, Mentor failed to enroll enough people in these studies. Sientra had poor follow-up rates. Zuckerman also called the letters “surprising but encouraging,” and questioned whether the FDA would take action if the companies failed to comply with the warning letters.
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