Food and Drug Administration

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The American Food and Drug Administration has approved several circumcision devices and products made from harvested infant foreskins.

Contents

Circumcision Injury Reports

As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the Mogen and Gomco clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage. Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications. The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction. In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries. Twenty-one of those reports were related to Mogen clamps, all but one of which involved injuries.

Products & Devices

Devices:

• AccuCirc

Products:

• Dermagraft-TC

• Apligraf
• AlloDerm
• TNS Recovery Complex

Lenient Regulatory Standards

On the 28 March 2012, Consumer Reports magazine issued a report critical of lenient FDA standards for approval of new medical devices. As reported by HealthDay News:

Spying on dissenting scientists

As reported by HealthDay News, the FDA collected thousands of e-mails that agency scientists sent privately to members of Congress, journalists, labor officials, lawyers and even President Barack Obama:

Investigations by the Department of Health and Human Services Office of Inspector General (OIG)

On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities. The report read in part:

On the 4 June 2012, the OIG published a report critical of the FDA's handling of scientific disagreements regarding medical device regulatory decisions. The report read in part: