Here's the letter I just emailed to the FDA Center for Devices and Radiological Health
CDRH/FDA
1350 Piccard Drive, HFZ-210
Rockville, MD 20850
e-mail:
dsmica@fda.hhs.gov
To Whom It May Concern:
I am writing to inform you of the unethical marketing of the Accu-Circ circumcision device.
This medical device is approved only for infant circumcision, as stated on their web page accessible at:
http://www.accucirc.com/faq.php
“When is use of the AccuCirc indicated/contraindicated?
The AccuCirc is indicated for circumcisions of the penile foreskin on full-term, newborn (up to 10 days) male infants.”
However, on their web page accessible at
http://www.accucirc.com/literature.php, they provide links to several studies on the so-called “benefits” of circumcision performed on ADULT men. For instance, one of the articles is titled “The Role of Male Circumcision in the Prevention of Human Papillomavirus and HIV Infection.”
As you may know, these studies are very controversial, with many in the medical community pointing out the many flaws of these studies and their lack of generalizability to infant boys in developed countries such as the U.S.
By providing these links on their web page, Clinical Innovations is implying that routine infant male circumcision has the “benefits” of prevention of STDs such as HPV and HIV when those boys become men.
Please communicate to this company that this is an unethical marketing practice, and should be stopped immediately.
Thank you for your attention to this matter,
Concerned Citizen
