Circumvent Circumcision

The Circumstraint™ is manufactured by Olympic Medical in Washington state. The following correspondence has taken place regarding this device:

March 17, 2001

US Food & Drug Administration
22201 23rd Dr SE
Bothell, WA 98021

Dear FDA:

As you may know, in 1999 the American Academy of Pediatrics issued a new position on circumcision stating that routine infant circumcision cannot be justified on medical grounds and the academy does not recommend this practice. 
(see: http://www.aap.org/advocacy/archives/marcircum.htm )

In light of this new position by the AAP, and the fact that not one national medical society in the world endorses routine infant circumcision, I would like to inform you that the Olympic Medical Corporation, 5900 1st Ave S, Seattle, WA 98108-3249 is manufacturing a device that is being used only to harm infant boys. This device is called a Circumstraint and has no place in a society that purports to protect children. 

The Circumstraint torture device must be discontinued because it has no valid medical reason.

Thank you for your attention to this important matter. Please investigate this matter and inform me of the resolution.

Sincerely,

Gary Burlingame

May 24, 2001

The Honorable Rick Larsen
United States House of Representatives
1529 Longworth House Office Building
Washington, D.C. 20515-4702

Dear Rep Larsen:

I have written to the Washington State Attorney General on June 1, 2000, August 21, 2000 and March 17, 2001, and I have not received an acceptable reply yet. I got one unsigned letter from the Attorney General office, but it did not even address the issue. 

I also wrote to the FDA on March 17, 2001, as the unsigned letter suggested, but they also have not replied.

Would you please contact the Attorney General, and the FDA, and find out for me if they will investigate the harmful Circumstraint(TM) product, or if they will not, why?

Thank you very much,

Sincerely,

Gary Burlingame
[address]

enclosures

June 13, 2001

Dr. Bernard A. Schwetz
Acting Principal Deputy Commissioner
US Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

RE: Mr. Gary Burlingame

Dear Dr. Schwetz:

My constituent, Mr. Gary Burlingame, has contacted my office for assistance with an issue within your jurisdiction. The following documents provide an explanation of my constituent's concern or request. I appreciate your prompt attention to this matter.

Please direct your response to Mr. Burlingame and provide a copy for Mr. Carl See in my Washington, DC office at 717 Hart Senate Office Building, Washington DC 20510. Mr. Carl See can also be reached via phone: 202-224-3441 or fax: 202-228-0514.

If I can provide any additional information, please do not hesitate to contact my office. Again, thank you for your assistance in this matter.

Sincerely,

Maria Cantwell
United States Senator

 
JUL1 3 2001

The Honorable Maria Cantwell 
United States Senate
Washington, D.C. 20510-4705

Dear Senator Cantwell:

Thank you for the letter of June 13, 2001, on behalf of your constituent, Mr. Gary Burlingame of Bellingham, Washington, regarding the Circumstraint, a medical device for performing infant circumcision.

The Food and Drug Administration (FDA or the Agency) is charged with protecting the public health by ensuring that, among other things, medical devices are safe and effective for their intended use, and adequately and truthfully labeled. The Agency accomplishes this by objectively evaluating scientific data on the performance and safety of medical devices proposed for marketing.

Routine infant circumcision is a legal medical procedure with strong cultural and religious bases. We recognize that there are those who question its medical value, necessity and appropriateness, as well as the long held belief that the procedure results in no adverse effects for the recipient. Nevertheless, the Agency cannot consider information unsubstantiated by valid scientific evidence when evaluating medical devices for marketing.

Thanks again for contacting us concerning this matter. If you have further questions, please let us know.

Sincerely,

[signed]

Melinda K. Plaisier 
Associate Commissioner
    for Legislation