It was in May of 2013, our very third post on the old circleaks blog (now transferred to circwatch) where we denounced the then ongoing circumcision experiment (cough, clinical trial, cough) at the Good Samaritan hospital in Cincinnati.
The trial had the purpose of finding out which circumcision clamp was “better”, in the sense that it caused less pain, less complications, and more parental satisfaction. Of course, it also meant finding which one caused more pain, more complications, and there was no word about the satisfaction of the patients themselves.
The babies were euphemistically called “volunteers” and had to be healthy and stable. Some of the measuring points included cortisol level, time crying, weight of blood soaked pads, facial expressions, vital signs and need for oxygen administration.
The trial was already redundant. Similar trials had occurred in 1999, and in Africa in 2013. While the studies consistently favored the mogen clamp, perhaps for the ability to perform the procedure faster, the mogen clamp has a bad track record in real life;
- The mogen clamp has an increased risk of injury or amputation of the glans, even with experienced physicians.
- The FDA warned in 2000 about the potential for injuries from both the Gomco and Mogen clamps.
- In 2010, Mogen Instruments Inc went out of business due to several millionaire lawsuits over injuries and amputations of the glans.
- In December of 2014 the FDA recalled a number of Mogen clamps from some manufacturers, including Boss Instruments, Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion and others. According to the text, “The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as “Pre-Amendment” devices.”
Nevertheless, the Good Samaritan researchers, Mounira Habli, MD, Michaela Eschenbacher, MPH, Rachel Sinkey, MD and others, presented their conclusions in oral format at the 35th annual meeting of the Society for Maternal-Fetal Medicine, San Diego, CA, Feb. 2-7, 2015, prior to publication in the American Journal of Obstetrics and Gynecology.
Back in 2013, when circleaks posted the call to action, organizations such as Intact America and NOCIRC took charge and protested outside the Good Samaritan. The protest was covered by Cincinnati’s WLWT5 and WCPO. Over 6000 signatures were collected requesting a stop to this trial.
The hospital released a statement that said: “The circumcision study compares two medically accepted circumcision processes. Only after the parent or guardian requests and consents to circumcision for their infant, is informed consent sought for this study; they are free to decline their child’s participation in this study. Steps to ensure pain relief are integral to the study protocol.”
Of course the statement ignored that the two “processes” had been subject of the FDA warning from 2000, or that a manufacturer of Mogen clamps had gone out of business due to lawsuits over irreversible injuries caused with the clamp to baby boys, or the fact that the subjects of the study (the babies) were not capable of providing informed consent – even though they were the ones who would experience the pain and live with the consequences.
While we don’t have full access to the article at this time -only the part they have made available freely-, we don’t anticipate that they were any more communicative about these risks, or the controversy caused by the study and the protests that took place just outside their door. They wish to pretend that nobody said anything, that nobody did anything. But we did.
The researchers may have just expected to see their names in print in the American Journal of Obstetrics and Gynecology, but they have also signed their names in the history of American mutilators of baby boys. Their study was not only pointless and redundant, but their result is not consistent with the real life catastrophic impact of some of the complications of the Mogen clamp.