Monthly Archives: December 2015

Medline – and the Mogen Clamp

While writing the previous post about the baby in Johannesburg who lost part of the penis during a Jewish circumcision, I went to look for a 2014 Recall notice that prohibits several companies, including Medline Industries, from distributing the Mogen clamp because they didn’t market the device prior to 1976, therefore they don’t meet the requirements to be considered “pre-amendment”.

But what I found was something different. I found the Mogen clamp listed in the online catalog of Medline Industries. And no indication whatsoever of this device being recalled.

Mogen clamp in Medline's online catalog - in spite of a 2014 FDA recall notice

Mogen clamp in Medline’s online catalog – in spite of a 2014 FDA recall notice

 

A South African baby loses part of his penis during circumcision – but what went wrong?

As reported by Sunday Times News (South Africa) on November 29th, a Jewish religious court decided that a Johannesburg mohel will not be allowed to perform circumcision again, as a consequence of a botched circumcision performed last year. During that circumcision, the penis of the baby was partially amputated.

The article states that “[n]o details were revealed of why this circumcision went wrong. The Sunday Times was unable to establish how the baby is doing now and whether there have been surgical attempts to rectify the partial amputation of his penis.”

The article then quotes one Rabbi Warren Goldstein saying that circumcision “has a longer track record of proven safety than any other surgical procedure” and that “Jewish circumcisions have been done in South Africa for more than 175 years and this case is the first time that an injury of this severity has been reported“.

The name of the (ex)mohel was not disclosed. Which is not a surprise, considering that even cases where babies die after a circumcision are usually kept secret, as we found happened in Canada recently.

Well, let me tell you what Goldstein won’t tell and the reporter won’t research. Jewish circumcisions typically use a Jewish shield (barzel) or a Mogen clamp. Neither of those two devices protects the penis. The devices are supposed to clamp on the foreskin leaving the glans on one side, but improper installation, device malfunction or anatomical variation can cause part or all the glans to be trapped by the device, allowing the scalpel to cut through it without the operator even realizing it. The mogen clamp has an increased risk of injury or amputation of the glans, even with experienced physicians.

I have no way of verifying that no cases have been reported in South Africa, but I can quickly reference one in Pittsburgh, where Rabbi Mordechai Rosemberg amputated the penis of a baby in 2013. The penis was re-implanted using microsurgery and… leeches, but there is no way to know yet if the baby will even have normal sexual function.

In 2004, another Rabbi, Daniel J. Krimsky, also amputated part of the penis of a baby during a bris in Florida. The resulting lawsuit ordered Mogen instruments to pay a settlement of 10.8 million dollars, but the company was already in default after another millionaire lawsuit, over similar injuries occurred in 2007.

In 2004, Dr. Haiba Sonyika amputated most of the glans of a baby circumcised with the Mogen clamp (in a Medical environment). Reattachment was not fully successful.

All these cases could have been prevented, since in 2000, the FDA warned about the potential for injury from Mogen and Gomco clamps – but no changes were made to the devices and the warning was later archived. Ten years later Mogen Instruments would be out of business due to the lawsuits mentioned above.

Another Floridian mohel posted a blog in 2010 warning others not to use the Mogen clamp.

In spite of all this, researcher Rebeca Plank conducted a trial of Plastibell vs. Mogen clamp in Botswana in 2010, concluding that the Mogen clamp could be safer in regions where immediate emergent medical attention is not available. We wonder what she would recommend in cases of penile amputation, without immediate emergent medical attention. BTW, when stating the safety of circumcision in Botswana, Plank neglected to mention that one “participant” baby died within 24 hours of being circumcised. No autopsy was performed and the death was simply not mentioned at all in the final report. Good to know that Dr. Plank holds her research to such high standards.

The Good Samaritan Hospital in Cincinnati also performed a trial, this one of Mogen vs Gomco clamp, between 2012 and 2014. When intactivists protested, a spokesperson for the hospital released a statement calling the clamps “two medically accepted circumcision processes” – neglecting to mention the FDA warning and incidents related to the Mogen clamp.

The Good Samaritan researchers concluded that “Mogen clamp is associated with less neonatal pain physiologically by significantly lower percentage change in salivary cortisol, lower heart rate, and mean arterial blood pressure. There was no difference in CRIES scores. Mogen clamp circumcision duration is significantly shorter than Gomco clamp. Both methods demonstrate satisfactory maternal and pediatrician short-term follow-up.” I’ll let the readers find for themselves what the metrics are in the CRIES pain score, so that you know what the babies were consciously subjected to by the researchers.

Other clinical trials took place in 1999 (USA) and 2013 (Zambia) favoring the Mogen clamp.

Additionally, the Mogen clamp is the favored device of Dr. Neil Pollock in Canada, and the many disciples he enlists. Pollock also exported it to Haiti and is currently looking for the support of Charlize Theron and Sean Penn to provide similar training in South Africa.

And with this we have gone full circle, starting with a Jewish botched circumcision in Johannesburg, South Africa, and finishing with a Canadian doctor who wants to export to South Africa the very same technique that caused said botched circumcision.

While the Mogen clamp appears to cause less pain through a faster procedure, the risk of glans or penis amputation may not be realized in 100 or 200 procedures, but will eventually occur. As it happened to this baby, in Johannesburg, in 2013. Even when performed by experienced doctors or mohelin.

Sean Penn, Charlize Theron, save your money. There are better ways to actually help people.