The Schmidt firm reported in April 23 that the parents of a boy who had his glans partially amputated during a neonatal circumcision in 2010, have filed a lawsuit against several companies that make or sell the Mogen clamp.
Now, the Mogen clamp has a known reputation for an increased risk of partial or total amputation of the glans and/or the penis. This is because unlike other devices, the mogen clamp does not protect the glans and forces the operator to cut without visualizing.
Is this really new information? No, and many of the following facts are also mentioned in the lawsuit:
In 2000, the FDA warned about the potential for injury from the Mogen and Gomco clamps for circumcision, after 105 reports of such injuries between 1996 and 2000. The devices however were not recalled nor modified. Injuries continued occurring, however the warning was later on archived.
In 2010, a single lawsuit resulted in a 11 million dollars settlement, after a complete amputation of the glans with a Mogen clamp. However, Mogen Circumcision Instruments was already in default after another 7.5 million dollars lawsuit (over a similar injury) in 2007, and was already going out of business.
In May of 2013, CircWatch / CircLeaks called the intactivist community to action after learning of a medical trial at the Good Samaritan hospital, comparing the Gomco and Mogen clamps to see which one caused less (or more) complications and pain. Five months later, Intact America and a group of intactivists protested outside the Good Samaritan hospital. The Good Samaritan responded that “the circumcision study compares two medically accepted circumcision processes” – but they failed to mention the FDA warning, or the millionaire lawsuits over penile amputations with Mogen clamps, or that a manufacturer had gone out of business due to those lawsuits.
Well, now we are finding about this new lawsuit. The case is not new, the injury occurred in 2010. But, could it have been prevented if the medical community had been more proactive over the FDA warning? More attentive of the lawsuits over penile injuries?
Perhaps this new lawsuit, filed in the Philadelphia Court of Common Pleas against three Pennsylvania-based companies that sell the Mogen Clamp, including Misdom-Frank Corporation, Sklar Corporation, and Medco Inc., may bring some recalls, but will this really change anything?
BTW, 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.”
And yet Mogen clamps can be purchased on ebay under $15, without license. What hope is there for our boys to ever be protected?