Three Mogen Manufacturers and Distributors Face A Civil Law Suit
Mogen Circumcision Instruments of New York, the makers of the Mogen circumcision clamp, went out of business five years ago, but a lawsuit has been filed against several companies that continue to sell and/or make the device, according to the Schmidt Law Firm.
The lawsuit has been filed on behalf of a boy whose penis was partially amputated during a circumcision procedure involving the use of a Mogen circumcision clamp. Doctors amputated the tip of the boy's penis during his circumcision, which took place one week after his birth. The boy was permanently injured, will require future corrective surgery, and will continue to experience significant complications.
The civil lawsuit was filed a week ago 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.
The lawsuit can be accessed in PDF format here.
It's All Happened Before
Five years ago, Mogen Circumcision Instruments was put out of business by a 11-million dollar lawsuit it couldn't afford to pay. The company was already in default for not paying previous judgements, including one where it was ordered to pay $7.5 million by a jury in Massachusetts. The injury behind another lawsuit at Fulton County Superior Court had already put Mogen on notice about the danger of the device.
In a separate case, a judge approved a $4.6 million settlement on a behalf of a boy who lost the head of his penis in a botched circumcision attempt, this time against Miltex Inc. and its parent company, Integra Life Sciences Holding Corp. The doctor who performed the circumcision used a Mogen clamp, though manufactured by Miltex Inc.
According to the plaintiff's court papers filed regarding the settlement:
"Because of the defective design of the circumcision clamp, there was no protection for the head of the penis, and [the doctor] was unable to visualize the glans (or head of the penis) when excising the foreskin."In this case, the boy, age 8 at the time of the lawsuit, lost 80% of his penis, according to the suit.
Data from Attorneys for the Rights of the Child, ARCLaw, show over 80 million dollars paid on settlements over botched circumcisions since 1985. Beyond the economic value (when compared to a billion dollar a year industry), those numbers represent children whose lives will have been impacted for the rest of their lives due to a non-medical elective surgery.
Notorious for Glans Amputations
The Mogen circumcision clamp is known for glans amputations, even when used by professionals.
In August 2000, the FDA issued the following Safety Communication:
“The clamp may allow too much tissue to be drawn through the opening of the device, thus facilitating the removal of an excessive amount of foreskin and in some cases, a portion of the glans penis. … We received 105 reports of injuries involving circumcision clamps between July 1996 and January 2000. These have included laceration, hemorrhage, penile amputation, and urethral damage.”The "Manual for early infant male circumcision under local anaesthesia,"published by the World Health organization in 2010, details that both the Mogen clamp and the Gomco clamp have a risk for penile laceration and amputation, but extends to say that "penile amputation can occur even under ideal circumstances" with the Mogen clamp.
In a 2013 study in Botswana, the Mogen clamp and the Plastibell were compared. The adverse events with the Mogen clamp were considered to be more frequent but "minor" (removal of too little skin and development of skin bridges and adhesions). Bleeding was more frequent with the Mogen clamp as well.
Unlike other circumcision devices, the Mogen Clamp has two major design flaws:
- The head of the penis is not protected by a shield or bell
- The doctor cannot see the head of the penis when cutting the foreskin with a scalpel.
Despite the Mogen clamp's notoriety for glans amputations, and despite the FDA warning given 10 years prior, Mogen Circumcision Instruments insisted 'till the very end that injury was impossible with the use of their clamp. When called for interview, the secretary for the company who was served the papers of the lawsuit that would put them out of business, said that the Mogen circumcision clamp was "painless and safe when used properly."Common Mogen Problem: The circumciser is blind to the condition of the child's glans. Some or all of the glans is pulled up along with the foreskin, resulting in partial or full glans amputations.
The Mogen Legacy Continues Today
5 years after the Mogen company was put out of business, and 15 years after the FDA issued their warning, other companies continue to manufacture and sell the Mogen clamp, doctors continue to use it, and the botches continue to happen. In addition, the devices are easily accessible. As of now, Mogen clamps can be purchased on eBay for under $15, and anyone with a credit card can buy them without license.
The FDA gave their warning in 2000, but the clamps were never recalled or modified, doctors kept using them, and the injuries kept on occurring. It wasn't until last year, in December of 2014, that the FDA recalled a number of Mogen clamps from a number of manufacturers, including Boss Instruments, Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion and others. The reason given in the text for the recall, however, was 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." Certain companies, however, such as Misdom-Frank Corporation, Sklar Corporation, and Medco Inc., continue to sell and/or make the device.
Although the Mogen clamp itself was invented in 1954, it is actually one of many successors to a much older, traditional barzel device. Even so, a number of interested doctors who use the device, try to market the Mogen clamp as "a new and innovative approach."
The Mogen clamp's design is based on
a traditional tool used by Jewish mohels.
The word "mogen" is derived from the
Hebrew word for "shield," or "magain."
Neil Pollock, Murray Katz, Pierre Crouse and other doctors who specialize in male infant circumcision, boast their use of the Mogen clamp, and claim their "technique" to be "new and innovative," going as far as saying that the circumcisions they perform are "bloodless, painless and taking under 30 seconds."
Neil Pollock, flashing the tools of his trade
Neil Pollock in particular, has taken it upon himself to promote the use of the Mogen clamp as far away as Rwanda in Africa, and Haiti in the Carribean Rim. In fact, the WHO has approved the Mogen clamp for use in infant circumcision in Africa, under the pretext of HIV prevention. They're currently being used in Kenya, Rwanda and Botswana.
Even given the disreputable history of the Mogen clamp, somehow, "researchers" at TriHealth Good Samaritan Hospital in Cincinnati thought it was necessary to conduct a comparative "study" to see what was the "better circumcision clamp." Given what is known about the Mogen clamp, the lawsuits, the FDA warning, the WHO etc., somehow the "researchers" have the audacity to begin with the hypothesis that the Mogen clamp is the superior circumcision device.
Conclusion
Even given the numerous reports of injury, even given the FDA warnings, even given the numerous lawsuits that put Mogen Circumcision Instruments out of business, even given the lawsuits against secondary manufacturers, even given the known design flaws of the clamp, even given the known risks for penile laceration and amputation even under the most ideal circumstances, the Mogen clamp continues to be made, sold, used and promoted as "medically acceptable."
It must be asked, why?
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