I never set out to become a medical expert witness.
After working with the World Health Organization and a team of international experts on the surgical chapters of the WHO Manual for Early Infant Male Circumcision under Local Anaesthesia,¹ I was contacted by an attorney about serving as an expert witness in a medical malpractice case involving a Mogen clamp and a newborn circumcision injury.
Initially, I was very much against the idea. I discussed it with my mentor, Dr. Anthony Caldamone, a world-renowned pediatric urologist with whom I had worked for many years. Tony challenged me to reconsider and encouraged me to participate. When I asked him why, his answer was simple: “You will learn something.”
He was right. Over the years, I have now served as a medical expert in more than 20 cases involving serious injuries associated with Mogen-style circumcision clamps. I wish I had never needed to see any of them. But each case taught me something about how these injuries occur — and, more importantly, how they might be prevented.
A preventable injury
One of the most recent cases I reviewed involved an OB/GYN performing a newborn circumcision in an outpatient practice. The physician was unaware that Mogen-style clamps can differ in important dimensions, including the size of the aperture through which the foreskin is drawn. The clinic that purchased the instrument did not appreciate the significance of that difference either.
During the circumcision, the glans became entrapped within the clamp, and a portion was amputated. What struck me was not simply the injury, but the series of failures that preceded it. A physician believed she was using a familiar instrument. A practice purchased an instrument for a routine newborn procedure. Yet, neither had been given the information necessary to recognize that seemingly small differences in device design could have profound consequences.
No one involved intended to harm this child. But the system allowed a catastrophic injury to occur.
The provider is not always the problem
This is an important point, and one I have emphasized in my testimony. In many of the cases I have reviewed, I do not believe the fundamental problem was the provider. Some clinicians had performed hundreds of circumcisions using the same technique without a serious complication. They followed their training, used the clamp as they had many times before, and exercised appropriate care. Yet, despite their best efforts, a catastrophic injury occurred.
The Mogen clamp does not place a physical barrier between the glans and the cutting plane. Once the foreskin is drawn through the clamp, the glans is hidden from view. If part of the glans is inadvertently drawn into the aperture, the provider may have no way of recognizing that before making the cut. Published reports describe this pattern of glans and urethral injury, and an FDA-cleared Mogen-style clamp specifically limits opening to 2.5 mm “in order not to trap the glans.”²
That is a design vulnerability. If a device permits a catastrophic injury despite an experienced clinician attempting to perform the procedure correctly, relying on operator vigilance alone is not an adequate safety system.
A device, labeling, and supply problem
These cases also taught me that the problem extends beyond the design of the clamp itself. It includes how these instruments are manufactured, distributed, labeled, and ultimately placed into the hands of clinicians.
The FDA has issued two warnings addressing this risk, and those warnings are intended to accompany the device.³ Yet, in the most recent case I reviewed, the OB/GYN received the Mogen-style clamp without that warning. She did not know that Mogen-style clamps can have different aperture sizes or that this seemingly small difference could have profound consequences. The practice that purchased the instrument did not know either. In my opinion, had the warning accompanied the device and alerted the physician to this hazard, this injury could have been prevented.³
A clinician cannot act on a warning she was never given. That is why it is too simple to characterize every catastrophic circumcision injury as provider error.
The history of these injuries has also created a difficult supply problem. Catastrophic Mogen clamp injuries have resulted in multimillion-dollar litigation involving manufacturers and distributors.⁴ Manufacturers have stopped selling these clamps, products have disappeared from the market, and older instruments have remained in circulation. Replacement clamps may come from different manufacturers and distributors, even though devices that look nearly identical may not have identical dimensions, regulatory histories, labeling, or warnings.
FDA records demonstrate how complicated this market has become. In 2014, 421 Mogen circumcision clamps sold under numerous brand names were withdrawn because the manufacturer did not meet FDA requirements to market them; FDA listed the cause as “No Marketing Application.”⁵ Properly FDA-cleared Mogen-style clamps do exist today.⁶ The point is not that every Mogen clamp is unauthorized.
The larger problem is that the fundamental failure mode has never gone away.
Over the years, manufacturers and distributors have changed. Products have entered and left the market. Warnings have been issued. Providers have been trained. Catastrophic injuries have been litigated. Yet, the same injury continues to occur: the glans becomes entrapped behind a clamp where the provider cannot see it, and it is injured when the foreskin is excised.
Changing the name on the package does not eliminate the failure mode.
A clinician should be able to know exactly who manufactured a surgical instrument, whether it is legally marketed, what its critical dimensions are, and what warnings apply to it. But even when those safeguards are functioning properly, we should still ask a more fundamental question: if a catastrophic injury has occurred repeatedly over decades, and can occur despite an experienced clinician attempting to perform the procedure correctly, should prevention continue to depend primarily upon operator vigilance?
I do not believe it should.
In the most recent case I reviewed, the safeguards failed before the physician ever began the procedure. She was given a device that appeared familiar without information that could have alerted her to an important hazard. The result was a devastating and preventable injury.
This is why I believe meaningful change must address not only training and labeling, but the design of the device itself.
Injuries we may never count
There is another lesson from these cases: our surveillance system does not necessarily capture every serious circumcision injury. A physician’s office is not considered an FDA “device user facility” for purposes of mandatory Medical Device Reporting. Healthcare professionals can report events voluntarily through MedWatch, but not every event will necessarily reach the FDA.⁵
That distinction is important to name. Some of the most serious injuries I have reviewed occurred outside hospitals. If those events are not reported, they may never become part of the data used to understand the true frequency and mechanisms of device-related injuries. An injury that is never counted is much harder to prevent.
A pattern that has not gone away
After reviewing the available FDA MAUDE reports and the cases that have come to me, my estimate is that catastrophic Mogen-associated glans injuries have continued to occur on the order of approximately two cases per year. That is my estimate from reviewing these reports and cases — not a population-based incidence rate — and underreporting means the true number cannot be known from MAUDE alone. FDA reports continue to document glans amputations and other serious Mogen-associated injuries, including cases requiring reconstructive surgery.⁷
This is not a new complication. The Mogen design has been used for decades, and these devastating injuries have been recognized for decades.² The FDA has issued warnings, adverse events have been reported, devices have been recalled, litigation has occurred, and clinicians have been trained.³˒⁵˒⁸ Yet, the same failure mode continues to injure newborns.
If a catastrophic injury has continued to recur for generations despite our knowing how it happens, continuing to accept it as an unavoidable complication is not enough. Unless something changes, newborns will continue to suffer the same injury.
Tony was right
With every case, I learned something. I learned about the instruments, differences in their design, how providers were trained, how practices purchased equipment, and how gaps in labeling, distribution, regulation, and adverse-event reporting can allow hazards to persist. I learned how devastating a few millimeters can become when the glans is hidden from view.
And with each case, I became more convinced that telling clinicians to “be careful” was not enough. If the same catastrophic injury can occur repeatedly, the question should not only be, “What did the clinician do wrong?” Sometimes the clinician did nothing wrong.
The better question is: “Can we design a system in which this injury cannot happen?”
Designing the injury out of the procedure
My background is in both mechanical engineering and medicine. Engineering teaches you to identify a failure mode and then ask whether it can be eliminated through design. That is fundamentally different from simply warning the operator about the hazard.
When we developed the AccuCirc® device, one of our fundamental objectives was to physically protect the glans during circumcision. The device was designed so that the cutting mechanism cannot reach the glans when the device is properly used. We also worked to address other failure modes through device design, standardized technique, training, and ultimately the model of care we are building at SafeCirc®.
The goal was never simply to build another circumcision device. The goal was to prevent an injury I had seen too many times.
The need for change
Serving as an expert witness was never something I expected to become part of my career. Behind every medical record is a newborn, a family, and often a clinician whose life has also been profoundly affected by what happened. That is why I believe these cases need to be discussed publicly — not to blame providers, but to learn from what happened and prevent it from happening again.
Tony understood something that I did not when he first encouraged me to participate. If we are willing to study our worst outcomes carefully, they can show us where our systems fail.
More than 20 cases later, the lesson is clear. A known catastrophic failure mode should not be accepted as an unavoidable complication when it can be addressed through safer device design, accurate labeling and warnings, transparent manufacturing and distribution, reliable adverse-event reporting, and safer systems of care.
The goal is clear: protect newborns from preventable injury. We know the injury. We know the mechanism. We know it continues to occur. Unless we change the system, newborns will continue to suffer the same devastating injury. We can — and must — do better.
References
World Health Organization, Jhpiego. Manual for early infant male circumcision under local anaesthesia. Geneva: World Health Organization; 2010.
Medicon eG. Medicon Mogen Circumcision Clamp, 510(k) K100916, U.S. Food and Drug Administration. The 510(k) summary states that the clamp opens to a maximum of 2.5 mm “in order not to trap the glans.” See also: Pippi Salle JL, et al. Glans amputation during routine neonatal circumcision: mechanism of injury and strategy for prevention. J Pediatr Urol. 2013;9(6 Pt B):763-768.
2. FDA warning materials reviewed by the author. Before publication, cite the two specific FDA warnings and the applicable labeling/package insert here. In the most recent case described, the author’s expert review found that the warning was not supplied with the clamp.
Saxena J. Victim gets $10MM to make up for botched circumcision. Gothamist. July 18, 2010. See also: Brooklyn, NY – Company that lost $10M in botched circumcision is going out of business. VINnews. July 19, 2010. https://vinnews.com/2010/07/19/brooklyn-ny-company-that-lost-10m-in-botched-circumcision-going-out-of-business/
3. U.S. Food and Drug Administration. Class 2 Device Recall, Mogen Circumcision Clamp, Recall Z-0538-2015 / Event 69471. Quantity in commerce: 421. FDA-determined cause: “No Marketing Application.”
4. U.S. Food and Drug Administration. König Mogen Clamp, Medline Industries, 510(k) K212911. Substantially equivalent decision November 18, 2022.
5. U.S. Food and Drug Administration. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities. Physician offices are excluded from the definition of a device user facility; voluntary MedWatch reporting remains available.
6. U.S. Food and Drug Administration, MAUDE database. Examples include Mogen-associated glans amputation requiring NICU transfer, reconstructive surgery, glans reattachment and urinary catheterization (including MDR 7673383, MDR 17333882 and MDR 10179996). MAUDE cannot establish incidence and is subject to underreporting, duplicate reports and incomplete reports.