Melanie Hall did not think she was putting her week-old son at risk when she brought him to a Los Angeles doctor to be circumcised. But after a nurse took the baby into an examining room, something went terribly wrong.
"I heard a scream, an excruciating kind of scream," Hall said. "You know your baby's cry."
The doctor called her in from the waiting room. He had cut off most of the tip of her son's penis.
Hall sued both the doctor and the distributor of the Mogen clamp he had used to circumcise her now 8-year-old son, Terrel. Although her claim against the physician was dismissed, Miltex Inc. and its parent company, Integra Life Sciences Holding Corp., agreed this summer to a $4.6-million settlement.
Still, Hall, 38, said the medical community needs to do more to ensure safety during circumcisions, especially those performed with the Mogen clamp.
"They cannot guarantee that it will not happen again," she said. "If you can't guarantee, I don't think it should be used."
The practice of removing the foreskin from the penis goes back to ancient times. Circumcision has religious meaning for Muslims and Jews, who cite a passage in Genesis in which God admonishes Abraham to be circumcised.
The Mogen clamp's name derives from the Hebrew word "magain," or shield. It was invented in 1954 by Rabbi Harry Bronstein, a Brooklyn mohel who wanted to standardize circumcision equipment then in use by both doctors and mohels without medical training who perform the procedure in private homes and other locations. A user first loosens the foreskin, then pulls it through the clamp and clips it off with a single cut.
These days, about 56% of boys born in the U.S. are circumcised in hospitals, according to the Centers for Disease Control and Prevention. (The CDC does not keep track of how many additional circumcisions are done by mohels.) Nearly all circumcisions in the U.S. are performed with a Mogen clamp, a Gomco clamp or a device called the Plastibell.
There have been numerous reports in recent years of patients being injured by the Mogen clamp, which is much less popular than the other two types of circumcision devices, which are two-part systems that protect the tip of the penis.
As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the Mogen and Gomco clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage. Instead of recalling the devices, the FDA advised users to make sure they were using the correct size Mogen clamp and that the space between the clamp's jaws met manufacturer's specifications. The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.
But complications continued. In the 11 years between the FDA warnings and the Hall settlement, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries, said spokeswoman Amanda Sena. Twenty-one of those reports were related to Mogen clamps, all but one of which involved injuries.
Miltex, one of several Mogen clamp manufacturers, stopped distributing the devices in 1994. "Although no obvious defect has been found with the clamp's design or manufacturing we have concerns over the possible mishandling of the instrument by practitioners and our inability to ensure the instrument's proper use," Miltex's then-president Saul Kleinkramer wrote in a letter announcing the decision.
But some of its devices are still in use. That troubles some medical experts, who say the Mogen clamp, unlike others, has a critical design flaw: It does not allow doctors or mohels to see what they are cutting.
In 2000, Miltex reached a confidential settlement with a North Hollywood couple whose newborn was injured during circumcision, according to their lawyer, Robert Mandell. Last year, a New York judge awarded $10.8 million in damages to a Florida couple whose son lost the head of his penis when he was circumcised with a Mogen clamp during a Jewish ceremony called a brith milah, or bris. The maker of that device, Mogen Circumcision Instruments of New York, already was in default on a $7.5-million judgment in Massachusetts.
The lawyer who represented the Florida couple, David Llewellyn, is an outspoken opponent of circumcision. He and other so-called intactivists have pushed for laws banning the practice.
Only about 10% to 20% of doctors use the Mogen clamp, according to Dr. David Tomlinson, who teaches family medicine at Brown University in Providence, R.I., and serves as the World Health Organization's chief expert on circumcision. But the clamp is popular with mohels because some orthodox Jews recognize only circumcisions performed with devices based on the traditional design, according to Dr. Fred R. Kogen, a mohel in Los Angeles.
Kogen has performed circumcisions with the Mogen, the Gomco and the Plastibell. He said he prefers the Mogen, which he has used on more than 7,000 babies, including his son.
With the Mogen clamp, a circumcision requires just one cut and is over in minutes. The Gomco and Plastibell devices require doctors to make multiple incisions, which takes more time and causes more pain, according to studies cited in the April issue of the Journal of Family Practice.
"In my mind, it was less traumatic to the child" to use the Mogen clamp, Kogen said. "I felt comfortable with it."
Besides, he added, "some families are specifically looking for a Mogen for religious reasons, and if I pull something else out, they might get suspicious."
An Integra spokeswoman in Plainsboro, N.J., declined to comment about the device. In its response to Hall's lawsuit, Integra argued that the Mogen clamp was safe, carried adequate warnings and that those who used it should be held responsible for any harm caused.
Terrel now lives with his mother in Austin, Texas. He has had two reconstructive surgeries, and doctors predict he will need at least two more while in his teens and 20s to repair the physical damage. Then will come plastic surgery.
Terrel's father, Terrence Hall, 44, a football and track coach in Los Angeles, said parents need to discuss circumcision with their child's doctor and do their research about the Mogen.
"Be very cautious," he said. "Find out what instrument your doctor uses for circumcisions, and if it's this one, cancel."