Production line efficiency reaches the penis

Bloodless circumcision of the newborn

Commentary: The T-model penis

Julian Wan’s tribute

Yellen and Goldstein’s work was the subject of an enthusiastic, not to say rhapsodic, eulogy by Julian Wan, published in the journal Urology in 2002. Wan praises the Gomco clamp for its "longevity and functional elegance", and as "a model of excellence in design and innovation". He notes that the device can exert from "800 to 20,000 pounds of hemostatic force against the prepuce", thus crushing it so effectively that stitches are rarely necessary. Wan also explains why Yellen was so keen to develop a new and simple circumcision method. Although American physicians had been demanding universal male circumcision since around 1910, they met strong resistance because all the available methods were clumsy, difficult and bloody, and often had unfortunate outcomes, such as dangerous bleeding, infection and death. By the mid-1930s the high level of injury and death had produced such disenchantment among British doctors that many were calling for the operation to be entirely abandoned; while in the USA Dr Winfield Scott Hugh recommended that it be treated as a major operation to be performed under local or general anaesthetic, and that every point of bleeding should be meticulously sutured.

It is easy to see that if circumcision was classified as such serious surgery it would remain only a minority practice and could never become as widespread as its advocates desired. It could certainly not be regarded as a simple, "routine" procedure performed at or soon after birth by obstetricians; it would rather be a serious operation reserved to surgeons, and correspondingly more expensive and less popular. Like Kistler’s clamp, Yellen and Goldstein’s device was intended to reduce objections to circumcision and to promote its performance throughout the nation. Its purpose was to silence the critics and ensure that Yellen’s professional fraction (the ob-gyns) got the job. In retrospect we can see (though Wan did not) that the whole affair was about business success and professional turf, and had very little to do with children’s health.

The T-model penis

Wan reports that Goldstein was inspired by watching a mechanic at work with a tyre lever on a Ford motor car. In a broader perspective, his invention may be seen as part of the drive for speed and efficiency so characteristic of American industry in the 1920s, and the application of Fordist production line techniques to surgery. Circumcised penises would henceforth roll out of the hospitals with the same speed and efficiency as Henry Ford’s cars poured out of his factories, all as standardised and uniform as the T-model itself.

Wan’s article is well worth studying, both for its historical information and the insights it affords into the standards of medical ethics current among American urologists. A pdf copy may be downloaded here. (PDF 157KB)

Warning from FDA

Contrary to Yellen’s claims and Wan’s breezy affirmations, however, the Gomco clamp has not been free from complications, and the literature offers many cases where its use has led to bleeding, infection, and amputation of the glans or entire penis. The following warning was issued by the Center for Devices and Radiological Health of the US Food and Drug Administration on 29 August 2000. They had received no fewer than 105 reports of injuries between July 1996 and January 2000 alone, including laceration, hemorrhage, penile amputation, and urethral damage.

Center for Devices and Radiological Health
Food and Drug Administration
29 August 2000

Dear Colleague

This letter is to alert you to the potential for injury from two commonly used circumcision clamps, the Gomco/gomco-type and Mogen/mogen-type clamps. Both are widely used during circumcision to remove the foreskin while protecting the glans penis.

Although research suggests that circumcision is generally a safe procedure, we are concerned that some serious device-related complications have occurred. We received 105 reports of injuries involving circumcision clamps between July 1996 and January 2000 [1]. These have included laceration, hemorrhage, penile amputation, and urethral damage.

We are providing recommendations below that can help avoid these complications.

Nature of the Problem

Gomco and Gomco-type Clamps

The use of Gomco and gomco-type clamps that have been reassembled by users with parts from different manufacturers, or that have bent parts or mismatched components, has led to clamps breaking, slipping, falling off during use, tearing penile tissue or failing to make a tight seal. Please note that although Gomco and gomco-type clamps may appear to have interchangeable parts, these parts may not always be safely interchanged because they may vary slightly in dimensions.

Mogen and Mogen-type Clamps

The use of Mogen and mogen-type clamps that have jaw gap dimensions greater than those in the manufacturer’s specifications, or use of clamps inappropriately sized for patients, has led to patient injuries. In such cases, 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.

Recommendations

General

Before performing a circumcision procedure, examine the clamp to determine that all parts are available, undamaged, and within the manufacturer's specification.

Gomco and Gomco-type clamps

If you cannot be certain that a clamp component is part of the original clamp or if the clamp has stripped threads, a warped or bent base plate, a bent arm, twisted forks, or a scored or nicked bell, either contact the device manufacturer to obtain replacement parts [2] or discard the clamp.

When requesting a replacement part, obtain the assurance of the manufacturer or supplier that the part ordered is compatible with the other components of your device. Do not substitute parts from different clamp manufacturers.

Make sure that you reassemble a clamp from only its own parts. Do not mix up parts from different clamps, even from the same manufacturer, unless the manufacturer has assured you that the parts are interchangeable.

If you choose to mark clamp parts to assure that you correctly reassemble them, ask the manufacturer about the best way to do this, because some marking methods may weaken the device or compromise your ability to sterilize it.

Mogen and Mogen-type clamps

Ensure that the clamp being used is appropriate for the patient size. Some manufacturers have two sizes of clamps, one for adults and the other for infants.

Periodically measure the gap between the device’s clamping jaws to ensure that it is within the manufacturer’s specification. [3]  Using a device with an inappropriate jaw gap could allow the tip of the penis to be drawn through the clamp with the foreskin and inadvertently severed or injured.

Reporting Adverse Events to FDA

The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. This means that if the use of a Gomco/gomco-type clamp or a Mogen/mogen-type clamp result in a death or serious injury, you must report that event. We request that you follow the procedures established by your facility for such mandatory reporting.

If a circumcision clamp malfunctions, you can report this directly to the manufacturer. Alternatively, you can report directly to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch four ways: online to https://www.accessdata.fda.gov/scripts/medwatch/ by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178, or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

Getting More information

If you have questions regarding this letter, please contact Sherry Purvis-Wynn, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by fax at 301-594-2968, or by e-mail at phann@cdrh.fda.gov. Additionally, a voice mail message may be left at 301-594-0650, and your call will be returned as soon as possible.

All of the FDA medical device postmarket safety notifications can be found on the World Wide Web at http://www.fda.gov/cdrh/safety.html. Postmarket safety notifications can also be obtained through e-mail on the day they are released by subscribing to our list server. To subscribe, send a message to fdalists@archie.fda.gov. In the body of the text, type "subscribe dev-alert".

Sincerely yours,
David W. Feigal, Jr, MD, MPH
Director
Center for Devices and Radiological Health
Food and Drug Administration
[29 August 2000]

References and Additional Information

1.  FDA MedWatch Reports, July 1992 through January 2000.

2.  IPM Procedure: Circumcision Clamps, Health Devices 2000 January; 29(1):22-3.

3.  Hazard: Routine inspection needed for scissors-type circumcision clamps, Health Devices 1999 Mar; 28(3):115-6.

4.  Hazard: Incompatibility of different brands of Gomco-Type circumcision clamps. Health Devices 1997 Feb; 26(2):76-7.

5.  Hazard: Amputations with use of adult-size scissors-type circumcision clamps on infants. Health Devices 1995 Jul; 4(7):286-7.

6.  Hazard: Damaged Allied Healthcare Products Gomco circumcision clamp. Health Devices 1993 Mar; 22(3):154-5.

http://www.fda.gov/cdrh/safety/circumcision.html

Correspondence between John Dalton and Julian Wan

Gomco-like device banned

One operator's confession

Gomco clamp as an S&M toy

Further information