|The Gomco clamp, 1935|
Production line efficiency reaches the penis
In 1935 Hiram S. Yellen (an obstetrician and gynecologist) and Aaron Goldstein (an inventor) collaborated in the invention of a new circumcision instrument which they called the Gomco clamp. Goldstein produced and marketed the device through his private company – the Goldstein Manufacturing Company (Gomco) – and patented it in 1940. They used the friendly pages of American medical journals to urge the necessity for early circumcision, and to promote their product as the best and most efficient means of performing it. It was a very successful example of medical entrepreneurship!
On this page are collected a number of documents relating to the history of the Gomco clamp.
Yellen’s original article
My commentary: The T-model penis
Julian Wan’s tribute the Gomco clamp
Warning from US Food and Drug Administration
Correspondence between John Dalton and Julian Wan
Recall of Pakistani "Gomco-like" device
One operator's confession
The Gomco clamp as an S&M toy
About a year ago Aaron Goldstein of this city [New York] developed a clamp which we have used in many cases. This efficient instrument is small, compact, light as strength will permit, and can be operated without an assistant. The technic is quite simple, and the time required is less than that by any other method. With the use of this clamp we never employ sutures, no bleeding is encountered, and it leaves a clean-cut incision which heals perfectly in 36 hours with practically no chance of infection because the mucous membrane and skin are securely clamped together.
Fig. 3 is the clamp itself, and Fig. 1 and 2 are diagrams showing the procedure. The following instruments and material are all that is really required: the clamp, 2 small haemostats, a probe with a flattened end, a scissor with one blunt blade, an abscess knife or sharp pointed scalpel (No. 12 Bard-Parker blade is ideal), sterile Vaseline, and Vaseline gauze.
After properly cleansing the penis (E) and pubis, the dorsal aspect of the prepuce (A) is put on a stretch by grasping it on either side of the median line with a pair of haemostats. A flat probe, anointed with Vaseline, is then inserted between the prepuce and the glans to separate adherent mucous membrane. The prepuce is then gently drawn backward, exposing the entire glans penis. This is again cleaned. In case where the prepuce is drawn tightly over the glans, a partial dorsal slit will facilitate applying the cone of draw stud over the glans [?? sic]. (Note: If too long a slit is made, the cone has a tendency to slip of the glans. The slit should, therefore, be made only sufficiently long to enable the cone to be easily applied.)
After anointing the inside of the cone (B) , it is placed over the glans, allowing enough of the mucous membrane to fit below the cone so that too much is not removed. The prepuce is then pulled through and above the bevel hole in the platform (F), and clamped in place. In this way the prepuce is crushed against the cone, causing haemostasis. We allow this pressure to remain five minutes, and in older children slightly longer. The excess of the prepuce is then cut with a sharp knife without any danger of cutting the glans, which is always protected by the cone portion of the instrument, leaving a very fine one-thirty-second of an inch ribbon-like membrane formed between the new union of the skin and mucous membrane. The pressure is then released. The circumcision is completed and the penis covered with Vaseline gauze.
No anaesthesia is used.
On children older than twelve months, we find it advisable to insert a few sutures. At this date we have performed more than 500 circumcisions on the newborn and as yet have not encountered any infection or haemorrhage.
Hiram S. Yellen, "Bloodless circumcision of the newborn", American Journal of Obstetrics and Gynecology, Vol. 30, 1935, p. 146-7
Journal of the American Medical Association in 1935 and at its annual meeting in 1936. It soon proved very popular with American physicians, and established itself as the most commonly used method for early circumcision. Although Yellen had warned that the device should be used cautiously so that "not too much" of the prepuce was amputated, the design of the device allowed any quantity of tissue to be trapped and excised, depending on how far the penile skin was stretched between the ring and the cone. The temptation was always to pull more rather than less. The outcome was that the American method of circumcision became increasingly severe, leading to the "high and tight" look in which about 50 per cent of the surface tissue of the penis is cut off, and the remaining skin is stretched thin, like the membrane of a drum. The instrument remains in frequent use today.
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.
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.
-- Original Message --
From: John D Dalton [mailto:firstname.lastname@example.org]
Sent: Saturday, May 18, 2002 16:18
To: Wan, Julian
Subject: Re: reprint
Thank you. I have now seen your article.
As a matter of interest, were you aware that the FDA had issued a
warning in respect of the Gomco clamp:
This one states "... 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
<http://www.fda.gov/cdrh/safety/#1>. These have included laceration,
hemorrhage, penile amputation, and urethral damage."
In message <77267925C48ED311AA2E0008C7916AA60DAED8A8 @kalmb01.kaleidahealth.org>, Wan, Julian <JWan@KaleidaHealth.Org> writes
>Dear Mr. Dalton:
>Thank you for your letter concerning the GOMCO reprint. I haven’t gotten
>them yet - there is a delay of some sort with the publisher - once they are
>in, I’ll mail you a copy; there just may be a small lag.
>Julian Wan, MD
Dr Wan’s reply to the question of whether he was aware of the FDA warning.
-- Original message --
To: ‘John D Dalton’ <email@example.com>
From: "Wan, Julian" <JWan@KaleidaHealth.Org>
Date: Sun, 19 May 2002 14:54:28 -0400
Dear Mr. Dalton,
Thank you very much for the note. I was aware of the various types of problems with both the Mogen and the GOMCO clamps, but not of this particular alert.
The Mogen and similar style clamps run the risk of a cross clamping injury and a blind cutting injury and have been reported in several articles in the urological literature. The GOMCO style clamps require good maintenance of the parts – damage due to wear particularly at the critical force bearing areas can be a problem – the older models were brass coated wit chrome, and could be deformed. The newer models are stainless steel and so are a bit more robust, but can develop sharp edges or burrs. Circumcision instrument trays are often created with different size clamps, and sometimes inexperienced personnel can mix up the components – a mismatched bell and plate can lead to distortion of the clamping force and problems. I suspect the critical common theme in these injuries is the experience of the surgeon. The inexperienced and occasional circumciser is most likely to have problems.
Julian Wan, MD
It seems strange that if Dr Wan was aware of "the various types of problems with both the Mogen and the GOMCO clamps", and that the older models were prone to warping, he did not refer to these problems in his article.
Chrome plated brass circumcision clamps, gomco like, made in Pakistan, individually packaged clamps in boxes labeled only with the catalog number, description, size and quantity.
All units of the following clamps
Catalog #83928, 1.1 cm, Extra Small
Catalog #83929, 1.3 cm, Newborn
Catalog #83930, 1.6 cm, Child.
Gogi Enterprises, Sialkot, Punjab, Pakistan.
Medco Instruments, Inc., Crestwood, Illinois, by fax on February 16, 2000.
In her testimony, Dr Kantak makes the extraordinary admission that in order to fasten the foreskin to the cone (here referred to as the bell) of the Gomco device, she pierced the baby's foreskin with several safety pins. She also states that she left the clamp on the crushed foreskin for seven minutes to ensure that there would be minimal bleeding when she used a scalpel to sever the foreskin and then removed the clamp.
The relevant section of her testimony is reproduced here. She is replying to questions from Zenas Baer, attorney for the plaintiffs.
22 Q. Now, Dr. Kantak, on page 22 I asked
23 you at Interrogatory Number 90 of Exhibit 16
24 what the circumcision tray consisted of, and you
25 describe it as including straight mosquito
2 A. Yeah.
3 Q. And then a straight Kellie forcep.
4 What is a Kellie forcep?
5 A. Kellie forcep is for to clean the
6 area for the -- to use the sterile, you know,
7 the Betadine that we clean the area before doing
8 the circumcision.
9 Q. Okay. Is there one mosquito forcep,
10 or two?
11 A. I think there are three, three.
12 Q. Okay. Three. Maybe I can just
13 refer you to the next page. I think that has a
14 more detailed description of what it contains.
15 What are safety pins used for?
16 A. The safety pins are used just to
17 hold the bell. Some people use it, some people
19 Q. Hold the what?
20 A. To hold the bell.
21 Q. The Gomco?
22 A. The Gomco bell.
23 Q. Hold it?
24 A. To hold it so it becomes easy to put
25 it without much manipulation.
1 Q. Where do you put the safety pins?
2 A. Just on the tip where the -- you
3 hold the bell.
4 Q. Do the safety pins puncture the
5 foreskin that you're going to remove?
6 A. Yeah.
7 Q. So you actually pull up -- or you
8 position the bell, and then you take safety pins
9 and push them through the foreskin you're going
10 to remove, and then attach or secure the safety
11 pin so that the bell stays in place?
12 A. No. Because you have to put the
13 hole -- the -- the instruments of the Gomco
14 apparatus, otherwise people use the -- what is
15 that called? I don't know what that's called.
16 They use some other things to pull it out from
17 the hole where the bell goes, so if you hold the
18 bell, the safety pins, it just becomes -- you
19 don't manipulate much and you get less bleeding,
20 is my experience.
21 Q. But the safety pins do puncture the
23 A. Yeah.
24 Q. And what is the med cup used for?
25 What is that?
1 A. To prep balls, they have some cotton
2 balls there and the nurse puts the Betadine and
3 then you clean the area before you do the
4 surgery so that there is no infection risk. It
5 reduces the infection risk.
6 Q. Okay. And the scalpel, is that used
7 to cut the foreskin once you have --
8 A. That's right.
9 Q. -- detached it and clamped it?
10 A. Yeah.
11 Q. And obtained hemostasis?
12 A. Yes.
13 Q. How can you tell when hemostasis has
14 been achieved?
15 A. Usually the bleeding time is seven
16 to nine minutes, so that's why I just go for
17 seven minutes. That's my preference to wait.
Cass District Court, State of North Dakota, USA, Court File CV-99-03761, deposition taken on 6 September 2000, by Carolyn's Reporting Service; transcript p. 148-51.
It is doubtful whether any of the thumbscrews found in the dungeons of the Inquisition, and used to torture heretics in the Middle Ages, could have produced so much agony for so little effort on the part of the operator. (Indeed, Jewish doctors have plausibly asserted that the Gomco clamp is far more painful than both traditional Jewish circumcision methods and many other instruments, such as the Mogen clamp.)
It is thus hardly surprising that the Gomco clamp has become a prop and sex toy in the sexual dungeons and play rooms of those who specialise in the more extreme reaches of S&M, and particularly for those who get a sexual kick out of genital surgery and mutilations. Examples can be found all over the Internet:
Chase Union, a supplier of S&M gear, sells not only Gomco clamps, but castration equipment.
A circumcision fetish site (pornography masquerading as medical advice and cultural studies) has pages in praise of the Gomco.
These fetishistic aspects are made very clear in this page of images and "hot" stories involving voluntary or forced circumcision: (Warning: sexually explicit)
And there are several internet communities devoted to the thrill of circumcision and the various instruments used in its performance, including one specifically in praise of the Gomco.
The perspective of the American medical establishment, as it was in 1998, may be viewed here.