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The Gomco clamp, 1935 |
Production line efficiency reaches the penisIn 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 Further information Bloodless circumcision of the newbornCircumcision is one of the oldest operations recorded in the history of medicine, and while the method of procedure has kept pace with medical progress in general, there has always been the possibility of a haemorrhage with each case. Medical literature records many fatal haemorrhages and many infections as a result of circumcision of the newborn, and it is known that 2 per cent of all skin cancers are penis cancers. With this in mind we set about to develop a safe and simple apparatus for the performance of this operation, with the result that we now have a clamp which not only eliminates the possibility of haemorrhage, but also restricts the minimum chance of infection without the use of sutures.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. Method 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 Commentary: The T-model penisThe Gomco clamp was heavily advertised in the 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.Julian Wan's tributeYellen 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. Warning from FDAContrary 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. Correspondence between John Dalton and Julian WanThis report was the subject of some correspondence between John Dalton, of Norm-UK, and Dr Wan, who confessed that while he was aware of "the various types of problems with both the Mogen and the GOMCO clamps", he was not aware of the FDA's warning.Dalton's question -- Original Message -- From: John D Dalton [mailto:[email protected]] 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: http://www.fda.gov/cdrh/safety/circumcision.html 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 <[email protected]> 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. > >Sincerely, > >Julian Wan, MD Dr Wan's reply to the question of whether he was aware of the FDA warning. -- Original message -- Subject: reprin' To: 'John D Dalton' <[email protected]> From: "Wan, Julian" <[email protected]> Date: Sun, 19 May 2002 14:54:28 -0400 Message-ID: <77267925C48ED311AA2E0008C7916AA60DAED8BF @kalmb01.kaleidahealth.org> 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. Sincerely, 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. Gomco-like device bannedA "Gomco-like" device made in Pakistan and sold to the USA was actually recalled by the distributor in February 2000.PRODUCT 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. Recall #Z-402/404-0. CODE 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. MANUFACTURER Gogi Enterprises, Sialkot, Punjab, Pakistan. RECALLED BY Medco Instruments, Inc., Crestwood, Illinois, by fax on February 16, 2000. http://www.fda.gov/bbs/topics/ENFORCE/ENF00632.html One operator's confessionJust how tricky the Gomco clamp can be, and how gruesome, is revealed in this astonishing testimony given by Dr Sunita Kantak in the course of a civil action for damages arising from a circumcision she performed in North Dakota, USA. Dr Kantak had circumcised a newborn boy using the Gomco method. Although she had obtained the mother's consent, the parents were horrified when they saw the result - an ugly and disfigured penis marked by a wound that required a long period to heal. They then sued the doctor and the hospital on the ground that they had not been warned that there was any risk of disfigurement, stating that they would never have agreed to the operation had they been given full information about the process and the possible result.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 1 forceps? 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 18 don't. 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 22 foreskin? 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. Gomco clamp as an S&M toyThe big advantage of the Gomco device for Yellen and his ob-gyns is that it helped to make circumcision a routine operation which could be performed by any GP, medical student, intern or obstetrician; it was no longer the preserve of specialist surgeons or those who knew something about male anatomy. This gain in efficiency and simplicity came at a heavy price that was paid by the one party to the transaction who could do nothing but scream: the baby boy. There can be little doubt that the new method was the most painful yet devised, requiring first the agonising process of tearing the foreskin from the infant glans, then crushing the foreskin, then cutting it off, then putting in stitches if necessary, and all performed without anaesthetic. Although the procedure is described as "quick", it often takes 20 minutes or longer.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. http://www.chaseunion.com/ A circumcision fetish site (pornography masquerading as medical advice and cultural studies) has pages in praise of the Gomco. http://www.circlist.com/instrstechs/instrumentset.html These fetishistic aspects are made very clear in this page of images and "hot" stories involving voluntary or forced circumcision: (Warning: sexually explicit) http://www.icon.co.za/~hugot/circum/circum.htm 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. http://groups.msn.com/CIRCUMCISEDGUYS http://groups.yahoo.com/group/Gomco_circumcision_adult Any web search will bring up thousands of pages on the subject. More sober information may be obtained from |