Plastibell®



Last updated: 14 July 2014, 15:57 UTC



Icon Content Advisory: This page includes images of child patients. The Plastibell is only made in child sizes, therefore it is not possible for us to illustrate its use with reference to an adult patient.



Description and commercial history of the device


Plastibell


Originally marketed in 1955, the Plastibell is a disposable plastic bell-shaped object with a groove close to its edge. The bell is inserted into the preputial cavity (over the glans and under the foreskin) and the foreskin is tied around it with a tight string. Blood flow to the prepuce is thereby ceased and the prepuce forward of the string is cut off. The handle is then snapped off. After several days, the prepuce caught under the string necrotizes and falls off, providing a bloodless circumcision with no open wound to become irritated or infected.

It took in excess of seven years for a patent to be granted. Why that is so is a matter of some debate; one possibility is that there was doubt about the true novelty of the device. The same technique of strangulation with a tied cord can be found in the Ross Ring dating from 1939; the two clamps differ only in respect of the material used to make them and the design of their respective handles. The US Patent Office may have taken the view that the “Utility Model” (the fundamental principle of operation) of the Plastibell was the same as that of the Ross Ring and therefore not eligible for protection of Intellectual Property Rights. That said, the differences between the Ross Ring and the Plastibell remained eligible for patent protection and it was those features (the use of plastic to facilitate the novel break-off handle) that were the subject of the grant of a patent in October 1962.

Even in the mid-1950s anybody could mimic Ross’s utility model, intellectual property rights to the fundamental concept having already expired due to passage of time.

The patent in respect of the Plastibell expired in the 1970s. Thus there is now a free-for-all as regards copying the original design as marketed by Hollister. Several companies currently manufacture such circumcision devices. However, the trade name Plastibell should be used only to describe the product of the current trademark owner. The trademark was originally registered to Hollister Inc. (incorporated in Illinois, USA), 2000 Hollister Drive, Libertyville, IL 60048. As at January 2011 the "Last Listed Owner" (renewed September 2006) is Briggs Manufactured Products LLC (incorporated in Delaware, USA), 7300 Westown Parkway, West Des Moines, IA 50266.

CIRCLIST is aware of several manufacturing sources, listed below. Not all are accredited by the USFDA (the United States Food and Drug Administration), despite the simplicity of applying for such accreditation via the “substantial equivalence” fast track procedure. Those not yet accredited are encouraged to apply. Some suppliers offer enhancements to the original design, such as elastic (“Spandex”) string in place of the traditional original inelastic material.



Sales outlet of the current Trademark owner:
USA flag Briggs Medical Service Company (and do a Product Search for "Plastibell")



Known manufacturers of look-alike products:
Chinese flag Weihai Medison Medical Devices Co. Ltd.
Other manufacturers and wholesale distributors wishing to have their names added to this list are invited to contact the Editor.



The Plastibell circumcision technique


Plastibell circumcision technique


Because of the danger of the plastic ring being pulled back behind the glans, only the foreskin that naturally covers the glans can be safely removed using the Plastibell. Hence it usually results in a loose circumcision.

The Plastibell is used in nearly 60% of all routine infant circumcisions in the US with the majority of the rest being done by the Gomco Clamp method.

For some 40 years the Plastibell was the only disposable child circumcision device in use, until the appearance of the Tara KLamp in 1995.


Case study, United Kingdom, March/April 1980

Child’s foreskin before circumcision


Plastibell in place

The left-hand image shows an 8-year old boy with a long, tight foreskin, who was circumcised during the Easter school holidays, 1980. The right-hand image shows the same boy with a Plastibell device in place and the overhang of foreskin excised. Applied to a boy of this age, the bell, ligature and necrotic foreskin remnant are likely to remain in place for approximately 7 days before falling off - usually in the bath.
Legal Notes:  In April 2013 an anonymous complaint was made to the Internet Watchdog NCMEC suggesting that publication of the left-hand image constituted “child exploitation”. That assertion was initially upheld by NCMEC but later withdrawn following appeal by the editor of this website. TAKE NOTE that the images are therefore deemed to be legal for public display in a medical-educational context, but in some countries it may nevertheless be illegal to possess retained copies without good cause. Therefore you are advised NOT to download these images to personal off-line storage. Both the above images are copyright and appear here with the knowledge and consent of the original photographer who was present at the circumcision by arrangement with the surgeon, the late Dr. Oswald Burnett Gibson, MB, BS, FFARCS (1930-1981).


During the 5 to 10 days that the device remains attached, it is pulled tight against the glans by the foreskin trying to retract back to its unstretched position. For this reason, Hollister recommend that the foreskin should not be pulled too far forward before being trapped by the thread around the Plastibell’s groove. This results in a necessarily looser circumcision than can be achieved with the Gomco clamp; the Plastibell is wholly unsuitable for tight styles. Furthermore, the position of the scar line behind the glans is determined only by the distance from the back of the glans to the groove in the bell. For a given glans circumference (and hence Plastibell size) the longer the boy’s glans the further back the resulting scar line will be and the looser the circumcision will be.

If the Plastibell is fixed too tightly then the front of it can dig into the glans and cause problems, including obstruction of the urethra. The photo above shows the Plastibell properly applied immediately after the procedure; the final result was most satisfactory with no loose foreskin covering the boy’s glans when flaccid.

The largest Plastibell generally available in the United States and Great Britain is designed to fit the average 11-12 year old boy.  Well-developed boys of this age may have too large a glans to use the Plastibell, whereas very late developers may be able to be circumcised with it up to 14 or so years old. It is very important that the correct size bell is used to avoid damage to the glans.

The Plastibell can be applied quickly and easily under local anaesthesia. Within the time that the anaesthesia remains effective, not only has the blood supply been cut off from the foreskin but also the nerve endings at, and forward of, the thread are rendered ineffective. All the boy will feel is a slight pressure from the bell on the glans.

Because no stitches are used with a Plastibell there is no need for dressings, antibiotics, etc which makes things very much simpler, especially with young children who cannot easily co-operate. Pain from the circumcision site is, to a great extent, related to the degree of desire for the operation. A boy who actively requests and wants it will not notice the pain as much as one who actively opposed the operation, or who simply wasn’t consulted.


Plastibell circumcision, sketch


Absence of adult sizes

The device is not produced in adult sizes. Post-puberty, the foreskin is simply too tough to be adequately ‘strangled’ by a string ligature alone. Inadequate isolation of the necrotic tissue can be very dangerous, potentially leading to severe infection. Historically speaking, overcoming this constraint appears to have been the motivation behind the development of the Zhenxi Ring and the Shang Ring.



movie icon       icon - baby       Click to watch a YouTube video of an infant circumcision done with a Plastibell. Note that you may need to sign into YouTube as an adult in order to view this item.




Articles in the medical press about the Plastibell


Pediatr Surg Int. 2006 Oct 6
Palit V, Menebhi DK, Taylor I, Young M, Elmasry Y and Shah T.  A unique service in UK delivering Plastibell® circumcision: review of 9-year results.

Muslim infants undergo circumcision for religious reasons and Bradford has a high Muslim population. The National Health Service in UK does not provide religious circumcision, so in1996 a nurse-delivered circumcision service led by consultant urologists was set up at a no-profit and cost-only basis. Plastibell circumcision was offered to all infants between 6 and14 weeks old and performed under local anaesthesia. Information leaflets and videotapes about the procedure were available to parents prior to the procedure. A three monthly audit of the service was undertaken. Between July 1996 and June 2005 (9 years) 1,129 circumcisions were performed. The common complications were problems with the ring (3.6%) and bleeding(3%). Overall, there was 96% satisfaction rate among the service users. The Plastibell technique for circumcision is a simple method and can be safely performed by trained nurses with acceptable complication rates.

PMID: 17024296 [PubMed]


J Pediatr Urol. 2009 Jun 12.
Samad A, Khanzada TW and Kumar B (Department of Surgery, Isra University, Hyderabad, Pakistan).  Plastibell circumcision: A minor surgical procedure of major importance.

OBJECTIVE: To determine the number of days taken by the Plastibell to fall off after circumcision and the Plastibell impaction rate in various age groups. METHODS: This was a prospective cohort study of male babies who underwent circumcision using the Plastibell technique. Patients were followed up 1 week postoperatively as well as soon after the Plastibell had fallen off. RESULTS: Mean age was 14.3 months and mean weight 8.2kg at time of surgery. The average time taken for the Plastibell to fall off after circumcision for babies under 3 months was 8.7 days; this period gradually increased to 16.8 days for children over 5 years of age. The overall complication rate was 7.4%. Plastibell impaction was the commonest complication, encountered after 6.1% of procedures, and was managed by cutting the Plastibell. The impaction rate was only 2.3% for babies under 3 months, but gradually increased to 26.9% for children over 5 years. CONCLUSION: The time taken by the Plastibell to fall off spontaneously as well as the Plastibell impaction rate increases gradually with age. In view of the overall safety, comfort and absence of any long-term complication, this procedure justifies recommendation in all children aged under 1 year, but its use is debatable in older children.

PMID: 19525148 [PubMed]



Acknowledgements

The following addditional resources were used in the preparation of this web page:
USA flag USPTO logo US Trademark Electronic Search System (TESS), accessed 07.Jan.2011.
USA flag (316 bytes) Free Patents Online logo (1687 bytes) http://www.freepatentsonline.com/3056407.pdf




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