Downloaded from www.ajronline.org by 117.253.166.61 on 10/22/15 from IP address 117.253.166.61. Copyright ARRS. For personal use only; all rights reserved
1
Cornrnentary
Bariurn Enernas, Reactions
Latex Balloons,
and Anaphylactic
David W. Gelfand1
Most radiologists are aware that the United States Food and Drug Administration (FDA) has ordered a recall of latex balloon-equipped enema tips used for barium enemas. The recall was prompted by an increasing number of severe anaphylactic reactions, including fatalities, during barium enemas, reported to the FDA. Allergy to latex products is a growing problem because of increased exposure of both medical personnel and lay people to latex since the emergence of the AIDS epidemic. Several recent publications document allergic and anaphylactic reactions to latex gloves [1 -5], and an anaphylactic reaction to a condom also has been reported. Of particular interest in the matter of latex balloon-equipped enema tips is a report of an anaphylactic reaction occurring during rectal manometry in which the finger of a latex glove was used to cover the transducer [6]. It was not recognized at first that the latex balloon on enema tips might be the source of allergic and anaphylactic reactions. These reactions were included among the allergic reactions reported as occurring during barium enemas and were attributed to the suspending agents in the barium suspension. However, reports were recently received of fatal anaphylactic reactions occurring after insertion of a balloonequipped tip but before administration of the barium suspension. At that point, attention was redirected toward the latex balloon. Latex is a natural product derived from the sap of the rubber tree, and consists of long-chain molecules with an average molecular weight of several hundred thousand. However, the liquid latex supplied to manufacturers also contains small amounts of water-soluble proteins of lesser molecular weight. After the latex rubber product is formed by heating 1
AJR
Department 156:1-2,
of Radiology, January
Bowman
Gray School
1991 0361 -803X/91/1
of Medicine,
561-0001
the liquid latex, water-soluble proteins remain in the product and can be eluted from its surface. It is believed that absorption ofthese proteins by the rectal mucosa triggers the allergic and anaphylactic reactions. Although historical evidence suggests that protein elutable from latex products is the allergen, more specific evidence has been provided by Dennis R. Ownby of the Division of Allergy of Henry Ford Hospital of Detroit (personal communication). Blood samples of six patients suspected of having severe allergic or anaphylactic reactions to latex balloons on enema tips were obtained. In vitro tests for latex-specific IgE antibodies were positive in five of the six patients, which provides presumptive evidence that the important allergen in these reactions is the protein elutable from latex. To confirm these initial results, Dr. Ownby requests that radiologists with patients who have had an allergic or anaphylactic reaction in connection with a barium enema contact him so that historical information and a blood sample can be obtained. Latex allergy is particularly likely to be found in medical personnel and in atopic persons. A 1987 survey of medical personnel in Finland found that 3% were allergic to latex and that 67% of these were atopic [1]. It is therefore advisable to question patients for indications of allergy or asthma before performing a barium enema because of the potential for rapid absorption of allergens through the rectal mucosa. An obvious precaution is that the materials necessary to treat allergic, anaphylactic, and vasovagal reactions should be available where barium enemas are being performed. The extent of the problem of allergy to balloon-equipped enema tips is reflected in the data base supplied to this author by E-Z-EM Company, which includes all incidents reported from December 1988 through September 1990. During this
300 S. Hawthorne
0 American
Roentgen
Rd., Winston-Salem,
NC 27103.
Address
reprint
Ray Society Thie
One
requests
to D. W. Gelfand.
Downloaded from www.ajronline.org by 117.253.166.61 on 10/22/15 from IP address 117.253.166.61. Copyright ARRS. For personal use only; all rights reserved
2
GELFAND
22-month period, 158 incidents related to barium examinations were reported, of which 148 (nine fatal) were associated with barium enema examinations and 10 (none fatal) were associated with oral barium administration. Five of the nine deaths were believed to be unrelated to allergy, with two due to myocardial infarction, and one each due to pulmonary edema, vasovagal reaction, and colonic perforation. In five fatal reactions, three of which were anaphylactic, no barium suspension had been administered; the reactions occurred after insertion of a balloon-equipped tip. It is believed very likely that an undetermined number of the nonfatal “barium” reactions reported in this data base also may be due to the latex balloons. Notably, only 10 reactions to orally administered barium were reported, and only one was severe. These statistics emphasize the far greater risk associated with barium enema examinations than oral barium examinations. This is probably due to the ability of the rectal mucosa to absorb large molecules into the circulation almost instantaneously. It may be recalled that rectal administration of medications in the form of enemas or suppositories was common practice before the advent of IV therapy. These data also indicate that fatal reactions due to anaphylaxis are rare. In the available data, four fatal anaphylactic reactions associated with barium enema examinations are recorded. During the reporting period, approximately eight million barium enemas were performed in the United States, suggesting a fatality rate from anaphylactic reactions of less than one in two million examinations. This extremely low fatality rate raises the question of whether the recall of the enema tips may have adverse consequences greater than the danger posed by anaphylactic reactions occurring during barium enemas. The recall primarily affects elderly, incontinent patients, who are extremely difficult to examine without use of a balloon tip. An unknown number of such patients are likely to be diverted from having a barium enema to undergoing colonoscopy. These patients willbe subjected to the far more dangerous colonoscopic examination, which has a mortality rate an order of magnitude greater than the barium enema. A recent publication summarizing reported complications indicates that colonoscopy has a major complication rate of 0.2% (1:500) and a fatality rate of 0.02% (1:5000) [7]. Several possibilities exist to circumvent the inconvenience caused by the recall of balloon enema tips. First, the largest manufacturer of such devices (E-Z EM) has developed a presumably less allergenic silicone rubber balloon tip that should be available in the near future, assuming that no problems are encountered during the FDA approval process. Second, the nondisposable Bardex rubber catheter (C. R.
AJR:156, January 1991
Bard, Murray Hill, NJ) is still available and remains the most effective of all balloon catheters for helping the incontinent patient retain a barium enema. This particular catheter can be repeatedly cleaned, sterilized, and reused, although the process is less convenient than using a disposable balloon tip. Apart from these substitutes, radiologists can and should make greater use of the ordinary nonbalboon tip, and the patient will be better served by this. Most balloon-equipped enema tips are used for convenience in retaining the tip within the rectum rather than for incontinence. However, nonbalboon tips are available with and without the air line required for double-contrast
enemas.
Retention
of these
tips can be en-
sured by properly taping the tip to the patient’s buttocks. After insertion of the tip, a strip of adhesive tape is pasted to one buttock, run around the tube below the enema tip, and pasted to the other buttock. This forms a V-shaped sling that retains the tip in the rectum far more successfully than the more common method of taping straight across the buttocks. Apart from minimizing the danger of allergic reactions, use of nonbalboon tips also minimizes perforation of the rectum by an enema tip being forced through the anterior wall as the balloon is inflated. The latex balloon tip recall is a serious inconvenience. However, it may result in safer barium enema examinations, because it seems very likely that many presumed allergic reactions to barium suspensions have all along been due to latex allergy. In time, the silicone rubber balloon tip will be available and should provide greater safety. Also, to the extent that radiologists may learn to forgo the use of balloon tips, fewer rectal perforations are likely to occur.
REFERENCES 1 . Turjanmaa K. Incidence of immediate allergy to latex gloves in hospital personnel. Contact Dermatitis 1987;1 7 : 270-275 2. Gerber AC, JOrg W, Zbinden 5, Seger RA, Dangel PH. Severe intraoperative anaphylaxis to surgical gloves: latex allergy, an unfamiliar condition. Anesthesiology 1989;71 :800-802 3. Leynadier F, Pecquet C, Dry J. Anaphylaxis to latex during surgery. Anaesthesia 1989;44:547-550 4. Turjanmaa K, R#{228}s#{228}nen L, Lehto M, M#{228}kinen-Kiljunen 5, Reunala T. Basophil histamine release and lymphocyte proliferation tests in latex contact urticaria. Allergy 1989;44: 181-186 5. Spaner D, Dolovich J, Tarlo 5, Sussman 0, Buttoo K. Hypersensitivity to natural latex.Clin Immunol 1989;83: 1135-1137 6. Sondheimer JM, Pearlman DS, Bailey WC. Systemic anaphylaxis during rectal manometry with a latex balloon. Am J Gastroenterol 1989;84:975977 7. Habr-Gama A, Waye JD. Complications and hazards of gastrointestinal endoscopy. WorldJ Surg 1989;13:193-201
1
Cornrnentary
Bariurn Enernas, Reactions
Latex Balloons,
and Anaphylactic
David W. Gelfand1
Most radiologists are aware that the United States Food and Drug Administration (FDA) has ordered a recall of latex balloon-equipped enema tips used for barium enemas. The recall was prompted by an increasing number of severe anaphylactic reactions, including fatalities, during barium enemas, reported to the FDA. Allergy to latex products is a growing problem because of increased exposure of both medical personnel and lay people to latex since the emergence of the AIDS epidemic. Several recent publications document allergic and anaphylactic reactions to latex gloves [1 -5], and an anaphylactic reaction to a condom also has been reported. Of particular interest in the matter of latex balloon-equipped enema tips is a report of an anaphylactic reaction occurring during rectal manometry in which the finger of a latex glove was used to cover the transducer [6]. It was not recognized at first that the latex balloon on enema tips might be the source of allergic and anaphylactic reactions. These reactions were included among the allergic reactions reported as occurring during barium enemas and were attributed to the suspending agents in the barium suspension. However, reports were recently received of fatal anaphylactic reactions occurring after insertion of a balloonequipped tip but before administration of the barium suspension. At that point, attention was redirected toward the latex balloon. Latex is a natural product derived from the sap of the rubber tree, and consists of long-chain molecules with an average molecular weight of several hundred thousand. However, the liquid latex supplied to manufacturers also contains small amounts of water-soluble proteins of lesser molecular weight. After the latex rubber product is formed by heating 1
AJR
Department 156:1-2,
of Radiology, January
Bowman
Gray School
1991 0361 -803X/91/1
of Medicine,
561-0001
the liquid latex, water-soluble proteins remain in the product and can be eluted from its surface. It is believed that absorption ofthese proteins by the rectal mucosa triggers the allergic and anaphylactic reactions. Although historical evidence suggests that protein elutable from latex products is the allergen, more specific evidence has been provided by Dennis R. Ownby of the Division of Allergy of Henry Ford Hospital of Detroit (personal communication). Blood samples of six patients suspected of having severe allergic or anaphylactic reactions to latex balloons on enema tips were obtained. In vitro tests for latex-specific IgE antibodies were positive in five of the six patients, which provides presumptive evidence that the important allergen in these reactions is the protein elutable from latex. To confirm these initial results, Dr. Ownby requests that radiologists with patients who have had an allergic or anaphylactic reaction in connection with a barium enema contact him so that historical information and a blood sample can be obtained. Latex allergy is particularly likely to be found in medical personnel and in atopic persons. A 1987 survey of medical personnel in Finland found that 3% were allergic to latex and that 67% of these were atopic [1]. It is therefore advisable to question patients for indications of allergy or asthma before performing a barium enema because of the potential for rapid absorption of allergens through the rectal mucosa. An obvious precaution is that the materials necessary to treat allergic, anaphylactic, and vasovagal reactions should be available where barium enemas are being performed. The extent of the problem of allergy to balloon-equipped enema tips is reflected in the data base supplied to this author by E-Z-EM Company, which includes all incidents reported from December 1988 through September 1990. During this
300 S. Hawthorne
0 American
Roentgen
Rd., Winston-Salem,
NC 27103.
Address
reprint
Ray Society Thie
One
requests
to D. W. Gelfand.
Downloaded from www.ajronline.org by 117.253.166.61 on 10/22/15 from IP address 117.253.166.61. Copyright ARRS. For personal use only; all rights reserved
2
GELFAND
22-month period, 158 incidents related to barium examinations were reported, of which 148 (nine fatal) were associated with barium enema examinations and 10 (none fatal) were associated with oral barium administration. Five of the nine deaths were believed to be unrelated to allergy, with two due to myocardial infarction, and one each due to pulmonary edema, vasovagal reaction, and colonic perforation. In five fatal reactions, three of which were anaphylactic, no barium suspension had been administered; the reactions occurred after insertion of a balloon-equipped tip. It is believed very likely that an undetermined number of the nonfatal “barium” reactions reported in this data base also may be due to the latex balloons. Notably, only 10 reactions to orally administered barium were reported, and only one was severe. These statistics emphasize the far greater risk associated with barium enema examinations than oral barium examinations. This is probably due to the ability of the rectal mucosa to absorb large molecules into the circulation almost instantaneously. It may be recalled that rectal administration of medications in the form of enemas or suppositories was common practice before the advent of IV therapy. These data also indicate that fatal reactions due to anaphylaxis are rare. In the available data, four fatal anaphylactic reactions associated with barium enema examinations are recorded. During the reporting period, approximately eight million barium enemas were performed in the United States, suggesting a fatality rate from anaphylactic reactions of less than one in two million examinations. This extremely low fatality rate raises the question of whether the recall of the enema tips may have adverse consequences greater than the danger posed by anaphylactic reactions occurring during barium enemas. The recall primarily affects elderly, incontinent patients, who are extremely difficult to examine without use of a balloon tip. An unknown number of such patients are likely to be diverted from having a barium enema to undergoing colonoscopy. These patients willbe subjected to the far more dangerous colonoscopic examination, which has a mortality rate an order of magnitude greater than the barium enema. A recent publication summarizing reported complications indicates that colonoscopy has a major complication rate of 0.2% (1:500) and a fatality rate of 0.02% (1:5000) [7]. Several possibilities exist to circumvent the inconvenience caused by the recall of balloon enema tips. First, the largest manufacturer of such devices (E-Z EM) has developed a presumably less allergenic silicone rubber balloon tip that should be available in the near future, assuming that no problems are encountered during the FDA approval process. Second, the nondisposable Bardex rubber catheter (C. R.
AJR:156, January 1991
Bard, Murray Hill, NJ) is still available and remains the most effective of all balloon catheters for helping the incontinent patient retain a barium enema. This particular catheter can be repeatedly cleaned, sterilized, and reused, although the process is less convenient than using a disposable balloon tip. Apart from these substitutes, radiologists can and should make greater use of the ordinary nonbalboon tip, and the patient will be better served by this. Most balloon-equipped enema tips are used for convenience in retaining the tip within the rectum rather than for incontinence. However, nonbalboon tips are available with and without the air line required for double-contrast
enemas.
Retention
of these
tips can be en-
sured by properly taping the tip to the patient’s buttocks. After insertion of the tip, a strip of adhesive tape is pasted to one buttock, run around the tube below the enema tip, and pasted to the other buttock. This forms a V-shaped sling that retains the tip in the rectum far more successfully than the more common method of taping straight across the buttocks. Apart from minimizing the danger of allergic reactions, use of nonbalboon tips also minimizes perforation of the rectum by an enema tip being forced through the anterior wall as the balloon is inflated. The latex balloon tip recall is a serious inconvenience. However, it may result in safer barium enema examinations, because it seems very likely that many presumed allergic reactions to barium suspensions have all along been due to latex allergy. In time, the silicone rubber balloon tip will be available and should provide greater safety. Also, to the extent that radiologists may learn to forgo the use of balloon tips, fewer rectal perforations are likely to occur.
REFERENCES 1 . Turjanmaa K. Incidence of immediate allergy to latex gloves in hospital personnel. Contact Dermatitis 1987;1 7 : 270-275 2. Gerber AC, JOrg W, Zbinden 5, Seger RA, Dangel PH. Severe intraoperative anaphylaxis to surgical gloves: latex allergy, an unfamiliar condition. Anesthesiology 1989;71 :800-802 3. Leynadier F, Pecquet C, Dry J. Anaphylaxis to latex during surgery. Anaesthesia 1989;44:547-550 4. Turjanmaa K, R#{228}s#{228}nen L, Lehto M, M#{228}kinen-Kiljunen 5, Reunala T. Basophil histamine release and lymphocyte proliferation tests in latex contact urticaria. Allergy 1989;44: 181-186 5. Spaner D, Dolovich J, Tarlo 5, Sussman 0, Buttoo K. Hypersensitivity to natural latex.Clin Immunol 1989;83: 1135-1137 6. Sondheimer JM, Pearlman DS, Bailey WC. Systemic anaphylaxis during rectal manometry with a latex balloon. Am J Gastroenterol 1989;84:975977 7. Habr-Gama A, Waye JD. Complications and hazards of gastrointestinal endoscopy. WorldJ Surg 1989;13:193-201
