- Email: [email protected]
Iatrogenic complications related to the use of herrick lacrimal plugs1
Iatrogenic Complications Related to the Use of Herrick Lacrimal Plugs William L. White, MD,1 George B. Bartley, MD,2 Michael J. Hawes, MD,3 John V. Linberg, MD,4 David B. Leventer, MD4 Purpose: To report a series of lacrimal complications associated with a specific type of lacrimal plug (Herrick Lacrimal Plug; Lacrimedics Incorporated, Rialto, CA.) Design: Retrospective, noncomparative case series and survey. Methods: Members of the American Society of Ophthalmic Plastic and Reconstructive Surgery were asked to submit personally treated cases of patients referred for treatment of complications after placement of a Herrick Lacrimal Plug. Main Outcome Measures: Failure of the device to be removed by simple lacrimal irrigation. Results: The clinical courses of 41 patients were analyzed. Patients ranged in age from 19 to 81 years, and all had symptomatic epiphora related to the presence of the lacrimal plug. Several interventions were used to treat lacrimal obstruction. Nasolacrimal duct probing with irrigation was used in 15 lacrimal systems, whereas six systems were probed and subsequently stented with silicone tubing. Eyelid margin cutdown was used in eight cases. Balloon dacryoplasty was performed in three systems, dacryocystorhinostomy in 18 instances, and conjunctivodacryocystorhinostomy in two patients. Conclusions: The Herrick lacrimal occlusion device sometimes cannot be removed by simple irrigation and is capable of inducing permanent, irreversible, symptomatic lacrimal drainage system obstruction. Ophthalmology 2001;108:1835–1837 © 2001 by the American Academy of Ophthalmology. Punctal or canalicular occlusion is commonly performed to treat patients with dry eyes.1–3 There are at least three commonly used methods of achieving punctal occlusion: tamponade, cautery, and surgery.2 Within each such category are several options. Reversibility is a desirable attribute, if not an absolute requirement, for all types of lacrimal occlusion in the treatment of dry eye patients. Placement of removable silicone plugs is one of the more commonly used methods of achieving punctal occlusion by tamponade. There are two general styles of plugs used to occlude the punctum or canaliculus. One variety is shaped like an arrow or umbrella and is placed into the vertical portion of the canaliculus (the ampulla). It has a collar or ring on the top of the plug with a narrow neck or midsection. The punctal
Originally received: February 20, 2001. Accepted: May 1, 2001. Manuscript no. 210118. 1 The Eye Foundation, Department of Ophthalmology, University of Missouri Kansas City, Kansas City, Missouri. 2 Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. 3 Department of Ophthalmology, University of Colorado Health Sciences Center, Denver, Colorado. 4 Department of Ophthalmology, West Virginia University, Morgantown, West Virginia. Supported in part by an unrestricted grant from Research to Prevent Blindness, Inc., New York, New York. None of the authors has any financial interest in any of the products or devices mentioned in the article. Reprint requests to William L. White, MD, 1004 Carondelet, Suite 405, Kansas City, MO, 64114. © 2001 by the American Academy of Ophthalmology Published by Elsevier Science Inc.
ring usually constricts around the neck to hold the plug in position. The collar also facilitates retrograde plug removal if necessary and decreases the risk of the plug migrating into the lacrimal drainage system. The other plug type, shaped like a fluted funnel or golf tee, is designed to be placed in the horizontal portion of the canaliculus. These plugs theoretically are removable in an antegrade fashion by lacrimal irrigation.4 Complications related to the use of punctal plugs previously have been reported to include difficulty in removal of the plugs and permanent nasolacrimal occlusions.5–7 We have observed what appears to be a disproportionate number of complications related to one specific collarless intracanalicular plug (Herrick Lacrimal Plug; Lacrimedics Incorporated, Rialto, CA).
Patients and Methods After several members of the American Society of Ophthalmic Plastic and Reconstructive Surgery requested assistance in treating patients who incurred complete symptomatic nasolacrimal duct obstruction after placement of Herrick Lacrimal Plugs, all members of the American Society of Ophthalmic Plastic and Reconstructive Surgery e-mail discussion group were queried as to whether they had treated any similar cases. When multiple members responded that they had indeed seen and treated such patients, concern arose within the group about the overall safety of using the device in question. A datasheet was developed and case reports were solicited from the group. The collective data are presented in Table 1. ISSN 0161-6420/01/$–see front matter PII S0161-6420(01)00718-7
1835
Ophthalmology Volume 108, Number 10, October 2001 Table 1. Patient and Treatment Characteristics
Patient No.
Age (yrs)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41
81 41 45 80 48 70 50 59 45 46 47 76 35 74 57 43 46 39 47 48 46 69 43 20 61 34 51 23 81 42 42 68 74 60 54 40 63 44 19 67 56 52 32 F 9M
Totals
Gender
Plug Placed by Optometrist or Ophthalmologist
F F F F F F M F F M M M F F F F F F F F F M F F F F M F F M F M F M F F F F F F F
OD OD OD MD OD MD OD OD OD MD OD MD OD MD MD OD OD OD OD OD OD OD OD OD MD MD OD — MD OD OD MD — MD — MD MD MD MD OD OD
Time to Symptoms after Plug Placement (mos) 48 30 12 1 6 1 1 21 ⬍1 1 36 2 — — 6 6 36 18 0 12 5 0 0 6 1 — — 12 1 — 1 15 3 1 20 0 1 9 8 4 6 10.1
23 OD 15 MD
Side
Intervention
R R R R/L L R/L R/L R R/L R R L L L R L R L L R L R R/L L L/R L R R L L L R R/L R R R L R L R R 19 R 15 L 7 OU
DCR w/intubation Pyogenic granuloma excised w/surgical plug removal DCR w/surgical plug removal DCR (bilateral simultaneous surgery) DCR DCR (bilateral simultaneous) NLD probing and irrigation (bilateral simultaneous surgery) DCR NLD probing and irrigation (bilateral simultaneous surgery) Lid cutdown, canalicular trephination, intubation Lid cutdown w/intubation Lid cutdown w/DCR, intubation Lid cutdown w/intubation Lid cutdown w/DCR, intubation NLD probing and irrigation DCR w/intubation NLD probing and irrigation, intubation CDCR (failed NLD probing and irrigation) NLD probing and irrigation Lid cutdown w/intubation Balloon dacryoplasty w/intubation Balloon dacryoplasty w/intubation Balloon dacryoplasty w/intubation Pyogenic granuloma excision w/plug removal Lid cutdown w/intubation in both eyes, DCR in the left eye NLD probing and irrigation Failed NLD probing and irrigation, declined further treatment Failed irrigation; occluded, declined surgery w/epiphora Failed irrigation; occluded, declined surgery w/epiphora Failed irrigation; occluded, declined surgery w/epiphora CDCR DCR w/intubation DCR w/intubation in both eyes DCR w/intubation DCR w/intubation NLD probing w/intubation NLD probing and irrigation DCR w/intubation DCR w/intubation NLD probing w/irrigation (canalicular fistula) Failed NLD probing and irrigation DCR-18, CDCR-2, balloon DCP-3 NLD probing & irrigation-15; Intubation (w/o DCR)-6 Lid cutdown-8
CDCR ⫽ conjunctivodacryocystorhinostomy with placement of silicone tube; DCP ⫽ dacryoplasty; DCR ⫽ dacryocystorhinostomy; MD ⫽ ophthalmologist; NLD ⫽ nasolacrimal duct; OD ⫽ optometrist Thirty-two women and 9 men are reported with a mean patient age at presentation of 52 years. Twenty-three patients were known to have had plugs placed by ophthalmologists, whereas 15 patients had plugs placed by optometrists, with an average time from plug placement to onset of symptoms of epiphora of 10.1 months. Nineteen patients had right-sided symptoms, 15 patients had left-sided symptoms, and 7 patients had bilateral simultaneous onset of symptoms. Eighteen dacryocystorhinostomies, two conjunctivodacryocystorhinostomies, and three endoscopic balloon dacryoplasties were performed. Fifteen lacrimal systems were probed and irrigated in the operating room, with six additional systems undergoing silicone lacrimal intubation. Eight systems required a formal lid margin cutdown to reestablish lacrimal outflow.
Results Forty-one patients had sufficient data submitted to be included for analysis. Unless the patient had onset of bilateral simultaneous obstructive symptoms, only the first eye presenting with symptoms was included. All patients had been referred for treatment of infection or epiphora, so data regarding age at onset of dry eye and treatment before placement of plugs were generally unavailable.
1836
Thirty-two of the patients (78%) were female. The average age was 52 years (range, 19 – 81 years). Time after plug placement to onset of epiphora varied considerably, ranging from immediately after plug placement to 48 months later. One patient experienced a cutaneous fistula from the horizontal canaliculus. Various surgical approaches were used by individual surgeons to treat induced lacrimal drainage obstructions. Dacryocystorhinostomy with silicone intubation was the most common procedure per-
White et al 䡠 Herrick Lacrimal Plugs formed. Five patients (12%) remain symptomatic and have declined surgery.
Discussion Previous authors have noted numerous problems associated with the use of punctal plugs. We believe that our observations are noteworthy because all of the complications occurred with one type of plug. The collarless Herrick intracanalicular plugs are easier to place in the lacrimal system than the collared varieties. We cannot estimate either the number of Herrick plugs that are implanted annually or the frequency of complications that require surgical intervention, but we believe that the Herrick plugs are associated with a higher frequency and severity of complications than those with collars. A collared punctal plug is designed to be removable by extracting it from the punctum in the reverse manner from which it was placed. Fracture of such plugs during attempted removal has been reported, as has spontaneous dislodgement of the plug distally into the lacrimal system.6 –9 Thus, no punctum plug is without some risk to the lacrimal system, potentially requiring surgical intervention. Collarless intracanalicular plugs, such as the Herrick design, typically cannot be removed in a retrograde fashion without surgically opening the punctum and canaliculus. Although collarless plugs theoretically can be flushed downstream through the nasolacrimal duct by lacrimal irrigation, the plug usually is not recovered from the nose. Thus, successful removal cannot be objectively documented. The ultimate position of a collarless plug may be anywhere in the lacrimal system, including the canaliculus, the common canaliculus, the nasolacrimal sac, or the nasolacrimal duct. Observations of pyogenic granulomas related to intracanalicular plugs indicate that, at least in some patients, the plugs are associated with an inflammatory process that can disrupt normal cellular functions, leading to fibrosis and reactive masses.10 We hypothesize that in some patients the collarless plug facilitates the overgrowth of bacteria and a chronic canaliculitis that can result in canalicular obstruc-
tion. Alternatively, the plug may erode through the canalicular mucosa, resulting in synechia, symptomatic lacrimal stenosis, or even formation of a cutaneous fistula. In each of the cases described herein, the surgeon correcting the lacrimal problem was not the individual who placed the device. When a seemingly routine office procedure results in a complication that requires surgical correction, patients understandably are unhappy. Some of the patients whom we and our colleagues have treated believed that the device and its implantation were misrepresented with respect to safety, reversibility, and the potential need for reparative surgery.
References 1. Giovagnoli D, Graham SJ. Inferior punctal occlusion with removable silicone punctal plugs in the treatment of dry-eye related contact lens discomfort. J Am Optometric Assoc 1992; 63:481–5. 2. Murube J, Murube E. Treatment of dry eye by blocking the lacrimal canaliculi. Surv Ophthalmol 1996;40:463– 80. 3. Beisel JG. Treatment of dry eye with punctal plugs. Optom Clin 1991;1:103–17. 4. Herrick RS. A subjective approach to the treatment of dry eye syndrome. In: Sullivan DA, ed. Lacrimal Gland, Tear Film, and Dry Eye Syndromes. New York: Plenum Press, 1994; 571– 6. 5. Soparkar CNS, Patrinely JR, Hunts J, et al. The perils of permanent punctal plugs. Am J Ophthalmol 1997;123:120 –1. 6. Rumelt S, Remulla H, Rubin PAD. Silicone punctal plug migration resulting in dacryocystitis and canaliculitis. Cornea 1997;16:377–9. 7. Maguire LJ, Bartley GB. Complications associated with the new smaller size Freeman punctal plug [letter]. Arch Ophthalmol 1989;107:961–2. 8. White WL, Glover AT. Difficulty in removal of silicone punctum plugs [letter]. Ophthalmic Surg 1989;20:523. 9. Levenson JE, Hofbaver J. Problems with punctal plugs [letter]. Arch Ophthalmol 1989;107:493– 4. 10. Rapoza PA, Ruddart MS. Pyogenic granuloma as a complication of silicone punctal plugs [letter]. Am J Ophthalmol 1992;113:454 –5.
1837
Originally received: February 20, 2001. Accepted: May 1, 2001. Manuscript no. 210118. 1 The Eye Foundation, Department of Ophthalmology, University of Missouri Kansas City, Kansas City, Missouri. 2 Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. 3 Department of Ophthalmology, University of Colorado Health Sciences Center, Denver, Colorado. 4 Department of Ophthalmology, West Virginia University, Morgantown, West Virginia. Supported in part by an unrestricted grant from Research to Prevent Blindness, Inc., New York, New York. None of the authors has any financial interest in any of the products or devices mentioned in the article. Reprint requests to William L. White, MD, 1004 Carondelet, Suite 405, Kansas City, MO, 64114. © 2001 by the American Academy of Ophthalmology Published by Elsevier Science Inc.
ring usually constricts around the neck to hold the plug in position. The collar also facilitates retrograde plug removal if necessary and decreases the risk of the plug migrating into the lacrimal drainage system. The other plug type, shaped like a fluted funnel or golf tee, is designed to be placed in the horizontal portion of the canaliculus. These plugs theoretically are removable in an antegrade fashion by lacrimal irrigation.4 Complications related to the use of punctal plugs previously have been reported to include difficulty in removal of the plugs and permanent nasolacrimal occlusions.5–7 We have observed what appears to be a disproportionate number of complications related to one specific collarless intracanalicular plug (Herrick Lacrimal Plug; Lacrimedics Incorporated, Rialto, CA).
Patients and Methods After several members of the American Society of Ophthalmic Plastic and Reconstructive Surgery requested assistance in treating patients who incurred complete symptomatic nasolacrimal duct obstruction after placement of Herrick Lacrimal Plugs, all members of the American Society of Ophthalmic Plastic and Reconstructive Surgery e-mail discussion group were queried as to whether they had treated any similar cases. When multiple members responded that they had indeed seen and treated such patients, concern arose within the group about the overall safety of using the device in question. A datasheet was developed and case reports were solicited from the group. The collective data are presented in Table 1. ISSN 0161-6420/01/$–see front matter PII S0161-6420(01)00718-7
1835
Ophthalmology Volume 108, Number 10, October 2001 Table 1. Patient and Treatment Characteristics
Patient No.
Age (yrs)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41
81 41 45 80 48 70 50 59 45 46 47 76 35 74 57 43 46 39 47 48 46 69 43 20 61 34 51 23 81 42 42 68 74 60 54 40 63 44 19 67 56 52 32 F 9M
Totals
Gender
Plug Placed by Optometrist or Ophthalmologist
F F F F F F M F F M M M F F F F F F F F F M F F F F M F F M F M F M F F F F F F F
OD OD OD MD OD MD OD OD OD MD OD MD OD MD MD OD OD OD OD OD OD OD OD OD MD MD OD — MD OD OD MD — MD — MD MD MD MD OD OD
Time to Symptoms after Plug Placement (mos) 48 30 12 1 6 1 1 21 ⬍1 1 36 2 — — 6 6 36 18 0 12 5 0 0 6 1 — — 12 1 — 1 15 3 1 20 0 1 9 8 4 6 10.1
23 OD 15 MD
Side
Intervention
R R R R/L L R/L R/L R R/L R R L L L R L R L L R L R R/L L L/R L R R L L L R R/L R R R L R L R R 19 R 15 L 7 OU
DCR w/intubation Pyogenic granuloma excised w/surgical plug removal DCR w/surgical plug removal DCR (bilateral simultaneous surgery) DCR DCR (bilateral simultaneous) NLD probing and irrigation (bilateral simultaneous surgery) DCR NLD probing and irrigation (bilateral simultaneous surgery) Lid cutdown, canalicular trephination, intubation Lid cutdown w/intubation Lid cutdown w/DCR, intubation Lid cutdown w/intubation Lid cutdown w/DCR, intubation NLD probing and irrigation DCR w/intubation NLD probing and irrigation, intubation CDCR (failed NLD probing and irrigation) NLD probing and irrigation Lid cutdown w/intubation Balloon dacryoplasty w/intubation Balloon dacryoplasty w/intubation Balloon dacryoplasty w/intubation Pyogenic granuloma excision w/plug removal Lid cutdown w/intubation in both eyes, DCR in the left eye NLD probing and irrigation Failed NLD probing and irrigation, declined further treatment Failed irrigation; occluded, declined surgery w/epiphora Failed irrigation; occluded, declined surgery w/epiphora Failed irrigation; occluded, declined surgery w/epiphora CDCR DCR w/intubation DCR w/intubation in both eyes DCR w/intubation DCR w/intubation NLD probing w/intubation NLD probing and irrigation DCR w/intubation DCR w/intubation NLD probing w/irrigation (canalicular fistula) Failed NLD probing and irrigation DCR-18, CDCR-2, balloon DCP-3 NLD probing & irrigation-15; Intubation (w/o DCR)-6 Lid cutdown-8
CDCR ⫽ conjunctivodacryocystorhinostomy with placement of silicone tube; DCP ⫽ dacryoplasty; DCR ⫽ dacryocystorhinostomy; MD ⫽ ophthalmologist; NLD ⫽ nasolacrimal duct; OD ⫽ optometrist Thirty-two women and 9 men are reported with a mean patient age at presentation of 52 years. Twenty-three patients were known to have had plugs placed by ophthalmologists, whereas 15 patients had plugs placed by optometrists, with an average time from plug placement to onset of symptoms of epiphora of 10.1 months. Nineteen patients had right-sided symptoms, 15 patients had left-sided symptoms, and 7 patients had bilateral simultaneous onset of symptoms. Eighteen dacryocystorhinostomies, two conjunctivodacryocystorhinostomies, and three endoscopic balloon dacryoplasties were performed. Fifteen lacrimal systems were probed and irrigated in the operating room, with six additional systems undergoing silicone lacrimal intubation. Eight systems required a formal lid margin cutdown to reestablish lacrimal outflow.
Results Forty-one patients had sufficient data submitted to be included for analysis. Unless the patient had onset of bilateral simultaneous obstructive symptoms, only the first eye presenting with symptoms was included. All patients had been referred for treatment of infection or epiphora, so data regarding age at onset of dry eye and treatment before placement of plugs were generally unavailable.
1836
Thirty-two of the patients (78%) were female. The average age was 52 years (range, 19 – 81 years). Time after plug placement to onset of epiphora varied considerably, ranging from immediately after plug placement to 48 months later. One patient experienced a cutaneous fistula from the horizontal canaliculus. Various surgical approaches were used by individual surgeons to treat induced lacrimal drainage obstructions. Dacryocystorhinostomy with silicone intubation was the most common procedure per-
White et al 䡠 Herrick Lacrimal Plugs formed. Five patients (12%) remain symptomatic and have declined surgery.
Discussion Previous authors have noted numerous problems associated with the use of punctal plugs. We believe that our observations are noteworthy because all of the complications occurred with one type of plug. The collarless Herrick intracanalicular plugs are easier to place in the lacrimal system than the collared varieties. We cannot estimate either the number of Herrick plugs that are implanted annually or the frequency of complications that require surgical intervention, but we believe that the Herrick plugs are associated with a higher frequency and severity of complications than those with collars. A collared punctal plug is designed to be removable by extracting it from the punctum in the reverse manner from which it was placed. Fracture of such plugs during attempted removal has been reported, as has spontaneous dislodgement of the plug distally into the lacrimal system.6 –9 Thus, no punctum plug is without some risk to the lacrimal system, potentially requiring surgical intervention. Collarless intracanalicular plugs, such as the Herrick design, typically cannot be removed in a retrograde fashion without surgically opening the punctum and canaliculus. Although collarless plugs theoretically can be flushed downstream through the nasolacrimal duct by lacrimal irrigation, the plug usually is not recovered from the nose. Thus, successful removal cannot be objectively documented. The ultimate position of a collarless plug may be anywhere in the lacrimal system, including the canaliculus, the common canaliculus, the nasolacrimal sac, or the nasolacrimal duct. Observations of pyogenic granulomas related to intracanalicular plugs indicate that, at least in some patients, the plugs are associated with an inflammatory process that can disrupt normal cellular functions, leading to fibrosis and reactive masses.10 We hypothesize that in some patients the collarless plug facilitates the overgrowth of bacteria and a chronic canaliculitis that can result in canalicular obstruc-
tion. Alternatively, the plug may erode through the canalicular mucosa, resulting in synechia, symptomatic lacrimal stenosis, or even formation of a cutaneous fistula. In each of the cases described herein, the surgeon correcting the lacrimal problem was not the individual who placed the device. When a seemingly routine office procedure results in a complication that requires surgical correction, patients understandably are unhappy. Some of the patients whom we and our colleagues have treated believed that the device and its implantation were misrepresented with respect to safety, reversibility, and the potential need for reparative surgery.
References 1. Giovagnoli D, Graham SJ. Inferior punctal occlusion with removable silicone punctal plugs in the treatment of dry-eye related contact lens discomfort. J Am Optometric Assoc 1992; 63:481–5. 2. Murube J, Murube E. Treatment of dry eye by blocking the lacrimal canaliculi. Surv Ophthalmol 1996;40:463– 80. 3. Beisel JG. Treatment of dry eye with punctal plugs. Optom Clin 1991;1:103–17. 4. Herrick RS. A subjective approach to the treatment of dry eye syndrome. In: Sullivan DA, ed. Lacrimal Gland, Tear Film, and Dry Eye Syndromes. New York: Plenum Press, 1994; 571– 6. 5. Soparkar CNS, Patrinely JR, Hunts J, et al. The perils of permanent punctal plugs. Am J Ophthalmol 1997;123:120 –1. 6. Rumelt S, Remulla H, Rubin PAD. Silicone punctal plug migration resulting in dacryocystitis and canaliculitis. Cornea 1997;16:377–9. 7. Maguire LJ, Bartley GB. Complications associated with the new smaller size Freeman punctal plug [letter]. Arch Ophthalmol 1989;107:961–2. 8. White WL, Glover AT. Difficulty in removal of silicone punctum plugs [letter]. Ophthalmic Surg 1989;20:523. 9. Levenson JE, Hofbaver J. Problems with punctal plugs [letter]. Arch Ophthalmol 1989;107:493– 4. 10. Rapoza PA, Ruddart MS. Pyogenic granuloma as a complication of silicone punctal plugs [letter]. Am J Ophthalmol 1992;113:454 –5.
1837