Exposed hydroxyapatite orbital implants. Report of six cases.

Six patients with complications of primary or secondary hydroxyapatite implants were studied. Complications included socket infection and/or conjunctival dehiscence. Complications were detected during regular follow-up examinations, and various treatment approaches were used. The hydroxyapatite implant exposure occurred 4 to 6 weeks (mean, 4.5 weeks) after implantation. Three of the six implants were wrapped in preserved donor sclera before implantation. One of the implants showed wide exposure and chronic infection and was removed. In two cases, scleral patch grafts with a conjunctival pedicle graft were performed, resulting in successful coverage of the implant without further conjunctival dehiscence. In one of the patients, a Tenon's conjunctival flap was advanced to cover the defect, and was unsuccessful with the spicules of the hydroxyapatite eroding through the vascular flap after 1 month. Three of the patients demonstrate a persistent conjunctival epithelial defect. These three patients with chronically exposed hydroxyapatite have remained stable with follow-up intervals ranging from 8 to 12 months. Early exposure of hydroxyapatite orbital implants is a potential problem despite meticulous technique. Implant coverage is difficult, although chronic exposure seems to be tolerated often in the hydroxyapatite orbital implant without migration or extrusion.     

Problems with the hydroxyapatite orbital implant: experience with 250 consecutive cases.

The coral derived hydroxyapatite sphere is a popular, integrated orbital implant designed to provide improved motility of the ocular prosthesis following enucleation. Although the implant has rapidly become widely used by ophthalmologists, little information is available regarding the problems of this technique in a large series of cases. Experience with 250 consecutive cases of hydroxyapatite orbital implant use was reviewed and the problems of the implants and their management investigated specifically. The reasons for enucleation included uveal melanoma (157 cases), retinoblastoma (70 cases), blind painful eye (22 cases), and intraocular medulloepithelioma (one case). Earlier treatment to the eye was performed before enucleation in 47 cases and included repair of ruptured globe (17 cases), plaque radiotherapy (18 cases), external beam radiotherapy (six cases), and others (six cases). During a mean of 23 months' follow up (range 6-40 months), there have been no recognisable cases of orbital haemorrhage related to the implant, and no cases of implant extrusion or implant migration. There was one case of presumed orbital infection (culture negative) that resolved with intravenous antibiotics and the implant was retained within the orbit. Other problems included conjunctival thinning in eight cases managed by observation and prosthesis adjustment, and conjunctival erosion in four cases managed by combinations of scleral patch graft, conjunctival flap, and prosthesis adjustment. The conjunctival erosion was caused by a poorly fitting prosthesis in three cases and wound dehiscence in one case. The problem rate in eyes receiving prior radiotherapy or surgery was not increased. The hydroxyapatite integrated orbital implant is a well tolerated motility implant without the high rate of extrusion and infection seen with other motility implants. The prosthesis fit may contribute to the tolerance of the implant.     

羟基磷灰石义眼座眶内植入139例分析

目的探讨带预置缝线的羟基磷灰石(hydroxyapatite，HA)义眼座直接植入眶内的手术效果。方法自1997年9月～2002年6月进行带预置缝线的HA义眼座直接植入眶内手术139例(139眼)，其中Ⅰ期眶内义眼座植入117眼，Ⅱ期眶内义眼座植入22眼。随访6～24月，平均11．8月。结果139眼术后出现轻微眼睑及球结膜水肿，4眼结膜切口裂开，经保守治疗自愈。2眼HA义眼座暴露，经修复后愈合。随访观察139眼义眼活动良好，眼窝饱满；Ⅰ期较Ⅱ期植入的义眼活动度大，外观更逼真。未发生义眼座脱出及感染等并发症。结论眼球摘除术后植入HA义眼座，提高了眼球运动效果和面部美观程度，效果较好。     

Complications of hydroxyapatite orbital implants in children: a series of 105 cases

PURPOSE: To describe the complications encountered using hydroxyapatite as an orbital implant in the pediatric population after enucleation, and try to define the risk factors for their occurrence. MATERIAL: and methods: Retrospective review of charts of children who underwent enucleation with placement of an hydroxyapatite implant between January 1991 and 1998. Complications and their type (conjunctival, extrusion, eyelids complications) have been specifically looked for. A statistical analysis trying to isolate the risks factors was performed. RESULTS: 105 implants have been used during this period with 26.7% of complications appearing during a median followup of 22 months. Extrusion of the implant was observed in 1.9% of the cases, a chronic conjunctival erosion in 15%, a conjunctival lesion without erosion in 4.75% and no eyelid lesion could be seen. Treatment (medical or surgical) achieved 75% good results. No risk factor could be found. CONCLUSION: Hydroxyapatite orbital implants were initially thought to have no or few complications. More recently, chronic erosions in particular were described. Little data exists on the pediatric population. Our series confirms that complications occur and that they are comparable to the adult population. Nevertheless the hydroxyapatite orbital implant seems better tolerated than other porous or non porous implants and warrants its use.     

Pyogenic granuloma as a presenting sign of hydroxyapatite orbital implant exposure: a clinicopathologic study

PURPOSE: We report 5 unusual cases of exposed hydroxyapatite orbital implants that presented as pyogenic granulomas. We propose pathogenesis and histopathologic correlations. METHODS: A clinicopathologic study of 5 patients with hydroxyapatite implants who presented with pyogenic granuloma. RESULTS: Pyogenic granulomas were detected 1.5 to 30 months after implantation in 5 patients. The lesions were multiple but were not related to the wound margin at the exposed area and were not covered by the surface epithelium in most instances. Exposure defects were detected in all patients at the time of lesion excision. The mean exposure size in the greatest dimension was 16 mm (range, 9-20 mm). Three patients were treated successfully with simple excision of the granulomas, burring down of the anterior surface of the implants, and direct repair of the exposure defects. Explantation of the implant was performed in 2 cases. Histopathologic examination revealed chronic inflammation and microabscess formation in the explanted implants. CONCLUSIONS: Five patients with pyogenic granulomas were found to have hydroxyapatite exposure. Pyogenic granuloma should not be considered a benign lesion on a hydroxyapatite orbital implant, especially in recurrent cases. Ophthalmologists must be aware of the possibility of conjunctival dehiscence with hydroxyapatite-implant exposure beneath the lesion.     

Clinicopathologic analysis of 15 explanted hydroxyapatite implants

PURPOSE: To report the clinical findings, treatment, outcomes, and histopathologic findings in patients with suspected orbital implant infection requiring implant removal. METHODS: Retrospective, observational case series of 14 patients (15 hydroxyapatite orbital implants) undergoing implant removal from September 1994 through December 2002. Patient age, type of surgery, implant type, symptoms, treatment, histopathology of implant, and follow-up course were analyzed. RESULTS: Of the 14 patients, 7 were female and 7 were male. The mean age at explantation was 42 years. The most common symptoms were discharge and socket tenderness. The most common signs were conjunctival inflammation (edema, hyperemia), discharge, and recurrent pyogenic granuloma. Clinical evidence of infection was documented in 13 patients. Histopathologic assessment of the 15 explanted implants showed acute inflammation and necrosis (abscess) with identification of microorganisms (5 patients), acute inflammation and necrosis without identification of microorganisms (4 patients), chronic inflammation with identification of microorganisms (1 patient), chronic inflammation without identification of microorganisms (3 patients), and a predominant foreign body granulomatous response without identification of microorganisms (2 patients). Osseous metaplasia was seen in 10 implants. Prompt resolution of symptoms and signs occurred in all but one case. CONCLUSIONS: The clinical course of porous orbital implant infection may be prolonged, and the early symptom of recurrent discharge, a common problem for implant recipients, may delay diagnosis. Implant infection should be suspected when there is persistent conjunctival inflammation and discharge after implant placement despite antibiotic therapy, discomfort on implant palpation, and recurrent pyogenic granuloma (indicative of implant exposure). Implant removal is usually required in these cases. If orbital pain (not necessarily related to implant palpation) is the main complaint, without signs of conjunctival inflammation and with or without discharge, one should consider other reasons for the symptoms.     

Six cases of bacterial infection in porous orbital implants

BACKGROUND: We present 6 cases of bacterial infection that developed after porous orbital implant surgery. CASES: Five patients with hydroxyapatite implants showed lid swelling, discharge, and suppurative granuloma 14 days to 3 years after surgery. The hydroxyapatite implants were removed 14 days to 41 months postoperatively, and synthetic porous polyethylene orbital implants were inserted. Thick discharge and conjunctival melting was noted 14 months after primary Medpor implant surgery in the sixth patient, and the infection was controlled by medical therapy. OBSERVATIONS: The culture of specimens removed with swabs from the conjunctiva of patients and from the hydroxyapatite implants showed growth of Staphylococcus aureus, Staphylococcus epidermidis, alpha-hemolytic streptococcus and peptostreptococcus in 4 patients, whereas Streptococcus pyogenes were cultured from the conjunctiva in the Medpor implant patient. Culture for the remaining patient was negative .CONCLUSIONS: If there is continuous pain, injection, and discharge after porous implant insertion, bacterial infection in the implant should be considered immediately. Systemic antibiotics and topical eye drops should be administered without delay. If no improvement is observed, the implant should be removed and a different approach must be considered.     

Polytetrafluoroethylene as a wrapping material for a hydroxyapatite orbital implant

PURPOSE: Porous coralline hydroxyapatite orbital implants have been used with great success in anophthalmic sockets. We used a substitute for donor sclera as a wrapping tissue. METHODS: Orbital implants were wrapped with polytetrafluoroethylene (PTFE) instead of homologous donor tissue in five patients after enucleation. RESULTS: The postoperative course was uneventful in three cases. Complications occurred in two cases: one with implant exposure, and one with severe implant infection leading to its eventual removal. CONCLUSIONS: PTFE is inferior to other wrapping tissue.     

新鲜羊膜联合唇黏膜移植治疗义眼座暴露的疗效观察

目的：探讨新鲜羊膜联合唇黏膜移植治疗义眼座暴露的手术方法及临床效果。

方法：对24例义眼座植入术后义眼座暴露的患者行新鲜羊膜联合唇黏膜移植,观察术后义眼座有无外露、感染。

结果：移植唇黏膜全部成活,眼座无外露,结膜囊无缩窄,患者基本满意。

结论：新鲜羊膜联合唇黏膜移植是治疗义眼座暴露的理想方法。     

带预置缝线的羟基磷灰石义眼座眶内植入术疗效观察

目的探讨带预置缝线的羟基磷灰石义眼座(hydroxyapatite,HA)直接植入眶内的手术效果。方法22例(22只眼)行带预置缝线的羟基磷灰石义眼座直接植入眶内手术,术后随访3~17月。结果22只眼术后均有眼睑轻度肿胀,球结膜水肿,眼眶区胀痛,2只眼球结膜切口裂开,经保守治疗后愈合。未发生义眼座暴露、脱出及感染等并发症。结论带预置缝线的羟基磷灰石义眼座眶内植入术方便易行、疗效可靠。     

眶内植入带线羟基磷灰石义眼座的临床分析

目的 探讨眶内植入带线羟基磷灰石（HA）义眼座的临床效果。方法 对85例（85眼）眼球摘除者眶内植入带线HA义眼座。结果 术后随访12-36个月,平均18个月。义眼座活动度良好。82例结膜创口Ⅰ期愈合,2例结膜变薄,1例结膜创口裂开,义眼座暴露。无眶内血肿或感染等并发症。结论 眶内植入带线HA义眼座手术操作简单,术后并发症少,美容效果佳,临床效果好。     

Primary banked scleral patch graft in the prevention of exposure of hydroxyapatite orbital implants

PURPOSE: The most frequently reported complication of hydroxyapatite orbital implantation is exposure of the implant, which may result in infection or extrusion of the implant. This study describes the use of banked sclera patch grafts to prevent implant exposure. DESIGN: A retrospective noncomparative interventional case series. PARTICIPANTS: The procedure was performed on 110 patients over a 2-year period. Hydroxyapatite implantation was performed either at the time of enucleation or as a secondary procedure to correct postenucleation socket syndrome. INTERVENTION: A banked scleral patch graft from the second eye of the same donor was placed over a scleral-wrapped hydroxyapatite implant at the time of operation. The case records were reviewed retrospectively. OUTCOME MEASURES: The primary outcome measure was the number of patients who developed exposure of their hydroxyapatite implant. The number of patients who had a postoperative conjunctival wound dehiscence was also recorded. RESULTS: No patients developed exposure of the implant. A significant percentage of patients developed conjunctival wound dehiscence (33%). Further surgery was not required in any of these cases, because the dehiscence spontaneously reconjunctivalized over the surface of the scleral patch graft. CONCLUSIONS: Insertion of a banked scleral patch graft at the time of hydroxyapatite orbital implantation is an effective means of preventing implant exposure, even in more complex cases. It thereby reduces the morbidity resulting from the procedure and obviates the need for further surgery when there is breakdown of the conjunctival wound postoperatively.     

Culture-proven Aspergillus fumigatus infection in a primary hydroxyapatite orbital implant

Hydroxyapatite orbital implants are widely used in enucleation surgery. Infection in this setting is an uncommon but severe complication. Herein a patient with a 3-year history of chronic socket discharge, orbital discomfort, conjunctival breakdown and implant exposure after enucleation and implantation of a hydroxyapatite sphere 7 years previously is reported. Repeated attempts at covering the exposed implant failed. Eventually the implant was removed, and Aspergillus fumigatus was cultured from the explanted material. This is the second reported case of Aspergillus infection of a hydroxyapatite orbital implant, and the first case where fungal cultures were positive.     

Bovine pericardium versus homologous sclera as a wrapping for hydroxyapatite orbital implants

PURPOSE: To report our experience with bovine pericardium as a wrapping material for hydroxyapatite orbital implants after enucleation and to compare the exposure rates of the implants wrapped with bovine pericardium versus donor sclera. METHODS: We retrospectively reviewed the records of all patients who received bovine pericardium-wrapped or donor sclera-wrapped hydroxyapatite implant after primary enucleation between March 1995 and December 2001. RESULTS: Of the 26 patients who received donor sclera-wrapped implants after enucleation, 1 (3.8%) had implant exposure. Of the 26 patients who received bovine pericardium-wrapped implants after enucleation, 6 (23%) had implant exposure. The incidence of implant exposure with the use bovine pericardium wrapping material was found to be significantly higher than with sclera (P = 0.05). Six of the 7 implant exposures were noted in the first 6 months after placement of the orbital implant. Five of the 6 exposed bovine pericardium-wrapped hydroxyapatite implants were associated with socket infection. The case of exposure of the sclera-wrapped implant was treated conservatively by observation. Six patients who had exposure of bovine pericardium-wrapped implants required multiple repairs because of recurrent exposures. Four of these patients eventually required removal of the implant. CONCLUSIONS: Despite the advantages of using bovine pericardium as a wrapping material for hydroxyapatite orbital implants, we observed a significantly higher incidence of exposure with bovine pericardium compared with donor sclera in the early postoperative period. Use of bovine pericardium as a wrapping material for orbital implants should be avoided unless some future modifications of the technique can be developed to prevent such complications.     

The use of vicryl mesh in 200 porous orbital implants: a technique with few exposures

PURPOSE: To report the results of a wrapping technique for porous orbital implants by using polyglactin 910 (Vicryl) mesh (Ethicon Inc., Somerville, NJ, U.S.A.). METHODS: We retrospectively reviewed the records of 200 consecutive patients from one author's practice who received a polyglactin 910 mesh-wrapped porous orbital implant after enucleation or as a secondary implant between October 1, 1996, and April 15, 2001. We recorded potential problems that might be attributed to polyglactin 910 mesh both before pegging (excessive inflammatory response to the material, conjunctival thinning, and implant exposure) and after pegging (exposure of the implant around the sleeve, conjunctival thinning, and implant exposure other than adjacent to the peg). RESULTS: One hundred twenty-two men and 78 women underwent placement of a polyglactin 910 mesh-wrapped porous orbital implant. The average age at the time of implantation was 48.9 years (range, 11 to 85 years). The average follow-up interval in the 200 patients was 19.4 months (range, 2 to 80 months). Thirteen of the 200 patients had less than 6 months of follow-up, leaving 187 patients with an average follow-up of 20.5 months (range, 6 to 80 months). There were 76 primary enucleations and 124 secondary orbital implants. Thirty-seven patients received a Bio-Eye hydroxyapatite implant (HA) (Integrated Orbital Implants, San Diego, Calif), 97 received a synthetic FCI hydroxyapatite implant (FCI, Issy-Les-Moulineaux, France), and 66 received a Bioceramic implant (aluminum oxide-Al2O3) (FCI, Issy-Les-Moulineaux, France). One hundred fourteen patients (57%) underwent peg placement. The average time to pegging was 9.9 months (range, 6 to 16 months). Before pegging, 4 of 187 patients (2.1%) had implant exposure. Three of these exposures followed secondary orbital implant placement (2 Bio-Eye HA, 1 synthetic FCI3 HA) and one followed an enucleation (synthetic FCI3 HA). Two patients required a temporalis fascia graft and one required a scleral patch; the remaining defect closed spontaneously. One patient had conjunctival thinning 6 months after orbital implantation, which remained stable with no frank exposure for 36 months. No patient had excess socket inflammation. After peg placement, 3 additional patients had exposure of the implant around the peg site. There were no cases of conjunctival thinning or exposure of the implant other than adjacent to the peg site. CONCLUSIONS: Polyglactin 910 mesh is an excellent option as a wrapping material for porous orbital implants. It is simple to use, readily available, eliminates the need for donor tissue, does not require a second operative site, and it is less expensive than other currently available wrapping materials. We attribute our high success rate to our technique, which emphasizes proper placement of the implant within the Tenon space, suturing the extraocular muscles anterior to their normal anatomic sites, and meticulous closure of the Tenon capsule and conjunctiva in separate layers.     

羟基磷灰石义眼台Ⅱ期植入矫正重度眼窝内陷

目的探讨羟基磷灰石义眼台Ⅱ期植入术矫正眼窝重度内陷效果。方法对26例（26眼）眼球摘除或眼内容摘除术后半年至38年采用羟基磷灰石义眼台Ⅱ期眶内植入。结果眼窝重度内陷矫正术后外观良好。义眼活动度好,双眼相似,真假难辨。术后随访3～5年无排斥反应发生,未发现义眼台移位、脱出或眶内感染者。结论Ⅱ期眶内植入义眼台矫正眼窝重度内陷要根据眶内容积大小和结膜囊腔大小选择术式和合适的义眼台,并需要用异体巩膜固定在4条直肌附着处覆盖于义眼台表面,可以增加义眼活动度,并可防止义眼台排出。     

Coralline hydroxyapatite orbital implant (bio-eye): experience with 158 patients

PURPOSE: To assess the problems seen in 158 patients with coralline hydroxyapatite (HA) orbital implants (Bio-Eye). METHODS: A consecutive case series of 170 patients receiving coralline HA implanted by two surgeons over a 5-year period were reviewed. The authors analyzed age, type of surgery, implant size, peg system, follow-up duration, time of pegging, problems encountered, and treatment. RESULTS: Twelve patients were lost to follow-up after 5 months, leaving 158 patients who were followed from 6 to 130 months (average, 39 months). Problems in unpegged implants occurred in 36 (22.8%) patients. Discharge occurred in 18 (11.4%) patients, implant exposure in 12 (7.6%), socket discomfort in 1 (0.6%), conjunctival thinning in 3 (1.9%), chronic conjunctival swelling in 2 (1.3%), and implant infection in 3 (1.9%). Problems after pegging occurred in 68 (50.7%) of 134 patients: discharge in 27 (20.1%), pyogenic granuloma in 24 (17.9%), conjunctiva overgrowing the peg in 4 (3.0%), implant exposure around the sleeve in 5 (3.7%), clicking in 6 (4.5%), peg on an angle in 2 (1.5%), loose sleeve in 1 (0.7%), peg falling out in 18 (13.4%), popping peg in 1 (0.7%), poor transfer of movement in 3 (2.2%), pain with movement in 1 (0.7%), and implant infection in 2 (1.5%). CONCLUSIONS: The Bio-Eye orbital implant represents a porous orbital implant that is biocompatible with orbital tissues and allows fibrovascular ingrowth and improved motility when coupled to the overlying artificial eye. It is more expensive than other commercially available porous orbital implants, such as synthetic FCI3 HA, porous polyethylene (Medpor), and aluminum oxide (Bioceramic) implant. Problems encountered with its use are similar to those problems seen in patients with the synthetic FCI3 hydroxyapatite and aluminum oxide orbital implants.     

Hydroxyapatite orbital implant exposure in children.

PURPOSE: Hydroxyapatite orbital implants are buried implants that may be integrated into the overlying prosthesis after enucleation. We report problems encountered using these implants during a 14-year period in a pediatric population. METHODS: Retrospective analysis of a pediatric population from 1987 through 2001. RESULTS: Indications for enucleation (N = 19) included retinoblastoma (n =17), persistent hyperplastic primary vitreous (n =1), and painful blind eye (n =1). Conjunctival erosion (36.84%) and consequent implant exposure (15.70%) were the main problems identified in this study. There were no cases of orbital infection. Management included resuturing and scleral patching. CONCLUSION: Conjunctival erosion of hydroxyapatite implants contributed to significant morbidity in 19 children who underwent enucleation and hydroxyapatite orbital implant.     

Primary placement of a titanium sleeve in hydroxyapatite orbital implants

BACKGROUND: To study a new surgical option of primary placement of a titanium sleeve into hydroxyapatite implants during enucleation or evisceration. METHODS: A standard enucleation or cornea preserved evisceration was performed, followed by preplacement of a titanium sleeve into the hydroxyapatite implant by a hand drill sleeve driver. Care must be taken to ensure that the titanium sleeve is positioned centrally when the implant is put inside the orbital socket or eviscerated shell. The Tenon capsule and conjunctiva were meticulously closed with minimal tension. Complications such as sleeve exposure, coralline exposure, and infection of the titanium sleeve were closely observed. RESULTS: In all, 30 patients were treated in the above fashion with 10 enucleation and 20 evisceration procedures. The follow-up period ranged from 9 to 24 months. Three of the sleeves were found to have exposed spontaneously at 5 and 7 weeks following original surgery. They had no further complication except one sleeve loosening. The remaining 27 sleeves that did not spontaneously expose pursued secondary exposure of the titanium sleeve and peg insertion by conjunctival cutdown procedure 3 months after original surgery. Two sleeves were found to be oblique positioned after the conjunctival cutdown procedure. Fortunately, all the 30 patients were successfully fit with a peg-coupled prosthesis with good motility. CONCLUSION: Primary placement of a titanium sleeve into hydroxyapatite implants has several advantages, including high patient acceptance, technical simplicity, and office-based conjunctival cutdown pegging procedure. By avoiding the expense of postoperative imaging study and additional prosthetic modification, a more rapid and efficient rehabilitation is possible.     

Tolerance of orbital implants. Retrospective study on 14 years

The authors report the results of enucleations performed from 1985 to 1998 and the different orbital implants used. MATERIAL AND METHODS: All patients undergoing enucleation from 1985 to 1998 were studied. RESULTS: 68 men and 32 women had an enucleation. The main indication was tumoral diseases, principally choroidal melanomas and ciliary melanomas (respectively, 26 and 8). More rarely the indication was orbital metastasis or eyelid carcinoma. The follow indications were traumatisms and neovascular glaucomas. The orbital implants used were mainly Allen implants, silicone implants and hydroxyapatite implants. The main complication was the expulsion of the implant, which occurred in about 20% of the cases, for the most part in the group of silicone and tunnel implants patient. These expulsions were found less with hydroyxapatite implants. For the hydroxyapatite implants we also noticed the some conjunctival erosion. The expulsion of the implant occurred most often before 2 years. CONCLUSION: The authors report on the survey of orbital implants used for 14 years. They noticed the high frequency of expulsions when they used tunnel or silicone implants and better results with hydroxyapatite implant.