| ◄▬ | Miragel artikelen - 1999 Roldán-Pallarés | ▬► |
Roldán-Pallarés, Long term complications of silicone and hydrogel explants in retinal reattachment surgery, Arch Ophthalmoll999;117:197-201
Roldán-Pallarés ea vergelijken in hun artikel de lange-termijn complicaties van silicone en hydrogel explants bij 757 patiënten tussen maart 1984 en december 1997.
The aim of our study was to compare long-term complications of the 3 materials (silicone sponge [Dow Corning, Midland, Mich], silicone rubber [Dow Corning], and MAI or MIRAgel hydrogel) used more commonly as episcleral buckling elements.
Results: A total of 757 patients were included in the study. Removal of the implant was necessary in 10 patients (1.3%).
Silicone sponge (3 [9%] of 32 patients) was more frequently removed than was silicone rubber (2 [0.6%] of 360 patients) or MIRAgel (5 [1.3%] of 386 patienls). Silicone sponge needed to be removed a short time after surgery, showing symptoms of acute infeclion and positive cultures. Silicone rubber was removed 1 year afler surgery with symptoms of chronic infection and positive cultures, and MIRAgel implants were removed after long-term follow-up (7-10 years), showing positive cultures in only 20%.Conclusions: Periodic long-term folluw-up previously recommended for use of other materials also must be recommended for MIRAgel use because of long-term alterations in its chemical composition and eventual swelling of material.
De auteurs signaleren dat inmiddels bij de hydrogel implants, de intrascleraal toegepaste MAI en de episcleraal toegepaste Miragel lange termijn complicaties waren gerapporteerd (p.197 lk).
Hydrogel implants (originally MAI and then commercialized as MIRAgel [MIRA, Waltham, Mass]) seemed to be the ideal implant material 7,8 when observed 6 to 53 months after surgery.9 Recently, longterm (7-11 years after surgery) complications have been reported in 8.5% of patients after an intrasclcral buckling procedure 10 and in 1 patient after episcleral buckle,11 related to the swelling properties of the hydrophilic implant.
De auteurs besteden bijzondere aandacht aan deze hydrogel implants (p.200 rk):
Problems ranging from subconjunctival bulge to intraocular erosion and migration of the implant have heen reported in 7 patients after intrascleral buckling with MAl hydrogel,10 the laboratory precursor of the commercial MIRAgel. Clinical complications appeared
7 to 10 years after surgery, and chemical changes related to swelling of the implant were demonstrated.10 However, Marin et al 10 stated lhat they have used MlRAgel as an episcleral implant in a large number of patients since 1986 and have not observed complications. We followed up 206 patients with MIRAgel as an episcleral buckling material for more than 7 years after surgery, and only 5 of these patients needed removal, 1 of them showing positive culture (Table 4). Three more patients with this follow-up also showed redness and required periodic antibiotic drug and corticosteroid treatment.
In 1997, Hwang and Lim 11 reported the first case of scleral buckle extrusion and fragmenlation associated with use of a MIRAgel episcleral explant. They illustrated the need to anticipate potenlial friability and swelling of MIRAgel buckle material and to meticulously search for fragments during removal.
However, erosion is not unique to the hydrogel implant and has characterized all the implants used to date.16 That is why Schepensl7 defended that the expected short-or long-lerm complications of the implants justily lifetime yearly follow-up after all scleral buckling implantations.
Bij de door de auteurs onderzochte 206 patiënten werden geen belangrijke complicaties gevonden, maar lange termijn veranderingen in de chemische samenstelling en mogelijke toenemende zwelling van het materiaal rechtvaardigen een sterke aanbeveling om patiënten periodiek te volgen.
Because of the physical properties of the MIRAgel material (MAI),8 it was thought initially to be a better buckling element.7-9 We followed up 206 patients with hydrogel explants (53.4% of all patients with hydrogel) for 7 years or more aflcr surgery, and no important complications were found. Signs of granuloma and chronic infection appeared in 8 or these patients (3.9%), and 5 of them needecl removal. No other complications were detected related to use of this material episclerally. However, we think that long-term altcrations in chemical composition and eventual increase in swelling of the material justify a high recommendation for the need for periodic follow-up, as with all use of scleral buckling materials.
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| ◄▬ | 1999 Roldán-Pallarés | ▬► |