The synthetic hydroxyapatite implant: a report on 65 patients.

Sixty-five patients receiving the FCI synthetic hydroxyapatite implant (FCI3, FCI, Issy-Les-Moulineaux, France) after enucleation, evisceration, or as a secondary implant were studied under human trial guidelines established by Health and Welfare Canada. The implant is chemically identical to the original coralline Bio Eye (Integrated Orbital Implants Inc., San Diego, CA, U.S.A.), is easy to work with, and was implanted without difficulty using a wrap of polygalactin 910 (Vicryl mesh, Ethicon, Inc.) in the majority of patients. Postoperative drilling was carried out at approximately 6 months and found to be much easier than drilling of the Bio Eye. The implant could be hand drilled using drill bits rolled between the thumb and index finger. Postoperatively, patients were followed-up from 7 to 24 months and did not have any problems different from those associated with the original hydroxyapatite implant derived from sea coral (Bio Eye). One case of conjunctival dehiscence occurred at 4 weeks and required a temporalis fascia patch graft to repair. One implant became infected after drilling and had to be removed. The motility obtained with the third-generation FCI implant (FCI3) was similar to that seen with the Bio Eye, in comparable patients. That is, those receiving implants after an evisceration, on the whole, had better motility than those receiving an implant after primary enucleation or secondary implantation. The FCI3 hydroxyapatite implant is a viable alternative to the original Bio Eye hydroxyapatite implant. It's advantages are: 1) reduced cost, and 2) ease of drilling (a motorized drill is not required). The implant was given Health and Welfare approval in Canada on February 26, 1997.