Surgical pitfalls with custom-made porous hydroxyapatite cranial implants

Aim: Cranioplasty implants are used primarily in cases of surgical cranial decompression following pathological elevations of intracranial pressure. Available bone substitutes include porous hydroxyapatite (HA) and polymethylmethacrylate. Whichever material is used, however, prosthetic cranial implants are susceptible to intra- and postsurgical complications and even failure. The aim of this study was to investigate such occurrences in HA cranioplasty implants, seeking not only to determine the likely causes (whether correlated or not with the device itself) but also, where possible, to suggest countermeasures. Methods: We analyzed information regarding failures or complications reported in postmarketing surveillance and clinical studies of patients treated worldwide with custom-made HA cranial implants (Custom Bone Service Fin-Ceramica Faenza, Italy) in the period 1997-2013. Results: The two most common complications were implant fractures (84 cases, 2.9% of the total fitted) and infections (51 cases, 1.77%). Conclusion: Although cranioplasties are superficial and not difficult types of surgery, and use of custom‐made implants are often considered the “easy” option from a surgical perspective, these procedures are nonetheless plagued by potential pitfalls. If performed well they yield more than satisfactory results from the points of view of both the patient and surgeon, but lack of appropriate care can open the door to numerous potential sources of failure, which can compromise-even irreparably-the ability to heal.