A rare late complication of silicone orbital implant

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This study describes clinical and radiological implications as well as early surgical treatment results of a rare and late complication of a nonporous silicone orbital implant, in particular its encapsulation with the formation of an inclusion cyst.


The formation of an inclusion cyst around implants made of nonporous polymers (silicone [7, 22, 35, 37, 38], and less often Teflon [17, 27] and supramid [34]) is a rare late complication following orbital floor reconstruction. We present a description of such a case encountered in our clinical practice.

Patient B, 31 years old, sought medical assistance due to visual impairment, double vision, orbital congestion feeling, and moderate pain radiating to the frontal, temporal, and parietal regions for 2 months. The disease history showed that in 2004, the patient underwent a surgical procedure in one of the hospitals of the Russian Ministry of Defense due to a blow-out fracture of the right orbital floor.

Upon physical examination, chemosis of the inferior palpebral sulcus, hypertrophy, proptosis, restricted eyeball repositioning into the orbit, and obvious oculomotor disorders were detected (fig. 1, a-c).


Fig. 1. Preoperative patient examination: a) Elevation of the globe (horizontal line), b) exophthalmos (horizontal line), c) restriction of the ipsilateral eye elevation, d–f) implant (big arrow) on the inferior orbital wall enclosed in pseudocapsule (small arrows). Mass lesion at the orbital roof (d) results in the elevation of the globe and increased intraocular pressure. Distance between the sclera and orbital roof (asterisk) significantly differs between the sides


A CT scan showed a mass lesion with relatively sharp borders and a soft tissue mass around the implant. It was located near the inferior orbital wall, and displaced the eyeball upward [10, 13] (fig. 1, d-f).

The investigation included differential diagnosis with inflammatory (infection of the implant and subsequent cellulitis) and vascular (varicose veins and carotid cavernous fistula) orbit disorders as well as mucocele and sino-orbital fistula [36].

Hemorrhagic fluid, typical for this condition, was obtained by diagnostic puncture [10, 11, 21, 25, 26]. No microorganisms were detected at bacteriological examination.

A thick pseudocapsule was found around the monolithic silicone implant at orbitotomy (fig. 2). The implant was removed after puncture of the subcapsular space and aspiration of hemorrhagic fluid (1 ml) and after partial excision of the pseudocapsule (without opening the cavity of paranasal sinuses [8, 26]). Explantation of the monolithic implant did not cause any technical difficulties. Orbital floor defect being already replaced by a new tissue and covered by a thick pseudocapsule, as expected, removal of the implant caused neither functional disorders nor cosmetic defects, [4, 17].


Fig. 2. Surgical technique: a) Chemosis of the inferior palpebral sulcus; b) blood clot in the subcapsular space; c) hole in the anterior capsule; d, e) explantation (d) of the silicon plate (e); f) removal of the pseudocapsule; g, h) final stages  



No complications were observed during the procedure and postoperative period (fig. 2; 3, a, b). After a course of antibacterial and anti-inflammatory therapy, the patient was discharged and followed-up by maxillofacial surgeons and ophthalmologists at the Saint-Petersburg Multifield Hospital No. 2. By the end of the first month after surgery, expected mild enophthalmos and hypophthalmos (fig. 3, c, d), considered as reasons for a 6-month delay of additional implantation of porous polytetrafluoroethylene into the orbit, became less obvious, partially due to the mild retraction of the inferior eyelid of the right eye (Fig. 4).


Fig. 3. Postoperative examination: a, b) Postoperative swelling of the lower eyelid (a, arrows) and mild restriction of the right eye elevation (b, horizontal line) next day after surgery, c, d) increased inferior palpebral sulcus (arrows) indicates enophthalmos after the swelling of the orbital fat has resolved (days 10 and 12), e) coronal CT demonstrates thickening of the lower muscle complex (arrow), f) sagittal CT shows the fracture line adjacent to the thick pseudocapsule of the implant


Fig. 4. Clinical photograph 1 month after surgery: a) Minimal enophthalmos (1 mm horizontal line through the center of the pupil of the contralateral eye), b) absence of the axial globe displacement (eno- and exophthalmos) (horizontal line), c) restored eye elevation


A histological examination of the excised tissue showed an epithelial lining at the silicone-facing surface of the pseudocapsule.


Until recently, monolithic silicone was the primary non-biological material for orbital floor reconstruction because of its biocompatibility, chemical stability, and availability [2, 3, 7, 14, 32, 33, 39].

However, this class of implants is unable to generate new connective tissue formation, and this may cause several complications such as migration under the skin of the inferior eyelid, into the nasal cavity, or into the maxillary sinus; rejection [5, 16, 24, 27, 29]; and infection of the material [20]. The use of monolithic implants in the presence of traumatic fistula with maxillary sinus is particularly dangerous because of suppurative complications [19].

The chronic character of perifocal inflammatory reaction, which prevents osteogenesis in the bone defect area, is another serious disadvantage of silicone [12, 30]. Silicone causes bone resorption when placed for a long period at the orbital floor. As a result, 70% of patients have the maxillary sinus involved in the pathological process.

The complication described above is quite rare, because it requires the formation of a pseudocapsule (cyst) around the implant, which is lined with one of the following types of epithelium: non-keratinized stratified squamous epithelium (introduced into the orbit through transconjunctival access), keratinized stratified squamous epithelium (introduced through transcutaneous access), or ciliated respiratory epithelium (introduced during the elevation of soft tissues, prolapsed into the maxillary sinus) [18, 23, 28, 37, 38].

Implant encapsulation results in recurrent hemorrhage into the subcapsular space, persistent diplopia, and vertical and axial dystopia and formation of a cutaneous or sino-orbital fistula and cellulitis [35].

Twenty-year follow-up showed that the removal of silicone implants due to complications was required in 13 %-14 % of cases [31]. On average, explantation was performed 4.3 years after osteoplasty, although complications may develop 10, 15, and even 25 years later [5, 9, 40]. The high frequency of late complications has encouraged many clinicians to avoid silicon use of in favor of other synthetic porous materials [1, 6, 15]. A high level of biocompatibility, no risk for infection transmission, well-established manufacturing process, and acceptable costs have made porous polymers the primary material for orbital floor reconstruction.

Genrikh A Khatskevitch

Saint Petersburg City Hospital No 2

Author for correspondence.
Email: genrih15@gmail.com

Russian Federation

MD, PhD, professor. Head of Department of Pediatric Dentistry

Mikhail M Soloviev

Saint Petersburg City Hospital No 2

Email: mmsolovyov@mail.ru

Russian Federation

MD, PhD, assistant professor of Department of Pediatric Dentistry

Tatiana L Onokhova

Saint Petersburg City Hospital No 2

Email: tanyaonokhova@gmail.com

Russian Federation

maxillo-facial surgeon

Vadim P Nikolaenko

Saint Petersburg City Hospital No 2

Email: dr.nikolaenko@mail.ru

Russian Federation


Tatiana Yu Panova

Saint Petersburg City Hospital No 2

Email: dr.panovatu@gmail.com

Russian Federation

ophthalmic surgeon of Ophthalmology department

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Copyright (c) 2016 Khatskevitch G.A., Soloviev M.M., Onokhova T.L., Nikolaenko V.P., Panova T.Y.

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