Pillar Palatal Implant System

The PillarĀ® palatal implant (Restore Medical, Inc., St. Paul, Minnesota, U.S.) was introduced as a treatment for snoring in 2003. These implants are composed of polyethylene terephthalate (PET). This material has been used since the 1960s in other implantable medical products. PET is biocompatible and inert resulting in minimal tissue reaction to the implant. The nature of the material allows tissue ingrowth to stabilize the material. Histologic analysis of the implant system indicates that a chronic inflammatory response occurs as a result of PET implantation. Inflammation results in the formation of a fibrous capsule. This process should be complete within four weeks.

The rationale for this procedure is to stiffen the soft palate, and thus reduce palatal flutter and snoring. Implantation of the PET material imparts a degree of rigidity to the palate. Additional stiffening of the palate is achieved by fibrosis and formation of capsule in response to the inflammatory reaction (97).

The procedure is minimally invasive and can be performed in the clinic setting. A handheld applicator is used to insert the PET implants. After the palate is anesthetized, an 18 mm by 1.5 mm implant is placed in the midline above the uvula. The implants should be positioned in the muscular layer of the soft palate. Two additional implants are placed 2 mm lateral to the midline on each side. Postoperative antibiotics are given to prevent infection. Pain can usually be controlled with over-the-counter analgesics (98,99).

The Pillar Implant received FDA clearance for the treatment of snoring and mild-to-moderate OSA. Originally, this implant was studied to determine its role in eliminating snoring. The outcomes of these studies indicate that the implant system has efficacy and relapse rates similar to other treatment modalities (98,100-101). However, these studies often excluded patients with OSA and did not always obtain a PSG. More recently, Nordgard evaluated 25 patients with mild-to-moderate sleep apnea to determine if palatal implants could alleviate SDB. All patients underwent PSG before and after treatment. Inclusion in the study required an AHI of 10 to 30 and a BMI of < 30. AHI was reduced from a mean of 16.2 to a mean of 12.1. The AHI was reduced to below 10 in 48% of patients at 90 days post-implant (102).

Pain and mild palatal swelling can occur postoperatively, yet they are transient. The most common complication was implant extrusion. Different rates of extrusion have been noted from 2.7% to 8.8% (98,99). The most feared negative outcome would be aspiration of an extruded implant. This has not been documented in the literature. The palate must have a length > 25 mm in order to be eligible to receive an implant. Surgeon inexperience and short palatal length may increase the incidence of implant extrusion.

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