Of the 396 patients who underwent this procedure and reconstructive process, 369 (93 percent) achieved a straight nasal septum after surgery and reported improvement in the nasal airway after surgery. In 324 (82 percent) patients, the improved nasal flow was reported as "remarkable." Overall, 18 patients (5 percent) required revision surgery to correct a redeviation or slight polly beak deformity; eight patients (2 percent) who experienced a redeviation chose not to undergo revision surgery because it caused no functional problems.
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August 2011Along with effectiveness, the long-term data also show the safety of the PDS plate. Among the 396 patients treated since 1996, no complications immediately followed surgery, and no long-term complications in terms of implant rejection or septal perforation occurred.
"The clinical experience over the last 14 years shows that the PDS plate is well tolerated by the body, and even in long-term follow-up, the results of this technique are encouraging," Dr. Boenisch said.
Hesham Saleh, FRCS, a consultant rhinologist and facial plastic and ENT surgeon at Charing Cross and Royal Brompton Hospitals and Imperial College School of Medicine in London, who has used the PDS plate for about seven years in over 150 patients, said he also has had good long-term outcomes, with a 98 percent success rate in a follow-up of 100 patients who were available for analysis. Among these patients, 15 percent had minor swelling of the septum at six weeks that resulted in some continued nasal blockage, which settled down in most cases by three months, he said. Overall, 2 percent of the patients required revision surgery for residual deviation, columellar retraction and dorsal irregularity. He plans to submit these results for publication in the near future.
Dr. Saleh emphasized that the most common use of the implant is for severe septal deviations and for use as columellar struts when available cartilage is either weak or insufficient. Other applications for which he uses the implant include extension grafts, spreader grafts and endonasal septoplasty, especially in cases with caudal dislocation.
Implementation in the U.S.
Although some physicians have begun using the PDS plate based on the data coming largely from Europe, Brian Wong, MD, professor of otolaryngology-head and neck surgery and biomedical engineering at the University of California, Irvine, in Orange, Calif., emphasized that there is still a need for otolaryngologists to clarify the specific applications for which the PDS plate is valuable, particularly in cosmetic-related applications.