In a new study on cosmetic nose surgery (rhinoplasty) conducted by researchers from the University of Colorado and the Oregon Health and Sciences University, the Medpor nose implant was found to have a higher rate of complications than previously expected. A product made of porous high-density polyethylene and manufactured by Stryker Corp. (who acquired the implants from Porex Technologies in 2010), Medpor is used in rhinoplasty when it is not practical to use the patient’s own tissue or cartilage from other areas of the body.
Study results showed that as many as one in five nose jobs using Medpor led to an infection, with the implant eventually poking out through the surgical wound in nearly all of those cases.
Researchers Study Rhinoplasty Procedures
For the study, researchers looked at a total of 662 rhinoplasty procedures performed by three faculty surgeons at the Oregon Health and Sciences University between 1999 and 2008. Facts such as patient demographics, medical conditions, operative details, and postoperative findings were all examined.
Out of the 662 procedures, a total of 151 involved the use of a plastic implant, either Medpor or Gore-Tex brands. Whereas Medpor is made of high-density polyethylene (pHDPE), Gore-Tex is made of expanded polyetrafluoroethylene, or ePTFE, and is more flexible than Medpor. Each implant is reportedly used for different reasons, to create different results.
The safety comparison between the two implants, however, was significant.
Study Results Show High Infection Rate
According to the study results, 19 of the 151 patients developed a postoperative infection. In all but one of these cases, the implant began to protrude through the skin. With Gore-Tex, researchers found an infection rate of 5 percent, but with Medpor, that rate jumped up to 19 percent.
The infection rate was extremely high and startling, said Dr. Andrew Winkler, a plastic surgeon at the University of Colorado and lead author of the study. Oftentimes in cases of infection, antibiotics aren’t enough, and patients have to go through a second surgery to have the implant removed.
In contrast, there were no complications when surgeons grafted cartilage from the patient’s own bodies, such as the ear or rib cartilage.
The researchers concluded that caution is strongly recommended when considering the use of pHDPE in rhinoplasty.
Stryker Corporation Defending Lawsuits
The results would seem to suggest that surgeons stick with using a patient’s own cartilage, but that can be more difficult and time-consuming, and is not always an option, such as when the patient’s nose and ear cartilage has been depleted. The risk for complications, however, though still present, is considerably lower.
Since rhinoplasty is the most common cosmetic or reconstructive surgery for individuals under the age of 35, according to the American Academy of Facial Plastic and Reconstructive Surgery, patients need to be aware of the potential risks.
Stryker is also the manufacturer of the Rejuvenate and ABG II hip implant systems that were recalled in July 2012 because of reports of fretting and metal contamination. The company is currently defending a number of lawsuits from injured plaintiffs across the country.
