Medpor polyethylene implant in reconstructive ear surgery in patients with microtia: rapid health technology assessment
Health technology assessment|
conducted a rapid health technology assessment on the use of Medpor polyethylene implants in reconstructive ear surgery in patients with microtia.
The Norwegian Institute of Public Health has conducted a rapid health technology assessment on the use of Medpor polyethylene implants in reconstructive ear surgery in patients with microtia. Children born with microtia have a congenitally small, malformed, or absent external ear. Microtia is also associated with an absent or narrowed ear canal resulting in different degrees of hearing impairment. In Norway, around 6-10 children are born with microtia each year. The technology being considered is intended as a supplement to current practice, which is the use of rib cartilage in ear reconstruction.
- We included 15 studies, most of them without any control group. The results indicated that the use of Medpor implant in ear reconstruction may have positive cosmetic effects, as well as positive effects on hearing when combined with measures to improve hearing, and quality of life. However, the studies had significant methodological flaws making it difficult to conclude on effectiveness.
- Adverse events occurred roughly in one out of 10 patients, yet this number is based on a small number of patients. Since the studies were largely without any control group, it was not possible to assess whether there were more adverse events when using Medpor implant compared to rib cartilage.
- Ear reconstruction using Medpor implant costs approx. NOK 25,000 less than reconstruction with rib cartilage. The investment costs linked to training of personnel will be approx. NOK 50,000 the first year and NOK 25,000 the second year.
- An advantage with this technology is that the operation can be performed already at 5-6 years of age, while the optimal age for current treatment is 9-10 years. Considering hearing function, this is positive as a hearing implant can be implanted in the same session, and the children can benefit from this from a younger age. In addition, avoiding use of autologous rib cartilage, will reduce postoperative pain and prevent scarring and other potential morbidity from this area.
- Potential disadvantages are tendency of breakthrough of the implant and need of reoperation. In addition, a Medpor implant will preclude atresia repair to achieve normal hearing. However, atresia repair has become less common due to risk of complications.
- According to clinical experience, the use of Medpor implants has similar positive effects on cosmetic outcomes and quality of life as the use of rib cartilage.
It is not possible to draw any conclusions about the effectiveness and safety of Medpor implants in reconstructive ear surgery in patients with microtia based on available evidence.
It is estimated that in the startup phase the technology will be cost-neutral, and cost-saving in the long run.
The technology has several advantages compared to current practice, including that the intervention can be performed at a younger age, that it requires fewer surgical procedures and the avoidance of using own tissue in the ear reconstruction. Potential disadvantages are the tendency of breakthrough of the implant with subsequent need for reoperation and the fact that it cannot be combined with atresia surgery.
As microtia is such a rare condition, we consider it unlikely that further research within this area in the next coming years will strengthen the documentation basis significantly