Literature Review
Medpor® Biomaterial and Porex Surgical Products
AURICULAR
Berghaus, A., Reinisch, F. F., “Ear Reconstruction Using Porous
Polyethylene Frames” American Academy of Otolaryngology – Head & Neck
Surgery Foundation Annual Meeting, Course Number: 4527-1, September
24, 2003
Educational Objectives: (1) Understand the background of different
choices for materials in ear reconstruction. (2) Learn about the pros
and cons of plastic and rib cartilage. (3) Understand the principles of
ear reconstruction in children and adults using a porous polyethylene
framework, temporoparietal flap and full thickness skin covering. (4)
Know about a number of helpful tricks and details to be able to perform
ear reconstruction with the method shown.
Course Description: This course will present a proven surgical
technique for total ear reconstruction in children and adults. It
will be shown that very good, lasting results can be achieved by
using component porous polyethylene frame, which is covered first
by vascularized temporoparietal flap, and then by full thickness
skin. The author has almost 20 years of experience with ear
reconstruction and research in biomaterials. He will explain
in detail the advantages and risks of both autogenous cartilage
and plastics, and it will be shown why the preference is given
to the porous plastic here. Digital presentation and video will
be used to show all details of the surgical technique precisely,
so that participants back home in principle should be enabled to
do the surgery themselves.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Romo III, T., Fozo, M.S., Sclafani, A.P. "Microtia
Reconstruction Using A Porous Polyethylene Framework", Facial Plastic
Surgery, Volume 16, Number 1, pp 15-21 (2000)
We describe our method for reconstructing microtic auricles using
a porous polyethylene framework in two stages. The first stage of
the procedure involves rotating a superficial temporoparietal fascial
(TPF) flap over the framework. The inferior two-thirds of this framework
is next inset into a local temporal skin pocket, while the superior
one-third is covered with a full thickness skin graft from the contralateral
postauricular sulcus. Lobular transposition is commenced in a second
stage procedure at the three-month postoperative period. Hearing
restoration surgery is encouraged at a later date in selected patients
with unilateral microtia. Use of the porous polyethylene framework
permits a more expedient, less invasive, and more reliable method
for auricular reconstruction than does the traditional method that
employs costal cartilage.
Key Words: Microtia, porous polyethylene auricular framework;
temporoparietal fascia flap.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Williams, J.D., Romo, T. III, Scalafani, A.P, Cho, H. "Porous
High-Density Polyethylene Implants in Auricular Reconstruction",
Archives of Otolaryngology - Head & Neck Surgery, Vol.
123, pp 578-583 (June 1997)
Objective: To evaluate the ability of porous high-density polyethylene
(MEDPOR®) implants to tolerate exposure and support skin grafts
when used to reconstruct defects in auricular cartilage in an animal
model.
Conclusions: Polyethylene implants are well tolerated as replacements
for native cartilage in auricular reconstruction. Polyethylene implants
tolerated wound exposure as early as 4 days after implantation and
demonstrated the ability to heal by secondary intention and support
skin grafts. This is likely because of the extent of fibrovascular
ingrowth from surrounding tissue, which allows the material to behave
more like native tissue and less like a foreign body in this setting.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Wellisz, T. "A Guide To External Ear Reconstruction For Microtia
Using The MEDPOR® Porous Polyethylene Framework", presented
at the 32nd Brazilian Congress of Plastic Surgery, Brazilia, Brazil
(November 1995)
Abstract: Traditionally, ear reconstruction for microtia has involved
a multi-stage procedure using rib cartilage grafts. While excellent
results were possible, they were relatively rare and consistently
attainable only by a few experienced individuals. The average practitioner's
results have often been less than ideal. The development of the
prefabricated porous polyethylene framework has changed the way
ear reconstruction is performed.
The procedure is performed in two stages. At the first operation,
the ear framework is implanted, establishing the final projection
of the ear and creating a deep post-auricular sulcus. The framework
is assembled using two components: a curved helical rim and a base
component. The components can be assembled to create a framework
that will match an auricle of almost any size or projection. The
framework is covered with a temporoparietal fascial flap and a skin
graft. The implant becomes rapidly vascularized with soft tissue
ingrowth and collagen deposition. The lobule is transposed at the
second operation. Porous polyethylene ear reconstructions have the
advantage of a shorter learning curve, less patient morbidity, fewer
reconstructive stages and a shorter hospitalization when compared
to the methods that utilize rib cartilage.
This paper presents an overview of the advances in the use of porous
polyethylene and describes in detail a technique for total ear reconstruction
using a porous polyethylene framework.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Wellisz, T. "Reconstruction Of The Burned Auricle", Journal
of Plastic Surgical Techniques, Vol. 1, No. 1, pp 35-45 (1995)
A technique for reconstructing the burned auricle, using a MEDPOR®
'pivoting helix' framework is described in detail. Covered with
a temporoparietal fascial flap and a skin graft, the two-piece porous
framework can be used to create an auricle of almost any size or
projection. The helix can move independently and can be compressed
against the head in the event of external pressure on the ear.
Using this method, 32 consecutive ear reconstructions were performed
over a three year period. In each the framework became rapidly vascularized,
allowing for soft tissue ingrowth which may reduce infection and
the deposition of collagen which provides strength and flexibility.
Two exposures occurred which were managed without removal of the
implant. All the reconstructions were successful in restoring an
aesthetic and functional external ear that is durable, remains flexible
over time and provides support for a pair of eyeglasses.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Reinisch, J.R., Wellisz, T. and Hoerr, G. "Microtia Reconstruction
Using A Porous Polyethylene Framework", presented at the California
Society of Plastic Surgeons, Coronado, California, U.S.A. (February
1994)
The authors describe a technique for microtia reconstruction using
a two-piece MEDPOR® framework covered with a temporoparietal
or postauricular fascia.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Jon, C. and Wellisz, T. "External Ear Reconstruction Using A MEDPOR®
Porous Polyethylene Framework", AORN Journal, Vol. 59, pp
411-422 (1994)
The role of the perioperative nurse is highlighted in this paper
that describes external ear reconstruction using the MEDPOR®
'pivoting helix framework' for patients with thermal injuries or
congenital microtia. Techniques for preoperative prepping, interoperative
carving and insertion and postoperative maintenance are described.
After using MEDPOR implants for five years, the authors report no
major complications. The implants became rapidly vascularized, allowing
for soft tissue ingrowth which reduces infection and the deposition
of collagen which provides strength and flexibility. All the reconstructions
in both adults and children were successful in restoring an aesthetic
and functional external ear that is durable, remains flexible over
time and provides support for a pair of eyeglasses.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Wellisz, T. "The Reconstruction Of The Burned External Ear Using
A MEDPOR® Porous Polyethylene 'Pivoting Helix' Framework", Plastic
and Reconstructive Surgery, Vol. 91, pp 811-818 (1993)
A new technique for reconstruction of the burned auricle using
a MEDPOR® pivoting helix framework is described. Twenty-six
consecutive ear reconstructions were performed using this method
over a two year period. Two exposures occurred which were managed
without removal of the implant. All reconstructions successfully
restored an ear that was both aesthetically pleasing and functional
so as to provide support for a pair of eyeglasses.
This surgical procedure involves using a two-piece MEDPOR framework.
The framework is covered with a temporoparietal fascial flap and
a skin graft. The two pieces of the framework are adjusted to create
an auricle of almost any size or projection. The helical rim can
also move independently and can be compressed against the head in
the event of external pressure on the ear.
The resulting ear reconstruction was found to be extremely durable
and it remained flexible over time despite often tenuous soft tissue
coverage and scar contracture. The author concludes that the MEDPOR
pivoting helix framework offers an excellent solution for a difficult
reconstructive problem.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
Shanbhag, A., Friedman, H.l., Augustine, J. and Von Recum, A.F.
"Evaluation Of Porous Polyethylene For External Ear Reconstruction",
Annals of Plastic Surgery, Vol. 24, pp 32-39 (1990)
MEDPOR® polyethylene material was compared to silicone rubber
in the external ear of eight baboons. Implants of 1.5 mm and 3.0
mm were used. Histological evaluation of the sites after nine weeks
revealed excellent anchorage of the thin MEDPOR implants with tissue
ingrowth into the pores and a thin capsule. The silicone rubber
implants, however, were encapsulated in a thickened tissue capsule.
When thicker implants were used, exposure occurred in all cases.
None of the MEDPOR implants were extruded and all the MEDPOR implants
had been incorporated into the soft tissue and were firmly anchored
in place. In contrast, half of the silicone implants were totally
extruded and the remainder were almost completely extruded.
A material analysis of the MEDPOR implant samples was performed.
Image analysis methods performed on 12 samples showed a mean porosity
of 46%. The pore diameter ranged from 160 to 368 ~um, with an average
pore diameter of 248 1lm. A structural analysis is quoted which
demonstrated that when the MEDPOR implant was boiled there was no
loss of strength. The reported modulus of elasticity of the MEDPOR
implant compared favorably with that of collagen bundles.
The authors believe that under normal physiological conditions,
fatigue failure of MEDPOR implants would not be of concern. The
authors concluded that if a synthetic framework is to be used, thickness
is critical to a successful outcome. They felt that the tissue ingrowth
into MEDPOR provided an advantage and they hypothesized it may be
possible to salvage partially exposed MEDPOR ear frameworks.
This abstract is provided for educational purposes only. It
contains information about cleared uses of the product. It may contain other
potential uses not cleared by the Food and Drug Administration and not advocated
by the manufacturer. The uses and opinions expressed within the article are
those of the author derived from his or her personal experience with the product.
For additional information on cleared product specific indications and to request
a copy of the cleared labeling please contact the manufacturer's customer care
department.
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