Technical Information

Literature Review
Medpor® Biomaterial and Porex Surgical Products

Midface - Reconstructive and Aesthetic

Damian McNamara, “Revision Rhinoplasty Can Recover Ethnic Identity” Surgery News, Vol. 1 No. 8, pp21 (August 2005)

Purpose: To describe a new conjunctiva-sparing technique for secondary orbital implantation after evisceration.

Boca Raton, Fla. – Patients who perceive a loss of ethnic identify after undergoing rhinoplasty may be satisfied with revision rhinoplasty, Thomas Romo III, M.D., FACS, said at the Combined Otolaryngology Spring Meetings.

“The demographics of patients are changing rapidly. You can no longer rely on Caucasian-based principles in rhinoplasty,” said Dr. Romo.

Most rhinoplasty operations in the United States are performed for the purpose of reduction, but an overresected dorsum and/or loss of cartilage can leave some patients dissatisfied, said Dr. Romo of the department of otolaryngology/head and neck surgery at the New York (N.Y.) Eye and Ear Infirmary.

“For those who practice in larger urban settings, we already experience a large diversity in the ethnicity of patients, but that will occur in more regions of the country,” said session discussant Richard E. Davis, M.D., FACS, of the division of facial plastic and reconstructive surgery at the University of Miami.

Dr. Romo cited a few patients who were dissatisfied with their initial rhinoplasty. For example, a young Indian woman desired a larger nasal dorsum and more tip ptosis to regain her ethnic identity, “She wanted a fuller nose with more of a dorsal hump,” he said.

Another patient was a younger Jewish man who also felt he had lost his ethnic identity, The patient sought revision surgery for a larger dorsum-a longer, narrower appearance to his nose, with increased tip and dorsal projection.

Dr. Romo, along with lead author Edward S. Kwak, M.D., a resident at the New York Eye and Ear Infirmary, studied 29 Patients from 1998 to 2004 who had revision rhinoplasty to correct a loss of ethnic identity. They found a high level of patient satisfaction with follow-up of 6 months to 7 years.

An exposed alar batten graft was the only complication. The patient was treated with local excision, primary closure, and antibiotics and has been doing well since then, said Dr. Romo.

Autologous grafts to replace lost volume are preferred for revision rhinoplasty, he added. Other graft materials options include Medpor, Gore-Tex, and Mersilene, he said. Surgical revisions can include an open technique to place a large dorsal tip graft. An infratip graft can be placed to increase nasal tip projection. In some patients, placement of a columellar strut improves postoperative patient satisfaction.

“The facial plastic surgeon must incorporate a customized facial analysis specific to a patient’s ethnicity,” Dr. Romo suggested.

“Maintaining ethnic heritage is important for some patients, not all. It’s important to ask each patient this beforehand,” Dr Davis explained. “Regardless of the ethnic background of the patient, it is wise to retain good skeletal projection. It is always a good idea to reduce less versus more. You can always go back and take more.”

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.

Hart, R.; Barnes, E.; Dickinson, A.J.; “Secondary Orbital Implants After Evisceration: A New Conjunctiva-Sparing Technique” Ophthalmic Plastic and Reconstructive Surgery, Vol. 21 No. 2 pp129-132 (March 2005)

Purpose: To describe a new conjunctiva-sparing technique for secondary orbital implantation after evisceration.

Methods: Two patients with conjunctival cicatrization and a volume-deficient anophthalmic socket had implantation of an intraconal biointegratable implant. This was placed through a lateral canthal approach, after temporary disinsertion of the lateral rectus, thereby avoiding further injury to the conjunctival.

Results: A good surgical outcome was achieved in both patients. There were no intraoperative or postoperative complications, and both have remained stable for nearly 2 years.

Conclusions: Secondary intraconal implantation through the lateral canthal approach is safe and effective and suitable for patients in whom it is desirable to avoid a conjunctival incision.

Thakker, M.M., Fay A.M., Pieroth L., Rubin P.; “Fibrovascular Ingrowth Into Hydroxyapatite and Porous Polyethylene Orbital Implants Wrapped With Accellular Dermis”, Ophthalmic Plastic and Reconstructive Surgery, Vol 20, No 5, pp368-373 (2004)

Purpose: Acellular dermis is a frequently used wrapping material for hydroxyapatite (HA) and porous polyethylene (PP) orbital implants. In an animal model, we determined by histology the extent of fibrovascular ingrowth within orbital implants wrapped in acellular dermis at 6 and 12 weeks after surgery.

Methods: Four Yucatan minipigs were used for the study. Two minipigs had HA implants and two had PP implants. Implants were harvested at 6 or 12 weeks after surgery and were examined histologically for fibrovascular ingrowth.

Results: There was complete fibrovascularization of HA implants harvested at both 6 and 12 weeks after surgery. The PP implant harvested at 6 weeks had incomplete fibrovascularization, whereas the PP implant harvested at 12 weeks had complete fibrovascular ingrowth. There was no histologic evidence of inflammation seen in any of the orbital implants. On gross and histologic examination, the wraps were found to persist on the surface of all orbital implants, with little histologic evidence of inflammation localized to the acellular dermis.

Conclusions: Acellular dermis wraps support fibrovascularization of both HA and PP orbital implants. Additionally, acellular dermis does not incite significant inflammation in association with HA and PP orbital implants and can persist in situ for at least 12 weeks after surgery.

Romo, III, T., Sonne, J., Choe, K.S., Sclafani, A.P., “Revision Rhinoplasty” Facial Plastic Surgery, November 2003, Volume 19, Number 4, pp. 299-307

Revision rhinoplasty can be one of the most complicated procedures performed by the facial plastic surgeon. As septal cartilage is often not available in revision procedures, grafting material is often needed. This material can come in the form of autogenous bone and cartilage. Allografts also can be used, including mersilene, expanded polytetrafluoroethylene, and porous high-density polyethylene (PHDPE). In this article, emphasis is placed on the senior author’s method in evaluating candidates for revision rhinoplasty as well as techniques using PHDPE. In addition, the properties of the more commonly used allografts are described, including the advantages and disadvantages of using each material in revision rhinoplasty procedures. In comparing the various alloplastic materials available, it is shown that PHDPE has properties that make it an excellent implant for revision rhinoplasty.

KEYWORDS: Revision rhinoplasty, rhinoplasty, porous high-density polyethylene

Romo, III, T., Litner, J.A., Sclafani, A.P., “Management of the Severe Bulbous Nasal Tip Using Porous Polyethylene Alloimplants” Facial Plastic Surgery, Volume 19, Number 4, November 2003, pp. 341-348

Reliable outcomes in correction of the severely bulbous nasal tip remains elusive. Reduction and binding of the tip cartilages result in a partial external nasal valve collapse. If a concurrent dorsal hump reduction is accomplished and osteotomies are completed to close the open roof deformity, then a severe constriction of the external valve may result. This is best avoided by resection of the residual lower lateral cartilages and substitution with external valve batten implants. The tripod of nasal tip supports is then rigidly reconstituted. When autogenous graft materials are considered inadequate or undesirable, the surgeon may safely use porous polyethylene alloimplants to support the external nasal valve. A dependable surgical technique based on extensive experience with these materials is outlined.

KEYWORDS: Rhinoplasty, severe bulbous tip, alloimplants, porous polyethylene

Romo, III, T., Choe, K.S., Sclafani, A.P., “Secondary Cleft-Lip Rhinoplasty Utilizing Porous High-Density Polyethylene” Facial Plastic Surgery, Volume 19, Number 4, pp. 369-377 (November 2003)

Secondary nasal deformity associated with cleft lip is a difficult surgical task. For more than 100 years, numerous surgical methods have been created to address the structural changes that occur over time after the primary surgery. Although early surgical methods have relied on various rotational flaps and local tissue manipulation, the recent advent of synthetic materials has provided facial plastic surgeons with more tools to correct the structural and supportive deficiencies. In this article, we describe our 10-year experience with porous high-density polyethylene (PHDPE) implants in secondary cleft-lip rhinoplasty. PHDPE implants have been well tolerated and achieved excellent long-term aesthetic results through fibrovascular ingrowth to the surrounding tissue.

KEYWORDS: Secondary cleft-lip rhinoplasty, porous high-density polyethylene (MEDPOR®), cleft-lip rhinoplasty

Romo, T., Soliemanzadeh, P., Litner, J.A., Sclafani, A. P., “Rhinoplasty in the Aging Nose” Facial Plastic Surgery, Volume 19, Number 4, November 2003, pp.309-315

The aging nose presents a difficult challenge for the rhinoplastic surgeon. To best address the patient’s wishes, the surgeon must possess a sound understanding of the atrophic changes associated with the aging nose, including tip ptosis, increased nasal bulbosity, a lengthened nasal appearance, and altered nasal airflow patterns. Surgical emphasis is placed on conservative structured reduction to address functional concerns. Over-resection risks destabilizing the nasal tip and altering the patient’s concrete self-image. This article outlines our approach to rhinoplasty in the aging nose with a special emphasis on the use of porous polyethylene alloimplants to provide added structural support.

KEYWORDS: Rhinoplasty, aging nose, alloimplants, porous polyethylene

Romo, T., Soliemanzadeh, P., Choe, K. S., Sclafani, A. P., “Reduction Structured Rhinoplasty” Facial Plastic Surgery, Volume 19, Number 4, November 2003, pp.317-323

Rhinoplastic surgeons continue to seek technical refinements that will result in a consistently reliable postoperative outcome. Over the past 25 years there has been a steady progression away from the simple Joseph reductive rhinoplasty technique toward the use of various grafts to improve both the functional outcomes and aesthetic end result of this procedure. The original reductive template continues to be a major component of a new conceptual paradigm, which has evolved to incorporate the understanding that structural components must be placed to allow a more precise outcome. Specifically, once the nose is reduced to proportions that correspond to the preoperative analysis, separate grafts and implants are placed to prevent a change in the shape of the nose by the constricting effects of the skin shrink-wrapping around the skeletal framework. This article focuses on the use of implants for structural architecture in the senior author’s primary reduction-structured rhinoplasty cases.

KEYWORDS: High-density porous polyethylene, MEDPOR, reduction-structured rhinoplasty, alloplasts

Yaremchuk MJ, “Improving Aesthetic Outcomes after Alloplastic Chin Augmentation” Plastic & Reconstructive Surgery, Volume 112, Number 5 (October 2003)

Objective: A novel approach to increase chin projection with alloplastic material is presented.

Methods: Key aspects of the technique include the consideration of anthropometric normal values in pre-operative assessment and planning, a sub-mental approach with wide sub-periosteal exposure of the area to be augmented, the use of two-piece porous polyethylene implants for augmentation, and screw fixation of the implant to the mandible. Screw fixation improves the predictability and precision of reconstruction by preventing implant displacement, by obliterating gaps between the implant and the facial skeleton, and by facilitating final implant contouring.

Results: In a series of 46 patients (24 primary and 22 secondary) operated on over a 6-year period, this approach allowed anatomically correct, stable chin contours to be created.

Conclusion: Iatrogenic problems with microgenia, mentalis dysfunction, and soft-tissue distortion resulting from implant migration and capsular contracture have been avoided. There have been no infections. Two patients who had had multiple previous chin operations requested revisional surgery to refine contour.

Steinsapir, K. D., “Aesthetic and Restorative Midface Lifting With Hand-Carved, Expanded Polytetrafluoroethylene Orbital Rim Implants” Plastic and Reconstructive Surgery, Vol. 111, Number 5, April 15, 2003

Discussion by Robert Alan Goldberg, M.D.
In the discussion response, Dr. Goldberg refers to his polyethylene orbital rim implant designs utilizing MEDPOR® Porous Polyethylene to address the relative inadequacy of the bony support of the orbital and midface projection.

The Midface lift represents an important advance in aesthetic and reconstructive surgery. However, the need for reliable fixation along the orbital rim has been a significant challenge. Furthermore, volume is needed at the orbital rim, to compensate for long-term remodeling of the bone of the orbital rim and malar face. A technique using a hand-carved, expanded polytetrafluoroethylene implant that is permanently anchored to the orbital rim with titanium microscrews, creating a site for fixation of the advanced midface soft tissues was developed. This report presents a retrospective, uncontrolled, case series of 41 consecutive patients who underwent transconjunctival midface operations with these implants, and it addresses a variety of midface aesthetic and reconstructive deficits. Only patients with at least six months of follow-up data were included in the study. To date, significant complications have been limited. The complications included two cases of implant palpability, with only one requiring surgical modification. One patient underwent implant removal because of skin breakdown and infection related to recurrent squamous cell carcinoma. One patient required revisional lateral canthoplasty for reasons of symmetry. On the basis of this series, hand-carved, expanded polytetrafluoroethylene implants seem to have significant advantages, compared with previously available orbital rim implants. These advantages include the ability to modify easily the implant for the individual anatomical needs, the creation of a secure anchor for fixation of advanced midface soft tissues, excellent tolerance of the implant material, and the ability to place the implant with limited exposure. The greatest disadvantage is the need for the surgeon to carve the implant, which requires time and carving skill. Despite this limitation, the technique is promising.

Romo, T., Abraham, M. T., “The Ethnic Nose” Facial Plastic Surgery, Volume 19, Number 2, pp. 269-77, 2003

There are distinctive anatomical differences between the non-Caucasian (platyrrhine, mesorrhine) nose and the Caucasian (leptorrhine) nose. In general, non-Caucasian patients requesting aesthetic rhinoplasty desire improvement and refinement of their noses with preservation of defining ethnic characteristics. Surgeons who perform rhinoplasty in this patient population must be familiar with variations in nasal anatomy and implement augmentation rather then reduction techniques to achieve the desired aesthetic and functional outcomes. We provide a brief review of recent historical trends in ethnic rhinoplasty, highlight relevant anatomical differences, and describe our strategy for addressing the challenges of ethic rhinoplasty.

Romo, T., Choe, K., Sclafani, A., “Cleft Lip Nasal Reconstruction Using Porous High-Density Polyethylene,” Archives of Facial Plastic Surgery, pp.175-179, Vol. 5, March/April 2003

Background: The multitude of factors involved with a unilateral cleft lip nasal defect has spurred various surgical techniques in the past. Recently, synthetic materials have been introduced for use in nasal reconstruction.

Objective: To report on and illustrate the use of porous high-density polyethylene implants in cleft lip nasal reconstruction.

Design: A retrospective review of cleft lip nasal reconstruction using porous high-density polyethylene in patients with a unilateral cleft lip defect from January 1, 1993, through June 30, 2000.

Patients: Eighteen patients with a unilateral cleft lip without a history of formal rhinoplasty.

Interventions: All 18 patients required multiple implants, including a columellar strut, premaxillary and prealveolar plumper grafts, a dorsal tip implant, and a unilateral nasal value batten, using the open rhinoplasty approach.

Results: Favorable aesthetics results, as judged by one of us (T.R.), were achieved in all patients. All implants were well tolerated. Postoperative follow-up ranged from 6 months to 7 years. A complication occurred in 1 patient (6%), which resolved with removal of a single implant and intravenous antibiotic therapy. No other complications, including skin erosion or implant extrusion, have been noted.

Conclusions: Porous high-density polyethylene implants for cleft lip nasal reconstruction are well tolerated and achieve good aesthetic results. Porous high-density polyethylene implants lend stability through fibrovascular ingrowth, with integration of the implants to the surrounding tissue.

Yaremchuk, M. J., “Restoring Palpebral Fissure Shape after Previous Lower Blepharoplasty,” Plastic and Reconstructive Surgery, Vol. 111, Number 1, January 2003

The youthful palpebral fissure can be described as long and narrow. Both the aging process and transcutaneous lower blepharoplasty can cause descent of the lower lid margin and medial migration of the lateral canthus, resulting in a rounding of the palpebral fissure. This article presents a technique to correct significant postsurgical lower lid malposition and palpebral fissure distortion without the use of outer or inner lamellar grafts. In overview, subperiosteal dissection frees scarred lid structure and cheek soft tissue, creating a continuous composite flap. Elevation of the cheek soft tissue recruits deficient outer lamellae and allows the sub-orbicularis oculi fat to be positioned between the orbital rim and scarred lid structures, filling this space and helping to support the repositioned lid margin. Titanium screws placed in the lateral orbit provide a point for secure fixation of elevated cheek tissue. Transosseous wire fixation securely repositions the lateral canthus. This procedure not only restores lower lid position and the vertical height of the palpebral fissure, but it also restores the palpebral fissure’s horizontal length and the lateral canthal angle. It has been effective in correcting palpebral fissure distortion after lower blepharoplasty in 15 patients during a 6-year period.

Militelli, F. A., “Transconjunctival Approach For Malar Bone Fracture And Orbit Reconstruction,” presented at XXXII Congreso de la Sociedad Argentina de Cirugia Plastica, Estetica Y Reparadora, Medoza, Argentina (August 14-17, 2002)

The objectives of this study are:

In the first place, to develop approach ways that allow to reduce and stabilize malar bone fractures, to explore the orbital floor and repair it and to reconstruct the orbit in a secure manner, without functional or aesthetic sequelae. The incisions performed were transconjunctival with and without canthotomy and the upper gingival endobuccal.

In the second place, to use porous polyethylene as implant for orbital fractures and reconstruction of the orbital rim.

According to the results obtained in this study it is concluded that the approaches performed were, in all cases, optimum to explore and solve the referred pathologies, offer good access to the orbital rim and the orbit floor and have a good aesthetic and functional results.

The material of the implant used, porous polyethylene (Porex), can be used to give or restore volume, is rapidly integrated by the body which avoids displacement and, in this series, no complications attributable to it were shown.

Öztürk, S., Sengezer, M., Coskum, Ü., Zor, F., “An Unusual Complication of a MEDPOR Implant in Nasal Reconstruction: A Case Report,” Aesthetic Plastic Surgery, Vol. 26., pp. 419-422 (2002)

There are few implant materials that have been successfully used for nasal reconstruction. Of these, the MEDPOR® Implant is the most accepted alloplastic material for reconstruction of the nasal framework. Here, an unusual complication of a MEDPOR Implant in nasal reconstruction is presented. A 24-year-old medical student suffering from saddle nose deformity after a primary rhinoplasty was admitted to our department. The MEDPOR Nasal Implant was used to restore the nasal dorsum. The surgical result was appreciated by the patient. No problem was encountered during two years after surgery. Recently, the patient suffered from an asymmetry of the nasal dorsum. The physical examination revealed a step on the nasal dorsum with caudal mobility of the implant. The nasal implant was suspected to be broken. Multislice CT scan and ultrasonographic imaging of the implant were obtained. The radiology evaluation of the region confirmed the fracture of the MEPDOR Nasal Implant. Nasal reconstruction with MEDPOR Implant is a good choice with low complication rates. This is the first case in the literature reporting a broken MEDPOR Nasal Implant. Moreover, in this study a new method is described for imaging the MEDPOR Implant Material.

KEY WORDS: Nasal reconstruction – MEDPOR – Complications - Imaging

Becelli, R., Carboni, A., Cerulli, G., Perugini, M., Iannetti, G., "Delayed and Inadequately Treaded Malar Fractures: Evolution in the Treatment, Presentation of 77 Cases, and Review of the Literature", Aesthetic Plastic Surgery, Volume 26, Number 2, pp 134 – 138 (March/April 2002)

Seventy-seven cases of delayed or inadequately treated zygoma fractures, treated between 1977 and 1999 in the Maxillofacial Surgery Division of the La Sapienza University in Rome, are presented. The functional and aesthetic problems caused by this pathology are analyzed. The results achieved resolve some of the various aspects of inadequately treated malar fractures. These are possible because of the development of a great biomaterials and the introduction of a rigid internal fixation. As a consequence the surgical techniques have been revolutionized. Cases, with functional –aesthetic deficits or only aesthetics deficits, are studied separately. An accurate preoperative study permits the operation suitable for the specific features of the individual case to be carried out.

Romo, T., McLaughlin, L. A., Levine, J., Sclafani, A., "Nasal Implants: Autogenous, Semisynthetic, and Synthetic" Facial Plastic Surgery Clinic of North America, Volume 10, pp155-166 (2002)

The approach to nasal reconstruction has evolved since biblical times. The earliest described nasal reconstruction occurred in India in 600 B.C. At that time, soft tissue coverage of nasal defects was the primary goal of nasal reconstruction. The quest for nasal symmetry and restoration of nasal contour led to experimentation with various alloplastic implants. Paraffin, gold, silver, aluminum, platinum, porcelain, ivory, cork, stone, and celluloid were some of the earliest alloplastic materials used. Prior to the development of aseptic technique, alloplastic implants typically failed from infection. Aseptic technique and improved anesthesia allowed surgeons to focus on the correction of more subtle nasal defects. Gradually, the goals of nasal reconstruction changed. Creating the desired nasal contour and enhancing nasal function became attainable objectives. By the mid-1800’s, sterile technique improved the outcomes of nasal alloplastic implants. By the twentieth century and as a result of World War I and II, significant advances in biomaterial sciences and implant technology were made. The lack of readily available material providing structural support without resorbing, extruding, or causing excessive fibrosis and contracture has hindered effects toward aesthetic and functional nasal reconstruction. Still, the ideal nasal implant exists only in concept.

An ideal nasal implant should provide stability, strength, and durability. It should be inert, noncarcinogenic, and nontoxic. It should also be pliable and readily available. An ideal implant should be easy to remove and should mimic the color and consistency of the tissue it replaces. It should interact favorably with the surrounding host tissue and resist extrusion.

Implants are classified according to the source from which they are derived. Autologous grafts are derived from the patient and include cartilage, bone, and dermis. Homographs are derived from a different donor of the same species. Xenografts are derived from another species and are not used in nasal reconstruction. Alloplasts are synthetic or semisynthetic materials. Alloplasts are the most promising group of implants today.

Yaremchuk, M. J. "Infraorbital Rim Augmentation", Plastic and Reconstructive Surgery, Vol.107 No. 6, pp 1585 -1592 (May 2001)

In patients with recessive infraorbital rims, alloplastic augmentation of the infraorbital rims makes the eyes appear less prominent and improves appearance. Ten patients (seven women and three men) with an average age of 30 years (range, 23 to 45 years) underwent augmentation of the infraobital rim with alloplastic implants over a 9-year period. With an average follow-up of 3 years (range, 6 months to 6 years), reconstructions have remained stable and satisfactory, with no incidence of infection, infraorbital nerve damage, or palpebral fissure distortion. One patient underwent additional surgery to correct contour irregularities, and one patient requested implant removal 1 month after surgery.

Mendelsohn, M., “Use of MEDPOR Splints To Manage Alar Collapse,” Australian Journal of Otolaryngology, Vol. 4, No. 1, pp 16-18 (January 2001)

Airway obstruction due to alar collapse presents a challenge for the rhinoplasty surgeon. The limitations of cartilage grafts have led to the use of MEDPOR grafting in this area. This paper outlines the technique of using MEDPOR grafts to the lateral nasal side walls as used in a series of 19 patients. The technique relies heavily on careful assessment of the exact site of collapse. In every case the MEDPOR graft provided strengthening of the alar side walls. There were no complications. Some minor widening of the nose can occur. Preliminary results in regard to airway improvement were favorable but require long-term follow up.

The author also references seven other published articles on the use of MEDPOR® Surgical Implants for rhinoplasty, and finds a cumulative 1.7% complication rate out of 532 cases.

Yaremchuk, M. J. "Mandibular Augmentation", Plastic and Reconstructive Surgery, Vol 106, No. 3, pp 697-706 (September 2000)

Porous polyethylene implants are available that are designed to augment the mandibular ramus and body. They can be used to increase the bigonial distance in patients with normal mandibular anatomy who desire an increase in lower facial width. When used in combination with extended chin implants, they can camouflage the skeletal contour inadequacies associated with class II mandibular deficiency. The implants are placed through intraoral incisions and fixed with titanium screws. In a clinical experience with 11 patients over 6 years, this technique has proven to be safe and effective.

Ramirez, O. "Mandibular Matrix Implant System: A Method To Restore Skeletal Support To The Lower Face", Plastic and Reconstructive Surgery, Vol. 106, No. 1, pp 176-189 (July 2000)

Disharmony between the skeletal support and the soft-tissue envelope is a common cause of aesthetic concerns regarding the lower face. A loss of volume or a genetically small mandible affects the aesthetics and function of the mouth, chin, and neck. Because of the limitations of correcting such problems with current implants made of silicone or porous polyethylene, the author developed an implant system and a method of restoring the entire volume of the mandible called the mandibular matrix implant system.

This implant system is made of high-density porous polyethylene and is composed of an articulated wraparound geniomandibular implant and a wraparound gonial angle implant. A prejowl implant can be integrated in the system as an addition or as a replacement for a chin implant. This implant system has different sizes and projections, and it can be modified by carving to fit the requirements of most patients. Carving is done using an appropriate sizer. This implant system is indicated for use in patients with a congenitally small mandible, edentulous patients, and patients requesting facial enhancement.

The mandibular matrix implant system is implanted either during a single procedure or simultaneously with a facial rejuvenation. The extended geniomandibular implant is introduced through an anterior oral sulcus incision or a submental incision. The mandibular angle implant is introduced through a retomolar incision. The posterior end of the chin implant overlaps the anterior end of the gonial implant, and screw fixation of each chin component helps to stabilize the entire system. Antibiotics, irrigation, and closure of the incisions are performed before any additional operative procedure. The complete system has been used in 13 patients; one additional patient had the complete system plus an overlapping additional left prejowl implant for correction of asymmetry.

Complications were manageable; these included one mandibular angle implant displacement and one infection. The implant displacement required a re-operation to reset the implant. The infection was treated with irrigation and closed system suction; the implant was salvaged. The satisfaction of patients has been high, and the author can now solve aesthetic problems that in the past were considered unsolvable.

Choe, K.S., Stucki-McCormick, S.U. "Chin Augmentation", Facial Plastic Surgery, Volume 16, Number 1, pp 45-54

The primary goal of facial aesthetic surgery is to restore, enhance, and rejuvenate the aging face to a more youthful appearance, achieving balance and harmony. The mental area must be addressed in order to have a complete synthesis of the face. The concept of augmenting the mental area with implants has evolved so significantly that it now stands by itself as an important procedure. Various autogenous implants for chin augmentation have been in use for over 100 years but have complications. The advent of synthetic materials has given rise to various types of alloplastic implants: Gore-Tex, MEDPOR, Supramid, Silastic, and Mersilene. No one implant is perfect for every face. This article overviews several alloplastic implants - their advantages, disadvantages, and complications, in addition to the different techniques of preparing and delivering the implants.

Key Words: Chin Implants; augmentation; mentoplasty

Romo III, T., Sclafani, A.P., Jacono, A.A. "Nasal Reconstruction Using Porous Polyethylene Implants", Facial Plastic Surgery, Volume 16, Number 1, pp 55-61 (2000)

Nasal reconstruction presents a significant challenge to the facial plastic surgeon. The dual goals of reconstruction are restoration of the desired aesthetic nasal contour and an improved nasal airway. Autologous cartilage and bone are considered optimal grafting material, but their supply is often limited and harvesting entails additional morbidity. Many synthetic materials have been introduced in nasal reconstruction, but high infection and extrusion rates limited their use. Porous high density polyethylene implants present an alternative to autologous material as they allow for fibrovascular ingrowth, leading to stability of the implant and decreased rates of infection. Herein we describe the use of porous high-density polyethylene implants for reconstruction of the platyrrhine nose and in revision rhinoplasty. The use of preformed nasal-dorsal tip and alar batten implants are described, as well as the use of columellar strut and premaxillary plumper implants. We believe that porous high-density polyethylene implants provide a safe, desirable alternative in functional and aesthetic nasal reconstruction.

Key Words: Porous polyethylene implants; nasal reconstruction; revision rhinoplasty; MEDPOR, platyrrhine nose; alar batten implants.

Karnes, J., Salisbury, M., Schaeferle, M., Beckham, P, Ersek, R.A. "Porous High-Density Polyethylene Implants (MEDPOR) For Nasal Dorsum Augmentation", Aesthetic Surgery Journal, Vol. 20, No. 1, pp 26-30 (January/February 2000)

Background: As rhinoplasty techniques are refined, the search for a permanent augmentation material continues. Use of autologous material creates a donor site deformity, and the material may be phagocytized over a period of time. Use of alloplastic materials often results in extrusion and infection.

Objective: The purpose of this study was to examine the results of nasal augmentation using porous high-density polyethylene implants.

Methods: A MEDPOR porous high-density polyethylene implant is carved to the approximate desired size and contour. A pocket is made in the dorsum, and sometimes over the caudal border of the septum, to accommodate the dimensions of the implant. The implant is fitted, removed, trimmed, and refitted until the precise desired contour and position are attained. The implant is rinsed in antibiotic solution and placed in position. The mucosal surfaces are closed with absorbable sutures.

Results: Over the last 12 years, this technique has been used with satisfactory results in more than 30 patients. Two implants were subsequently removed because of partial implant exposure and possible infection. There were no other significant complications. Four typical cases are presented with up to 12 years of follow-up.

Conclusions: When substantial strength is needed, porous high-density polyethylene implants may be used for dorsal augmentation or correction of dorsal defects with satisfactory long-term results and limited complications.

Niechajev, I "Porous Polyethylene Implants for Nasal Reconstruction: Clinical and Histologic Studies", Aesthetic Plastic Surgery 23: pp 395-402 (1999)

Abstract. This paper describes a technique of using Medpor porous high-density polyethylene implants for nasal reconstruction and chin augmentation. This biocompatible material has been used successfully during the last decade for various applications in the reconstruction of the facial skeleton. Among its most frequent uses are repair of the orbital flora and reconstruction of the burned ear, which became standard methods at many centers. Relatively little experience is, at present, on hand concerning the use of porous polyethylene in reconstruction of the nasal framework. Twenty-three consecutive, difficult nasal reconstructions were performed using this method since 1996. Patients were followed up for from 1 to 3 years (mean, 2 years). The results were durable and stable over the time. Eight patients had saddle nose deformity and 15 had catastrophe noses, mostly referrals, previously operated on from one to four times. My aesthetic goals were correction of the depressed nasal dorsum, creation of an acceptable nasal dorsum in the thick and/or twisted noses, and tip elevation. For nasal applications Medpor is available as a strut or sheet. Its body, once implanted, becomes rapidly vascularized and both soft tissue ingrowth and collagen deposition occur. This was confirmed by the microscopic investigation of biopsies. One patient of Vietnamese origin had an aesthetically pleasing result, but her family refused to accept her westernized nose. This gave me a unique opportunity to study the whole Medpor implant 6 months after implantation. There were two complications, one small implant exposure and one low-virulent infection involving the nasal tip. Following revision and antibiotic treatment, both patients healed without sequel. All reconstructions were successful in restoring nasal aesthetics and function.

Four patients underwent chin augmentations with an uneventful clinical course.

Key words: Alloplast - MEDPOR - Implant - Rhinoplasty - Reconstruction

Sclafani, A.P., Romo III, T. "Alloplasts for Nasal Augmentation, Clinical Experience and Scientific Rationale", Facial Plastic Surgery Clinics of North America, Vol. 7, No. 1, pp. 43-54 (February 1999)

The technique of nasal reconstruction has undergone a slow transformation from simple skin coverage of gross midfacial tissue defects, to aesthetic contouring and finally to the dual goals of functional and aesthetic reconstruction. We have progressed in our understanding of implant physiology enough to make a rational decision on their use when adequate autogenous tissue is unavailable. Although autogenous tissue is still by far the preferred material for nasal augmentation, it is no longer acceptable to maintain that alloplasts should never be used in the nose. Patients requiring significant amounts of augmentation, as well as those in whom sufficient autologous tissue of acceptable quality is unavailable, should be considered as candidates for alloplast augmentation in the nose. Further refinements in the form, texture and microstructure, as well as the chemical composition of thee implants, will improve the short- and long-term cosmetic and functional results of nasal reconstruction using alloplasts.

Frodel, J.L., Lee, S. "The Use of High-Density Polyethylene Implants in Facial Deformities", Archives of Otolaryngology - Head and Neck Surgery, Vol. 124, No. 11, pp 1219-1223 (1998)

Objective: To determine the usefulness of porous high-density polyethylene implants (MEDPOR®) in a variety of facial skeletal deformities and subcutaneous defects, excluding those associated with acute maxillofacial trauma.

Thirty-four patients (age range, 20-74 years) with facial deformities requiring skeletal defect reconstruction or augmentation (38 cases), treated between January 1, 1992 and January 1, 1997. Follow-up ranged from 6 months to 40 months.

Main Outcome Measures: Age, type and origin of the deformity treated, type of treatment and complications.

Results: Types of deformities and defects treated include 7 patients with orbital defects (secondary traumatic or oncologic deformities), 8 with temporal fossa defects, 8 with frontocranial defects, 4 with maxillary or malar defects, 7 with calvarial bone graft donor site defects, 2 with microtia and 2 with chin deficiency. Forty implants were placed. Complications included implant exposure in 4 patients and inappropriate augmentation in 1 patient (chin implantation).

Conclusions: High-density polyethylene implants offer an excellent alternative to autogenous and other alloplastic materials in reconstruction of many facial defects and deformities. Advantages include its versatility and relatively ideal pore size that allows for excellent soft tissue ingrowth and coverage. Disadvantages include its rigid nature and difficulty in contouring to the surface of complex skeletal structures.

Robiony, M., Costa, F., Demitri, V., Politi, M. "Simultaneous Malaroplasty With Porous Polyethylene Implants And Orthognathic Surgery For Correction Of Malar Deficiency", Journal of Oral and Maxillofacial Surgery, Vol. 56, Issue 6, pp 734-741 (1998)

Abstact: Patients with skeletal malrelationships caused by maxillary anteroposterior defect and midface hypoplasia may present with an alteration of cheekbone contour. High osteotomies, segmental osteotomies of the zygomatic complex and malar expansion with alloplastic materials can be performed to improve facial aesthetics. This article describes the restoration of cheekbone-nasal base-lip contour by performing a malaroplasty using an alloplastic implant in addition to orthognathic surgery.

From 1995 to 1996, 17 patients with maxillomandibular malrelationships and deficient cheekbone contour were tested by malar augmentation with porous high-density polyethylene in association with maxillary advancement and mandibular setback. The diagnosis of cheekbone contour alteration was made after observing the patient from a lateral, frontal and oblique point of view. The position of the implant was determined by using Mladick's point, with lateral or medial extension in relation to the depressed area.

Results: By the restoration of normal cheekbone-nasal base-upper lip contour produced excellent aesthetic results in all patients. Porous polyethylene biomaterial (MEDPOR®) was utilized in this series.

Conclusions: Malaroplasty in association with bimaxillary orthognathic surgery seems to be an effective procedure for treating midface skeletal deficiencies.

Romo T. III, Sclafani, A.P., Sabini, P. "Use Of Porous High-Density Polyethylene In Revision Rhinoplasty And In The Platyrrhine Nose", Aesthetic Plastic Surgery, Vol. 22, pp 211-221 (1998)

Abstract- Nasal reconstruction presents a significant challenge to the facial plastic surgeon. Reestablishment of the desired aesthetic nasal contour and restoration of respiratory function are the dual goals of this endeavor. While autologous cartilage or bone is considered optimal grafting material, the supply is often limited and harvesting entails additional morbidity. Many synthetic materials have been introduced for use in nasal reconstruction, but high infection and extrusion rates have left most surgeons dissatisfied with conventional implants. Porous polyethylene (MEDPOR®) implants were used for nasal reconstruction in 187 patients; 66 (35.3%) patients underwent primary rhinoplasty, while revision surgery was performed in 121 (64.7%) patients. Most patients required multiple implants, including columella struts, plumper grafts, dorsal tip implants and nasal valve battens. Postoperative follow-up ranged from 6 months to 3.5 years. Complications occurred in five (2.6%) patients. Three early and two delayed infections necessitated implant removal in five patients, all of whom had compromised skin-soft tissue envelopes secondary to heavy smoking, cocaine abuse, or prior surgery. One case of an overly augmented nasal dorsum and tip required implant removal, reduction and reinsertion. All implants were easily removed. No other complications including implant extrusion or skin erosion have been noted. Porous polyethylene (MEDPOR) implants allow for fibrovascular ingrowth, which lends stability to the implant. Porous polyethylene implants are well tolerated and provide an ideal material for nasal reconstruction.

Yaremchuk, M.J., Israeli, D. "Paranasal Implants For Correction Of Midface Concavity", Plastic and Reconstructive Surgery, Vol. 102, No. 5, pp 1676-1684 (October 1998)

Abstract- Central midface concavity was corrected with the placement of porous polyethylene implants in the paranasal area. This simulated the effect of skeletal osteotomies and advancement without altering dental occlusion. Implants were placed to correct congenital, post-traumatic and cleft-related skeletal midface retrusion in nine patients. In seven of the patients, paranasal augmentation was performed in conjunction with rhinoplasty. There have been no implant-related complications during a mean 33 -month follow-up (range 5 to 83 months). Screw fixation of these implants ensures stable positioning and allows precise final contouring during surgery.

Ramirez, O.M. "High Tech Facelift", Aesthetic Plastic Surgery, Vol. 22, pp 318-328 (1998)

The author reports on his use of technological advances to improve aestheticoutcomes including laser skin resurfacing, endoscopy, newer fat grafting procedures, new alloplastic materials for bone augmentation and the use of computer imaging. For skeletal augmentation, the author details his preference for MEDPOR® porous polyethylene material because it "mimics" the structure of bone and has excellent adhesiveness to the recipient bone. Also, the author states that because of the porous nature, there is minimal capsular formation and the tissue ingrowth prevents or minimizes the potential for late infection and immobilizes the implant in the recipient.

Romo, T., Sclafani, A.P., Sabini, P. "Reconstruction Of The Major Saddle Nose Deformity Using Composite Allo-Implants", Aesthetic Plastic Surgery, (June 1998)

Abstract- Nasal reconstruction presents a significant challenge to the facial plastic surgeon. Reestablishment of the desired aesthetic nasal contour and restoration of respiratory function are the dual goals of this endeavor. While autologous cartilage or bone is considered optimal grafting material, the supply is often limited and harvesting entails additional morbidity. Many synthetic materials have been introduced for use in nasal reconstruction, but high infection and extrusion rates have left most surgeons dissatisfied with conventional implants. Porous polyethylene (MEDPOR®) implants were used for nasal reconstruction in 187 patients: 66 (35.3%) patients underwent primary rhinoplasty, while revision surgery was performed in 121 (64.7%) patients. Most patients required multiple implants, including columella struts, plumper grafts, dorsal tip implants and nasal valve battens. Postoperative follow-up ranged from 6 months to 3.5 years. Complications occurred in five (2.6%) patients. Three early and two delayed infections necessitated implant removal in five patients, all of whom had compromised skin-soft tissue envelopes secondary to heavy smoking, cocaine abuse, or prior surgery. One case of an overly augmented nasal dorsum and tip required implant removal, reduction and reinsertion. All implants were easily removed. No other complications including implant extrusion or skin erosion have been noted. Porous polyethylene (MEDPOR) implants allow for fibrovascular ingrowth, which lends stability to the implant. Porous polyethylene implants are well tolerated and provide an ideal material for nasal reconstruction.

Ramirez, O.M. "RZ Mandibular Matrix System Instructional Guide", presented at Advances in Facial and Body Contouring, University of Utah School of Medicine - Winter Symposium (February 1998)

Abstract - The RZ Mandibular Matrix System is composed of a series of MEDPOR® Implants (Porex Surgical Inc.), designed to address many of the problems associated with the loss or genetic absence of an adequate contour of the mandible, from the angle and ascending ramus posteriorly to the chin symphysis anteriorly.

The implants can be used in conjunction with facial rejuvenation or in isolated procedures. The versatility of the multiple pieces makes it possible to augment the entire mandible or individual segments. Each implant has been designed with a wrap-around component to allow fit onto the free borders of the mandible. The implants are self-stabilizing and require minimal screw fixation. They differ from the two dimensional onlay type of implants by providing a tri-dimensional restoration and/or enhancement of the volume of the chin and/or mandible, as well as the gonial angle.

Türegün, M., Sengezer, M., Güler, M. "Reconstruction Of Saddle Nose Deformities Using Porous Polyethylene Implant", Aesthetic Plastic Surgery, Vol. 22, pp 38-41 (1998)

Abstract - Various materials have been employed for nasal contour restoration. We used porous polyethylene implants in reconstruction of saddle nose deformity in 36 cases. Only one complication occurred in the 8-18 months follow-up period. No implant was removed. Both cosmetic and functional results were accepted as pleasing by the patients.

Rubin, J. P., Yaremchuk, M. J. "Complications And Toxicities Of Implantable Biomaterials Used In Facial Reconstructive and Aesthetic Surgery: A Comprehensive Review of the Literature", Plastic and Reconstructive Surgery, Vol. 100, No. 5/Complications of Implantable Biomaterials (October 1997)

The use of implantable biomaterials has become an integral part of aesthetic and reconstructive surgery of the face. Metals are used for fracture fixation devices, whereas polymers are used primarily for bone or soft-tissue substitution. This review of the scientific literature examines the risks and complications of these materials. First, we present an overview of commonly used materials. Second, we address general considerations of toxicity relevant to all biomaterials. Third, we present data from a large number of clinical series on the incidence of complications for individual materials used in specific applications.

Belinfante, L.S. "Aesthetic Contouring Of The Mentolabial Fold As An Adjunct To The Osseous Sliding Genioplasty", Journal of Oral Maxillofacial Surgery, Vol. 55, pp 1023-1025 (September 1997)

Abstract - Many times when performing a genioplasty, the resultant mentolabial fold becomes too acute. This usually occurs because of the discrepancy between the residual mandible and the anterior sliding segment. To overcome this problem, an implant can be placed that obliterates the dead space above the newly created step and transforms a potentially acute mentolabial angle into one that is more obtuse and esthetic.

Special MEDPOR® Genioplasty shapes are used in this technique.

Ramirez, O.M., Pozner, J.N. "Endoscopic Assisted Facial Implant Insertion", Plastic Surgery Products (February, 1996)

The author describes his surgical techniques including the endoscopic placement of Porex (MEDPOR®) RZ malar implants.

Cenzi R., Guarda-Nardini, L. "The Use Of Porous Polyethylene (MEDPOR®) in Maxillofacial Surgery", Minerva Stomatol, Vol. 44, pp 559-582 (1995)

Adamo, A.K., Pollick, S. A., Lauer, S. A., Sterman, H. R. "Zygomatico-Orbital Fractures: Historical Perspective and Current Surgical Management", The Journal of Cranio-Maxillofacial Trauma, Vol. 1, No. 2 (Summer 1995)

This article presents s general historical review of zygomatico-orbital (ZO) fractures with application of contemporary surgical procedures. Two surgical cases are presented, in which the ZO fractures were approached via a transconjunctival incision with a lateral canthotomy. A two-point rigid internal fixation, combined with a porous high-density polyethylene orbital floor reconstruction, produced uniformly excellent cosmetic and functional results in a total of 42 patients with ZO fractures who were treated over a 2-year period.

Clinical References Prior to 1995

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Literature Review Medpor® Biomaterial and Porex Surgical Products