Subcutaneous Implantation of Microparticulate PTFE (Gore-Tex)

Otolaryngology - Head and Neck Surgery, 1999

Dermatologic Surgery, 1997

BACKGROUND. Injectabtc synthetic materials have been used for augmentation of soft tissue defects, correction of ivrinkles, and augmentation of facial features such as the nasal dorsum. Success has been limited by inflammatory reactions, material migration, and the difficulty of removal should complications oceiir. OBJECTIVE. To evahtate complications resulting from soft tissue augmentation with injectable alloplastic materials. METHODS. Retrospective review of seven cases. Clinical history, treatment, histopathotogic findings, and outcomes are assessed. RESULTS. Inflammatory reaction and tissue damage zvere refrac-tory to antibiotics and steroids, and surgery was required to remove the foreign material Histologic examination revealed giant cell foreign body reaction in ail cases. CONCLUSION. Injectable synthetic polymers can produce significant complications including deformity and inflammatory tissue destruction, the control of which is complicated by the difficulty of removing the materials. Removable tissue fillers, such as e-PTFE, or natural materials such as collagen, autologous, fat, or Alloderm, should be considered instead.

European Journal of Plastic Surgery

Today an increasing number of patients seek aesthetic improvement through minimally invasive procedures, and interest in soft tissue augmentation and filling agents is rising steadily. However, a thorough understanding of these substances, their indications and contraindications, as well as a profound knowledge of different implantation techniques is essential to provide an aesthetically pleasing result for the patient. This presentation gives an overview of the current injectable biomaterials, their major indications, advantages and disadvantages, with focus on collagen, hyaluronic acid, poly-l-lactide, and autologous fat grafting.

Journal of Craniofacial Surgery, 2008

Aesthetic Plastic Surgery, 2010

After more than 25 years of research and development, in October 2006 ArteFill Ò became the first and only permanent injectable wrinkle filler to receive FDA approval. ArteFill is a third-generation polymeric microsphere-based filler, following its predecessor Artecoll Ò , which was marketed outside the United States between 1994 and 2006. ArteFill is approved for the correction of nasolabial folds and has been used in over 15,000 patients since its U.S. market introduction in February 2007. No serious side effects have been reported to date according to the FDA's MAUDE reporting database. Ar-teFill consists of polymethylmethacrylate (PMMA) microspheres (20% by volume), 30-50 lm in diameter, suspended in 3.5% bovine collagen solution (80% by volume) and 0.3% lidocaine. The collagen carrier is absorbed within 1 month after injection and completely replaced by the patient's own connective tissue within 3 months. Each cc of ArteFill contains approximately six million microspheres and histological studies have shown that long-term wrinkle correction consists of 80% of the patient's own connective tissue and 20% microspheres. The standard injection technique is subdermal tunneling that delivers a strand of ArteFill at the dermal-subdermal junction. This strand beneath a wrinkle or fold acts like a support structure that protects against further wrinkling and allows the diminished thickness of the dermis to recover to its original thickness. Keywords ArteFill Á Dermal filler Á Permanent filler Á Soft tissue augmentation Á Wrinkle treatment The first commercially successful, FDA-approved injectable filler for soft tissue augmentation was a solution of soluble collagen [1, 2] marketed by Collagen Corporation in 1983. Until then, the only widely used ''off-the-shelf'' injectable filler had been liquid dimethylpolysiloxane (silicone). Complications from liquid silicone (LIS), however, were often disfiguring and challenging to correct. Collagen injections, on the other hand, were never held out as permanent corrective devices for the treatment of soft tissue defects, whether scar depressions, atrophy, or wrinkle lines. The corollary mantras ''temporary solution, but temporary problems'' (if an adverse event should occur), and ''permanent solution, permanent problems'' were associated with collagen and silicone, respectively. However, although both patients and physicians accepted the inconvenience and repeated expense of short-term fillers, they have long sought a dermal filler substance that

Journal of Craniofacial Surgery, 2013

Objective/Hypothesis: The aim of this study was to assess the tissue response to Gore-Tex (expanded polytetrafluoroethylene) in rats and compare the results of surgical placement modalities. Study Design: Prospective animal study. Materials and Methods: Experiments were performed in 18 young Sprague-Dawley rats that were divided into 3 groups. Gore-Tex patches were implanted subcutaneously over the periosteum in the first group and under the periosteum in the other groups. Gore-Tex was immersed in an antibiotic-containing solution in the third group. All animals were killed 4 weeks after the procedure. The tissue samples were stained with hematoxylin and eosin stain and evaluated using a light microscope. Results: The Gore-Tex patches were displaced and not observed at the originally implanted sites in the first group. The Gore-Tex patches were observed at the originally implanted sites in the other groups. In group 1, edema and inflammation were prominent. In the second group, ossification was detected in 5 rats and foreign-body reaction and edema were identified in 1 rat. In the third group, all of the rats were found to have developed ossification, but no inflammatory reactions were observed. Conclusions: The results suggest that implanting synthetic graft materials immersed in an antibiotic solution at the subperiosteal plane provides better stabilization and low complication rates.

Dermatologic Therapy, 2000

Cosmetic surgery is more prevalent than ever before. Cosmesis, the art of preserving one's beauty, has become an important concern in young and old alike. As the Baby Boomer population begins to show signs of aging, dermatologists can play an integral role. Skin resurfacing is often considered the firstline approach for facial rejuvenation. Topical agents, chemical peels, dermabrasion, and lasers are used for this purpose. However, one must not forget about soft tissue augmentation. Filler substances may be essential for adequate correction; especially when there is significant associated atrophy. Currently there are many filler materials available in our therapeutic armamentarium (Table 1). From a practical standpoint, it makes sense to divide these into agents placed into the dermis and agents placed in the subcutaneous tissues. This article reviews several of the newer filler substances available for soft tissue augmentation.

Aesthetic Plastic Surgery, 2010

Patients ask for procedures with long-lasting effects. ArteFill is the first permanent injectable approved in 2006 by the FDA for nasolabial folds. It consists of cleaned microspheres of polymethylmethacrylate (PMMA) suspended in bovine collagen. Over the development period of 20 years most of its side effects have been eliminated to achieve the same safety standard as today's hyaluronic acid products. A 5-year follow-up study in U.S. clinical trial patients has shown the same wrinkle improvement as seen at 6 months. Long-term follow-up in European Artecoll patients has shown successful wrinkle correction lasting up to 15 years. A wide variety of off-label indications and applications have been developed that help the physician meet the individual needs of his/her patients. Serious complications after ArteFill injections, such as granuloma formation, have not been reported due to the reduction of PMMA microspheres smaller than 20 lm to less than 1% ''by the number.'' Minor technique-related side effects, however, may occur during the initial learning curve. Patient and physician satisfaction with ArteFill has been shown to be greater than 90%.

Aesthetic Plastic Surgery, 1992

The development of small, textured implant particles suspended in a hydrogel has allowed for subdermal injection therapy to fill tissue defects. The microimplant particles were placed subdermally into the ears of white New Zealand rabbits in order to characterize the foreign body response and the permanence of the implant. Serial micrometer readings were performed on the implant sites to determine any change in thickness of the augmentation following baseline measurement. An initial increase in the thickness was noted approximately 20-30 days postimplantation, as expected. A stable thickness was noted for the remainder of the experiment. Serial histological sections were performed at irregular intervals from one week to one year. Histology demonstrated a mild foreign body response with collagen surrounding each individual microimplant particle. The response was stable after 30-40 days and has remained stable for over one year. It was determined that the histology demonstrated a Boros 1A type, or nonimmunogenic, low-turnover foreign body reaction.