Pterygopalatine-Infratemporal Fossa Hydatid Cyst Resembling Cystic Tumor.

Hydatid cyst is an endemic disease in Mediterranean and Middle Eastern countries, Eastern European countries, East Africa, China, New Zealand, Australia. We aimed to present this educational case, which is endemic in our country and seen in a very rare localization, with the combined surgical approach, within the literature.

Retrieval analysis of the Essure® micro insert female sterilization implant: Methods for metal ion and microscopic analysis.

The Essure® Device is a female sterilization implant comprised of four alloys (Ni-Ti, 316L SS, Pt-Ir and Sn-Ag) and Dacron fibers. As part of the mandated 522 post-market surveillance study, implant retrieval and metal-ion analysis methods were developed separate from patient clinical data, to quantify trace metal ions found in tissue and to assess implant degradation present. Three segments of tissue (proximal implant, distal implant, and tissue distal from the implant) stored in neutral buffered formalin, were retrieved. Tissue was prepared for metal ion analysis using inductively coupled mass spectrometry (ICP-MS). Implant sections from four patients, were analyzed using digital optical microscopy (DOM), scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS). Image analysis showed Sn-Ag solder corroded and elevated Sn ion levels in tissue proximal to the solder compared to tissues more remote in all cases observed. The 316L SS exhibited signs of degradation with high surface concentrations of molybdenum and chromium and low iron compared to the parent alloy. Evidence of elevated iron, chromium and nickel within the tissues and storage solutions combined with precipitation of an iron-calcium-phosphorous material on some implants indicate evidence of SS corrosion. Ni-Ti, Pt-Ir and Dacron appear to have no major damage. This study includes preliminary results as part of the ongoing 522 study and therefore no final conclusions regarding the device or patient data can be drawn from this present study until the entire 522 study is complete. STATEMENT OF SIGNIFICANCE: The Essure Device is a female sterilization implant that was implanted into approximately 750,000 women. The device is composed of polyethylene terephthalate fibers and 4 metal alloys, 316L stainless steel, Nickel-Titanium, Tin-Silver and Platinum-Iridium. Following an increase in patient reported adverse events, the FDA required a 522-post market surveillance study. As part of this study, implants are retrieved from patients via salpingectomy or hysterectomy. This study focuses on the development of the implant retrieval methods following surgery, with focus on measuring local tissue metal ions, their distribution and assessing the degradation of the implant without correlation to patient clinical condition.

In Vitro Corrosion Assessment of the Essure® Medical Device in Saline, Simulated Inflammatory Solution and Neutral Buffered Formalin.

The Essure® permanent contraceptive implant, comprised of four alloys (nickel-titanium, 316L stainless steel, platinum-iridium, and tin-silver solder) and Dacron (PET) fibers, has been approved for use in the US for about two decades. However, little has been published on this implant's biomaterials performance, and as this implant gains interest in terms of in vivo performance, methods of implant post-retrieval storage also need to be assessed. This study investigated the electrochemical properties and ion release profile of Essure® during storage in phosphate buffered saline (PBS), 10 mM H2O2/PBS, a simulated inflammatory solution, and 10% neutral buffered formalin (NBF) to investigate the corrosion behavior and metal ion release. First, a galvanic test method was used to measure the galvanic interactions between alloys within the device. Second, an ion-release study over 107 days was performed. Ions were measured using inductively-coupled plasma mass spectrometry and the implants were assessed using digital optical microscopy, scanning electron microscopy, and energy dispersive x-ray spectrometry. The tin-silver (SnAg) solder continuously corroded in PBS and H2O2/PBS. In the presence of H2O2, nickel and titanium ions were released from the nickel-titanium (NiTi) coil, whereas release of these ions was minimal in PBS alone. Overall, corrosion of the SnAg solder, which holds the NiTi and 316L SS together, was significant in both PBS and H2O2/PBS and may result in loss of connection of the NiTi and 316L stainless steel portions of the implant. Storage in NBF exhibited very low corrosion rates for all alloys and low levels of ion release were observed indicating that formalin storage minimally affects the implant's corrosion status. STATEMENT OF SIGNIFICANCE: The Essure® device is an FDA premarket-approved female permanent sterilization device containing four different metal alloys and poly(ethylene terephthalate) polymer fibers. Significant concerns related to this device have been raised by the FDA since its introduction in 2002. This study is the first published in vitro work to specifically assess the corrosion mechanisms in this multi-alloy device and the role of different solution environments, including formalin storage, inorganic physiological saline and a simulated inflammatory condition. Significant evidence of corrosion of the tin-silver solder is documented, the release of Ni and Ti under simulated inflammatory conditions, and the relative inertness of storage of these implants in neutral buffered saline is presented. The tin-silver corrosion corroborates recent clinical evidence of tin corrosion products in tissues adjacent to these devices in vivo.

Factors Affecting Dimensional Accuracy of 3-D Printed Anatomical Structures Derived from CT Data.

Additive manufacturing and bio-printing, with the potential for direct fabrication of complex patient-specific anatomies derived from medical scan data, are having an ever-increasing impact on the practice of medicine. Anatomic structures are typically derived from CT or MRI scans, and there are multiple steps in the model derivation process that influence the geometric accuracy of the printed constructs. In this work, we compare the dimensional accuracy of 3-D printed constructs of an L1 vertebra derived from CT data for an ex vivo cadaver T-L spine with the original vertebra. Processing of segmented structures using binary median filters and various surface extraction algorithms is evaluated for the effect on model dimensions. We investigate the effects of changing CT reconstruction kernels by scanning simple geometric objects and measuring the impact on the derived model dimensions. We also investigate if there are significant differences between physical and virtual model measurements. The 3-D models were printed using a commercial 3-D printer, the Replicator 2 (MakerBot, Brooklyn, NY) using polylactic acid (PLA) filament. We found that changing parameters during the scan reconstruction, segmentation, filtering, and surface extraction steps will have an effect on the dimensions of the final model. These effects need to be quantified for specific situations that rely on the accuracy of 3-D printed models used in medicine or tissue engineering applications.