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.

Fretting corrosion testing of acetabular modular tapers for total hip replacements: A comparison of two designs.

Acetabular components (DePuy Pinnacle (A) and Stryker Trident (B), Ti-6Al-4V shells and CoCrMo liners) with varying geometries were assembled under a 4 kN seating load. Liner-displacement was recorded. Cyclic compression to 4 kN, R = 0.01, 9 Hz was applied for three million cycles to evaluate fretting corrosion currents (n = 5). Fretting currents, load-displacement, ion dissolution, and disassembly loads were used to compare device performance. Data were analyzed using ANOVA with Tukey post hoc comparisons (p < 0.05). Liner seating displacements were not significantly different between groups. Fretting currents averaged over the initial 10 h and over three million cycles were 0.17 µA (A) and 0.55 µA (B) and 0.05 µA (A) and 0.17 µA (B), respectively (p = 0.19). No variation in ion averages between A and B (0.23 and 0.45 ppm for Ti [p = 0.21], 0.63 and 0.85 ppm for Co [p = 0.47]) existed. Average push-out forces, -2.41 (A) and -2.42 kN (B), were not significantly different (p = 0.97). SEM and EDS showed some titanium and metal oxide transfer from the shell to the liner in both designs. Overall, both implant designs exhibited very minor MACC in these experiments. This study demonstrates quantitative measures of in vitro fretting corrosion over the course of three million cycles and the minimal degree of acetabular taper damage. Clinical Significance: Retrieval studies show dual mobility acetabular shell-liner tapers with metal-on-metal contacts are susceptible to fretting corrosion in vivo.