Implants in Urogynecology
1Lukas Hospital Neuss, Neuss, Germany
2German Center for Implant-Pathology, Duren, Germany
3University Hospital of the RWTH Aachen, Aachen, Germany
Implants in Urogynecology
Description
Currently, due to reported complications and consecutive law issues especially in the USA there is a high uncertainty among clinicians and patients about the application of urogynecologic implants. New regulation strategies are urgent and in debate now. In a Public Health Notification (PHN), from 2008, the Food and Drug Administration (FDA) reported more than 1000 unexpected and severe adverse events, mostly associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2011 and 2012, the second and third FDA amendments have been published questioning the role of mesh application for POP and SUI repair and proposing a change to Class III status that would allow the request of premarket approval and postmarket surveillance studies. Structured development process and long-term registers (IDEAL recommendations, McCulloch, Lancet 2009) for the implants are necessary, in order to provide better patient counselling and to promote technological improvements of alloplastic materials.
Thus, we invite authors to submit original research and review articles that will focus on the implants in urogynecology. Articles published in this special issue are of interest to researchers and clinicians. The special issue will become an international forum for researchers and clinicians to summarize the most recent developments, advances in techniques, surgery, materials, assessment, and ideas in the field, with a special emphasis given to the technical and observational results obtained within the last five years.
Potential topics include, but are not limited to:
- Recent development and indications for mesh application for POP and SUI
- Artificial urinary sphincter
- Postoperative complications and law issues on implants
- Immunological and inflammatory reactions on the implantation of alloplastic materials and their impact on the biocompatibility in the host
- Latest technologies for clinical evaluation and advances in biocompatibility of implants
- Next generation implants
- IDEAL criteria: strategies for clinical evaluation and long-term surveillance