Abstract
During the transvaginal mesh era some women have suffered unexpectedly poor outcomes following the insertion of transvaginal mesh for the surgical management of pelvic organ prolapse. To minimize the risk of these events repeating, we support changes to approval process of new devices including premarket demonstration of safety and efficacy. Clinicians should demonstrate greater vigilance in the introductory phase of new technologies including incorporating ethics committee approval for procedures without adequate safety and efficacy data. Formalization of an ‘arm’s length’ relationship between clinicians and industry would help minimize conflicts of interest which may unduly bias the introduction of new technologies and create improved transparency and confidence. Colleges and educational societies where the elected representatives are free of any relationship with industry could facilitate the ‘arm’s length’ relationship between clinician and industry that our community demands. These changes to regulatory approval, caution in the introduction of new technologies and greater transparency surrounding the relationship between industry and clinicians should minimize the risk of patients suffering significant unforeseen complications and poor outcomes.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.
No writing assistance was utilized in the production of this manuscript.