Ethical Issues Associated With the Introduction of New Surgical Devices, or Just Because We Can, Doesn’t Mean We Should

The short life cycle of a surgical device – Literature analysis using McKinlay׳s 7-stage model

“…The evidence provided in the licensing process is not published, and therefore this process is not identified in the medical literature. TVT Secur, like many devices in this area of practice, was licensed in Europe, the US and Canada on the basis of a predicate licensed moderate risk device, so that no additional evidence of safety or efficacy was required [1][2][3][4]. Ethicon claimed the device was substantially equivalent to the company's TVT and TVT-O devices already on the market, and released the TVT Secur accompanied by data on the outcome and follow-up of the older devices.…”

“…the challenges created by such derivative moderate risk devices for evidence-driven policy and clinical practice. In particular, rigorous objective evaluation of innovations (preferably through clinical trials) prior to their introduction, as recommended by McKinlay and advocated by critics of the commercialization of medical devices [2][3][4]9,10], seems increasingly unlikely.…”

“…Device regulations in these jurisdictions did not require new evidence of safety and effectiveness [1] to license TVT Secur, and no studies had been carried out in live humans before the device was approved [2][3][4].…”

“…The announcement emphasized that the company continued to have confidence in the safety and efficacy of TVT Secur, and that the decision to discontinue the device was based on commercial considerations, specifically related to the changing regulatory environment and competitive worldwide market. The regulatory environment is coming under increasing scrutiny as product advisories related to transvaginally-implanted surgical mesh appear [5][6][7], the number of withdrawals increases [8] and commentators criticize the licensing of devices without evidence of safety or effectiveness [2][3][4]9]. The pelvic floor device market is fiercely competitive, including many device manufacturers each with a variety of competing devices.…”

Ethical Issues and Training in Laparoscopic Surgery

“…5 During the training program in WLH a qualified laparoscopic surgeons will guide the trainees how to assess the effectiveness and safety of a new laparoscopic surgical device before using it. Because human dignity is the priority in WLH, Professor Mishra obliges himself to teach the trainees how to obtain informed consent from patients in a manner that is comprehensible and in accordance with the language, customs and culture of the patient.…”