[No registration of complications for implants used in gynaecological surgery].

Introduction: In recent years, many new surgical implants (biological and synthetic) for female urinary incontinence and pelvic organ prolapse (POP) surgery have been launched in Denmark. In the literature, complications have been reported in up to 40% of cases depending on the type of operation, 2-5% as serious complications. An implant can achieve CE-marking if it seems likely that it is substantially equivalent to an implant already on the market. Thus implants can be launched without clinical data.

Material And Methods: Correspondence or contact by phone to: 1) The Danish Ministry of Public Health, 2) The Danish National Board of Health (DB), 3) Danish Medicines Agency (DM), 4) Dansk Standard, and 5) companies/manufacturers in order to establish who has the responsibility for surveillance and approval of such medical devices in Denmark. Furthermore, we established how many surgical implants for urine incontinence and POP surgery are currently on the Danish market.

Results: Twenty-five different surgical devices are currently being marketed in Denmark. DM has the responsibility to collect, register and to act on complications. DM had four reports of complications in the period 2001-2006. Both the surgeon and the manufacturer/company have a duty to report complications.

Conclusion: The Danish medical authorities have no records showing which surgical implants have been launched on the Danish market. There is an urgent need to establish a reliable registry which can facilitate surveillance of new surgical implants in order to improve patient safety. There is also a considerable need to increase the requirements, including the requirements for clinical data, before new surgical implants may be launched.