Authors' objectives:

This report summarises the assessment of hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implant

Authors' results and conclusions: To date, no pregnancies have been reported in patients who have relied on the intrafallopian implant as their primary form of contraception. However, further long-term follow-up and additional studies are required to fully establish the effectiveness of the intrafallopian implant over time. One condition of a recommendation by the US Food and Drug Administration's Center for Devices and Radiological Health (2002) for premarket approval of the Essure system was that the manufacturer follow the subjects for five years. It is the stated intention of the manufacturer to collect data from patients in the Phase II and Pivotal studies for five years post-implantation. In total, 86 per cent (194/227) of patients who commenced the Phase II study and 83 per cent (430/518) of patients from the Pivotal study currently rely on the intrafallopian implant as their primary method of contraception. One patient with unilateral placement in the Phase II trial relied on the intrafallopian implant as the sole method of contraception due to proximal tube occlusion in the contralateral tube. Two patients with unilateral placement in the Pivotal study were also able to rely on the device for contraception due to possession of a unicornuate uterus. It should be noted that approximately 15 per cent of patients are unable to rely on the implants for contraception, often due to anatomical factors. Overall, hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implant (HSTCPII) appears to be a relatively effective procedure, which has not been associated with any pregnancies to date. However, as with safety considerations, further follow-up data and additional studies are required to ascertain the full effectiveness of HSTCPII.

Authors' recommendations: The MSAC recognised that hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implant is an evolving technology but as there was presently insufficient evidence pertaining to its safety, effectiveness and cost-effectiveness, the MSAC recommended that public funding for the procedure should not be supported at this time. The Minister for Health and Ageing accepted MSAC's advice on the safety, effectiveness and cost-effectiveness of this technology. However, as more Australian data are due to become available shortly, the Minister approved a continuation of interim reimbursement until November 2007, to allow further assessment to occur.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/pdfs/reports/msac1055.pdf

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee