Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:
(a) whether the Government is considering the inclusion of Implan on into the basket of contraceptive choices available in the public health system;
(b) if so, the details in this regard along with the likely time for the release of the report by the Government;
(c) whether Indian Council of Medical Research (ICMR) has submitted its report on Implan on trial to DGCI; and
(d) if so, the details thereof?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SMT. ANUPRIYA PATEL)
(a) & (b): As informed by Directorate General of Health Services and Indian Council of Medical Research, no such information is available.
(c) & (d): Indian Council of Medical Research (ICMR) has informed that a report on Implan on trial is submitted to Drug Controller General of India (DCGI) in June, 2016.
ICMR evaluated Implanon through its research centres located in the ObGyn department of 22 Medical colleges/Hospitals representing all regions. A total of 3119 women were provided the device after a written informed consent.
There was no report of involuntary pregnancy (method failure) among 3119 Implanon users at 3 years of use. The overall continuation rate was 66.1 per 100 users at the end of 3 years. The Lost-to-follow-up in the study was very low at 3 years of observation.
A total of 1069 women discontinued Implanon use before 3 years mostly due to unpredictable menstrual bleeding. Amenorrhoea and irregular bleeding accounted for lower discontinuation rate of 3.4 and 3.7 per 100 users respectively. The other reasons for discontinuation included planning pregnancy/desire for another child, other medical reasons and weight gain. Personal reasons and relocation of residence accounted for a discontinuation rate of 2.6 and 3.1 per 100 users respectively. Fewer women discontinued due to Implanon insertion related issues. There was no discontinuation due to infection at site of insertion. The lost-to-follow-up in the study was very low at 3 years of observation.
In majority of the women no difficulty was observed by physicians trained in insertion and removal of Implanon. Regarding women’s perception of menstrual pattern change during Implanon use, 66.1 % stated that they experienced change in their menstrual bleeding pattern during Implanon use however, majority stated that the change in menstrual bleeding pattern did not interfere with their daily activities.
Return of fertility in women exposed to risk of pregnancy after discontinuation of Implanon use indicated a cumulative pregnancy rate of 70.8 per 100 users at one year post discontinuation of Implanon.
The overall results of the ICMR study indicates that etonogestrel implant Implanon or the newer version Nexplanon single-rod subdermal device could be a viable additional contraceptive choice as a long acting contraceptive method in the National Family Welfare Programme (NFWP) of Govt. of India.