Lok Sabha Question No. 570 (UNSTARRED), answered on 2016-11-18
Subject: Implan on Trial
Ministry: HEALTH AND FAMILY WELFARE
Asked by: DHARAM VIRA GANDHI

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH RESEARCH

## LOK SABHA UNSTARRED QUESTION NO. 570 TO BE ANSWERED ON 18 TH NOVEMBER, 2016

## IMPLAN ON TRIAL

## 570. SHRI DHARAM VIRA:

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 thereport 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?

## ANSWER 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  o Medical Research, no such information is available.
- (c)& (d) : Indian Council of Medical Research (ICMR) has informed that a report on Impla 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 departmen of 22 Medical colleges/Hospitals representing all regions. A total of 3119 women were pro thedevice 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 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  lo discontinuation  rate  of  3.4  and  3.7  per  1 00  users  respectively.  The  other  reasons  for discontinuation included planning pregnancy/desire for another child, other medical reaso weight gain. Personal reasons and relocation of residence accounted for a discontinuation

2.6 and 3.1 per 1 00 users respectively. Fewer women discontinued due to Implanon insertion related issues. There was no discontinuation due to infection at site of insertion. Th - to follow - up in the study was very low at 3 years of observation.

In majority of the wo men no difficulty was observed by physicians trained in insertio 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 p during I mplanon use however, majority stated that the change in menstrual bleeding pattern not interfere with their daily activities.

Return  of  fertility  in  women  exposed  to  risk  of  pregnancy  after  discontinuati Implanon  use  indicated  a  cumulative  preg nancy  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 newer version Nexplanon single - rod subdermal device could be a viable additional contraceptive  choice  as  a  long  acting  contraceptive  method  in  the  National  Family  We Programme (NFWP) of Govt. of India.