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The Why and How of Sterilisation
Failures and Mortality
Dr.K.Gomathi,MBBS,DGO
Govt.Hospital,
Thirumayam
Why standards on Sterilisation
Standards on Sterilisation Services ensures
provision of quality services to the clients
by programme managers and service
providers providing permanent methods of
contraception.
Counselling
Counselling is the process of helping clients
make informed and voluntary decisions about
fertility.
General courselling should be done whenever a
client has a doubt or is unable to take a decision
regarding the type of contraceptive method to
be used.
However,in all cases,method-specific counselling
must be done.
Sterilisation-Explain to the client
It is a permanent procedure for preventing
future pregnancies
It is a surgical procedure that has a
possibility of complications,including
failure requiring further management.
It does not affect sexual pleasure,ability,
or performance.
Explain to the client
It will not affect the clients strength or her
ability to perform normal day-to-day functions.
Sterilisation does not protect against RTIs,STIs,
or HIV / AIDS.
Clients must be told that a reversal of this
surgery is possible, but that the reversal involves
major surgery and that its success cannot be
guaranteed.
Specific
points on
surgical
techniques
Preparation of the surgical site
The operative area should not be shaved.
The hair can be trimmed, if necessary.
The operative site should be prepared
immediately preoperatively with an
antiseptic solution,such as iodophor or
chlorhexidine gluconate.
Alcohol preparation should not be applied
to the sensitive genitalia.

Preparation of the surgical site
Iodophor and chlorhexidine are safe to
use on mucous membranes and can be
used to cleanse the vagina and vervix.
Iodophor requires 1 to 2 minutes to work
because a certain amount of time is
needed for the release of free iodine,
which inactivates the micro-organisms.
Preparation of the surgical site
Antiseptic solution should be applied liberally at
least two times on and around the operative
site,which should be thoroughly cleansed by
gentle scrubbing.
The antiseptic solution should be applied in a
circular motion,beginning at the site of incision
and working ot for several inches.
This inhibits the immediate re-contamination of
the site with local skin bacteria.
Preparation of the surgical site
The excess antseptic solution should not
be permitted to drip and gather beneath
the clients body as this may cause
irritation.
After preparing the operative site,the area
should be covered with a sterile drape.
Important do s and dont s
The operating surgeon should identify each
fallopian tube clearly following it right up to the
fimbria.
Excise the tube at the isthmal region only
Excision of 1 cm of the tube should be done.
Always use a avascular window of the
mesosalpynx(an area without any blood vessels)
for ligation.
Use of cautery and crushing of the tube should
be avoided.
Important do s and dont s
An interval minilaparotomy procedure
would benefit from the use of a uterine
elevator to bring the fallopian tubes into
the operative field.
The incision for a minilaparotomy
(interval,post-abortal,or post-partum )
may be transverse or longitudinal.
Important do s and dont s
A single round or square suture is
sufficient for tubal occlusion.
Never go round the tube or in between
the cut ends unless it is required for
hemostasis.
Important do s and dont s
Before closing the abdomen always ensure
complete hemostasis.
Look for anomalous or additional falloian tubes.
This should be more carefully looked for in cases
of failure of sterilisation.
If there is any problem during the procedure
always DOCUMENT the fact and manage
accordingly in the post op period.
MOST IMPORTANT DON T
Do not perform
Fimbriectomy as a tubal
sterilisation technique
Laparoscopy Procedure
To avoid hypoventilation,the patient must
not be placed in the Trendelenburg
position in excess of 15 degrees.
An uterine elevator should be used to
visualize the fallopian tube.
Pneumoperitoeum should be created with
Veres needle.
Laparoscopy Procedure
Insufflation of abdomen with carbon
dioxide is the prefered method Intra
abdominal pressure must not exceed 15
mm of mercury.
Slow insufflations with graded insufflator
and gradual desufflation should be done.
The skin incision should not exceed the
diameter of the trocar.
Laparoscopy Procedure
The trocar is to be angled towards the
hollow of the sacrum.
The opeator must lift the anterior
abdominal wall before introducing the
trocar.
Tubal occlusion must always be done with
Falopes rings ( no cauery is to be used).
Precautions to be followed in
applying Falope rings
Draw the tube slowly and smoothly into the
sleeve of the laparoscope after proper
identification (include only the amount of tube
necessary to provide adequate occlusion).
To prevent injury to the mesosalpinx /
tube,avoid pulling up or back on the laparocator.
Do not apply rings in case of thick oedematous
or fixed tubes.
In such cases,tubal occlusion should be done
with laparotomy by conventional method.
Precautios to be followed in
applying Falope rings
After applying the second ring,the operator
should systematically inspect the pelvis to verify
that both tubes are now occluded that there is
unusual bleeding,and that there is no visceral
injury.
The surgeon should expel all the gas from the
abdominal cadvity slowly before removing the
trocar.
What is failed sterilisation ?
Conception that occurs after sterilisation is
termed failed sterilisation.
It can occur several years after the procedure.
10-year cumulative probability of pregnancy of
18.5 per 1000 procedures
(US CREST study; Peterson et al.1996)
8 per 1000 procedures ( canada; Trussell et
al.,2003)
Sterilisation fails due to variation in
The characteristics fo the women
undergoing sterilisation.
Operator experience.
Operating Centre
Sterilisation method chosen

Sterilisation failure
Although sterilisation failure can occur
at any time, the rate of pregnancy after
tubal ligatioon goes up after ten years.
Age plays a major role because the
younger the women, the greater are the
chances of failure which could be because
they are more fertile when compared to
the older women.

Causes of sterilisation failure
A fistula or re-anastomosis is formed at
the ends of the tube that grows back
together when the gap between them is
not very large.
In cases, where a falope ring is used then
the clamp can get loose or fall off
resulting in pregnancy.

Causes of sterilisation failure
If the tube is not blocked totally o not cut
properly or if the device used for the
occlusion was not placed properly in the
right position.
The round ligaments are tied mistakenly
instead of fallopian tubes.
Cause of sterilisation failure
Obesity or pelvic adhesions might make
the procedure difficult.
Inefficiency or inability of the surgeon to
complete the procedure effectively or
problem with the equipment.

Causes of sterilisation failure
The failure rate depends the technique
used to perform tubal ligation. If the
procedure used causes more demage to
the tubes there is lesser rate of tubal
ligation failure.
If a procedure causes least damage to the
tubes like the use of clamps and cllips
then they have the highest failure.

Negligent and Non-negligent failure
If the mechanism of failure is due to tubal non-
occlusion or wrong structure sterilisation, these
are considered negligent mechanism
Sponaneous tubal recanalisation or fistula
formation mechanisms of failure are considered
non-negligent.
A short interval to failure is suggestive of a
negligent failure mechanism.
Consequences of sterilisation failure
Women who have udergone sterilisation
performed negligently are entitled to
recover damages according to wrongful
conception,negligence and wrongful birth.
Also, women are entitled to recover
general damages for pain and suffering
during pregnancy and delivery, and loss of
earnings during pregnancy.
Common pitfalls in the case sheets
Interval sterilisation LMP not mentioned.
All interval TAT size of the uterus and the
method of uterine elevation should be
mentioned ( If no elevation is used, the same
should be documented).
Follow up notes are mostly incomplete. Even the
pulse is not mentioned in the notes.
Most of the case sheets are not discharged.
Common pitfalls in the case sheets
When LCB is 45 days, , to rule out pregnancy,
USG is better than UPT.
In PS case sheets no mention about babys
condition.
In Lap sterilisation the no. of rings applied to be
mentioned and the area of the tube where it is
applied.
Lap sterilisation done for a lactating mother (
LCB 45 /365). The nature of the tube-
edematous, normal ?
A good case sheet
Under IVS, Incision Sub umbilical. Entry was
easy. Abdomen opened in layers Bil. Tubectomy
done by MPT. After securing complete
hemostasis, abd. Closed. Skin closed with silk.
Pt. withstood the procedure well.
Followed by prescription and other orders.
Regular nurses notes.
Regular follow up notes for 2 days.
Confidential enquiry report on
failure
Linear salpingectomy done earlier for ectopic
pregnancy partial recanalisation!!. What was
done for that tube ?
Evidence of sterilisation absent in one tube
Reason for failure complete recanalisation ?
Rings present on both tubes Failure to
sterilise?
Close but not continuous and also Wide apar !! ?
Confidential enquiry report on
failures
Close but not continuous complete
recanalisation.
Previous lap sterilisation both tubes
patent evidence of sterilisation on both tubes
present both tubes are very close and
continuous both rings are present on both
tubes Rt. Tube complete recanalisation;
Lt. tube partial recanulation ???!!
Confidential enquiry report on
failures
No mention about ring on one tube complete
recanulation.
Evidence of sterilisation present on both tubes
left tube recanalisation seen Reason for
failure Complete recanalisation of right tube
as seen by laparoscopy ?
Ring slipped on the left tube not seen
anywhere in the peritoneal cavity or in any
structure.
Resterilisation
Ring slipped in one tube position of the
ring not mentioned- bil.fimbriectomy
done?
Signs of sterilisation seen on both sides
bil.fimbriectomy done ?
Evidence of spontaneous recanalisation of
both tubes bil.fimbriectomy done ?
Resterilisation
Slipped ring found in the left fimbria and on the
right mesosalpinx-bil.fimbriectomy done ?
Left tube 2 rings seen right tube-evidence of
recanalisation seen what happened to the
rings ? repeat lap sterilisation done.
Left side ring seen at the edge of the tube-
bil.fimbriectomy done ?
Lessons learnt
More care is needed for lap sterilisation.
In lap sterilisation, most of the time, it is
the wrong application of rings which result
in pregnancy.
More number of sterilisation failure in a
particular period needs further study to
analyse the surgeon, technique or
materials at that time.
Lessons learnt
Confidential enquiry reports are important.
Needs more care in filling them.
Case sheets are legal documents. What is
written there is the final word. Hence
proper documentation is very important.
Follow up notes with vital monitoring and
prescription is MANDATORY.
Deaths following Female
Sterilisation
The death could be associated with or
attrubtable to sterilisation.
A death is attributable to sterilisation is it
occurs within 42 days of sterilisation and results
from a chain of events initiated by
anesthesia,operation, or from aggravation of an
unrelated condition by the physiological or
pharmacological effects of the anesthesia or
surgery.
Deaths following Female
sterilisation
A death is associated with sterilisation is
it occurs within 42 days of sterilisation but
is not causally related to the operation,
anesthesia, their complications or their
management.
Common causes for deaths
following sterilisation
Complications associated with anesthesia
(respiratory and cadiovascular
complication)
Peritonitis with or without injuries to the
internal organs.
Infection and hemorrhage.
Can they be prevented ?
YES
Minial pre op. evaluation
Asssessing the acceptor before posting her for
surgery(where expertise or infrastructure is lacking refer
them to the higher centre)
Hb
Urine Alb, Sugar, Deposits
LMP. USG or UPT before interval procedure
Pulse
BP
Temperature Evidence of peurperal sepsis / sepsis
Can they be prevented ?
YES
Minimal Intr op.monitoring and caution
Use of pulse oxymeter or constant monitoring of
the vitals.
Use of safe anesthesia technique (LA)
Adhering to basic surgical caution while opening
and closing the peritoneum.
Identification of the fimbria and the entire length
of the tube before cutting or applying the ring
Surgery should never be time bound
When in doubt CALL FOR HELP
Can they be prevented ?
YES
Minimal Post op. monitoring and caution
Follow up the acceptor in the post op. ward at the end
of the surgery.
Ensure constant monitoring for the first 24 hours.
Tachycardia is a more ominous sign than hypotension
All emergency drugs should be available in the post
op.ward itself.
When in doubt CALL FOR HELP
If referring, refer early with complete and proper
documentation.

A small comparison
US (1977-81)
Deaths due to
sterilisation

108
Tamil Nadu
2011 to Till date


35
To Conclude
It is not sufficient that we work but what we do
must also be PROPERLY documented.
When in doubt or trouble, always call for help.
When a satisfactory sterilisation could not be
performed, document the same, explain to the
client, advise other contraception and it
necessary send her to a higher centre.
Accept responsiblity for commissions and
omissions.
THANK U
DISTRICT FAMILY WELFARE BUREAU
PUDUKKOTTAI DISTRICT

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