Contraceptive Choice: Safety vs Efficacy
Item
- Title
- Contraceptive Choice: Safety vs Efficacy
- Creator
- Sathyamala
- Date
- 1987
- extracted text
-
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CONTRACEPTIVE CHOICE ; SAFETY VS EFFICACY.
(,'ty^ckground paper prepared, for the XIII Annual Meet of MFC, Jan 1987).
- Sathyamala
There is a general belief that contraceptives reduce maternal morta
lity rates considerably. Statements such as "Like! all medicines, birth control pills occasionally cause
serious problems in certain perons.... Of the 15,000 women, who
become pregnant, 75 are likely to die from problems of pregnancy
or child birth; of the 15,000 women who take the birth control
pills only one is likely to die from problems related to having
taken the pill. Conclusion; It is much safer to take the pill
than to be’come pregnant. "
are made to highlight what a boon the modern day contraceptives are
to the procreating women. Even when attempts are made to discuss _>
complications or mortality rates in relation to contraceptive methods,
they are usually rationalised as'"..It may be emphasised that though
the mortality of interval sterlization is much higher than that of
post partum ..sterlizations, the mortality of either of the two proce
dures is much lower than the maternal mortality for this country
(India) which is the risk the patient (emphasis added) would be
exposed to if she were not sterlized." (2). Complacency is also
expressed in statements like-contraceptive 'X1 has no life threaten
ing side effects and therefore it is safe.
The underlying assumption
in all these statments is that the contraceptive methods that are
currently being promoted are far safer than the 'risk' of becoming
pregnant.
While it may be true that child bearing adds a certain risk to the
woman population, it becomes a definite risk in only those population
mortality rate : and it is the
purpose of this paper to present the hypothesis that while contrace
ptive use may theoretically decrease the possibility of pregnancy
which has an already high overall
related deaths, the quantum of morbidity it produces is far too high
to justify its wide use in developing countries where the very
factors responsible for the high maternal mortality rate would lead
to an increase in mortality due to contraceptive use as well.
Morbidity load due to the currently available female methods of
contraception;
An estimate of the probable morbidity load can be made on the basis
of the data available on the incidence rates of complications arising,
from the use of contraceptive methods.‘ The morbidity rates have been
calculated on the number of acceptors in 1980-81.
-2-
Con treceptive
method
Morbidity
Incidence
lUCDs
Bleeding
and pain
10-15/100
users
No. of accepNo. of women
tors in.-1980-81 who would
have suffered
ill health
6,00,000
PID
10/100
users
Infertility 10/100
users
Ectopic
pregnancies 0.8 to 4% of
method failure
Spontaneous 50% of method
abortions
failure
Perforation 1/2500 users
of uterus
Tubectomy
Post op.
menorrhagia 5.1%
Pelvic
infections
ii
60,000
ii
60,000
ii
240 to 1200
ii
15,000
n
240
1,550,000
!l
12.42/1000
60,000 to
90,000.
79,050
19,251
.Total morbidity due to these two methods
3
293781
Total number of acceptors
S
2150000
Morbidity rate due to these two methods
s 137/1000 acceptors
3 326-3^7/1000
acceptors
Morbidity rate due to IUCD alone
(ref No.3)
The incidence rates used in these calculations are probably an
underestimation of the actual incidence in rural areas. The calcu
lations have also not taken into account
the total morbidity
subsequent to contraceptive failure. It shoulc, be noted that the
complication rates for tubectomies are from surgeries performed in
teaching hospitals. The incidence rates in the field situation ie.
Primary Health Centres and FP Camps would probably be much higher
than the ones quoted.
The morbidity due to oral pill use was not included in the table
because the acceptance and the continuation rate for oral pill use
in India has generally been very low.
Infact it is so low that oral
pill use rate is not included in the assessment of eligible couple
protection rate. In 1983, to overcome the problem of the non accep
tance of the pill, the Health Ministry came up with the bright idea
of distributing the pills through the Village Health Workers. This
plan was dropped later because of the opposition from the Indian
Women's Scientists Association on the grounds that such a plan would
neither be safe nor effective.
However from the report of the
'Revised Strategy for National Family Welfare Programme', it appears
that there are definite plans to expand the use of the pills through
-3—
” social marketing and by using a new cadre of workers, the'Village
Level Women Volunteers Corps'.
Reports have also come from several
parts of the country that this new cadre has swung into action and that
the pill is being promoted through the door to door sales technique*.
An even more worrying aspect of the strategy is for the first time an
official policy states "acceptance of oral pills in rural areas can
be expanded if medical consultation is not prescribed."(4)
The potent_al morbidity and mortality due to oral pill use should this
scheme become successful can be seen from data available from other
countries.
The following table presents the episodes of hospitalization
and mortality rates in a group of oral pill users from UK.
Serious side effects associated with rhe use of
combined oral contraceptive.
Excess morbidity and mortality per year
100,000 users
Deaths.
Diagnosis Hospitalizations
Side effect
S troke
35
9.7
125
70
3.4
17
17
8.0
79
79
31
Deep Vein Thrombosis
or Pulmonary Embolism
Superficial or unspeci
fied thrombosis
Heart attack and other
non-rheumatic heart Dis.
Gall bladder Disease
'(surgically confirmed)
91
Kidney Infection
383
Benign liver tumor
Hypertension
1
406
1
0.1
1.7
Total
1133
202
22.9
(Ref. No. 5)
This data indicates that “one out of every 500 pill users are hospita
lized annually due to serious side effects caused by this method. An
estimated one out of every 5000 users die annually from pill caused
strokes, thromboses and heart attacks... roughly two thirds are among
smokers and one third among non smokers".(5)
It is generally alleged that these risks do not apply to Asian Women
because they do not have the same problems if heart attack and throm
botic disease.
This assumption is unfounded because according to the
ICMR report of 1981,"...Available data on Indian women with CVD(cardio
vascular disease) show that though their .lipid levels were higher- than
the normal Indian women, the levels were far below their Western
counterparts".(6) and concludes that epidemiological studies are needed
to confirm if Indian women using oral contraceptive might be at a lower
risk of developing CVD. Epidemiological studies from Hong Kong have
-4-
shown that there has been an increase in heart ailments among women
between 1969-75 or since the pill was introduced.
If the pill progra
mme indeed becomes successful one could still expect complacency
because Indian women especially from the rural areas will neither be
diagnosed nor hospitalized to tire same extent as their British counter
parts for obvious reasons.
But one can say witii surety that should
the programme become successful the mortality and morbidity rate in
women user.- under unsupervised conditions will be very high.
A recently released report (1982) from the Centre of Disease Control
USA has shown that for the first time- in che USA contraceptive-
related deaths outnumber pregnancy - related deaths. This could
very well be the situation in India if the trend towards pushing
even more hazardous contraceptives persist.
The report of the ‘Revised Strategy for National Family Welfare
Programme1 makes its intentions very clear.
Under 'Family Planning
Research' it states
"New technologies like injectables, sub-dermal implants,etc,
are currently undergoing trials before introduction in the
programme.
The procedures and the protocols and the time
scales of induction of new technologies will be revised to
enable faster introduction of such technologies in the
programme." "Development of simple, reversible, safe and
long acting contraceptives such as the anti-fertility vaccine.
would seem to offer great potential.
Research efforts in
developing such a vaccine will receive high priority."(7)
Anyone with even a rudimentary knowledge of the mechanism of action
of these- methods would know that -the complications arising out of
their wide-use will be of a magnitude never witnessed before in
contraceptive history. An added problem with these contraceptives
is that the morbidity and mortality risks will not be confined to
the women alone but is going to be extended to their progeny as well.
The question that gets posed is why then this strange attachment to
hazardous contraceptives when available data already indicates that
they are a definite threat to women's lives. This is when the red
herring in the form of "effectiveness" is thrown up to confuse every
one.
It is stated that more and more invasive a method is better and
better is its effectiveness because it will act at so many levels
that conception will not stand a chancel
*
The following taele shows that if one compares the lowest observed
failure rates for the currently available methods, the effectiveness
is almost similar.
-5-
Method
Lowc-st observed failure rate (%)
Tubal sterlization
0.4
Vasectomy
0.4
Combined pills
IU3
0.5
Condom
2
2
Diaphragm with spermicide
Cervical cap
Fertility awareness
(Ref. No.8)
1.5
2
2 -20-
That means that theoretically at least in a well'controlled'
situation the effectiveness of invasive contraceptives are very
similar to the non-invasive barrier methods.
The problem comes
when effectiveness is discussed in terms of actual use.
For instance,
if a woman takes the pill everyday and does not miss even once then
the theoretical effectiveness would apply to her.
But in a real
situation in a group of pill takers the effectiveness would be
influenced- by the irregularity or the regularity with which each
member takes the pill. Hence the actual failure rate can range
from 5 (IUD) to 10 (Condom) to 19 (Diaphragm). This- is what the
population' experts are really concerned abouts the performance of
a method in a population which they may not be able to "control".
Hence the attachment to invasive methods which hopefully will not
be affected by the vagaries of human nature.
The medical establishment however rationalises in a different way
the need for a method whose theoretical use comes closer to the
actualise. It is argued that if the failure rate is high with
contraceptive use, the women accepting a method with the high
failure rate would continue to run the risks of pregnancy, A comparison of cumulative risk of deaths associated with fertility
control methods which includes both maternal deaths susequent to
contraceptive failure and method-related deaths show that despite
the additional risk of high failure rates, condoms backed by abortion
is the safest method available.
Cumulative Risk of Death Associated with Ferti1ity Control Methods
(per 100,000 nonsterile womenT
Method
15-34
35-39
40-44
15-44
Pill/smoker
257
588
132
977
Pi11/n onsmoke r
70
21
160
251
Rhythm
36
14
18
68
Diaphragm/spermicide
28
14
11
53
IUD
10
25
10
45
Abortion
26
41
.9
6
Condom
19
2
2
23
C on dom/abo rti on
1
1
1
1
No method
192
129
141
462
(Ref. No.9)
It is obvious that if a Family Planning policy is really concerned
with the health of the women, then it would stop viewing hysterically,
the possibility of an inadvertant pregnancy due to contraceptive
failure as a national disaster.
Till such time it docs that, the
attempt of the population controllers will be to develop methods
which tend towards the mythical 100% effectiveness leaving the
concept of safety to the four winds.
The question that remains to be answered is - is pregnancy really
such an enormous risk that the wide use
hazardous contraceptives
can not only be justified but should in fact be promoted in the
. interests of women?
In this context it must be remembered that
while comparing mortality and morbidity risks in contraceptive use
and pregnancy there are two different populations at risk.
Only
women who become pregnant can die of pregnancy related causes.
A much larger number of women is at a risk of death from contrace
ption related causes, and this population would have already faced
the risks of becoming pregnant before they accept a method. Finally
it must also be remembered the complications arising from contra
ceptive use are generally long-term effects and could lead to
permanet disability.
Notes and References s
1. "Where there is no doctor",Indian adaptation, by Sathyamala, VHAI.
2. ±CMR Bulletin,June 1982, P 59.
3.
(a) Incidence Rate(Ir) for bleeding and pain,'Contraceptive
Technology, 1986-1987,1 13th Revised Edition, Irvington
Publishers, p 202.
(b) IR for PID, 'Population Reports,
'Series B, No.4,July 1982,
p. B-121, "Other recent studies in developed countries have
found the relative risk of developing PID ranges from 1.5
to 10 for IUD users." I have takenthe higher figure because
in developing countries it must be higher than this.
(c) IR for infertility, population Reports, Series B, No.4,July
l,9flZ, Thu s~._ec topic. pregnancy .or inf ertiJLi_ty /jia^-rgicu-r even
after only one episode (of PID in the falTLctpian tunes) tl
(d) IR for ectopic pregnancies, Population Reports,Sereies B,
No.4, p, B-125.
(e) IR for spontaneous abortions, Population Reports, SeriesB,
No. 4 p. B 124. "About 50% of uterine pregnancies spontaneously
abort if the device is not removed". In some studies over
half of the spontaneous abortions inlUD users is in second
trimester and a spetic second trimester abortion is 26 times
more likely in women with an IUD in place.
in actual users of IUD is 5,'ICO.
The failure rate
»'
<•
-y-
(f) IR for perforation of uterus, Contraceptive Technology,
1986-1987, p 208.
U) IR for post op. menorrhagia and Pelvic infections, ICMR
Bulletin June 1982, p 59.
4.
"Revised Strategy for National Family Welfare Programme, II
GOI.- 1986 (?) p. 6.
5.
"Con traceptivc-s and Developing Countries ; the role of-Barrier
Methods," Bruce and Schearer, Inter" "■tional Symposium on
Research on the Regulation of human fertility, Sweden, Feb.1983,
p 407.
6.
ICMR Bulletin, Dec. 1981.
7.
"Revised Strategy for National Family Welfare Programme,"
GOI 1986(?), p 123.
8.
Contraceptive Technology, 1986 - 1987, p 102.
9.
"Out look", Vol 1, No. 3, Sept. 1983, p 4, Figures adapted
from Ory of the US Centres of Disease Control.
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