Comment & Reviews
Contraceptive Implant Withdrawn
By Maxine Lattimer
A controversial contraceptive implant which hundreds of women
claim has made them ill is to be withdrawn from the UK. The
distributors of Norplant blamed their decision on a four-year
'trial by media' and lengthy legal action by women who claimed
they had suffered serious side effects from the contraceptive.
Norplant, which works by inserting six hormone-charged rods
under the skin, would be discontinued by the end of October,
six years after its UK launch. Continuing controversy had
caused demand to dwindle 'to levels which are no longer commercially
viable' said the drug's UK distributors, Hoechst Marion Roussel.
The company stressed that its decision was commercial and
said 'confidence in the safety and effectiveness of Norplant
remains unchanged'. More than 50,000 women in the UK have
opted for the five-year implant, hailed as a revolution in
contraception, since it was launched in this country in 1993.
But by last year more than 400 had joined the Norplant Action
Group, set up in 1995 after women claimed they had suffered
severe side effects from having the hormone-charged implant
inserted under their skin. The women claimed the implant had
left some of them with endless periods and others with no
periods at all, and had caused skin problems, hair loss, mood
swings and other side-effects.
A group of 275 women who brought a class damages action against
Hoechst Marion Roussel had to abandon it in February after
legal aid was withdrawn. The distributors said the women who
had claimed problems represented less than 0.5% of UK users.
Women in the United States are still bringing class actions
against Wyeth, the American distributors of the drug, which
was invented by the company Leiras Oy. Hoechst Marion Roussel
said that UK demand had levelled off since 1995 when the British
Medical Association advised GPs not to offer Norplant to new
patients. The BMA issued the advice after a still-unresolved
row between doctors and the Department of Health over how
much GPs should be paid for performing the 20-minute procedure
to insert the implant.
A spokesman for Hoechst Marion Roussel said 'In effect, a
major therapeutic advance, fully approved by the UK Medicines
Control Agency, and widely welcomed by doctors and users,
has been killed off for non-medical reasons by an unholy alliance
of bureaucrats, lawyers and the media. It raises serious questions
as to who in the end decides which products survive on the
UK prescriptions market. One has to ask whether the UK healthcare
environment, with its reluctance to invest and its mushrooming
US-style litigation culture, really wants new technologies
despite clear benefits to the user and to the NHS.
Paul Balen, the Nottingham solicitor who acted for the women,
said 'The women who contacted us had genuine problems with
Norplant as a product which the company steadfastly refused
to admit. There was never any criticism of Norplant as an
effective contraceptive. The high profile marketing campaign
at the time of launch of Norplant led to an explosion of interest
amongst doctors and women and many misguided expectations.The
blaming of lawyers and bureaucrats for the demise of Norplant
does a disservice to the doctors and women who were able to
make their own judgments as to whether Norplant was a product
which they wished to use in the future.'
From the perspective of widening women's contraceptive choices,
the decision to withdraw Norplant is regretable as it was
one of the most effective methods of contraception available.
Given that around two thirds of women seeking abortion claim
to be pregnant as a result of contraception failure, Norplant
was ideal for many women since it was in a 'fit it and forget
it' means of protection against pregnancy. It is understandable
that the product was withdrawn as a result of atht negative
publicity surrounding norplant, but disappointing as it was
a safe and very reliable method. Fortunately Organon are developing
a single-rod implant and hopefully this will be available
before Norplant becomes unobtainable so that women do not
have to miss out on the additional choice that implants provide.