§ Mr. AshleyTo ask the Secretary of State for Social Services (1) when the Dalkon shield was withdrawn in Britain; when his Department circulated advice of its withdrawal; what action was recommended to them; what efforts were made to inform women using the shield of the risks of side effects; and whether there was any media advertising or leafleting in doctors' surgeries or family planning clinics to inform women;
(2) if he will estimate the number of women currently using the Dalkon shield;
(3) if, when a medically related device is withdrawn because of side effects, he will make it his policy to place 342W advertisements in national newspapers to inform long-term users of the withdrawal and to urge them to contact their general practitioners;
(4) how many regional health authorities organised recall systems for women using the Dalkon shield; and what was the departmental advice to health authorities;
(5) if he will make representations to A. H. Robins to allow those making a late application for compensation because of damage from the Dalkon shield to have their cases considered;
(6) what discussions were held with A. H. Robins, the manufacturer of the Dalkon shield, regarding its 1985 advertising campaign warning against continued use of the shield; and what conclusions were reached;
(7) when the Committee on Safety of Medicines advised him to approve the use of the Dalkon shield; what action was taken by his Department when the shield was withdrawn from the United States market in 1974; on whose initiative it was withdrawn in Britain; and if he will make a statement.
§ Mr. Newton[holding answer 11 January 1988]: The Dalkon shield was voluntarily withdrawn by the manufacturer, A. H. Robins, from the United Kingdom market in July 1974 immediately after similar action in the United States of America. The manufacturer notified all doctors of the withdrawal. Such devices had not by that time been made subject to licensing controls under the Medicines Act and therefore the Committee on Safety of Medicines was not required to advise on approval.
I understand that, as a result of its investigations in the United States, the Food and Drugs Administration did not insist on withdrawal of the Dalkon shield from the United States market.
The 1974 handbook of contraceptive practice sent to all GPs and family planning doctors advised annual follow up checks for users of intra-uterine devices generally, and the Department did not consider that it was necessary to issue specific guidance or to undertake publicity through the NHS.
In 1980 and 1985, the manufacturers again wrote to all doctors about the tracing of women still fitted with the device and in 1985 the Committee on Safety of Medicines, in an issue of "Current Problems" sent to all doctors, referred to the possible risks of over-extended use of the Dalkon shield, as with any other IUD, and repeated the manufacturer's advice for removal in cases where the shield was still being worn. Advice sought by the 343W Department at that time from leading medical bodies, indicated that the number of women still using the device was likely to be very small.
In 1985 the manufacturers had discussions with Ministers about their plans for publicising the need for women still using the device to see their doctors. They placed advertisements in the women's press.
In 1986, at the direction of the United States District Court of Virginia, the manufacturers publicised, in the United Kingdom and other countries, the need to file any claims in connection with Dalkon shield by 30 April 1986, the date set by the court.
It would not be appropriate for the Government to intervene in a matter of litigation. Late claims are a matter for the courts and no guidance was issued to health authorities on this matter. I am aware, however, of initiatives taken over a number of years in one regional health authority, West Midlands, to recall the shield and latterly to advise about claims.
344WThe Government's general position if side effects of medical devices are reported is that the action which is; needed will be considered in the light of the particular circumstances of each case.