Fw: Health department misled women over breast implant risks ~ BMJ

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Friday, March 30, 2001 3:31 PM

Subject: Health department misled women over breast implant risks ~ BMJ

i was very pleased to see Ms. Heasman's statement regarding banning

implants for those under 25 ~ it seems like a step in the right direction.

ilena ~~~

British Medical Journal

2001;322:756 ( 31 March )

http://bmj.com/cgi/content/full/322/7289/756/d

News Extra

Health department misled women over breast implant risks,

groups claim

Zosia Kmietowicz London

Campaigning groups concerned about the safety of breast

implants have strongly criticised the UK Department of

Health for the way it has handled the issue.

Many women have been misled about the risks associated

with breast enlargement surgery because of information

issued by the government, said some of the groups giving

evidence to the House of Commons select committee on

health last week.

The committee was collecting evidence on the government's

response to concerns over the safety of breast implants

for a report to be published later in the year. One of the

sources of dissatisfaction is a booklet produced by the

Department of Health entitled Breast ImplantsóInformation

for Women Considering Breast Implants, which was published

last October and is currently being reprinted.

Balen, a partner with Freethcartwright solicitors,

who represents more than 4000 women in the United Kingdom

who have had breast enlargement operations, said that

information contained in the British booklet was very

different from that in a similar US brochure.

For example, according to the British booklet, breast

feeding is not a problem after implant surgery. But in the

United States, women are advised that 64% of women are not

able to breast feed after surgery.

" If British women read this booklet [the UK one] they

could be misled, " said Mr Balen. " The state of knowledge

in this country is inadequate, and therefore there is

danger of the blind leading the blind. "

A spokeswoman for Action Against Silicone Gel UK complained

about the inadequacy of the way adverse events to breast

implants are reported. As they are classed as medical

devices, rather than drugs, breast implants come under the

supervision of the Medical Devices Agency, and doctors are

under no obligation to report adverse events. In the booklet

women are not told of the role of the agency but are

advised to seek the help of their surgeon if things go

wrong.

The group would like to see a form of moratorium on the

use of silicone breast implants until more evidence exists

of their safety, similar to the situation imposed by the

Food and Drugs Administration in the United States. Maxine

Heasman, founder of the Breast Implant Information Society,

said that breast enlargement operations should be banned

among women aged under 25.

Both groups believe that women who decide to go ahead with

surgery should have to sign a preoperative consent form to

say that they have been counselled about the risks of the

operation, similar to that used in New Zealand.