Bravo! Safety measures on breast implants introduced in Britian
Congratulations to all the British and European activists who have
fought so hard for years to receive at least this acknowledgement in
Britain that implants have not been proven to be "safe."

The wonderful woman in the photo in the first article below, is, I am
nearly certain, Dutch Support Group Leader, MarLou Boots, with just a
small portion of her "explant" collection. They are indeed a gruesome
melange… especially when you realized each of these fungal filled,
moldy and otherwise deteriorated implants were removed from innocent
women, never warned of these dangers.

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2003/08/31/uimpl...

Safety measures on breast implants introduced
(Filed: 31/08/2003)

New strict quality control standards covering all breast implants sold
in Europe come into force this week.

Worries about some implants used in breast enlargements in Europe and
America led the Department of Health to announce that they would be
reclassified to the highest risk category for medical devices.

They will have to pass extensive tests, similar to those already
carried out in the UK, the Department of Health said in July.

Health fears over breast implants have been prompted by cases where
women have had to have them removed because of leakages, which have
left them in pain and possibly at risk of diseases like cancer.

The new regulations, which come into force tomorrow, follow guidelines
issued by the European Commission in 2001 and a directive recommending
a reclassification of implants from medium to high risk.

The new measures will see manufacturers having their design dossiers
examined and clinical data checked by an independent body. In the UK,
that body will be appointed by the Medicines and Healthcare products
Regulatory Agency (Devices).

Although the safety of breast implants currently used in the UK has
already been carefully checked, it is possible for breast implants to
be placed on the European market without the same checks being made.
Safety measures on breast implants introduced
(Filed: 31/08/2003)

New strict quality control standards covering all breast implants sold
in Europe come into force this week.

Worries about some implants used in breast enlargements in Europe and
America led the Department of Health to announce that they would be
reclassified to the highest risk category for medical devices.

They will have to pass extensive tests, similar to those already
carried out in the UK, the Department of Health said in July.

Health fears over breast implants have been prompted by cases where
women have had to have them removed because of leakages, which have
left them in pain and possibly at risk of diseases like cancer.

The new regulations, which come into force tomorrow, follow guidelines
issued by the European Commission in 2001 and a directive recommending
a reclassification of implants from medium to high risk.

The new measures will see manufacturers having their design dossiers
examined and clinical data checked by an independent body. In the UK,
that body will be appointed by the Medicines and Healthcare products
Regulatory Agency (Devices).

Although the safety of breast implants currently used in the UK has
already been carefully checked, it is possible for breast implants to
be placed on the European market without the same checks being made.

http://news.bbc.co.uk/2/hi/health/3198075.stm

Breast implant safety crackdown

Tough safety standards for breast implants, created in response to
fears over safety, come into force this week.

The rules were drawn up by the European Commission in 2001 in response
to a campaign by British women.

Many women have been forced to undergo surgery to have implants
removed after they say silicone leakage from the implants ruined their
health.

The regulations will mean that new types of implant should be more
thoroughly tested before going on sale.

Safety checks on implants have already been stepped up in the UK, but
the new rules mean should improve standards across Europe.

The majority of implants used to contain silicone gel - but studies
suggested that as many as 69% of the implants would rupture within a
decade.

Many modern implants use saline - salt water - as an alternative to
silicone.

This would leave patients facing more painful surgery to have them
removed.

Health worries

While silicone gel is thought to be a "neutral" substance that does
not react with the body, even if the implant ruptures, there are
widespread fears that it can cause ill health.

Many women have reported "connective tissue disorders" causing
painful, swollen joints, and even chronic fatigue syndrome, blaming
the illnesses on their leaky implants.

Studies looking into this have not so far found a link.

Although no firm evidence of health risks to humans has yet emerged,
the UK authorities set up a registry of breast implants in 1993 so
that further long-term studies could be carried out - and women
recalled for medical help more easily should a problem be found.

Dr David Jeffreys, Head of the Devices Sector of the Medicines and
Healthcare products Regulatory Agency said: " I welcome the move to
tighten safety checks on breast implants.

"We have pushed strongly for these changes. It will ensure that all
breast implants sold throughout Europe meet the same high standards of
quality and safety."

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www.BreastImplantAwareness.org