Fw: Bravo! Safety measures on breast implants introduced in Britian

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----- Original Message ----- From: ilena rose

ilena@...

Sent: Monday, September 01, 2003 12:46 PM

Subject: Bravo! Safety measures on breast implants introduced in Britian

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/uimplant.xml & sSheet=/portal/2003/08/31/ixportaltop.html

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 s, 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

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