CONSENSUS
DECLARATION - Regensburg, Germany, June 28, 1996
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Currently available data indicate that silicone breast implants do not
cause cancer nor other malignant diseases.
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The reduced risk of breast cancer associated with breast implants merits
further research.
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There is conclusive scientific - clinical, immunological, epidemiological
- proof, that silicone breast implants do not cause identified and recognized
auto-immune diseases nor connective tissue diseases such as rheumatoid
arthritis, scleroderma, systemic lupus erythematosus. There is no consistent
evidence, that implants are responsible for undefined connective diseases.
At present, there is no scientifically identified "new disease" caused
by silicone implants. There exists no such thing as silicone allergy, nor
silicone (associated) disease nor intoxication. There is immune reaction
to every foreign body, but this is not identical with immune disease.
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Silicone implants do not adversely affect pregnancy nor breast-feeding
nor the health of breast-fed children.
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Patients with breast implants need regular follow-ups and, if indicated,
appropriate mammography.
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Since no specific antibodies against silicone have been detected, silicone
laboratory tests are of no value.
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Silicone is a widely used and essential material in every day life, at present. We have no better alternative material
available. In all fields
of medicine and surgery, implants and medical devices made of silicone
are essential not only for well-being, but often critical for the continuation
of life itself.
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EQUAM supports the use of silicone implants which are approved by CE makes
or meet ISO standards outside Europe and calls for continuous clinical
and basic research to further improve the quality of silicone implants.
-
Objective media reports will contribute to the reassurance of patients.
EQUAM will provide updated information about breast implants to the media.
CONSENSUS
DECLARATION on Breast Implants 4 July, 1998
1. Silicone is a widely used and an essential material in every day
life, at present. We have no better alternative material available as yet.
In all fields of medicine and surgery, implants and medical devices made
of silicone are essential not only for well-being, but often for survival.
2. Updated studies continue to show that silicone gel-filled implants
do not cause cancer nor other malignant disease.
3. There are conclusive scientific - clinical, immunological, epidemiological
- data, that silicone gel-filled breast implants do not cause any auto-immune
nor connective tissue diseases.
4. There is no scientific evidence that such things as silicone allergy,
silicone intoxication, atypical disease, or a 'new silicone disease', exist.
There is a normal foreign body reaction to every implant, but this is not
immune disease.
5. Silicone implants do not adversely affect pregnancy nor breast-feeding
nor the health of breast-fed children.
6. Patients with breast implants need regular follow-up and - if indicated
- appropriate imaging of the breasts.
7. Laboratory tests for the detection of silicone are of no clinical
value. No specific antibodies against silicone have been detected.
8. EQUAM is of the opinion that there is a great need for a functioning
harmonized, specific EU-standard for breast implants. EQUAM urges the European
countries to reach a consensus in this matter soon.
9. EQUAM calls for continuous clinical and basic research to further
improve breast implants and new technologies in plastic surgery.
10. Objective media reports contribute to the reassurance of patients.
EQUAM will provide updated information about implants and new technologies
in plastic surgery to the media.
Regensburg, 4 July, 1998
President: Marita Eisenmann-Klein, M.D.
Secretary: Jean-Philippe Nicolai, M.D.
April, 26th , 1999
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Trilucent Implants, the soybean-oil lilled device was taken off the
market. The CE-mark was with-drawn. See also http://www.trilucentinfo.com/
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The petition committee of the European Union recommended a ban of
silicone gel-filled breast implants after a conference with consumer groups.
The European Commission (the authority which developped the above mentioned
guidelines) rejected this proposal and said that there was no justification
for it.
CONSENSUS
DECLARATION ON BREAST IMPLANTS -
23
June 2000
EQUAM, the European Committee on Quality Assurance and
Medical Devices in Plastic Surgery, raises concerns regarding the potentially
deleterious use of products, devices and technology, or their application in
unsuitable indications. EQUAM aims to ensure that both medical devices and
technologies used in plastic surgery are safe, and to guarantee the safety of
patients.
On 23 June 2000, EQUAM issued its consensus
declaration, which read as follows:
1) Since EQUAM’s 1998 declaration, silicone has
continued to be a widely used and essential material in every day life. No
better alternative material has become available. In all fields of medicine
and surgery, implants and medical devices made of silicone remain essential
not only for aesthetics, but also for reconstructive procedures and to support
survival.
2) Additional medical studies have not demonstrated any
association between silicone-gel filled breast implants and traditional
auto-immune or connective tissue diseases, cancer nor any other malignant
disease. These studies re-affirm prior data.
3) EQUAM states that there are new conclusive
scientific, clinical, immunological and epidemiological data indicating that
silicone-gel filled breast implants do not cause any traditional auto-immune
or connective tissue diseases.
4) EQUAM continues to believe that there is no
scientific evidence that silicone allergy, silicone intoxication, atypical
disease or a “new silicone disease” exist. Normal foreign body reaction
occurs with every type of implant but this is not immune disease.
5) Silicone-gel filled breast implants do not adversely
affect pregnancy, fetal development, breast feeding or the health of breastfed
children.
6) Patients with breast implants should have regular
follow-up and, if indicated, appropriate imaging of the breasts.
7) Laboratory tests to detect silicone are of no
clinical value. No specific antibodies against silicone have been detected.
8) There is no valid scientific evidence to associate
silicone or silicone-gel filled breast implants with neurological disease or
symptoms.
9) EQUAM agrees with the IOM that breast implants can
produce severe local complications by themselves, which may result in medical
and surgical interventions with their associated risks.
10) EQUAM believes it is extremely important to advise
the patients of the hazards and risks as well as the benefits of breast
augmentation or reconstructive surgery and has prepared a Patients Information
and Consent Form to be used in discussion with the patient.
11) EQUAM believes there is a continuing need for a
functioning, harmonised, specific EU-standard for breast implants. EQUAM
endorses the Guidelines for Conformity Assessment of Breast Implants.
12) EQUAM calls for continuous clinical and basic
science research to provide more accurate information on rupture rates of
breast implants and better definition of the longevity of all silicone gel,
saline, and other filler materials of breast implants.
13) EQUAM believes that a European and world-wide
registry of patients is crucial for identifying information on short-term and
long-term complications such as capsular contracture or rupture, and to provide a
database for long-term research on breast implants. Principles of
confidentiality and the safeguarding of the privacy of patients must be
maintained for such a registry to be successful.
14) Objective media reports contribute to the
reassurance of patients. EQUAM will continue to provide updated information
about implants and new technologies in plastic surgery to the media.
15) After evaluation of current data, EQUAM joins the
British Medical Devices Agency in their recommendation of June 6, 2000 for
removal of the soybean oil-filled (Trilucent) implants.
16) Based on current knowledge, EQUAM confirms the safe
use of silicone gel and saline-filled breast implants.
EQUAM
PRESS RELEASE - June 25, 2000
At its 4th Consensus meeting held in
Israel, EQUAM the European Committee on Quality Assurance and
Medical Devices in Plastic Surgery conferred to the British Medical Devices'
Agency (MDA) in recommending the removal of soybean oil filled breast
implants also known as Trilucent implants. This is a dramatic and
unprecedented move especially in light of the fact that previous silicone
scares never resulted in a recommendation to allocate patients and remove
the silicone implants.
It had been previously thought that spillage of
filler would not be risky as it was assumed that soybean oil would be
quickly and harmlessly absorbed into the body. However, following previous
reports of high rupture rate, irritation following rupture, and finding high
levels of degradation products from the spillage of the contents into
surrounding breast tissue, an advisory group of the MDA has made a new
recommendation. The MDA has now stated that spillage from the soybean oil
implants may expose the tissue to genotoxic or carcinogenic material and in
light of these findings it recommends the removal of all soybean oil
implants.
Based on updated reports, EQUAM re-emphasised that
the use of silicone gel and saline filled breast implants is a safe option.
EQUAM emphasised the need for an international joint registry of all breast
implants in order to enable follow up on all side effects following
implantation.
EQUAM reviewed the use of ultrasound assisted
liposuction and concluded that the long-term biosafety of its use are
questionable. Research indicates that the use of ultrasound with liposuction
may result in long term risks. Further research, according to EQUAM, is
mandatory.
EQUAM finds Botulinum Toxin A safe for use in
aesthetic plastic surgery in conjunction with or as a substitute for
aesthetic surgery and calls for the authorization of its use in this
application.
Moris Topaz, MD
Secretary General EQUAM
