IQUAM was established as EQUAM in 1992 for
the purpose of addressing the issue of safety when using silicone
gel and other filling materials during plastic surgery. In the
past years, within the framework of advanced technological devices,
additional issues have been discussed during the biennial meetings.
The organization was founded by a group of plastic surgeons from
various European, Central and South American, African, Southeast
Asian and Middle-Eastern countries. Representatives participating
at meetings are plastic surgeons, scientists, manufacturers and
delegates from governmental bodies involved in the development
and surveillance of advanced technologies, devices and techniques
in the field of plastic surgery. Consensus Conferences are held
biennially in an informal setting.
The IVth Consensus Conference,
held in June 2000, focused on the recommendation by the British
Medical Devices Agency (MDA) for the recall of the TrilucentTM
breast implant. It also discussed the European Parliament's
assessment of the continuing use of the silicone gel-filled breast
implant and their demand to ban its use. Other key topics discussed
were the growing experience with the use of Botulinum toxin in
aesthetic surgery, the implementation of an international breast
implant registry (IBIR), and the latest updates regarding safety
issues of ultrasound-assisted lipoplasty (UAL).
Breast implants
are still considered to be an issue of safety in the field of
plastic surgery, and the main concern is primarily the need for
repeat surgical procedures. Therefore, the field of fillers is
obviously going to be one of the most important topics in the
forseeable future, especially in view of the upsurge of procedures
forecast to take place within the coming years.
Another topic
that will require evaluation will be the use of vacuum treatment
for closure of chronic wounds and wounds that have typically
undergone a difficult healing period.
A major step towards the
implementation of the IBIR was taken at the Vth Consensus Conference
held in July 2002. The IBIR should be regarded in the context
of post marketing surveillance and the safe use of breast implants.
A universal form to be used by national registries has been laid
out. Recent data demonstrating extreme oxidation of soybean oil
in the TrilucentTM breast implants substantiated the call for
the immediate explantation of soybean oil-filled breast implants.
The safe use of silicone gel-filled breast was re-emphasized.
Various UAL technologies used in plastic surgery apply the same
basic physical properties of ultrasound whose long-term effects
are still being questioned. Botulinum toxin has been widely applied
in aesthetic plastic surgery in the last decade, and its application
in the appropriate indications seems safe. Botulinum toxin A
may be applied as a substitute or in conjunction with aesthetic
plastic surgery. Various resorbable and non-resorbable injectable
materials for soft tissue augmentation are available at present.
Substantial biochemical and biophysical differences exist. Not
all of the non-resorbable materials have withstood the test of
time, and some should still be considered experimental.
The IBIR
continued to be the focus of the VIth Consensus Conference, held
in Regensburg in June 2004, as were the issues of UAL and injectable
filling material.
At the close of meetings, a Consensus Declaration
is drawn up summarizing the conclusions of the meeting, and is
presented to the health ministry and plastic surgery society
of each member country. In this last decade of high tech and
the advent of more sophisticated equipment, our responsibility
as surgeons to evaluate the safety of these new technologies
becomes increasingly important. The interaction between clinicians,
scientists and manufacturers prior to and during the implementation
of new technologies is essential in order to ensure the safe
application of these technologies in clinical use. It is imperative
that IQUAM continue its vigilance and scientific evaluation of
both old and new technologies, devices and surgical procedures,
for the assurance of safety and enhancement of patient education.
IQUAM thus serves to reassure patients, physicians, medical bodies
and the general public of the commitment to safety and high standards
on the part of the plastic surgery community. |