Mentor And Silicone Implants
The Role of the Manufacturer
(Mentor) Working On the Silicone Implants Project
Mentor is
a premier and a leading supplier of medical products in general and
silicone implants in particular in the U.S.A. and worldwide. More
recently, FDA and the advisory body related to it declared that the
Mentor’s silicone gel-filled implants are effective and safe for
application in augmentation and reconstruction for women. The
7–2 suggestion for
approval, with a string of
conditions forwarded by the FDA’s General and
Plastic Surgery
Advisory Panel, demonstrate a
very important step towards
complete approval of Mentor’s
silicone gel-filled implants in U.S.A.
In a way,
this can be considered a big victory for the women, who are contemplating
upon implants or already have undergone it. This advisory body or
panel very clearly approved what people knew for years and decades.
Silicone implants are a good and safe option for women who like to
enjoy a natural feel, natural shape and looks that these products provide.
The consensus and then vote of the
review panel was founded upon
the review of
Mentor’s pre market approval
(PMA) notice filed
in December 2003 and on the Company’s
PMA amendment filed in 2004. The vote came after Recommended Panel
vote advising against recognition of Inamed Corporation’s silicone
gel-filled implant application. In case, the Food and Drug
Administration follows both suggestions of its Recommended Panel,
Mentor’s Memory Gel (TM) products in all probability would be the only
recognized silicone gel-filled implants in the United States.
For the moment
in U.S.A., silicone-related products
are the only available choice for
ladies who fall under the criteria
and elect to
join in
an FDA- recognized continued access study for augmentation
or reconstruction and revision
clients. In case, the
implants are finally given a green signal
by the FDA, Mentor’s Memory Gel (TM) implants
will be a very important contribution
to the choices for
women trying to get
reconstruction or augmentation
in U.S.A. Therefore, the
panel deserves credit for completely scrutinizing the scientific data
before finding a similar conclusion the manufacturer had reached. Thus,
precisely speaking, the Mentor’s silicone gel-filled implants are
not only effective but also safe choices for women. Mentor is focused on
offering effective and smart solutions for surgeons and the aspired women
they serve.
The entire products of Mentor’s
gel filled implants are filled with Memory Gel(TM), a kind of
proprietary silicone gel formulation that forms its style and shape yet
remains soothing and soft resulting in a more natural look. By reshuffling
or varying the proportion of the constituents of the gel, Mentor is in a
position to offer a wide variety of choices of products that represent the
complete range of client’s requirements. As per estimation, exceeding
one million women in over fifty nations have procured Memory Gel(TM)
implants.
Though, Mentor at present markets
saline-filled implants, its Memory
Gel(TM) silicone gel-filled products offer a choice for clients seeking a more
natural feel and looks.
Mentor’s gelatin-like, cohesive implants are made to imitate or
mimic the tender tissues of the human organ. No doubt, the individual
requirements of the person fluctuates, but experienced surgeons are in a
position to apply Memory Gel (TM) Products to offer both reconstruction
and augmentation surgery. Needless to say, the company being of the status
of the international standard and a leading supplier of medical products
for the world healthcare market tries to meet the valid standards.
Further, the company manufactures, develops, and markets very innovative
and unique, science-based products for urologic specialties and clinical,
aesthetics and consumer healthcare markets throughout the world.
Implants and Clinical Studies
With the passage of time, Mentor
has conducted a very thorough research and studies regarding safety
evaluation of both gel-filled and saline-filled implants.
Additionally, Mentor has sponsored the innovative and state-of-the-art
tests done at leading educational and stipulated institutions. The biggest
of these research studies happens to be the clinical study of over seventy
thousand women having silicone implants. The research or study was
conducted and established by Mentor in 1992 in collaboration with the US
and FDA (Food and Drug Administration). More so, Mentor has conducted
surveys in a big way relating to saline-filled implants having
approximately five thousand users. The general motive of these surveys was
to collect information about the effectiveness and safety of silicone
implants.
Implants Safety Information
For many years in the past, there have been many reports from
different sources stating that women having silicone implants had
cancer or autoimmune disease. More so, many enlightened medical
institutions and professionals have undertaken scientific studies about
the effectiveness and safety of implants. Now, Mentor is quite
pleased to give complete information to the general public related to the
implants, whosoever requires it.
National
Cancer Institute
More recently, the National Cancer Institute undertook
a survey of around thirteen
thousand five hundred women who got silicone gel implants for cosmetic
purposes, prior to 1989. In the findings, there was no tangible increase
in cancer mortality or incidence.
Institute
of Medicine
The National Academy Institute of Medicine stated in a report that the committee reported that seeing the vast sections of the women population in the United States having implants, many of these women could be expected to develop connective tissue diseases, neurological diseases. This situation is no more common in women with implants than in women without implants. Thus, the study clearly indicates about the effectiveness and safety of silicone implants. This is all possible, because of Mentor’s best effort in providing the best product to its users.
Role of Silicone Implants in Reconstruction
How Far Along is the Approval Process of the FDA?
The Role of the Manufacturer (Mentor) Working on the Project of Implants
Surgery Procedure and Techniques
Silicone Implants and Cosmetic Use
Application of the New Silicone Implants for Cancer Victims
Issues Associated With Silicone Implants
The Role of New Technology in Making People Safer With Silicone Implants
Effects on Pregnancy, Lactation, and Children
Enlargement and Public Opinion
Removal and Replacement of Silicone Implants
Copyright 2005
Silicone Implants (www.silicone-implants.info)
All rights reserved
Information and opinions provided here are never to be construed as medical advice. Readers should consult appropriate health professionals on any matter relating to their health.