Breast Implant Clinical Studies
Your Assurance of Safety
Over the years, Mentor has made a very thorough safety evaluation of both saline-filled
breast implants and gel-filled breast implants. In addition to our own testing,
Mentor has sponsored other state-of-the-art tests performed at leading academic
institutions. These studies have combined to include more than 200,000 women with silicone
gel-filled breast implants.
Mentor has also conducted extensive investigations of saline-filled breast implants
involving nearly 5,000 patients. The general objective of these studies was to gather
information about the safety and effectiveness of saline breast implants. MENTOR® MemoryGel™
Breast Implants (round shape) and Saline Breast Implants have received PMA (pre-market application) approval
from the US FDA.
As we have for many years, Mentor will remain committed to providing the public
with objective information about breast implant safety.
The Safety of Silicone Breast Implants
An approval based on science: In 1997, the Department of Health and Human Services
began one of the most extensive research studies in medical history by appointing
the Institute of Medicine of the National Academy of Science (IOM) to examine potential
complications during or after an operation. The committee included members of the
medical, scientific and educational communities with experience in radiology, women's
health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology,
internal medicine and plastic surgery. No IOM members had on-going relationships
or conflicts of interest related to any implant lawsuits.
After reviewing years of evidence and research concerning silicone gel-filled breast
implants, the IOM found that "Evidence suggests diseases or conditions such as connective
tissue diseases, cancer, neurological diseases or other systemic complaints or conditions
are no more common in women with breast implants than in women without implants."
You can read the complete IOM report online for free.
The Independent Review Group (IRG) on Silicone Breast Implants was assembled by
the Chief Medical Officer of the UK to also review the possible health issues associated
with silicone gel breast implants. Members of the IRG were selected for their independent
views, their knowledge and understanding of the issues, and lack of any financial
interest in the conclusions they reached.
Led by Professor Roger D. Sturrock, MD, FRCP, the IRG reported in 1998 that there
is no scientific evidence of an association between silicone gel-filled breast implants
and any established connective tissue disease. The complete report is available
on the Internet at www.silicone-review.gov.uk.
In July 1998, the European Committee on Quality Assurance and Medical Devices in
Plastic Surgery released a report that contained the following conclusions: "There
are conclusive scientific—clinical, immunological, epidemiological—data, that silicone
gel-filled breast implants do not cause any autoimmune nor connective tissue diseases."
Their report also stated, "Updated studies continue to show that silicone gel-filled
implants do not cause cancer nor other malignant disease." The entire declaration
can be found on the internet at www.worldplasticsurgery.org.
Information Regarding All MENTOR® Breast Implants
Important Safety Information
MENTOR® MemoryGel™ and MENTOR® Saline-Filled Breast Implants are indicated for breast
augmentation—in women who are at least 18 years old—or for breast reconstruction.
Breast implant operations should not be performed in women with active infection
anywhere in their body or with existing cancer or pre-cancer of their breast who
have not received adequate treatment for those conditions or who are pregnant or
There are risks associated with breast implant operations. Breast implants are not
lifetime devices and breast implantation is likely not a one-time operation. You
may need additional unplanned surgeries on your breasts because of complications
or unacceptable cosmetic outcomes. Many of the changes to your breast following
implantation are irreversible (cannot be undone) and breast implants may affect
your ability to breastfeed, either by reducing or eliminating milk production.
The most common complications with MemoryGel™ Breast Implants include reoperation,
capsular contracture, asymmetry and breast pain. A lower risk of complication is
implant rupture, which is most often silent (meaning neither you nor your doctor
will know you have a rupture). The health consequences of a ruptured silicone gel-filled
breast implant have not been fully established. Screenings such as mammography,
MRI or ultrasound are recommended after an initial implant operation to assist in
detecting implant rupture.
The most common complications with MENTOR® Saline-filled Breast Implants include
reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation.
CONTOUR PROFILE™ Tissue Expanders and Smooth Round Tissue Expanders with Remote
Dome are used for breast reconstruction following mastectomy. These expanders are
intended for temporary subcutaneous or sub muscular implantation and are not intended
for use beyond six months. You should not have an MRI while the CONTOUR PROFILE™
Tissue Expander is implanted. The device
could be moved by the MRI, causing pain or displacement and potentially resulting
in a revision operation. The incidence of extrusion of the expander has been shown
to increase when the expander has been placed in injured areas: scarred, heavily
irradiated or burned tissue, crushed bone areas or where severe surgical reduction
of the area has previously been performed.
Patients are reminded to discuss the indications, contraindications, warnings and
precautions, as well as the risks and benefits associated with MENTOR® Breast Implants
with their doctors or review detailed risk information online at
www.mentormedical.co.uk. It is important that you understand the risks associated
with breast implant operation when considering MENTOR® Breast Implants.