Breast Implant Clinical Studies
Your Assurance of Safety
Over the years, Mentor has done 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 are clinical studies of more than 200,000 women with silicone gel-filled breast implants.
Mentor also has 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 breast implants. Mentor silicone gel and saline breast implants have received PMA (pre-market application) approval from the FDA.
As we have for many years, Mentor will remain committed to providing the public with objective information about breast implant safety.
Core Gel Clinical Study of Mentor's Round
Silicone Gel-Filled Mammary Implants
Mentor is conducting a clinical study to evaluate the safety and effectiveness of our silicone gel-filled breast implants. In this nationwide study, 1,000 patients enrolled at up to 60 study sites were implanted with Mentor silicone gel-filled breast implants and are being followed for 10 years.
The study follows three groups of patients: those seeking implants for general breast enlargement (Augmentation); those who are undergoing breast reconstruction (Reconstruction); and those patients who need a revision of a previous saline or silicone gel breast implant (Revision).
Silicone gel breast implants have not been generally available since 1992, when the Food and Drug Administration (FDA) additional implant manufacturers to collect clinical trial data. This core study will provide the additional information to the FDA. While all patients will be followed for 10 years, Mentor has received Pre-market Approval (PMA) from the FDA due in part to Core Study data that, demonstrates the safety and effectiveness of our MemoryGel® breast implants.
Alternative products and surgical options to silicone gel-filled breast implants are limited. These options include saline-filled breast implants for augmentation and reconstruction procedures, as well as autologous tissue, which utilizes the patient's own tissue during reconstruction procedures.
Current Status: Post Approval Study (PAS)
Patient enrollment for this study is complete. Patients are currently being seen for their additional postoperative follow-up.
Contour Profile® Gel (CPG) Clinical Study
Mentor is conducting a clinical study to evaluate the safety and effectiveness of our Contour Profile® (shaped) Gel breast implants. While the PMA has been submitted to the FDA, all patients are currently being seen for their additional postoperative follow-up. In this nationwide study, 950 patients enrolled at up to 60 study sites have been implanted with Mentor CPG breast implants and will be followed for 10 years.
The CPG study follows three groups of patients: those seeking implants for general breast enlargement (Augmentation); those who are undergoing breast reconstruction
(Reconstruction); and those patients who need a revision of a previous saline or
silicone gel breast implant (Revision).
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The Safety of Silicone Breast Implants
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 surgery. 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
Mentor MemoryGel® breast implants are now FDA approved for breast reconstruction!
The MemoryGel® implants you've been reading and hearing about have been successfully
used and trusted for 20 years by millions women all over the world. Why? Because
our implants feel more like natural breast tissue - without compromising reliability
or safety. After almost two decades of research and testing with surgeons and patients,
MemoryGel® breast implants are now available to women in the U.S.
Learn more about the
Important Information
MemoryGel® Breast Implants
Saline Breast Implants
All Implants
Important Safety Information
Mentor MemoryGel® and Saline-filled breast implants are indicated for breast augmentation - in women who are at least 22 years old for MemoryGel® and at least 18 years old for Saline - or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. 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. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent 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 are used for breast reconstruction following mastectomy. This expander is intended for temporary subcutaneous or submuscular implantation and is 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, potentially resulting in a revision surgery. 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.
Detailed information regarding the indications, contraindications, warnings, precautions and the risks and benefits associated with Mentor breast implants are provided in brochures available from your surgeon (Important Information for Augmentation Patients about Mentor MemoryGel® Silicone Gel-Filled Breast Implants, Important Information for Reconstruction Patients about Mentor MemoryGel® Silicone Gel-Filled Breast Implants and Saline-Filled Breast Implants, Making an Informed Decision) or on line at www.mentorcorp.com. It is important that you read and understand this information when considering Mentor breast implants prior to deciding on surgery.
MemoryGel® Implants
Important Safety Information
Mentor MemoryGel® breast implants are indicated for breast augmentation in women who are at least 22 years old or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. 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. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture.
Detailed information regarding the indications, contraindications, warnings, precautions and the risks and benefits associated with Mentor MemoryGel® breast implants are provided in two brochures available from your surgeon (Important Information for Augmentation Patients about Mentor MemoryGel® Silicone Gel-Filled Breast Implants and Important Information for Reconstruction Patients about Mentor MemoryGel® Silicone Gel-Filled Breast Implants) or on line at www.mentorcorp.com. It is important that you read and understand this information when considering Mentor breast implants prior to deciding on surgery.
Saline Implants
Important Safety Information
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 surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation is likely not a one-time surgery. 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 Mentor Saline-filled breast implants include reoperation, implant removal, capsular contracture, wrinkling, breast pain and deflation.
Detailed information regarding the indications, contraindications, warnings, precautions and the risks and benefits associated with Mentor breast implants are provided in a brochures available from your surgeon (Saline-Filled Breast Implants, Making an Informed Decision) or online at www.mentorcorp.com . It is important that you read and understand this information when considering Mentor Saline-filled breast implants prior to deciding on surgery.