Silicone Gel Implants
You have heard the news about the availability of
silicone breast implants. Look through the pages on implants, silicone and FAQ's
and get the facts. Many more people now have a choice between saline and
silicone implants.
Silicone Gel implants, contrary to what many people believe, were not
taken off the market. These implants were reclassified at the time of the implant
controversy, and were only available in an FDA approved study of gel implants under the
care of an approved investigator. Dr. Studin is one of the relatively few surgeons
in the country who was authorized as an investigator in this study
and has a vast experience with silicone implants.
Conditions that may suggest that
Silicone Gel Implants
are best for you...
- Thin skin with small, hanging breasts.
- Thin chest muscle
- Need for a lift and Breast Implants simultaneously.
- Rippling of the skin with saline Breast Implants
- Chest wall deformities
- Saline Implants that can be felt
Silicone Gel Breast
Implants, according to many surgeons, are the best way to correct skin rippling that
occasionally occurs over saline Breast Implants and can result in a softer
breast.
What are the rupture rates for MemoryGel™ Implants?
Mentor has very low rupture rates for our MemoryGel™ products. Our Core Study
had 1007 patients, 420 of which participated in a MRI cohort to help study
silent ruptures. At three years, our confirmed rupture rate (through explant) is
0.2% by patient and 0.3% by implant.
Some patients in the study have had MRIs that appear to have ruptures.
However, the patients have chosen not to have surgery to confirm the status of
their implants-- these are called suspected ruptures. The confirmed and
suspected rupture rate is 1.1% by patient and 1.6% by implant.
It is important to note that 3 suspected ruptures have undergone explant
surgery and all implants were intact.
The augmentation patient satisfaction rate was 98% for the respondents.
What are the new conditions of approval?
There are several conditions that the FDA has mandated with approval of
silicone gel implants that are different from saline implants.
- The augmentation patient must be at least 22 years of age. See
Patient Labeling for
more information about the process of Informed Decision that is also a new
requirement.
Why is there now an age of 22 for breast augmentation?
FDA required this limitation.
Mentor agrees that women who choose breast augmentation should be ready
both physically and emotionally, and that this decision to have a procedure
should be reached only after informed consultation with their physician.
This decision involves a different set of factors when a reconstruction or
revision procedure is involved.
Are there similar age restrictions for saline breast implants?
The labeling for saline breast implants restricts breast augmentation to
patients 18 years or older.
MemoryGel™ Implants: A More Evolved Breast Implant
- Multi-layered barrier inhibits silicone gel bleed
- Highly compliant shell for ease of placement through standard incision
- A proprietary formula for a feel that is similar to actual breast tissue
- Lifetime replacement guarantee
- Moderate, moderate plus, and high profile options offer a wide selection
of projection per base width in round gel implants
- Highest quality materials used to optimize implant integrity
The right choice for you
can sometimes make the difference between a natural and unnatural result.
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