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See a 3D Demo of a Silicone Breast Implant through the Armpit
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In November of 2006, the Federal Drug Administration re-approved silicone gel implants after 15 years off the market. They have been deemed safe and effective and the FDA will continue to monitor them by requiring each breast implant manufacturer (currently Mentor and Inamed) to conduct large post-approval studies. These studies will include 30,000 women for ten years after receiving silicone implants.
The decision to take silicone breast implants off the market was made after complaints of hardening around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery.
So why the change of heart, FDA? It's based on a thorough review of both Inamed and Mentor's clinical and preclinical studies,a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, the FDA conducted inspections of each company's manufacturing facilities.
To be concise, this decision was not made lightly. The majority of women in the core studies reported being satisfied with their implants.
In the past decade, a number of independent studies examined whether silicone implants were associated wtih connective tissue disorder or cancer. These studies concluded that there is no convincing evidence that silicone breast implants are associated with either of these diseases. However, the FDA will continue to monitor these complaints in the future studies conducted by Mentor and Inamed.
A good source of information is the manufacturer's websites. We at Certified Plastic Surgeons encourage you to review the product information therein before making a decision as to whether silicone breast implants are the right option for you. And, of course, discuss your options with your surgeons.
Mentor's MemoryGel Website
Inamed's Breast Implants Today Website
Want to learn about saline breast implants? Click here!
Read about Saline versus Silicone in an article here!
What is a silicone breast implant exactly?
A silicone breast implants is comprised of three layers of shell surrounding a silicone gel. The multiple layers reduce the amount of gel bleed, the process by which small amount of the gel "bleeds" through the implant shell (remember that silicone has not been proven to cause cancer or other illnesses and that this leaked gel rarely migrates outside of the implant pocket area). The additional layers do, however, make the implants a bit firmer than they were before. Most report the feel to still be very soft and natural.
Silicone breast implants come pre-filled. This means that your incision will have to be a bit longer. Expect that incision to increase more if you choose a textured silicone (firmer than the smooth silicone). In general, however, incisions are small and easily hidden.
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The
Best Candidates for
Silicone Breast Implants |
| Silicone breast implants can enhance your appearance and your
self-confidence, but it won't necessarily change
your looks to match your ideal or cause other people
to treat you differently. Before you decide to have
surgery, think carefully about your expectations
and discuss them with your surgeon. The best candidates
for silicone breast implants are women who are looking
for improvement, not perfection. If you're physically healthy and realistic
in your expectations, you may be a good candidate.
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