Gel Breast Implants Maryland
Silicone and Saline Breast Implants: Making an Informed Decision
If you are considering breast augmentation surgery, your most important decision is selecting a plastic surgeon with a record of good safety and results. Next, you have to make decisions about whether you want to have your breast augmentation with silicone gel or saline breast implants. This decision will affect your health and your results, so it is important to take care when making it and gather as much information as possible.
Using Informed Consent Documents
In order to receive FDA approval, all manufacturers of medical devices must perform a series of tests to prove their device is both safe and effective for the intended application. Then the manufacturers must create what are known as informed consent documents which describe the device, including its benefits and risks, in an objective fashion so that you, as a potential recipient of the device, will know what you might expect if you agree to have them.
Your plastic surgeon of choice should give you these documents during your consultation, but you don’t have to wait until then. The FDA requires that device manufacturers make the informed consent documents available on their websites. If you go to the Mentor LoveYourLook.Com site or Allergan’s Natrelle.com, you can find these documents. On the Mentor site, you have to scroll all the way down below the site map and look for the two large horizontal “download” links. On the Allergan site, scroll to the bottom and click on the safety information tab on the brown horizontal bottom navigation.
Learning about Risks
You can count on your surgeon and the breast implant manufacturers to tell you elsewhere about the benefits of breast augmentation, but there is nowhere like the informed consent documents for learning about risks. Here, the FDA requires that manufacturers be open and honest about risks. Each of the risks will be described in detailed but plainspoken language so you will understand what complications may follow your breast augmentation. The FDA also requires that complication rates from actual studies be presented.
Below is a summary of some of the complication rates for silicone and saline breast implants by both major manufacturers for primary (first-time) breast augmentation patients:
Mentor Saline (1yr)
Mentor Saline (3yr)
Mentor Silicone (3yr)
Natrelle Saline (1yr)
Natrelle Saline (3yr)
Natrelle Silicone (7yr)
Capsular contracture
4.6%
9%
8.1%
7%
9%
15.5%
Implant removal
3.6%
8.1%
5.1%
6%
8%
14%
Implant leakage
1.4%
3.3%
0.5%
4%
5%
8.6%
Infection
0.9%
1.7%
1.5%
2%
<1%
<1%
Reoperation
N/A
13.2%
15.4%
N/A
21%
30%
Rippling
N/A
20.8%
<1%
N/A
11%
1.2%
There are a few important things to note about these particular complication rates. First, note that these studies are several years old, and that minor technological improvements and education of doctors about the best procedures may have led to their reduction. Second, note that complication rates are highly variable between doctors. Ask any doctor you are considering about his or her personal complication rates. Finally, remember that although these are scientifically-run studies, they are still only studies with relatively small populations and might not be completely accurate. An example of variability can be seen in looking at the implant leakage rates for Mentor and Natrelle Silicone Implants. The above rates are for primary breast augmentation, and seem to imply that Mentor implants have a much lower rate of rupture, but if we look at secondary breast augmentation rupture rates, the trend is reversed. For Mentor implants, the rupture rate was 7.7%, while for Natrelle implants the rupture rate was 0% among secondary breast augmentation patients.
Overall, though, note that visible rippling is a significant risk for saline breast implants, and that reoperation is a significant risk for all breast implants, with a risk rate running from 13-30%. If you are considering breast augmentation, you must consider the possibility that you will need a second (or even third) operation and discuss this possibility with your surgeon.
About the Author
If you would like to learn more about silicone and saline breast implants for breast augmentation surgery in Virginia, Maryland, or Washington, D.C., please consult the website of The Austin-Weston Center for Cosmetic Surgery today.
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