The Food and Drug Administration (FDA) issued a word of caution about silicone implants for women considering them for cosmetic or reconstructive surgery. In a statement issued on June 22, 2011, the FDA warned that these ‘devices’ are not for lifetime use and cited several problems found with silicone implants for the women who have them.
The data the FDA reviewed to reach its conclusions came from the following sources:
- Preliminary safety data from 2 silicone implant manufacturers (Allergan and Mentor)
- Post approval studies
- Adverse events reports
- Comprehensive review and analysis of recent scientific publications on subject
The report issued words of caution about the following when it comes to women and silicone breast implants: The FDA urged women to realize that the silicone breast implants are not lifetime devices. In other words, women should expect to have them removed and/or replaced at some time in their lives. The reports showed that generally speaking, one in five women who have received silicone implants for cosmetic reasons will have to have them replaced within ten years. Half of the women who have had silicone implants for reconstructive purposes will be forced to have them taken out and replaced within that same ten year period.
These are the two main reasons the FDA has issued the warning to women so that they understand the rate of removal and/or replacement of the implants is high. Again, as the FDA stated, the devices are not meant to be used for a lifetime.
The FDA issued the following statement warning women,
“The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms,” Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
Women with silicone implants should be aware of any warning signs such as pain or breast changes that could have something to do with their silicone implants. Women who have received breast implants should also keep in close contact with their operating physicians to keep him or her updated on their progress with the silicone implants. If you have silicone implants and have enrolled in any follow up or tracking program it’s vital to stay in contact with that group. This will allow for the long term study of silicone implants to determine any changes or recommendations that need to be made.
Adverse Problems with Silicone Implants Requiring Removal
The main complaints that are associated and reported by women with silicone implants they had removed are the following:
- Hardening of tissue area around implant
- Additional surgeries
- Implant rupture
If you are considering breast augmentation it’s essential that you know the risks. Getting comfortable with your own body and loving it for exactly how it is has no side effects or risks involved.