After a 14-year long wait, the U.S. Food and Drug Administration has approved the use of silicone breast implants for women over the age of 22. However, with this highly welcomed news also comes a number of other concerns and questions—mainly in reference to the FDA’s rules and recommendations about the use of silicone.
The details and fine print of the government’s decision are making some plastic surgeons and patients less than excited about the silicone implant approval. Some important questions many are considering are related to the additional costs associated with the FDA’s recommendation of MRI scans and the potential future danger these types of implants may pose.
Silicone Implant Cost Concerns
The FDA’s decision to re-approve silicone breast implants in the U.S. was followed by a number of recommendations and guidelines. The most important being that every patient should get a breast check by an MRI three years after the procedure and every couple of years over her lifetime. This is to ensure there has been no rupture or leakage of the implant, which can cause health complications such as autoimmune diseases.
Furthermore, if leaks or ruptures are detected “the implant should be removed and replaced, if needed,” said the FDA.
So who will fund the recommended tests, or if necessary, the removal or replacement of the silicone implant? And what possible dangers does the FDA foresee if they device ruptures?
The Good News
While women older than 22 now have the option of silicon implants—which have been preferred over the less natural looking and feeling saline device—there are currently many new improvements and techniques being used in breast augmentation procedures.
Over the last several years, plastic surgeons have worked to improve the look and feel of saline implants in an effort to overcome the folds and wrinkles that may appear in the breast by placing the implant behind muscle and breast tissue.
In addition, a newer and more advanced generation of “highly cohesive” silicone implant is currently going through the FDA approval process. This device has a thicker gel consistency that is designed to resist against any ruptures or leakage and won’t pose any harm to patients.
“Patients that really are interested in gel implants have done their homework” and are aware of the future advances, said Dr. Walter Erhardt, chairman of the American Society of Plastic Surgeons’ public education committee.
“It will be interesting to see how many people will want to accept the old technology” that has been approved after such a long study, when newer advances may only be a couple of years down the road.
Considering breast augmentation? Please contact us to set up a consultation with a highly qualified and experienced board certified plastic surgeon near you.