How accurate are the statistics for silicone breast implants?

I have spoken with many women with silicone breast implants. When I ask about the 2year MRI check, none of them have had it done. How does this affect the safety statistics for silicone breast?

Doctor Answers 4

MRIs and Silicone Breast Implant Safety

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The recommendation to have MRIs done after the placement of silicone breast implants was issued by the FDA when they again became available for cosmetic breast augmentation in 2006. The purpose was to periodically look for silent implant ruptures. (which is how many of them occur)  The cost of obtaining the MRIs, hpwever, is borne by the patient. So while the FDA, manufacturers and plastic surgeons pass along the MRI recommendation I suspect the vast majority of implanted women never follow through on having them done. Whether the MRIs are done or not does not impact safety nor expose women to any medical risks.

Silicone safety.

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The statistics are based on the 10 year prospective study performed before the silicone gel implants were released to the market after being pulled off the market in the mid-1990's and the ongoing after-market studies.  The data suggests that their is no higher incidence of any medical problem in people with silicone gel implants and those without implants.  This is why they were placed back on the market. 

Todd C. Case, MD
Tucson Plastic Surgeon

How accurate are the statistics for silicone breast implants?

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Excellent question!!  The FDA recommends getting an MRI every couple of years for silicone breast implants b/c there's a small chance that you can have a "silent rupture" where the implant ruptures and is clinically undetectable.  An imaging study would be the best way to detect such a rupture in this case.  Silicone ruptures can lead to capsular contractures and silicone granulomas.  The implant makers recommend that silicone implants be removed if they're ruptured.  If you do not have the recommended imaging follow up, there is a higher risk that such a rupture would go undetected until it becomes physically apparent. 

The following data is based on primary breast augmentation with regular screening MRI scans:

RUPTURE ALLERGAN Natrelle silicone gel
10.1% FDA Update on Silicone
Gel Implants, June 2011 MENTOR MemoryGel silcone gel
24.2% Health Canada, Summary Basis
of Decision, January 2014 ALLERGAN 410 anatomic form-stable gel
(“gummy bear”)
17.7% Aesthetic Surgery Journal Vol
35, Pages 145-155, February 2015

Hope that helps!

Zachary Farris, MD, FACS
Dallas Plastic Surgeon
5.0 out of 5 stars 23 reviews

Silicone Breast Implant Followup

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All the recommendations for MRI followup were made on studies performed on the old, non cohesive implants. It was also based on the assumption that a ruptured implant was bad and required replacement. Having followed many patients with known implant rupture for many years without any symptoms or health problems (only a few ever had any symptoms), I believe this assumption is false. Besides, the new implants are all cohesive gel which means that an MRI may not even show a rupture. I, therefore, do not advise my patients to have regular MRI screenings unless they have symptoms. Of course, the initial procedure is done with significant modification of what is done by many surgeons. This has resulted in a redo rate of

Robert T. Buchanan, MD
Highlands Plastic Surgeon

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.