Web Log – April 2010 – Silicone Gel Implant Surveillance

Ensenada Coast
Ensenada Coast

Approximately 3 years ago, the FDA released silicone gel implants back onto the market after studying them for greater than a decade.  Their reintroduction has greatly benefited women seeking breast surgery, especially patients with thin coverage over their implants.  I find that I recommend silicone implants for most reconstructive patients as they have thin coverage after their mastectomies.  Silicone helps to minimize rippling and it feels better than saline.  I recommend silicone to augmentation patients about 50% of the time.  Those patients usually have particularly small breasts  and or have thin skin.  In augmentation patients who have a lot of breast tissue, silicone is largely unnecessary as the implant is well covered.  I sometimes cannot tell if these patients have silicone or saline implants when I examine them at their 6 month follow up.

Well conducted studies have concluded that leaking silicone implants do not lead to any diseases, mysterious or otherwise.  It is thought, however, that leaking silicone can put patients at higher risk for capsular contracture.  Therefore, the FDA has recommended that all patients have an MRI at 3 years post op and then every 2 years thereafter to look for leaking.  Those first patients to get silicone implants are now coming due for their MRI’s.  Reconstruction patients should have their studies through their primary care physicians or their oncologists.  Augmentation patients are responsible for arrangement and payment for their own MRI’s.  Local radiology groups offer less expensive MRI’s that are specifically tailored to look for silicone leaks only and not for any breast tissue problems such as cancer.  If a leak is found, implant exchange is recommended.

When the 3 and 2 year MRI guideline was made, there was skepticism on the part of most plastic surgeons. Were so frequent exams really necessary?  We know that leaking gel does not cause systemic disease.  Now that the first 3 year period is up, there has been more push back from Plastic Surgery Leadership and recognized authorities in the field.  MRI is a useful study to detect a leak.  Unlike saline, when a silicone implant leaks, it does not deflate, and is basically undetectable otherwise.  There can, however, be false positive studies.  That is, the MRI can say there is a leak, but there may not really be one.  In that case, an expensive operation with all the usual risks is performed when it did not really have to be done.

So what do I tell my patients?  I’m the type of person who asks permission first rather than forgiveness later, so I dutifully present the recommendations as part of the required additional silicone gel consent document supplied by the manufacturer and mandated by the FDA.  Medicine is no longer as paternalistic as it once was.  Patients demand information and choice.  With these rights, however, come responsibilities. Therefore, it is up to each individual patient to evaluate the science as well as the guidelines and come to her own conclusion.  After all, the FDA will not be organizing shuttles to the MRI machine, nor will they be paying for the studies.

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