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FDA Approves Highly Cohesive Silicone Gel Implants

By Brian Kobienia, MD, FACS on March 07, 2013


 

The Food and Drug Administration (FDA) recently approved another type of silicone gel breast implant.  This device is brought to the market by Allergen.  The Natrelle 410 is a more cohesive silicone gel device.  This extra cohesiveness is accomplished by extra cross linking of the silicone molecules.  The advantage of a more cohesive gel is not completely known.  It will make the implant feel firmer.  This may be an additional tool to offer patients who are interested in breast augmentation and breast reconstruction after mastectomy for cancer treatment.  It is anticipated that the other two major breast implant manufacturers who sell implants in the United States, Mentor and Sientra, will have devices approved by the FDA in the near future as well.

 

Is there any advantage to a more cohesive device?  Perhaps.  Most women who desire breast implants have expectations size, shape and feel.  Most of these expectations can be met with the devices on the market currently.  There are rare patients who need a more cohesive device to manage visible wrinkles.  One could argue that this problem can be managed with a higher profile device instead of a increasing cohesiveness.  Clinical trials have yet to be done.

 

Alternatively, some patients actually desire a firmer  or harder feeling breast.  There is a fine line between too soft and too firm.  Just like Goldylocks.  When a breast is too firm we usually label this a complication (e.g. capsular contractor).  If a breast is too firm it, in my opinion, imparts the sensation of ‘fakeness’.

 

My fear is that these devices with inspire the further development of shaped breast implants.  Shaped implants require the shell to have texturing to prevent twisting of the implant.  You don’t want the implant to twist or the thick and thin ends of the implant could flip and lead a really oddly shaped breast.  It is the texturing of breast implants the we believe has led to the scariest complication that nobody is talking about - ALCL (anaplastic large cell lymphoma).

 

The approval of the highly cohesive breast implant is not the best thing since sliced bread.  Visit with your board certified plastic surgeon to discuss which breast implant device may be best for you.  Expect the manufacturers to bypass the doctors and directly market the devices to the general public which appears to be the trend lately.

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