Silicone Breast Implants

In November of 2006, the Food and Drug Administration (FDA) approved the use of cohesive silicone gel breast implants.  They are approved for both breast augmentation and breast reconstruction.  The FDA requires that patients who use these newer silicone gel implants follow certain guidelines—some are mandatory and others are “suggestions”.  I advise any woman considering this type of implants to visit the websites of both of the two companies that have received approval.  The Mentor Corporation website is www.mentorcorp.com; the Allergan Corporation website is www.allergan.com. 

Essentially, the FDA requires that you read a booklet about silicone implants provided by the implant manufacturer, you sign a form stating you have read the booklet and that you understand the information including the risks of the implant and that with this understanding you agree to proceed.  The FDA advises that you wait one to two weeks between reading the booklet and actually having the surgery.  You also will be required to have the implant, (considered a “device”) tracked by the company which will include some information about you.  The FDA also advises- but does not require- you to have periodic MRI exams of your implants.  This is because silicone leak or rupture is rarely detectable just by physical exam.  Thus, you can see that there is a certain “burden” placed on you as the patient which you must be willing to bear.

Silicone implants have been used in Europe for many years.  They have been used in the US for several years as part of a “study”.  Most surgeons using them believe that they “feel” more natural than saline implants and thus are better to use.  This is not yet fully clear.  It is important to understand the potential risks and complications of these implants.  A full discussion is available in the booklets discussed above which is why you should read them.  There are some major risks worth highlighting:

Rupture: The leak rate of the implants varies with the two manufacturers.  For augmentation the rupture rate is 1 to about 3 percent after three years.  This is found by MRI (an x-ray test).  You and your doctor can’t really tell if a silicone implant is ruptured by physical exam alone. 

Capsular Contracture:  The risk that a hard or painful scar capsule will form around a silicone implant is reported to be from 8 to 14 percent after 3 to 4 years.

Reoperation:   The need to reoperate on a patient with silicone implants is about 25 percent within 3 years of initial surgery.

Connective Tissue Diseases: Multiple scientific studies have failed to show that silicone implants cause such diseases as Lupus or other rheumatologic diseases but any symptoms you develop after silicone implant placement will be followed by the implant companies.

Breast Cancer:  There are no data that silicone implants will increase your risk of breast cancer.  However, having an implant will decrease the amount of breast tissue seen with a mammogram (less so if the implant is placed under the muscle).  There are no data that even with this mammogram visibility issue that implants interfere with or delay the detection of breast cancer.

Again, these are not all the risks but some of the major issues you need to know about.  The FDA approved silicone implants, from a practical standpoint, feel a bit heavier than saline implants and they are more expensive .  The incision needed to place them may be a bit larger than that needed for saline implants.

Again, if you would like to talk with Dr. Topol about silicone implant augmentation or reconstruction, give our office a call at (603) 622-0900 or send us an e-mail.