Natrelle Cohesive Silicone Gel Implants: if Ruptured Do They Cause Any Harm to the Surrounding Tissue?

Yes the gel is very cohesive and does stick to itself much better than the old "syrup" type of silicone and in most cases it stays hidden in the pocket if the implant does rupture, but in some instances the ruptured silicone can cause hardening or irritation of the capsule. But remember, in order for can gel to leak into the tissues, the capsule must be torn as well and not just the implant.

For peace of mind and a newly FDA approved and available implant consider the IDEAL Implant - a double lumen saline implant made to feel like silicone. My patients love them ! For silicone implants prior to 2006, ruptures occur at rates of approximately 1-2% per year for the first ten years then markedly increases after that time period. A rupture or deflation of the implant may be experienced at any point after the initial augmentation; this complication may be increased by an under-filling or overfilling of saline solution into the implant, excessive compression, trauma, and other causes. (If the implant shell if not filled with the correct amount of saline, there may be a crease or fold in the shell which often leads to a rupture). You will be able to self-diagnose the need for an implant exchange (if using a saline implant) because if the current implant ruptures, the breast will shrink to approximately its preoperative size. A silicone implant that has a rupture is usually noted on a routine mammogram or MRI scan. In either case although the situation needs to be corrected on a timely basis, it is not dangerous to your health from our current knowledge base. In most cases, any free silicone will be contained within the capsule to prevent damage to surrounding tissue. Silicone implants after 2006 are more cohesive and less likely to leak or have silicone migration. Although the newer implants are more cohesive they are still very sticky when ruptured and you do need a removal of the surrounding capsule (capsulectomy) if this happens vs simple implant replacement with saline implants.

Hi Meg

The newer generations of cohesive silicone gel implants (last decade or so) are made from a tough silicone outer shell and a silicone gel inner. The inner gel is made so that it is the consistency of Turkish Delight or a Gummy Bear.

You can cut an implant in half and hold it upside down and the gel will not leak out of the shell. If a new cohesive gel implant ruptures, the outer shell can still peel away from the inner gel with time (due to body movements), at least in spots - and this gives the radiologists a way to see the rupture. However the inner gel cannot migrate. 

This does not mean that any exposed gel will not irritate the surrounding capsule (or inner scar around the implant). Surrounding irritation will not definitely occur, and some of the ruptured implants I have removed have had remarkably thin pliable capsules.

Hi Meg,

In general I agree with the statements made by your plastic surgeon.  The silicone gel in the current implants is very thick and sticky; thus it really cannot "seep" into the tissues.  Also, as already pointed out, the capsule which forms around the implant usually "contains" the leak, preventing the silicone from getting into the tissue.  However, if the implant has a leak, and  the capsule tears, for example after an accident, it is possible that some silicone would be forced out of the implant and into the tissues.  There is no evidence that this would cause you a medical problem, such as leading to some type of systemic disease.  However, it could cause a local problem such as the onset of capsular contracture or lumps in the breast which patients usually want removed.  When deciding between saline and silicone I explain it to my patients this way.  Silicone implants have all the aesthetic advantages:  they are more compressible and hence usually feel softer, they have less rippling, they are lighter, they stretch the tissues less.  Saline implants are the opposite:  heavier, in thin patients do not feel as natural, more rippling, more tissue stretch.  The advantage of saline is that it is very easy to detect a leak (because the breast gets smaller) and very simple to remove and replace if leaking.  I do not consider the lower price an advantage because this is a short term advantage and I don't advise making decisions regarding your body/health based on cost.   The disadvantage of silicone is that in most cases one needs an MRI to detect a leak; this may or may not be covered by insurance.  In our area breast MRI can cost between $500 (unusual) and $2400.  Secondly, the surgery to remove a leaking silicone implant is slightly more involved as it involves a capsulectomy.  So these are the issues we focus on.  The most important thing is that you are comfortable with the type of implant you have and education about the implants is important for you to make an informed decision.  My only absolute is that I do not recommend saline implants for patients who have very thin tissues or who need a breast lift.  I have many patients with saline implants who have a beautiful result.  The key is that they had enough breast tissue to really cover the implant.  Hope this helps.

Tracy M. Pfeifer, MD, MS

No implant lasts forever.  I tell my patients to think that the life of the implant should be about 10 years.  They will last less time if the patient gets a capsular contracture, and the implants feel hard.  This causes a fold in the implant and then they wear out at the fold.  The best way to get them to last is to keep them soft, and not get a contracture.  There have been 5 different generations essentially of gel in implants. 

1.  Silicone in the late 60's and early 70's was a bit more cohesive

2.  Second generation implants were made in the late 70's to the mid 80's.  The silicone was very runny and would "bleed" through the tissues and into the lymph nodes

3.  The implants of the Mid 80's to the late 90's were the 3d generation silicone that became a bit more cohesive, but mainly the shells became stronger.

4.  Fourth generation implants are the implants of today (started in the late 90's) that are more cohesive and is much less runny.  But not as much cohesive in the patient as it is in ads.

5.  Gummy bear implants are the 5th generation implants that when cut in half really does look like gummy bear, and is much less runny. 

Each generation has less risk of bleeding into the surrounding tissue, and into lymph nodes.  But you should get an evaluation frequently by your plastic surgeon that is certified by the American Board of Plastic Surgery.  Good Luck to you.

When the shell of a cohesive gel implant tears, free silicone is not released into the surrounding tissues.  The vast majority of the time, the silicone sits within the torn shell, causing no problems.  It is possible for the tear and subsequent exposure of the gel to the surrounding capsule to create an inflammatory response that may cause calcifications, and/or a contracture.  Pain, change in shape of the breast, and firmness may result.

Again, the occurrence of these events is the exception rather than the rule following rupture of a cohesive gel implant.

All gel implants leak over time, no matter how cohesive the gel. Your surgeon is right in that the gel will tend to 'stay together', however when there is a tear in the silicone rubber shell (a leak) the sticky gel inside will contact the tissue surrounding the implant and produce irritation, perhaps tenderness, calcifications, and eventually capsular contracture. This is what all the FDA warning and MRI stuff is all about.

Best of luck, peterejohnsonmd.com

Although I can assure you that the silicone gel in Natrelle's cohesive gel implants stays together even if the shell of the implant is damaged, it helps to see it for yourself. If a picture is worth a thousand words, this video will explain it better than anything. In it, I cut one of these in half, not easy to do by the way. Here's what happens.