Most Silicone Gel Breast Implant ruptures are "silent", MRI recommended periodically in all patients
The majority of silicone gel breast implant ruptures are "silent", i.e., the patient, nor the surgeon or examining physician can definitively make the diagnosis of silicone gel breast implant rupture. For approximately 15 years, the FDA placed a moratorium on silicone gel breast implants, because of concerns about occult implant rupture, interactions of silicone gel with tissues surrounding the implant, effects of silicone gel outside the area of the breast, possible immune reactions to silicone within or outside the implant, and other common sequelae such as scar tissue formation (medically termed, capsular contracture) and its effect on the breast shape and constrictive pain syndromes.
The FDA released the moratorium in November of 2007, after a research committee of renowned specialists from all the involved specialized medical fields found that they were safe for implantation with several stipulations. The FDA recommended that plastic surgeons inform their patients that it is very difficult to detect silicone breast implant rupture, since the silicone gel stays in the “pocket” (space that surrounds the breast implant) and the breast does not appear “deflated”. It is difficult for both the patient and the surgeon to detect silicone gel breast implant rupture.
MRI (magnetic resonance imaging) is the best technique to detect silicone gel breast implant rupture, as this test can look for small amounts of silicone that are outside the shell of the implant suggesting rupture that is difficult to detect. The FDA recommends that all patients be informed by their plastic surgeons that they should obtain an MRI 3 years after the breast augmentation, and then every 2 years thereafter, to detect silent rupture at an early stage, so the implants can be removed and replaced before any long term sequelae of silicone breast implant rupture occurs.
I am certain that during all of my consultations that my patients are informed of “silent” rupture of silicone gel breast implants and the need for them to be committed to having MRI’s taken to detect any potential rupture at an early stage. Patients should continue to be vigilant about doing monthly breast exams and if there is any abnormality that they detect, the patients know that they should call my office for an evaluation. Silicone gel breast implant ruptures can sometimes present as a lump, change in shape of the implant and other physical changes in the breast, but this is less common than “silent” rupture.
I also inform my patients that they will still need to have mammograms yearly at age 40 and every year thereafter to detect breast cancer and that the mammogram is the test for breast cancer and the MRI is for breast implant rupture and one does not replace the other. Each patient is advised to return to my office at the advised intervals to have the MRI scheduled at the appropriate time. My patients feel very well informed about their option of seeking a breast augmentation with silicone gel breast implants, as I feel it is important for my patients to make intelligent, non-emotional decisions when deciding the type of implant they desire.
Implant integrity cannot be guaranteed for your lifetime. If you have a saline implant a "deflation" will usually become obvious as the implant volume shrinks over a period of time. This can be fast and dramatic or occasionally may take place slowly over a longer period of time. If you have gel implants, a "rupture" will not cause the breast to shrink because the gel stays together. The breast doesn't feel any different either. An MRI is the only reliable way to detect modern gel implant rupture.
Implant Rupture: Gel and Saline
With saline implants you will know within hours that your implants are leaking. The saline fluid is similar to intravenous fluid and should be absorbed harmlessly by your body.
With gel implants you will generally not be able to tell if and when your implant leaks or ruptures, unless you develop adverse reactions to the material. The most common reaction is scar lumpiness called silicone granuloma. This may show up on ordinary mammograms. As noted by other surgeons, magnetic resonance imaging (MRI) is fairly reliable at detecting ruptures and recommended by the FDA on a routine basis for gel implant patients.
MRI scan is best way to detect "silent implant rupture"
First of all, the previous concern about health risks associated with silicone ruptures have been disproven since 1998. So let's get to your question. Silent ruptures occur at a certain percentage per year, just like life expectancy of anything. The longer you have implants , the higher the likelyhood of them being ruptured. Usually this occurs at a rate of about 1/2 of 1 % per year per implant. The best way to detect a rupture is by MRI scan. This is a good idea about 6-10 years after implants are placed, or at any time you are worried about it. The MRI scans will play bigger part or early breast cancer detection in the future.
Breast Implant Rupture Detection
Yes, silicone gel implant rupture is difficult to detect. There are actually two types of rupture- one is intracapsular and the other is extracapsular. The "capsule" is the scar tissue that naturally forms around the implant. Thus, an intracapsular rupture is where the implant has an opening but the silicone gel "leak" is contained within the scar capsule sack. An extracapsular rupture is where the silicone gel "leak" is found outside the scar capsule sack, as well. Most ruptures are intracapsular. Regardless, it is difficult to determine if a silicone gel implant shell has lost its integrity. One may feel an irregularity or "nodule" as opposed to a completely smooth shell. Very rarely, one may also feel a tinge of pain or tenderness at the site of a rupture. What all women should know is that there may not be any symptoms at all and that the FDA has recommended that women with silicone gel implants undergo a MRI of the breasts every 2 to 3 years to determine the integrity of her implants.
Although it is a little easier to determine if saline breast implants have leaked or deflated, it is still possible to have a rupture of a saline breast implant and not know it. Many times patients who experience leaks with saline-filled implants see the difference and may have a feeling of general discomfort as the implant deflates and "collapses" the scar capsule as surrounding tissue is pulled with it.
In the case of silicone gel-filled or saline-filled implants, if one suspects a rupture or deflation, the patient should feel comfortable returning to her plastic surgeon to have him/her order appropriate studies and, if needed, surgery to remove and/or replace the implant.
Yes most gel implant ruptures are "silent" but new generation gel is very thick and contained
This is a great question! We are in the latest generation silicone devices with the shells getting stronger and the gel much thicker or "cohesive". I am an Allergan guy but you may be surprised that the round gel implants filler inside is essentially the same gel, memory or not. It is like a thick jello material so even if the shell does fail, most of the gel stays inside the implant itself. If some knucles out it nearly 100% stays inside the implant capsule or internal "zip-lock" bag your body forms around your implant (called an intra-capsular rupture). The latest generation form stable implants like the Natrelle 410 or CPG that are currently available in the US in clinical trials only...hopefully approved soon...contain even thicker more cohesive gel with even lower shell failure rates less than 1% at 8 years.
The FDA when approving gel implants back on the US market about 3 years ago have recommended MRIs at 3-5-7 years looking for shell abnormalities. We are just beginning a very exciting IRB study with GE looking at gel implants with high resolution ultrasound looking at shell abnormalities and comparing them with MRI. Early results are exciting...so hopefully in the future we will have an easy inexpensive test to follow and screen your implants over time.
Nearly All implants will need to be replaced at some point so you should be prepared for that but it is very straightforward to replace a current generation implant because the gel is so much more thick and your pocket is already stable.
Even with this potential of "silent rupture", the research shows that every disease a woman can get including autoimmune disease and breast cancer is the same in women with a silicone gel implant or a woman with no implant.
All my Best!
Rupture vs. significance of rupture
Most of the concerns with rupture or leakage in silicone gel implants have to do with the physical, not chemical, risks. Rupture rates are difficult to come by which is why there are ongoing clinical studies and a registry for these implants to keep track of complications. Rupture is related to length of time of implantation: the longer you have implants, the higher the risk of rupture.
Rupture does not mean they explode, but just that the shell loses its integrity and allows gel to leak. Some studies show that a majority of the implants leak after 10-15 years. All leaks start out as intra-capsular leaks contained within the capsule of the implant.
However, 15-18% of the leaks become extra-capsular and these are the leaks that cause problems because they allow the gel to migrate away from the capsule. The idea of the cohesive nature of the gel is that the more cohesive it is, the less any leaking gel will be able to migrate. If you have no signs of symptoms of leaks, then you have a silent leak. The breast looks and feels normal. That is the dilemma for patients and surgeons: what to do with silent leaks.
Some doctors, and most lawyers, say you need to have the implants removed and replaced. Some doctors feel you can leave a silent rupture untreated as long as you keep vigilent of changes to size, change, or consistency of the breast. The problem is many patient will have no health issues related to silent ruptures so if you force all women with silent ruptures to undergo secondary surgery at great cost, you are probably over-treating a great number of them. However, it is difficult to tell a woman not to do anything if the implant in her has "failed".
The most accurate method of detection is surgery, but MRI scans are the most sensitive non-invasive test and is why the FDA recommends scans every 2-3 years. Mammograms can be helpful but have higher false negative and false positive rates.
When you undergo breast augmentation you should be aware of all the significant risks and accept the fact that it is a potentially highly beneficial but imperfect procedure. Breast implants require ongoing 'maintenance' and follow-up, and invariably, ongoing future expense.
Indeed, most gel implant ruptures may be silent. The implants will ALL develop a scar capsule around them. When gel leaks out ot the implant it is contained within this capsule. Depending on the capsule size and tightness the leaking gel may never be detected clinically. Sometimes a leaking gel implant will soften, flatten or change shape prompting further study by the plastic surgeon. The issue then becomes whether leaking gel contained within a capsule is of any significance. From the numerous clinical studies that have become available since the FDA banned gel implants in 1992 it appears that silicone does not cause disease. This information prompted the FDA to lift the gel ban in 2006. Good luck!
Implants can fail over time. Gel implant failures occur less than 1% a year. Rounding it off in 10 years there is a less than 10% chance of failure; in 25 years about 25%, etc. There is usually no signs or symptoms of failure. Implant failure is best diagnosed with an MRI and soon a type of ultrasound may be available to accomplish this. You should consider getting an MRi sometime after breast augmentation with gel implants, perhaps 10 years or so. This is a good way to check on the status of the devices.
Recommendations are for MRI
WIth the new silicone memory gel, if you have a rupture in the shell or if the shell cracks, it will likely go unnoticed by you unless you have imaging studies performed. With saline implants if there is a leak in the implant, you will visually see the difference in your breast size in a day or two. Some leaks are small enough that the decrease in size will happen very slowly.
With silicone since the gel is cohesive like a gummy bear, the silicone will likely not "leak" like saline would. So the FDA has made recommendations that and MRI should be performed within 3 years after your surgery and then every 2 years after that.
The implant company will tell you that the implants are very well made, infact they are so certain of the make that they cover the implants with a lifetime warranty, meaning they will replace the implants if there is a leak secondary to manufacturer defect.
Hope that helps.