How Safe Are Breast Implants?

Breast augmentation has been the most popular cosmetic procedure for years now, helping women achieve fuller, youthful, more symmetrical breasts with the use of implants. Millions of women around the world have breast implants, but there is a lot of controversy surrounding their safety, especially with the recent ban on Biocell textured implants in Europe and (in Canada) the recent CBC Marketplace reports discussing “Breast Implant Illness”. We’ll discuss how safe your breast implants really are to help you become more informed when making your augmentation and/or explantation decisions.

The saline vs. silicone debate

For anyone who has read my blogs or followed me on Instagram you’ll know I’m not shy about saying there is no “best” implant. It’s all about choosing the right implant for each patient based on aesthetic, medical and “peace of mind” factors. Saline vs. silicone is a long-standing debate in the plastic surgery world. While one is not necessarily better than the other, there are advantages and disadvantages of each. First of all, ALL implants that are available in North America have essentially the same silicone rubber shell, regardless of what it is filled with. Some are smooth and some are textured, but it’s the same silicone rubber.

Saline implants are filled with sterile salt water, which causes them to behave like water balloons. For patients that have enough tissue coverage and really only need volume they are a great option. For patients with thinner tissues they can give a fairly fake look and have a higher risk of rippling.

Silicone implants are filled with a cohesive silicone gel which tends to keep its shape better, resembling the natural breast tissue. It is less likely to ripple and tends to feel more like real breast tissue. Anatomically shaped highly cohesive implants are even better at keeping their shape and will tend not to deform under stress and strain. These, however, require a textured shell to prevent rotating and it is this shell that is the center of a lot of the controversy.

When it comes to safety, the saline implant appeals to many because, in the event of a rupture, the implant would deflate which lets the patient know there is a problem. The saline solution can be safely absorbed by the body, and since the body is mostly made up of saline, people think of it as “a natural substance”. If a silicone implant were to rupture, it can keep its shape and go undetected (the so-called ‘silent rupture’). That is why those who choose silicone implants may opt to have regular MRIs to ensure the structure and safety of their implants. It is worth noting that while the cohesive gel typically keeps its shape in the event of rupture, sometimes some can spill into the pocket. It DOES NOT migrate through the bloodstream to other areas in the body as many patients have asked me over time.

While implants do not need to be replaced on a particular schedule (i.e. they have no expiration date) and in some women last a very long time, they are not meant to be “lifetime devices” and so breast augmentation patients should expect to have at least one additional operation at some point down the road. Across the board, we generally consider implants to have a rupture rate of about 1% per year. This means that by the 10 year mark there is an approximately 10% chance that the implants will have ruptured. The warranty on the implants that are currently available in Canada is 10 years, so that is a good time to consider replacing silicone implants.

If you don’t want to compromise on your implants and try to get the best of both worlds, there is also the IDEAL implant. The IDEAL implant is filled with saline but consists of multiple chambers, giving it the structure that is more like silicone (although not exactly as soft). Patients can choose this option to combine the peace of mind that comes with saline and the more natural look and feel of silicone.

The ban on textured implants

There are two main ways that breast implants are texturized. Either the shell is stamped with something that makes an impression in the still wet silicone as it dries, or it is dipped in salt while wet and this salt is then removed leaving larger texturizations. Biocell texturization uses the lost salt technique, other texturizations use the stamping technique. Europe recently banned the use of Allergan’s Biocell textured breast implants, which are less commonly used in Canada and the United States (where we are notorious users of smooth implants). The ban came from the conclusion of several studies showing an increased risk for breast implant associated anaplastic large cell lymphoma (BIA – ALCL) in those with biocell textured implants. ALCL is a type of blood cancer involving the immune system and while in theory ALCL can be associated with any implant, essentially all of the cases that have been documented involved a patient having biocell textured implants. Issues with biocell textured implants have been considered for many years leading up to this ban, which is why I stopped using biocell textured implants in 2014.

Breast Implant Illness

Over the years there have been concerns regarding how silicone breast implants may affect a woman’s overall health. Silicone is found in almost all medical implants – replacement lenses for cataracts, replacement heart valves etc. – because silicone is generally felt to be inert as far as the immune system is concerned. There have been concerns raised in the past, and they are being raised again by the online breast implant illness community, and these led to a ban on silicone implants through the 1990s to allow for further study. All of the studies showed no evidence of breast implants causing any of these issues. That being said, there is a group of women who feel that their implants are making them sick and feel better when they have them removed using the ‘en-bloc’ technique (which removes the entire capsule along with the implant). There are many possibilities for why this is happening and the implants being toxic is simply one of them. At this point we have so many breast implants in use and under study (in addition to millions of other implantable medical devices that contain silicone) that it is highly unlikely that the implant itself is toxic, however there are other possible explanations for the symptoms.

There are two areas of medicine that are rapidly evolving and we are learning that there is so much more to them than we initially thought. In non-medical terms they are essentially 1.) the immune system is even more complex and nuanced than we thought (and it was already one of the most complex things in medicine) and 2.) the mind-body connection is ridiculously strong. In terms of the immune system, we are seeing things like how bacteria in your gut can influence symptoms elsewhere in the body (something that was considered complete quackery a decade ago when I was in medical school). We are also seeing that each person’s immune response to various stimuli is different, and that a person’s response can change overtime. In my mind that means there is the potential that a small percentage of women have (or can develop) an immune response to silicone that could cause the symptoms being described. This is something that we may not have appreciated when studying tens of thousands of women in the core implant studies, but now that literally millions of women have had implants in for some time it may be showing up in some of them. At the moment there are about 50,000 women in the healing breast implant illness facebook group out of an estimated 5,000,000 women with breast implants in the United States alone which works out to about 1% of women with implants. This is a number low enough that it may not have shown up in the studies (or would not have been statistically significant if it did). It is a number that would also not prevent any medical device or medication from being considered safe and put on the market (because no drug or medical device is 100% safe for everyone). It is also a number that does warrant further consideration, because if there truly is an immune reaction in a small percentage of women, it would be really nice to figure out what it is and ideally be able to order a test before surgery to predict it.

Another explanation, which may be a bit controversial, is something along the lines of the mind-body connection. We are learning how important mindfulness can be for treating all sorts of conditions, including chronic pain, which is one of the toughest conditions to treat. If the mind can treat disease, it’s not a giant leap to think it can create it. The subconscious is a very powerful thing, and the level of concern some women have about this condition and its symptoms could cause the body to actually manifest them. I need to be clear here, I am not saying that these women are imagining their symptoms or are making anything up. The pathway I am describing is the mind subconsciously creating REAL symptoms which are then perceived consciously by the patient. These symptoms are no less real than if the implant was toxic or the immune system was reacting to the implant, they are just created by a different pathway. One big strike against this theory however, is that in many (if not most) of these women, the symptoms show up long before they have ever heard of “breast implant illness”, and in-fact, often find out about it while researching causes for their symptoms that no doctor can find a cause for.

Regardless of the cause of the symptoms, for a lot of women experiencing them, en-bloc removal of the implant seems to resolve them. It does not resolve the issue for all of them however.

So…are breast implants safe or not? Should I have mine removed?

All the information we have from years and years of research studies shows that  breast implants are generally very safe, especially when the procedure is performed by a board certified plastic surgeon. Given the way that companies have handled problems with defective implants in the past, specifically through the 1980s and early 1990s, it’s understandable that some patients have a baseline of distrust for the industry and may not be completely reassured when the manufacturers tell them the products are safe (please don’t hold me responsible though, I was still in grade school when that went down!).

Bottom line, there is no need to run and have your implants removed if they are not causing any problems, but there are a few take home points:

  1. While textured implants have been banned in Europe, and abandoned by the vast majority of North American surgeons, there is no recall on already implanted devices and no recommendation to remove them. This is NOT a PIP breast implant situation. There is no guarantee that someone with these implants will eventually go on to develop BIA-ALCL, and if they do it is something with fairly clear diagnostic criteria and is quite treatable when caught early….so just be vigilant and go to your surgeon ASAP if you notice a sudden change in the appearance of one of your breasts. That being said, if you have biocell textured implants and they are coming out for another reason I’d suggest having the capsules removed as well.
  2. Silicone gel implants are generally considered safe, but approximately 1% of women experience symptoms that they cannot attribute to any other cause, even after significant investigation by various specialists. Unfortunately we have no objective evidence to suggest why this may occur and in whom. This also means we can’t predict it, we have no diagnostic criteria to apply to it, and we have no definitive treatment for it. En-bloc removal helps many women with the symptoms of ‘breast implant illness’ but not all, so there is no guarantee this will help you. If you are very concerned about this but still want a breast augmentation then perhaps consider saline or IDEAL implants, or transferring your own fat.
  3. Implants do not have an expiration date, but they are not designed to last forever. Like any mechanical device subject to stress and strain they will eventually fail. . Before you proceed with your first breast augmentation procedure know that you can essentially guarantee you’ll be having at least one more procedure on your breasts at some point in the future whether it is to revise, replace or remove them. Be vigilant for any changes in your breast and consider replacing them after about 10 years. You will get a new pair without any wear and tear and a new warranty. It is worthwhile to note that the warranties are constantly improving so you’ll likely end up with a better one than you have now. All companies have been forced by way of competition to include warranty for capsular contracture (they used to only cover rupture) and now that Sientra in the United States is offering a 20 year warranty you can pretty much bet that Allergan and Mentor will have to follow suit shortly if they want to remain competitive.
  4. Significant anxiety over your silicone implants is, in my mind, a problem no less important than capsular contracture. Most women get them to be more confident, not to be more anxious. Even if the implants are not causing any physical symptoms, if you are so worried about them you aren’t enjoying life, then there is no point in having them and you should consider removing them or replacing them with saline or IDEAL implants or your own fat.

If you are considering breast augmentation, revision of a breast augmentation or removal of your breast implants, contact the office today to schedule a free consultation where you will meet with me personally and we can have an honest discussion about what is the best course of action for your particular situation.