Are textured breast implants causing cancer? Breast implants have been used for more than half a century and have undergone improvements and changes along the way. For nearly 14 years silicone implants were banned from elective use due to concerns that the silicone could cause autoimmune diseases like lupus. The devices were studied extensively before the FDA determined they are safe for use in the mid 2000s. 

First, let’s define what we are talking about. Implants are used for breast augmentation in cosmetic breast surgery where the implants are placed behind the natural breast tissue to make the breasts larger and/or more shapely. Implants are also used in breast reconstruction where they are placed behind the skin after mastectomy surgery to replace the shape and volume of the breast tissue that was removed. Implants are filled either with saline (imagine a thick zip-lock bag full of water) or filled with silicone (like those baggies of slime your kids keep leaving around the house).

Some of the newer ones feel more like a gummy bear full of slime which makes them more stiff but less likely to leak and better at holding their shape. The leak risk has always been a concern, even after the FDA stated that silicone does not cause lupus, since no one wants to wonder about the safety of the product once it is inside their body. The benefits of reduced leak risk and having more control of the implant shape made these very attractive for breast reconstruction however with a more defined shape, the position of the device becomes crucial to a pleasing cosmetic effect.  To keep the implants from shifting out of position or flipping over, manufacturers added a textured coating. The outer layer of the textured breast implant would interact with the recipient’s body to adhere the device in place.

Back to the cancer question: In the body’s reaction to this texture there have been cases where the immune system has gone awry and the result has been a form of non-Hodgkin’s lymphoma. More specifically this disease is known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL.) This cancer of the immune system presents as a mass and/or fluid pocket around the breast implant. It can spread elsewhere in the body and often requires surgery, chemo, and radiation.

The incidence of disease is relatively uncommon. It is estimated to occur in between 1/30,000 to 1/3,000 patients.  Compare that to the incidence of breast cancer which affects 1/8 women.

As of their official statement last week, the FDA has decided not the ban textured breast implants. Due to safety concerns most of the plastic surgeons I have spoken with have stopped placing the textured version when it can be avoided, but what about patients who already have implants in place? I have had many patients ask for my opinion about whether to have an additional operation to change out their implants for the non-textured version. 

Most women with implant-based breast reconstruction will need future operations to revise or replace their implants an average of about every 10 years. These occur due to scar tissue, leak, infection, implants shifting out of place, or change in patient body habitus and the implants no longer being the right size. Based on the available evidence and the relatively low risk of BIA-ALCL, I have been advising my patients to not rush off for another operation just to change out the implants, but that when the reconstruction needs to be revised for any of the above reasons that would be the ideal time to change to non-textured implants or consider natural tissue reconstruction.  If there are any concerns about fluid building up around the implant or new lumps those of course need to be evaluated with imaging (ultrasound, possibly MRI) and probably biopsied. 

So are breast implants safe? Well- mostly yes.  There are risks involved but those risks are low and for most women the benefits outweigh the risks. A careful plastic surgeon will explain those risks and help a woman make a well-informed decision.

Jennifer Fiorini, MD FACS

Thank you for reading and please share with anyone you know who might benefit from this information. JF