Help! I’ve got Allergan BIOCELL Textured Implants and they just got recalled…
Yesterday Allergan announced a worldwide recall of its biocell textured implants due to an FDA request that they do so because of the link to a rare cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
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, and to the best of our knowledge the vast majority are safe. At the moment there is a lot of controversy surrounding the safety of some implants, which has lead to the worldwide recall of Allergan’s BIOCELL Implants. At the moment there is no concern for a link between smooth silicone or saline implants and BIA-ALCL. Other brands’ texturization is also being looked at, but seems to have a much lower incidence than BIOCELL.
This is a specific type of implant with a highly cohesive silicone gel filling (a.k.a. Gummy Bear Implants) that also has a textured (rather than smooth) surface. It is a specific type of texturization made through a process that is proprietary to Allergan, called BIOCELL texturization. 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.
BIA – ALCL is a type of blood cancer involving the immune system and while in theory BIA – ALCL can be associated with any implant, every reported case where the type of implant was known involved biocell textured implants (86% of all cases). There are other issues with biocell textured implants that have been discussed for a few years leading up to this ban, which is why I stopped using them in 2014.
We don’t entirely know but two leading theories are: 1) that the biocell texturization (which has much larger pores than the competitors’) can pick up bacteria at a level that isn’t enough to cause an infection, but is enough to cause inflammation which then causes the cancer, or 2) the process allows loose particles of silicone to remain on the implant that then get incorporated into the capsule causing chronic inflammation which then leads to ALCL.
In the past few months both Europe and Canada banned the use of Allergan’s Biocell textured breast implants, and yesterday the FDA followed suit. The ban came from the conclusion of several studies showing an increased risk for BIA – ALCL in those with biocell textured implants. It is important to note that all of these regulatory agencies (as well as the American, Canadian or International Societies of Plastic Surgeons) have clearly stated that they DO NOT recommend removing these implants if they are not causing any active issues.
Bottom line, probably not. There is no need to run and have your implants removed if they are not causing any problems. All the information we have from years and years of research studies shows that breast implants as a whole 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, and the more recent PIP breast implant scandal 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 still on the market are safe (please don’t hold me responsible though, I was still in grade school when that went down!). but there are a few take home points:
- We have no evidence to link smooth implants to BIA-ALCL, so if you have smooth implants then there really isn’t much to worry about
- While BIOCELL textured implants have been voluntarily recalled by Allergan, there is no recall on already implanted devices and no recommendation to remove them. The risk of developing ALCL is less than 0.03% so 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. All surgery comes with risks, so at this point in time the benefit of removing implants that are not causing an issue does not outweigh the risk. That being said, if you have biocell textured implants and they are coming out for another reason I’d definitely suggest having a total capsulectomy or an en-bloc removal at the same time.
- Significant anxiety over your implants is, in my mind, a problem no less important than any of the aesthetic concerns that I fix on a regular basis as part of my Breast Implant Revision practice. 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. If you are worried about how your breasts will look after they can be replaced with smooth implants or your own fat, and I can also do a lift at the time of removal if you are just done with implants all together.
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.