You’ve probably heard that the FDA asked Allergan, the manufacturer of textured breast implants made with Biocell(R) technology, to voluntarily recall these implants from the US market.
After reviewing 573 new cases of ALCL compiled from worldwide data by Medical Device Reports (MDRs), the FDA found that 83% of these patients had Allergan textured implants in place at the time of diagnosis. Of the 33 of these cases that ended in patient death, 92% had Allergan textured implants.
I was concerned on hearing this news because I know there are women without symptoms of the rare ALCL cancer who will be worried about the risk of developing the disease and will want to have their textured Allergan (Biocell technology) implants removed.
If you have any concerns related to your breast implants or further questions, do not hesitate to call 1-858-247-2933.
Who Should Be Concerned?
Historically, plastic surgeons recommended the textured breast implant for a few potential reasons. These include shaped (teardrop) implants, often used in reconstruction for cancer
but sometimes in cosmetic enhancement too. Additionally, some surgeons feel that texturing helps “hold up” the implant in its pocket with less risk of the implant “bottoming out” (dropping.) However, there is some data that textured implants may be at a higher risk of leakage.
Not many women who underwent augmentation in the United States chose the textured breast implant upfront because they are not as widely adopted in the US, whereas textured implants are more commonly used in Latin America and Europe. In recent years there has been an upswing in the use of textured shaped implants for breast cancer reconstruction patients undergoing mastectomy, but not all of these patients have Allergan implants (many surgeons prefer devices by Mentor or Sientra).
All the FDA-approved implant companies in the U.S. that sell silicone implants (Mentor, Allergan, and Sientra) have offered textured implants among the options, but only Allergan’s devices used a process called “Biocell” texturing, which has been demonstrated to increase the risk of ALCL when compared to other companies’ texturing or when compared to smooth (non-textured) implants.
This Biocell material prompted the FDA to advise Allergan to voluntarily remove its textured devices from the US market, after they had already been removed from the European market a few months earlier. Allergan is offering replacement devices with smooth implants for patients wishing to exchange their textured implants under a coverage policy.
Do I Need to Consider Implant Removal?
Yes. Patients who have textured Allergan implants in place should consider removal, although the recall does not specifically recommend removal in patients with no symptoms of ALCL (fluid around the implant, redness in the breast, and other symptoms).
However, I would advise my own family member, if she had a textured Allergan implant, to get it removed. Overwhelmingly the majority of women with textured Allergan implants will never develop ALCL, but patients who DO develop ALCL are usually ones who have Allergan textured devices, so in an abundance of caution it would make sense to exchange the implant, especially if Allergan is offering a free replacement device (this does not mean they will cover all costs of a replacement surgery, like anesthesia, facility or certain surgeon fees).
If you don’t remember which device you received, contact your plastic surgeon who may still have records. For those who received implants many years ago and are unable to get access to their records, I recommend contacting Allergan directly to see if your data is in their implant registry.
Key Takeaways from the Allergan Textured Breast Implant Recall
It is very important to understand that this recall strictly means Allergan will no longer sell its textured Biocell devices. It does not require you to remove or replace yours, but as a plastic surgeon, I’d strongly recommend you consider it.
It is also important to distinguish that ALCL is not the same thing as “Breast Implant Illness,” a nonspecific set of constitutional and other symptoms which may be seen in a small minority of women with smooth or textured, saline or silicone implants.
The recall of Allergan textured implants does not necessarily suggest that Mentor or Sientra textured implants (which use a totally different method to create texture), or any smooth implants from any of the companies, are at imminent risk for recall.
Breast implant illness patients need to make a personal decision regarding removal of their devices and capsules and confer with an experienced plastic surgeon who performs en bloc capsulectomy routinely, in order to learn more about what we understand and don’t understand about Biocell and to discuss options for their personal circumstances.