On July 24th, 2019 Allergan voluntarily recalled their BIOCELL® textured breast implants and tissue expanders. Click here for the official release by the FDA.
What is a textured implant?
There are two types of breast implant shells. The shell is the casing that holds either saline or silicone. One type of shell is a smooth shell, which is exactly how it sounds, smooth surface. The other type is slightly textured to the touch. The idea behind the texture is such that when implanted the surrounding tissue will adhere to its surface and force it to stay in place. To the eye, the smooth implant looks more clear where the textured implant looks more foggy.
Why did they recall this type of implant?
According to the FDA, “Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”
What is BIA-ALCL and how do I know if I have it?
BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) is a type of non-Hodgkins lymphoma. It is not a form of breast cancer. Rather, it’s a form of cancer affecting the immune system.
The reported symptoms commonly associated with BIA-ALCL can include: persistent pain in the breast region and/or persistent swelling around the breast region. In addition, redness around the swollen breast has also been associated with some reports of BIA-ALCL. These symptoms followed by an examination with your healthcare provider are often accompanied by fluid around the area in question.
Consistent self-breast exams are always important regardless of having implants or not. If you detect a change in your breast area you should talk with your healthcare provider immediately for further evaluation and testing.
What is the prevalence of BIA-ALCL?
According to an article posted on the NCBI website, the first reported case of BIA-ALCL was in 1997. Since then, there has been a total of 573 reported cases of BIA-ALCL with 481 (~84%) of those associated with Allergan’s BIOCELL® textured implants. Of those 573 total reported cases, there has been 33 deaths. The incidence of BIA-ALCL overall reported in those with breast implants is 1 in 30,000.
Is BIA-ALCL treatable?
If you have been diagnosed with ALCL, your doctor will discuss the best plan of treatment for you. Your treatment will depend on several factors such as: age, general health, stage of the disease, location of the ALCL, and type of ALCL.
Treatments vary according to these factors and can include: surgery, chemotherapy, and/or radiation.
As stated previously, there have been 33 total deaths associated with BIA-ALCL. This number though significant is very small indicating that this rare type of cancer is very treatable.
How does this recall affect those planning to get implants?
The FDA recommends this type of implant is no longer used and those that have already been distributed to surgeons be returned to Allergan. Ask your surgeon what type of implants he/she uses and make sure you have all of the information available to make an informed decision.
What should I do if I have implants?
The FDA is not recommending women who are asymptomatic do anything. If you experience any of the above symptoms you should first contact your board-certified plastic surgeon for a thorough examination and testing.
As always, perform regular self-breast exams and maintain routine follow-ups with your healthcare provider.
If you would like more information regarding this recall, you can contact Allergan directly at: 1-800-678-1605 option #2. To visit the FDA’s website for more information and specific recalled products, click here.