BIA-ALCL and the Allergan Textured Breast Implant Recall: What you need to know
It’s been about a month since Allergan announced a worldwide voluntary recall of its BIOCELL textured breast implants at the request of the FDA, due to their association with an increased risk of breast implant-associated large cell lymphoma (BIA-ALCL). Since then, we’ve fielded a few calls from concerned patients wondering whether or not their breast implants are safe, and what, if anything, they need to do about this recall. In this post, we’ve answered these and hopefully a few more questions.
First things first. We do not use Allergan textured implants at Granite Bay Cosmetic.
If you’re one of Dr. Clark’s patients, you can breathe easy. She uses smooth, round implants for breast augmentation almost exclusively, and has done so for years. They’re softer, they feel more natural, and they look great in anyone, thanks to Dr. Clark’s surgical skill.
If you have smooth silicone implants, you are at no greater risk for BIA-ALCL than a patient with smooth saline implants, and your risk is far lower than someone with textured implants of any kind.
Allergan Biocell textured implants have been recalled because they have been shown to carry the highest risk of BIA-ALCL.
Of the 573 reported BIA-ALCL cases worldwide, none are known to have occurred in patients who only ever had smooth implants. Studies have shown that BIA-ALCL is 6 times more likely to occur with BIOCELL implants than with other types of textured implants.
The estimated lifetime risk of BIA-ALCL with BIOCELL implants is 1 in 2,207 (0.045%). The overall risk with textured implants is 1 in 30,000 or 0.003%.
The Allergan recall means that Biocell breast implants can no longer be sold or placed in patients.
It does not mean that all patients with these implants need to have them removed. That’s because this disease is so very rare. So, if you have BIOCELL textured implants (i.e., Natrelle 410s, INSPIRA textured, etc.) and you are not experiencing any symptoms (more on that below), continue with routine care as recommended by your plastic surgeon and the FDA. To see a full list of recalled implants, click here.
The lifetime risk of developing BIA-ALCL, even if you have BIOCELL implants, is very low. Additionally, undergoing surgery to remove healthy implants carries its own risks.
BIA-ALCL is a cancer of the immune system. It is not actually breast cancer.
This type of cancer (lymphoma) occurs in immune cells that are found within the normal scar tissue capsule that surrounds a breast implant. If fluid then develops between the breast implant and capsule, ALCL will be found in this fluid too (the diagram on this FDA resource gives a good visual). BIA-ALCL does not develop in breast tissue, and mastectomy is not usually needed to treat the disease.
Silicone implants do not present a higher risk than saline.
The implant shell surface is the main risk factor. It has to do with the biofilm, or layer of microbes, that forms around the implant shell. BIOCELL implants have a high surface area, which provides a biofilm environment that is more likely to lead to BIA-ALCL in some women.
If you have smooth silicone implants, you are at no greater risk for BIA-ALCL than a patient with smooth saline implants, and your risk is lower than someone with textured implants of any kind.
Symptoms include breast pain, swelling, and late seroma (fluid build-up). If you experience any symptoms, call us.
The most common BIA-ALCL symptoms are swelling and late seroma, with or without pain, occurring at least 6 months after the initial breast implant surgery. Occasionally, the disease accompanies capsular contracture (a complication that should be addressed regardless).
If you experience these symptoms, Dr. Clark will examine you and then may refer you for an ultrasound and/or needle biopsy to test for the disease. According to medical device reports, the average BIA-ALCL patient is diagnosed 9 years after her initial surgery.
If caught early, BIA-ALCL can be fully treated with breast implant removal and capsulectomy.
In the early stages, BIA-ALCL is usually fully contained within the breast capsule, so surgically removing it (en bloc if possible) along with the breast implant completely removes the cancerous cells. In rare cases, radiation and/or chemotherapy may be needed to ensure complete treatment.
Early detection is key. Of the 33 reported deaths from BIA-ALCL, all patients received a late diagnosis, after the disease had spread. Many of these patients never underwent breast implant removal.
If you are not showing symptoms, you do not need to have your implants removed.
Remember, the lifetime risk of developing BIA-ALCL, even if you have BIOCELL implants, is very low. Additionally, undergoing surgery to remove implants carries its own risks, although these are small when you are in qualified hands. If you are happy with your breast implants and experiencing no issues, continue with routine care, including your follow-up visits with your plastic surgeon!
If you want your implants out anyway, give us a call. Dr. Clark will be happy to help and can go over your options for breast implant removal.
Allergan is offering a special BIOCELL warranty for concerned patients
If you have BIOCELL textured implants, and you would like them replaced with smooth implants, Allergan will provide smooth implants of a similar fill type for free until July 24, 2021. You’ll still have to cover surgical costs. If you wish to take advantage, you will need to go through your plastic surgeon, who will file the claim on your behalf.
Patients who are diagnosed with BIA-ALCL are covered under Allergan’s Natrelle Confidence Plus warranty, which includes reimbursement of up to $1,000 in diagnostic fees and up to $7,500 in surgical fees for diagnosis and treatment of BIA-ALCL, as well as free replacement implants.