Let’s Talk About the Allergan Biocell Textured Implant Recall: How Does it Affect You?

As you may have heard, Allergan issued a voluntary worldwide recall of its BIOCELL textured breast implants on July 24th, 2019, at the request of the FDA. This is a precautionary measure to further reduce the risk of a very rare form of cancer called BIA-ALCL (breast implant-associated large cell lymphoma).

If you are a little confused, or perhaps even worried, you are not alone. Word of the recall spread quickly, and as often is the case, the news raised more questions than it answered.

Your being confused is the last thing we want! Our board certified plastic surgeons have put together the following Q&A about the Allergan breast implant recall to help you understand what’s really going on, why, and what (if anything) you need to do.

First, a note to our patients: as a rule, we use Mentor implants at The Swan Center and have done so for years. If you had your breast implant surgery with us, it is highly unlikely that you are affected by the recall. Please see your Mentor Warranty Card or view warranty info here for more information.

• What breast implants have been recalled?
• What does a breast implant recall mean?
• Why were these breast implants recalled?
• Should I have textured implants removed?
• What should you do if you have implants affected by the recall?
• Will Allergan pay to have my implants replaced?

What breast implants have been recalled?

Only BIOCELL textured implants from Allergan have been recalled. This includes:

• Natrelle Saline textured breast implant styles 168, 363, 468
• Natrelle 410 anatomically shaped highly cohesive and 410 Soft Touch breast implants
• Natrelle INSPIRA textured breast implants
• Natrelle 133 (with or without suture tabs) and 133 Plus tissue expanders
• Other Natrelle silicone-filled textured breast implants. See a full list here.

Smooth-shelled breast implants of any kind are not impacted by the recall.

What does a breast implant recall mean?

When we hear the word “recall,” we automatically think of automobiles or toys—you take your car to the dealer or toy back to the store to replace the faulty part. The breast implant recall works differently. It means that BIOCELL implants may no longer be sold to or used by doctors and that any of these implants on the shelves must be sent back to the company. It may help to instead think of it as immediate discontinuation, or recall of unused BIOCELL products.

The recall does NOT mean that all patients who currently have these implants need to have them removed. This is because BIA-ALCL is such a rare condition. You simply need to be aware of breast symptoms that can be cause for concern and continue with routine follow-up care as recommended by your plastic surgeon.

Why were these breast implants recalled?

While the risk of developing BIA-ALCL is very rare (an estimated 1:2,207 to 1:86,029 if you have textured breast implants), BIOCELL implants have been shown to have the strongest association with the disease. In fact, the incidence of BIA-ALCL has been reported to be over 14 times higher in patients with BIOCELL implants vs. patients with other types of textured implants.

Importantly, the research indicates that it is the specific BIOCELL texturing method, not the presence of a breast implant itself, that raises the risk of BIA-ALCL. 

The texturing method of BIOCELL implants results in a very high implant surface area that can harbor significantly more bacteria than other types of textured implants. Studies show that a “chronic biofilm infection” results in heightened immune cell response. As BIA-ALCL is a cancer of the immune cells, it is believed that that the BIOCELL texture creates a more favorable environment for BIA-ALCL to develop compared to other types of implants.

Should I have textured implants removed?

It is currently not recommended that patients have BIOCELL or any other textured implants removed if they are not experiencing symptoms, such as breast pain or late-onset seroma (fluid accumulation in the breast 6 months or longer after implant placement).

If it seems odd to you that they would recall breast implants but say it’s okay for those who already have them to keep them, here’s the reasoning: the lifetime risk of developing BIA-ALCL, even for those with the recalled implants, is extremely low, about 1 in 2200, or 0.045%, at most. Worldwide, there are only 573 confirmed cases of BIA-ALCL out of tens of millions of women who have breast implants, and undergoing surgery carries its own risks. Additionally, if you are happy with the way your breasts look and feel with implants, having them removed may negatively affect your self-confidence.

All that said, if you would like your implants removed for personal reasons, we encourage you to discuss your options with an experienced, board certified plastic surgeon.

What should you do if you have implants affected by the recall?

The most important thing is to follow through on your recommended follow-up care after breast augmentation or reconstruction. Keep your appointments with your plastic surgeon, and get routine MRI or ultrasound imaging as recommended. Additionally, monitor your breasts for any changes or symptoms and report anything unusual or of concern to your primary care physician and your plastic surgeon.

Additionally, educate yourself about BIA-ALCL, including the risks, symptoms, and treatments. Here are a few resources to help:

• Breast Implant-Associated ALCL: The Facts About Your Risk (from the Swan Center)
• Questions & Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (from the FDA)
• BIA-ALCL Resources: By the numbers, and what they mean (from the American Society of Plastic Surgeons)

Will Allergan pay to have my implants replaced?

Allergan is offering a partial replacement warranty for patients who currently have BIOCELL implants. If you choose to have your implants replaced, Allergan will provide you with smooth Allergan implants for free. This covers the cost of the device only; you will still have to pay surgeons’ fees, operating room and anesthesia costs, and any other costs associated with surgery. This offer is valid for 24 months, from July 24, 2019, until July 24, 2021, and applies to U.S. based patients only.

If you choose to keep your BIOCELL implants, you will still be covered under the Natrelle ConfidencePlus® warranty program, which includes up to $1,000 in diagnostic costs and up to $7,500 in surgical fees in the unlikely event you need to be tested and/or treated for BIA-ALCL.

Please reach out if you have any questions

We hope reading this has helped you better understand the breast implant recall, but if you have more questions, or would like to discuss your safe options for breast augmentation, reconstruction, or revision, please reach out to us! Our Atlanta plastic surgeons will be happy to help. Call 770-667-0904 or contact us online.