Allergan Textured Breast Implant Recall: What My Breast Reconstruction Patients Need to Know

Last month, Allergan announced a voluntary global recall of BIOCELL textured breast implants and tissue expanders, due to their link to an increased risk of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. This means that BIOCELL devices may no longer be sold or used in patients during breast reconstruction or cosmetic surgery.

Although textured implants account for only about 10% of all breast implants sold in the United States, and BIOCELL textured implants account for only 5%, they are most frequently used in breast reconstruction, as textured implants can achieve a very nice aesthetic result in patients with little natural breast tissue.

If you have undergone implant reconstruction, news of this recall may be especially concerning to you. Having already battled breast cancer, the last thing you want is to hear is the possibility that your implants may increase your risk of BIA-ALCL.

You do not need to have BIOCELL breast implants removed if you are asymptomatic. Continue to see your plastic surgeon and cancer surgeon for follow-ups, including breast implant imaging as indicated.

First, I want you to know that the disease is extremely rare and, even with BIOCELL implants, the risk of developing BIA-ALCL is very low (only 573 cases have been confirmed worldwide). I encourage you to read my previous post for information about the risk, symptoms, and treatment for BIA-ALCL.

Below, I’ve outlined key information about the BIOCELL recall as it pertains to breast reconstruction patients.

Which implants are included in the Allergan recall?

The recall includes only Allergan textured implants made specifically with the BIOCELL texturing method, which is a “macro” texturing method. This includes:

  • Natrelle Saline breast implant styles 168, 363, 468
  • Natrelle and McGhan 410 and SoftTouch 410 breast implant styles
  • Natrelle INSPIRA® breast implants, textured styles only
  • Natrelle 133 tissue expanders with and without suture tabs
  • Natrelle 133 Plus tissue expanders

For more detail about the exact models included in the recall, please click here.

Textured implants from Mentor and Sientra are NOT part of the recall, and nor are other devices from Allergan, including NATRELLE Smooth implants and MICROCELL implants and tissue expanders.

Is a history of breast cancer a risk factor in BIA-ALCL?

Based on the evidence we have, you are not at greater risk for BIA-ALCL because you had breast cancer. BIA-ALCL is a non-Hodgkin’s lymphoma, a cancer of immune cells, not breast tissue. It specifically develops in the scar tissue and fluid surrounding a breast implant, and the primary risk factor appears to be the implant surface: a macro-textured surface allows for increased microbe growth, which can lead to more inflammation, which can in some patients lead to BIA-ALCL.

The recommended treatment for BIA-ALCL is removal of both the breast implant and surrounding capsule. When treated early, this has shown to be effective at curing BIA-ALCL.

What should you do now?

If you have or have had BIOCELL implants or tissue expanders in the past, it is especially important that you continue with routine care and monitoring of your breasts. Although the risk of developing BIA-ALCL is extremely low overall, patients who have been exposed to these textured devices are thought to have a higher risk.

If you are not experiencing symptoms

You do not need to have BIOCELL breast implants removed if you are asymptomatic. Continue seeing your plastic surgeon and cancer surgeon for follow-ups, and do not skip recommended breast implant imaging. This is the best way to ensure your breast health and catch BIA-ALCL in its early stages, when complete treatment is possible.

Additionally, monitor your breasts for any changes in shape, size, or sensation as well as any breast skin changes. Report anything you notice to your doctor and plastic surgeon.

Finally, know the specific symptoms of BIA-ALCL: the most common is swelling or fluid accumulation in one or both breasts, and less commonly, breast pain. If you experience these or other symptoms, see your doctor ASAP.

What happens if you develop BIA-ALCL after breast reconstruction?

The recommended treatment for BIA-ALCL is complete capsulectomy, or removal of both the breast implant and surrounding capsule. When treated early, when cancerous cells are still contained within the breast capsule, this treatment has shown to be nearly 100% effective at curing BIA-ALCL.

If you have Allergan textured implants, Allergan will reimburse you for up to $1,000 in diagnostic fees and up to $7,500 in surgical fees related to the treatment of BIA-ALCL. They will also provide smooth implants at no cost should you desire implant replacement. This is in accordance with the Natrelle ConfidencePlus warranty, and in addition to any insurance coverage for breast implant removal (please check your policy).

If you are diagnosed with BIA-ALCL while you have a different brand of implants, check with the specific manufacturer regarding warranty coverage.

What if you want to have your BIOCELL textured implants removed anyway?

If you have implants or tissue expanders that are included in the recall, I completely understand if you would prefer to have these devices removed, and I will be happy to discuss your options with you. Allergan has offered to provide smooth devices for free for patients who wish to replace BIOCELL textured devices. This includes the cost of the device only; surgery, anesthesia, and all other fees will need to be covered by you or your insurance company.

I hope this information is helpful to you; if you have any questions, please feel free to call my office at 804-355-3410. My patients’ health and safety are very important to me and my colleagues, and we will be glad to assist in any way we can.