Allergan Issues Worldwide Recall of Biocell Textured Breast Implants and Tissue Expanders

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On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) requested the recall.

The recall comes after a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Lymphoma is cancer of the lymphatic system.

Currently, 38 other countries have recalled this implant because of its link to ALCL.

The FDA also updated the number of worldwide cases of ALCL associated with breast implants: 573 women have been diagnosed, and 33 women have died from the disease.

Of the 573 cases of ALCL, 481 are attributed to Allergan implants. Of the 33 deaths, the FDA reports that the implant maker was known for 13 women. Of these 13 women, 12 of them were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis.

Read the Allergan media release.

Read the FDA media release.

“Although the overall incidence of ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Amy Abernethy in a statement.

The FDA has not recommended removal or replacement of textured breast implants or tissue expanders in women who are having no symptoms.

About ALCL

In January 2011, the FDA first reported a possible link between both saline and silicone breast implants and ALCL in the tissue near the implant.

Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are two ways to reconstruct a breast:

  • using tissue transplanted from another part of your body (such as your back, belly, or thighs)
  • inserting an implant that's filled with saline (salt water) or silicone gel

A saline implant has a silicone shell that is filled with saline. Silicone gel implants are filled with firm silicone gel. They tend to feel softer than saline implants, and some women think the texture is more like natural breast tissue.

Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. ALCL can develop in and around the tissue capsule.

In January 2018, a Dutch study estimated the risk of ALCL in women with breast implants to be:

  • 1 in 35,000 for women at age 50
  • 1 in 12,000 at age 70
  • 1 in 7,000 at age 75

The risk of ALCL is higher in women with textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA. The material inside the implant — silicone or saline — doesn't seem to affect the risk of ALCL.

So while the risk of ALCL is low, women with breast implants, especially textured breast implants, do have a higher risk of the disease compared to women without breast implants.

Most of the women who have been diagnosed went to their doctors and were diagnosed with ALCL because fluid had collected around the implant (called a seroma) years after the implant was placed. In some cases, testing the seroma fluid led to the diagnosis. In other cases, ALCL was diagnosed after a mass was found in the breast or because the tissue capsule tightened (called capsular contracture) and caused discomfort or cosmetic problems.

Most ALCL associated with breast implants has been treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren't needed but may be recommended in some cases.

In January 2019, a panel of expert oncologists and plastic surgeons from the National Comprehensive Cancer Network developed treatment guidelines for ALCL linked to textured breast implants.

Recalled products

The recalled Allergan products include:

  • Natrelle saline breast implant styles 168, 363, 468
  • Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle 510 Dual-Gel styles LX, MX, FX
  • Natrelle Inspira breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
  • Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
  • Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
  • Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
  • Natrelle 150 Full Height and Short Height double lumen implants
  • Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
  • Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T

The recall does not affect Allergan’s Natrelle smooth or Microcell breast implants and tissue expanders.

What this means for you

If you have an implant, the FDA recommends:

  • regular monitoring for symptoms of ALCL
  • if you have no symptoms of ALCL, there is no need to remove the implant and no need to change your routine medical care and follow-up

If you are considering breast reconstruction with an implant, talk to your doctor about the risks and benefits of implants, including the differences between textured and smooth implants.

Still, there are two questions that don't have good answers:

  • Does it make sense to leave an implant with no problems in place if the opposite breast had an implant and tissue capsule removed because of ALCL?
  • Is it safe to replace an implant removed because of ALCL with a new implant?

More research is needed to address these issues.

“We understand that today’s news may be alarming to some patients with breast implants,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “In the safety communication issued today, we’re providing actionable information for individuals with specific breast implants and their health care professionals. The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps.

“Moving forward, we are committed to continuing to share updates with patients about this issue,” he said. “We will continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. In addition, we are continuing our assessment to determine whether the risk of developing ALCL is limited to specific models of textured, or all textured breast implants.”

If you have an implant and are concerned, don't hesitate to call your doctor. Definitely call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry, especially if these problems develop years after the implant was placed.

You also can report implant problems on the FDA MedWatch reporting site. Select the consumer/patient form link.

Visit the Breastcancer.org pages on Breast Reconstruction to learn more about breast implant surgery and other breast reconstruction options.

To talk with others about experiences with breast implants and other reconstruction options, join the Breastcancer.org Discussion Board forum Breast Reconstruction.

Editor’s Note: For more information on illness linked to breast implants and what is currently known, listen to our podcast with Frank DellaCroce, M.D. FACS . Dr. DellaCroce is a founding partner of the Center for Restorative Breast Surgery and St. Charles Surgical Hospital. This article was updated on Aug. 29, 2019, with more current information about breast implant reconstruction.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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