Allergan Breast Implant Recalls

On July 24, 2019, Ireland-based medical company Allergan PLC issued a worldwide recall for its Biocell textured breast implants sold under the Natrelle, McGhan and Inamed brands. The recall came after U.S. Food and Drug Administration data linked the devices to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

Allergan’s July 2019 Biocell textured breast implant recall doesn’t include its smooth or Microcell breast implants or tissue expanders, which have a much smaller risk of BIA-ALCL. The recalled breast implants represent less than 5 percent of implants sold in the United States. The FDA has not released the exact number of implants affected.

Natrelle Smooth Implants vs Textured Implants
Allergan’s smooth implants are not a part of the July 2019 recall.

The FDA first acknowledged a connection between breast implants and anaplastic large cell lymphoma in 2011. During a review of scientific literature published between 1997 and 2010, the agency had identified 34 unique cases of ALCL in women with breast implants throughout the world, though it determined there were too few cases to take definitive action.

“Women with breast implants may be more likely to be diagnosed with anaplastic large cell lymphoma (ALCL),” the agency said in its 2011 FDA Update on the Safety of Silicone Gel-Filled Breast Implants.

But lawsuits against Allergan say the company might have been aware of the risk in the 1990s.

In February 2019, the FDA provided an update about the disease. It had found 457 unique cases of BIA-ALCL, including nine patient deaths, from 2010 to September 2018.

In March 2019, the FDA held a public advisory committee meeting during which patients, manufacturers and experts weighed in on breast implant risks. After the meeting, the agency said it would not issue a ban or recall while it continued to investigate.

From February 2019 to July 2019, the number of reported global BIA-ALCL cases jumped to 573 — 481 of those patients had received Allergan textured implants. After the agency saw the marked rise in reports, it requested a recall of Allergan textured breast implants sold in the United States.

Allergan had already pulled the products from markets in Canada, Europe and the United Kingdom in April.

Did you know?
From February 2019 to July 2019, the number of reported global BIA-ALCL cases jumped to 573 — 481 of those patients had received Allergan textured implants.
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Is My Implant on the Recall List?

Allergan released a list of all its recalled textured breast implant products sold across the globe. But this list contains models not sold in the United States.

Americans should check the list released by the FDA for the implants specifically marketed in the United States.

Breast Implant and Tissue Expanders in July 2019 U.S. Recall
BRAND/MODEL FDA PREMARKET APPROVAL FDA PREMARKET APPROVAL
Natrelle Saline-Filled Breast Implants P990074 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants

168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)

363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection

468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants P040046 410 LL, 410 LM, 410 LF, 410 LX, 410 ML, 410 MM, 410 MF, 410 MX, 410 FL, 410 FM, 410 FF, 410 FX
Biocell Textured Round Gel-Filled Implants P020056 110, 115, 120 — Moderate, Midrange and High Projection
Natrelle Inspira Biocell Textured Responsive Silicone-Filled Breast Implants P020056 TRL, TRLP, TRM, TRF, TRX
Natrelle Inspira Biocell Textured Cohesive Silicone-Filled Breast Implants P020056 TCL, TCLP, TCM, TCF, TCX
Natrelle Biocelle Textured Soft Touch Silicone-Filled Breast Implants P020056 TSL, TSLP, TSM, TSF, TSX
Natrelle 133 Tissue Expanders with suture tabs K102806 All styles
Natrelle 133 Plus Tissue Expanders K143354 All styles
The FDA provided this list of recalled Allergan products sold in the United States. If you aren’t sure what model and style you have, contact your surgeon.

The Premarket Approval or PMA number is a reference number for the original application the FDA used to approve the device for sale.

If you aren’t sure if your implant is on this list, make sure you check with your surgeon.

Previously Recalled Natrelle Devices

Allergan had previously recalled other products in its Natrelle line in 2015. These include an implant sizer and tissue expanders. Unlike the textured implant recall, these recalls involved a relatively small number of devices.

  • Natrelle Re-sterilizable Breast Implant Sizer, Size 410

    Dates: June 8, 2015 to Dec. 16, 2015

    Reason: Labeling error. Allergan shipped expired products. The company sent recall letters to customers.

    Number in Commerce: 9 units

  • Natrelle 133 Series Tissue Expanders

    Dates: June 18, 2015 to Dec. 16, 2015

    Reason: Incorrect or no expiration date. Allergan shipped expired products.

    Number in Commerce: 167 units total, 114 in the United States

  • Natrelle CUI Series Tissue Expanders

    Dates: June 18, 2015 to Dec. 16, 2015

    Reason: Incorrect or no expiration date. Allergan shipped expired products.

    Number in Commerce: 23 units total, 16 in the United States

McGhan and Inamed Textured Breast Implants

Allergan sold most of the recalled products under its Natrelle brand, but some Americans may have received older textured breast implants sold by McGhan and Inamed. Allergan bought these companies and became responsible for these products and all liability associated with them. McGhan and Inamed textured implants are also a part of the recall.

McGhan RTV Saline-Filled Mammary Implants became Allergan Natrelle Saline-Filled Breast Implants, and Inamed Silicone-Filled Breast Implants became Allergan Natrelle Silicone-Filled Textured Breast Implants.

Most cases of BIA-ALCL occur many years after receiving a textured implant, according to the FDA. So women with older implants may be at increased risk.

For example, Sandra Rush — a woman who filed an Allergan breast implant lawsuit — received a McGhan textured saline implant in 1995. Doctors diagnosed her with BIA-ALCL in 2017.

What Should I Do If My Implant Is Recalled?

If your breast implant is on the recall list and you have no symptoms, the FDA does not recommend that you remove your implants. Though BIA-ALCL is a serious and potentially fatal disease, the risk of developing the cancer is low.

Women who received Allergan textured implants should know the symptoms of BIA-ALCL and monitor their health.

Keep a record of the device manufacturer, unique device identifier and implant model. This information may be in your medical records, or you may have received it on a medical device card at the time of surgery. If not, you can call your surgeon or the surgery center.

Should I Have My Implants Removed?
The FDA says women who don’t have symptoms of BIA-ALCL shouldn’t remove their implants.

At the first sign of persistent swelling or pain around the implants, women should speak to their health care providers and undergo tests for BIA-ALCL. The disease is highly treatable, especially if diagnosed early.

Diagnosing BIA-ALCL usually involves MRIs and ultrasounds to check for fluid buildup and scar tissue. Health care providers may also perform a biopsy to test for cancer cells.

Women diagnosed with BIA-ALCL will have to have the implant and surrounding scar tissue removed. Sometimes, the doctor will recommend chemotherapy or radiation therapy. Some women may choose to have breast reconstruction using another implant or their own fat tissue.

Other Countries Issued Allergan Recalls

Allergan issued a worldwide recall on July 24, 2019, but other countries had already asked the company to stop selling its implants because of BIA-ALCL concerns. While textured implants like those sold by Allergan make up a relatively small percentage of the U.S. market, in Europe and other countries it is as high as 80 percent.

France and Other Countries in Europe

In late 2018, French regulatory agency Agence Nationale de Sécurité du Médicament (ANSM) requested Allergan recall its textured breast implants and tissue expanders from European markets.

In order to sell its breast implants in 33 European countries, Allergan needs a safety certificate known as a CE mark. The company’s CE mark for the products expired in December 2018 after a French certification firm decided not to renew it because of BIA-ALCL concerns.

Worldwide Recall
Allergen issued its textured breast implant recall in the United States in July 2019, but France had requested the company recall its products from Europeans market in back 2018.

Allergan insisted the actions were not related to new safety issues and said ANSM’s request was not based on new scientific evidence. But the company complied and halted all sales and recalled the devices.

Canada

In May 2019, Health Canada suspended Allergan’s licenses to sell its macro-textured Biocell breast implants in Canada after a 2017 safety review found that the rate of BIA-ALCL in Canada is significantly higher in patients with those implants compared to other implants.

“Because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licenses for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada),” the regulatory agency said in a press release. “This means that no one can sell Allergan’s Biocell breast implants in Canada or import them into the country.”

Allergan said Health Canada’s decision didn’t match the positions held by other countries’ regulatory bodies, including the FDA, according to Reuters. At the time, the FDA had said it would not ban or recall any textured devices.

Australia

On July 11, 2019, the Australian Therapeutic Goods Administration proposed either canceling or suspending several textured implants because of their link to BIA-ALCL. Brands included in the proposed cancellation list were all Allergan textured implants.

TGA gave manufacturers until July 24, 2019, to respond. On Aug. 2, 2019, Allergan announced it would recall the products from the Australian market.

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

22 Cited Research Articles

  1. Allergan. (2018, December 19). Allergan Suspends Sales and Withdraws Supply of Textured Breast Implants in European Markets. Retrieved from https://www.allergan.com/news/news/thomson-reuters/allergan-suspends-sales-and-withdraws-supply-of-te
  2. Allergan. (2018, December 19). FAQ on CE Mark Non-Renewal of Textured Breast Implants and Textured Tissue Expanders. Retrieved from https://www.allergan.com/getmedia/c305b7a3-f3c8-46e6-9ff0-378247d23184/FAQ-on-CE-Mark-Non-Renewal-of-Textured-Breast-Implants-and-Textured-Tissue-Expanders-121918.aspx
  3. Allergan. (2018, December 31). Form 10-K for Year Ended December 31, 2018. Retrieved from https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allerganinvestors/financial-information/proxy-materials/2018_10-k.pdf
  4. Allergan. (2019, August 2). Withdrawn Affected Product Names and Styles. Retrieved from https://www.allergan.com/getmedia/a39a1e7c-ef2d-4054-9bd0-0fb05bf69402/BIOCELL-styles-recall.aspx
  5. Associated Press. (2019, July 24). Allergan recalls textured breast implant tied to rare cancer. Retrieved from https://www.statnews.com/2019/07/24/allergan-recalls-textured-breast-implant-tied-to-rare-cancer/
  6. Bowers, S. & Boland-Rudder, H. (2018, December 19). Allergan Textured Breast Implant Sales Halted in Europe Amid Safety Controversy. Retrieved from https://www.icij.org/investigations/implant-files/allergan-textured-breast-implants-recalled-in-europe-pending-safety-review/
  7. Chavkin, S. (2019, July 11). Australia set to join nations banning textured breast implants over cancer links. Retrieved from https://www.icij.org/investigations/implant-files/australia-set-to-join-nations-banning-textured-breast-implants-over-cancer-links/
  8. Hale, C. (2019, July 24). Allergan issues worldwide recall of textured breast implants over cancer cases. Retrieved from https://www.fiercebiotech.com/medtech/allergan-issues-worldwide-recall-textured-breast-implants-over-cancer-cases
  9. Health Canada. (2019, May 28). Information Update - Health Canada suspends Allergan's licenses for its Biocell breast implants after safety review concludes an increased risk of cancer. Retrieved from https://www.newswire.ca/news-releases/information-update-health-canada-suspends-allergan-s-licences-for-its-biocell-breast-implants-after-safety-review-concludes-an-increased-risk-of-cancer-880208806.html
  10. Lim, D. (2018, December 20). Allergan loses CE mark for textured breast implants, opening EU market. Retrieved from https://www.medtechdive.com/news/allergan-loses-ce-mark-for-textured-breast-implants-opening-eu-market/544885/
  11. Maddipatla, M. (2019, May 28). Allergan to recall textured breast implants in Canada. Retrieved from https://www.reuters.com/article/us-allergan-canada/allergan-to-recall-textured-breast-implants-in-canada-idUSKCN1SY2BX
  12. Rush v. Allergan et al. (2019, May 10). Complaint and Demand for Jury Trial. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-5-10-bia-alcl-rush-complaint.pdf
  13. Therapeutic Goods Administration. (2019, August 6). Breast implants and anaplastic large cell lymphoma. Retrieved from https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma
  14. U.S. Food And Drug Administration. (2011, June). FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Retrieved from https://www.fda.gov/media/80685/download
  15. U.S. Food and Drug Administration. (2015, June 18). Class 2 Device Recall Natrelle CUI Tissue Expander. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137978
  16. U.S. Food and Drug Administration. (2015, June 8). Class 2 Device Recall Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137741
  17. U.S. Food and Drug Administration. (2015, June 8). Class 2 Device Recall Natrelle 133 Series Tissue Expander. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137972
  18. U.S. Food and Drug Administration. (2019, August 2). The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
  19. U.S. Food and Drug Administration. (2019, February 12). Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-binita-ashar-md-fdas-center-devices-and-radiological-health-agencys-continuing-efforts
  20. U.S. Food and Drug Administration. (2019, July 24). FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
  21. U.S. Food and Drug Administration. (2019, July 24). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
  22. U.S. Food and Drug Administration. (2019, August 7). The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue
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