Allergan Breast Implant Recalls

The U.S. Food and Drug Administration requested in July 2019 that Allergan recall its Biocell textured breast implants because they had been linked to breast implant-associated anaplastic large cell lymphoma, a rare cancer. The FDA advises women with BIA-ALCL to have their implants removed.

Last Modified: September 5, 2023
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Why Were Allergan Breast Implants Recalled?

The U.S. Food and Drug Administration recommended an Allergan recall in July 2019 following the agency’s extensive research that established a connection between breast implants and anaplastic large cell lymphoma. The World Health Organization also expressed concerns about implants in 2016. Allergan voluntarily recalled its Biocell textured breast implants in August 2019.

Breast implant-associated ALCL is a type of non-Hodgkin lymphoma that can develop around breast implants. It most commonly presents in the scar tissue around the implant, but in more advanced cases in the lymph nodes in the chest wall and armpits

Common adverse effects of Allergan implants include:
  • Changes in breast shape or size
  • Enlarged lymph nodes
  • Hardening of the breast
  • Lumps or masses in the breast or armpit
  • Pain or discomfort in the breast area
  • Persistent swelling or fluid accumulation around the breast implant
  • Skin rash or redness on the breast

If your breast implants are on the Allergan Breast Implant Recall list, consult your medical provider. Your doctor may advise that you monitor for symptoms, such as persistent swelling, pain or lumps in the breast area. They may also discuss implant removal or replacement.

Lawsuits filed against Allergan suggest that the company might have been aware of the risk in the 1990s. Other breast implant manufacturers have also faced recalls and regulatory actions.

Lawsuit Information
The main injury claimed in Allergan breast implant lawsuits is BIA-ALCL, a rare type of cancer.
View Lawsuits

What You Should Know About the Allergan Recall

Most recalled Allergan implants are its Natrelle brand. McGhan and Inamed textured implants are also part of the recall. Allergan bought the companies and accepted all liabilities.

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

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

According to the FDA, most cases of BIA-ALCL occur many years after receiving a textured implant, potentially putting women with older implants at increased risk. Sandra Rush, for example, received a McGhan textured saline implant in 1995. Doctors diagnosed her with BIA-ALCL in 2017 and she later filed an Allergan breast implant lawsuit.

The FDA first acknowledged a connection between breast implants and ALCL in its 2011 FDA Update on the Safety of Silicone Gel-Filled Breast Implants. During a review of scientific literature published between 1997 and 2010, the agency identified 34 unique cases of ALCL in women with breast implants throughout the world, though it determined at the time that there were too few cases to take definitive action. The WHO designated BIA-ALCL as a distinct clinical entity in 2016.

Allergan Implant Recall List

The Allergan recall represents less than 5% of implants sold in the U.S. The recall list doesn’t include the company’s smooth Microcell breast implants, for example.

All the details about your implant surgery, including make and model number of your implants, should be documented in your medical records. You can ask your surgeon’s office to confirm your model and for a copy of your operative report for future reference.

Allergan implants included in the 2019 recall include:
Natrelle Saline-Filled Breast ImplantsP990074

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 ImplantsP040046410 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 ImplantsP020056110, 115, 120 — Moderate, Midrange and High Projection
Natrelle INSPIRA BIOCELL Textured Responsive Silicone-Filled Breast ImplantsP020056TRL, TRLP, TRM, TRF, TRX
Natrelle INSPIRA BIOCELL Textured Cohesive Silicone-Filled Breast ImplantsP020056TCL, TCLP, TCM, TCF, TCX
Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast ImplantsP020056TSL, TSLP, TSM, TSF, TSX
Natrelle 133 Tissue Expanders with suture tabsK102806All styles
McGhan Croissant Shaped Tissue ExpanderK862203134
Source: The FDA

The FDA didn’t release the exact number of implants affected. But in August 2022 it reported receiving 1,130 reports of BIA-ALCL, and 953 of those reports were related to Allergan implants. In September 2022, the FDA also received additional reports of other cancers not related to BIA-ALCL that were found in scar tissue of smooth and textured implants.

Allergan had previously recalled other products in its Natrelle line in 2015. That recall included the Natrelle Re-sterilizable Breast Implant Sizer, Size 410 for a labeling error. The company’s Natrelle 133 Series Tissue Expanders and Natrelle CUI Series Tissue Expanders were also recalled at that time for having an incorrect expiration date or no expiration date. These recalls involved a small number of devices.

Global Allergan Implant Recalls

Several countries asked Allergan to stop selling its implants because of BIA-ALCL concerns. While textured implants make up a small percentage of the U.S. market, in Europe and other countries their market share was as high as 80%.

In late 2018, French regulatory agency Agence Nationale de Sécurité du Médicament requested Allergan recall its textured breast implants and tissue expanders from European markets. A French certification firm also decided not to renew Allergan’s safety certificate that allowed it to sell implants in 33 European countries because of issues related to BIA-ALCL.

Health Canada and the Australian Therapeutic Goods Administration both took action in 2019. Following a study that found significantly higher rates of BIA-ALCL in people with Allergan’s macro-textured Biocell breast implants, Health Canada suspended its licenses in May. In Australia the cancellation or suspension of use of textured implants was proposed in July. Allergan recalled the products from the Australian market in August 2019.

Manufacturers of Textured Breast Implants

Manufacturers of breast implants typically make both textured and smooth implant shells. Companies initially began producing textured breast implants because texturing was believed to decrease the risk of associated complications.

Textured shells allow tissue to grow into the surface of the implant, keeping it in place. Smooth shells allow the implant to move under the skin or muscle, mimicking the movement of natural breast tissue.

Manufacturers of textured breast implants include:
  • Allergan (Natrelle Biocell)
  • Cereplas (CERENATEX Textured)
  • Establishment Labs (Motiva Textured)
  • Eurosilicone (Biodyne Textured)
  • G&G Biotechnology (Guangzhou Wanhe Plastic Materials Co., Ltd.)
  • Groupe Sebbin (Sebbin Textured)
  • HansBiomed (HansBiomed Textured)
  • Ideal Implant (Ideal Implant Textured)
  • Implantech Associates Inc. (Mammary Implant)
  • Mentor (MemoryGel Textured)
  • Motiva (SilkSurface and Ergonomix SilkSurface)
  • Nagor (Contour Profile Gel Textured and Impleo Textured)
  • Polytech (Microthane Textured)
  • Sientra (Sientra Textured)

Textured implant surfaces potentially promote the growth of bacteria, leading to inflammation and the development of BIA-ALCL. There are questions about the integrity of the surface structure texturing and its propensity to shed particles. Studies show textured implants produce surface shedding, and Allergan implants show the most shedding.

What Should I Do if My Allergan Implant Is Recalled?

If your breast implant is on the recall list, but you’re not experiencing adverse effects, the FDA does not recommend implant removal. However, for those who develop BIA-ALCL, the FDA does recommend removal of the implant and surrounding scar tissue.

At the first sign of persistent swelling or pain around the implants, women should speak to their doctor. Diagnosing BIA-ALCL may involve an ultrasound to check for fluid buildup and scar tissue, an MRI and a biopsy.

BIA-ALCL is treatable, especially if diagnosed early. Chemotherapy or radiation therapy may be advised. Some women may choose breast reconstruction using another implant or their own fat tissue.

Allergan Implant Recall FAQs

What should I do if I’m considering breast implants?
Consult with a board-certified plastic surgeon who will assess your overall health, discuss your desired outcomes and help you develop a plan that’s best for you.
Will my doctor reach out to me if my breast implant has been recalled?
Communication protocols may vary among healthcare providers. You can contact your doctor and check the FDA website for medical updates.
Do all Allergan breast implants cause cancer?
Not all Allergan breast implants have been linked to cancer. Some Allergan textured breast implants have been connected with a rare form of cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma.
Will Allergan pay to remove my breast implants?
No, Allergan is not paying for removal procedures. The company has offered to pay for the costs of a new set of implants for women who currently have recalled implants, but is not covering surgical costs.
What are my options if I am diagnosed with cancer?
BIA-ALCL is treatable if diagnosed early. Treatment typically involves removal of the implant and surrounding scar tissue, and may include chemotherapy or radiation.
Please seek the advice of a medical professional before making health care decisions.