Allergan Breast Implant Recalls

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 as a fluid accumulation called a “malignant effusion” in the scar tissue around the implant. In a minority of patients, it can also present as a tumor. In more advanced cases, the disease may spread to the lymph nodes in the chest wall and armpits on the same side.

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.

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.

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.

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.

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 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.

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.

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.