Allergan Breast Implant Recalls

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.

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 August 2022, the FDA reported that it had received 1,130 reports of BIA-ALCL, and 953 of those reports were related to Allergan implants. In September 2022, the FDA received additional reports of other types of cancer not related to BIA-ALCL found in scar tissue of smooth and textured implants.

Allergan released a comprehensive list of all its recalled textured breast implant products sold globally. People who received Allergan implants in the U.S. should check the FDA-released list for implants they may have received that were recalled.

The following Allergan breast implants and tissue expanders were on the FDA’s July 2019 recall list:

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.

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.

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.

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.

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.

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.

Can Allergan breast implants cause cancer?

The FDA has linked Allergan’s textured breast implants, mostly those sold under the Natrelle brand, to a rare cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Not all Allergan breast implants have been linked to cancer.

Will Allergan pay to have my breast implants removed?

Allergan has agreed to pay for the medical expenses of women who were diagnosed with BIA-ALCL after using its textured breast implants. The compensation will vary depending on whether the patient has already been diagnosed with cancer or is choosing to have them removed as a preventative measure.

What are my options if I was diagnosed with cancer?

If you have Allergan textured breast implants and were diagnosed with cancer, the FDA recommends that you have your implants removed. You may also be eligible to file a lawsuit against the manufacturer.