Breast Implant Recall Issued by Allergan for Textured Surfaces in Canada

Allergan intends to recall Biocell breast implants in Canada, after health officials in the country banned the product earlier this year, amid concerns that the textured surfaces increase the risk of women developing a rare type of cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The breast implant recall comes after Health Canada issued an announcement last Tuesday, indicating that the sale and import of the Allergan Biocell implant would no longer be allowed in the country.

In early April, Health Canada warned that the Allergan Biocell ban was coming, advising the manufacturer that the license to sell the product in Canada would be suspended.

“Health Canada received a response from Allergan on April 17, 2019, which departmental experts reviewed,” the press release states. “It was determined that the information provided by the manufacturer was insufficient to support the ongoing licensing of the devices. The department concluded that the potential risks associated with the devices outweigh the potential benefits.”

Allergan’s Biocell breast implant was the only device with a macro-textured surface sold in Canada, according to the announcement. No other Allergan breast implants sold there are affected.

In April, French regulators also announced a macrotextured breast implant recall in that country, saying that the implants have been overwhelmingly associated with development of ALCL that develops in the surrounding tissue.

Despite growing evidence linking textured breast implants and lymphoma, similar recalls have note been announced in the U.S., where the textured surfaces make up only a small portion of sales. The FDA recently decided against a complete ban, indicating cases of BIA-ALCL have also been linked to smooth textured implants, leading the agency to instead opt to place stronger warning labels on the implants.

Breast Implant Cancer Risks

The FDA first warned about case studies and epidemiological research that suggested there was a link between breast implants and ALCL in January 2011. Several years later, in 2017, the agency issued an updated statement about emerging information on breast implant lymphoma problems, and a number of subsequent studies have confirmed the risk of breast implant-associated ALCL.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants. Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. A year later, in March 2019, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.

Despite growing concerns, the panel of FDA advisers decided against recommending any breast implant recalls, indicating that it was too early to determine whether the risks were limited to specific breast implant designs.