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April 12, 2019

Breast implant-associated lymphoma: an example of post-market surveillance and device regulation

More than 350,000 women in the US underwent breast implant procedures in 2018, including both elected augmentation and post-mastectomy reconstruction.

By GlobalData

In today’s media-driven society, it is becoming easier and easier for people to compare themselves to the superficial perfection portrayed by many actors, actresses and social media stars.

Breast implants and lymphoma

For many women, having breast implants is a seemingly innocuous way to improve their self-image in order to feel better about themselves.

Some women, however, choose to have breast implants for vastly different reasons, as approximately 30% of women diagnosed with breast cancer elect to undergo a single or double mastectomy and subsequently undergo breast reconstruction.

GlobalData reports that more than 350,000 women in the US underwent breast implant procedures in 2018, including both elected augmentation and post-mastectomy reconstruction.

Implants and BIA-ALCL

However, most women undergoing this surgery do not know that some implants come with a small risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

While lymphomas, in general, are the most commonly-occurring hematological cancer, arising from either B or T lymphocytes, BIA-ALCL is a rare but potentially aggressive subtype of lymphoma.

Health Canada estimates that approximately one in 12,000 Canadian women who receive textured breast implants (a specific type of implant) will later develop BIA-ALCL. The pathogenic mechanism leading to the disease in these women is still unclear, but some animal studies suggest that cancer progression may be related to implant-related chronic inflammation or activation of the immune system in response to the implant.

In 2011, the US Food and Drug Administration was the first governing body in the world to recognise the link between breast implants and cancer. Since then, more and more research has accumulated documenting cases of breast implants leading to BIA-ALCL.

These revelations have made a huge impact on breast implant manufacturers and health care providers, as they are expected to more carefully regulate and report on incidences of BIA-ALCL related to these devices.

As of September 2018, the FDA has received a total of 660 Medical Device Reports of BIA-ALCL. In February 2019, the FDA released a letter to health care providers in relevant specialities providing specific recommendations related to the risk of BIA-ALCL, such as to always provide patients with the breast implant manufacturer’s labelling and educational material, as well as to perform specific diagnostic tests if signs of BIA-ALCL are noticed.

On 12 February 2019, Health Canada released a statement indicating that it will be updating its safety review of breast implants following increased reports of BIA-ALCL in Canadian patients.

Mentor Worldwide LLC and Allergan Inc

GlobalData reports that the North American and European breast implant markets are dominated by Mentor Worldwide LLC (a subsidiary of Johnson & Johnson) and Allergan Inc.

In France, the Agency for the Safety of Medicines & Health Products recently ordered that Allergan Inc. stop manufacturing and selling its most popular implants, the Microcell and Biocell devices.

These particular implants have a significant amount of texturing, which is thought to contribute to BIA-ALCL risk. This recall does not affect the North American market or sales of Allergan’s smooth implant products. However, as women considering breast implantation become more and more aware of the underlying BIA-ALCL risk, GlobalData expects that fewer women will elect to receive textured breast implants in the future, shrinking this market and driving manufacturers to develop technologies that have a lower risk of BIA-ALCL.

The discovery of the link between breast implants and BIA-ALCL provides an example of post-market medical device surveillance that has had a big impact on a large market worldwide. Thanks to improved regulations and incidence reporting, the market will shift accordingly and patient safety related to these devices will be improved.

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