FDA Confirms Link Between Textured Breast Implants & Lymphoma

The FDA has received at least 359 reports of anaplastic large cell lymphoma, a rare blood cancer now officially-linked to breast implants.

Breast Implants




At least 9 women have died of anaplastic large cell lymphoma, a rare form of blood cancer linked to breast implants, the US Food & Drug Administration reports.

Breast Implant-Associated Large Cell Lymphoma

In a report published on March 23, 2017, the federal agency officially acknowledged the connection between breast implants and cancer for the first time. The FDA says it has received 359 adverse event reports of patients who developed large cell lymphoma tumors after receiving breast implants.

Medical researchers have been worried about a potential association since at least 2011, but the disease's rarity made conducting conclusive studies impossible.

Anaplastic large cell lymphoma (ALCL) is marked by a specific protein - CD30 antigen - which appears on the surface of lymphoma cancer cells. It can be either aggressive or slow-growing, but most cases will remain unexplained. Overall, the cancer is more common in young people, according to WebMD, especially young boys. The disease is so rare that no official statistics on its incidence have been published.

WHO, FDA Struggle To Understand Problem's Extent

In 2016, officials at the World Health Organization devoted a specific cancer classification to forms of lymphoma that arise after the implantation of breast implants, dubbing the cases breast implant-associated ALCL. With its new announcement, the Food & Drug Administration has thrown its weight behind the World Health Organization's decision, defining the cases of anaplastic large cell lymphoma linked to breast implants as a distinct form of cancer.

The link between breast implants and lymphoma is still ill-defined. A lack of global sales data on breast implants, along with limitations in cancer reporting, have hampered the FDA's efforts to define the problem's scope. Despite these challenges, Australian regulators have attempted to calculate the risk, finding that between 1 in 1,000 and 1 in 10,000 women who receive breast implants will develop breast implant-associated ALCL. Obviously, this estimate spans an order of magnitude and will need to be refined before researchers can reach a workable understanding of the danger.

There is some evidence, however, that breast implant-associated ALCL is more frequent in women who receive implants with textured surfaces, rather than smooth surfaces. In France, officials at the country's National Agency for Medicines and Health Products Safety have asked companies that manufacture textured breast implants to conduct enhanced safety testing on their products. The implant's filling, on the other hand, appears to have no effect on the risk of cancer, although the FDA is cautious to note that its statistics are not sufficient to rule out any causal theories.



The Legal Herald
By | 2017-05-04T09:38:50+00:00 April 21st, 2017|Medical Devices|1 Comment

About the Author:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including products liability, nursing home abuse and personal injury.

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One Comment

  1. Michelle April 25, 2017 at 5:25 pm - Reply

    The link was NOT to textured implants only. It is for all implants.

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