The U.S. Food and Drug Administration (FDA) has been aware of the possible connection between breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) since 2011.
This condition is a rare type of non-Hodgkin’s lymphoma, which is a cancer of the immune system, rather than a cancer of the breast tissue. It occurs in the scar tissue and the fluid surrounding the implant within the breast capsule, but can also spread throughout the body.
The most recent data available suggests that BIA-ALCL most often occurs among patients with textured breast implants, as the surface of the implant provides space for bacteria to attach and proliferate.
On March 21 2017, the FDA reported that the exact number of cases of BIA-ALCL has been difficult to determine “due to significant limitations in world-wide reporting and lack of global implant sales data.”
Despite the limitations, the FDA released updated information on the number of reported cases earlier today. In this March 2018 news report, they state the following:
As of September 30, 2017, the FDA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients.
272 of the 414 reports included information on the surface information of the implant at the time of the report, including 242 with textured surfaces and 30 with smooth surfaces…In the MDR reports, half of the reported cases were diagnosed within 7-8 years of implantation.
This data was last updated in September 2017.
In the report released earlier today, the FDA provided the following information on their efforts:
[W]e are working to update and enhance the information we have on this association, including updating the total number of known cases of BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in medical literature.
We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue.
Going forward, we will continue to monitor the medical and regulatory information for updates on the number of reported BIA-ALCL cases and the condition’s association with breast implants.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Previous articles on this topic:
- New Data Released on Risk of Lymphoma Due to Breast Implants
- Breast Implant-Associated Lymphoma Diagnoses on the Rise
- What is the Risk of Death Due to Breast Implant-Associated Lymphoma?
- Breast Implants and Lymphoma: Who’s to Blame?
- Breast Implant Lymphoma: Causes Uncertain, but Costs Undeniable
- Breast Implants Linked to Rare Lymphoma Blood Cancer