Additional Cases Of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Reported To FDA, Health Canada
For our first 2019 update about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare T-cell lymphoma, we will start with recent developments in the United States and then move up to Canada.
As background, beginning about two years ago when a March 2017 Update was issued by the FDA, there has been an increasing amount of attention paid to BIA-ALCL, which is sometimes called breast implants lymphoma cancer. This serious medical condition can develop in the capsule around a silicone gel- or saline-filled implant, with the average lag time between surgery and diagnosis is 9.2 years (at least as of this point in our understanding of BIA-ALCL cases).
In February 2019 the FDA announced that it has received a total of 660 medical device reports (MDRs) regarding BIA-ALCL cases in the United States since 2010, with an increase of about 246 new reports of breast implants lymphoma cancer cases in the past year. According to analysis, this total of 660 MDRs corresponds to 457 unique cases of BIA-ALCL, including nine patient deaths.
I want to share the following new 2019 information from the FDA:
Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants (Issued: February 6, 2019)
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers (Issued: February 6, 2019)
Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (Last Updated: February 6, 2019)
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (Last Updated: February 6, 2019)
Strictly Confidential, No Obligation.
Next we point out the latest news on breast implants lymphoma cancer cases in Canada, where this Information Update document was issued on February 12, 2019, "Health Canada will be updating its safety review of breast implants", from which we get the following:
Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased awareness by healthcare professionals and the public about BIA-ALCL is believed to be the largest contributing factor to the increased reporting of cases of BIA-ALCL to Health Canada.
It is expected that the updated safety review will be completed in spring 2019. Upon completion, Health Canada will take action as required and inform Canadians and healthcare providers.
Be assured that we will continue to monitor medical and regulatory developments concerning breast implants lymphoma cancer cases -- albeit this is an "off-topic" subject for the Drug Injury Watch blog.
We have been reviewing breast implant lymphoma cases as possible lawsuits against Allergan, Mentor, and other breast implants manufacturers since March 2017, and will continue to do so. If interested, you can use our Breast Implants Cancer Case Evaluation Form.