Yesterday, after years of reports connecting textured breast implants to a rare form of cancer known as anaplastic large-cell lymphoma, the FDA finally issued a world-wide recall of the implants. I emphasize the word “finally” because I want to know what took them so long?
Here at productattorney.com we have been blogging about the link between the implants and this rare form of malignancy dating back to April 2017 when the FDA already had 9 deaths reported as being related to the breast implants, dating as far back as 2011. See our original blog post here.
Given that we know that only 10-15% of adverse reports are ever submitted to the FDA, these 9 reports should have set off alarm bells with the FDA years ago, triggering recall action at that time.
A year ago, in August, the Philadelphia Inquirer ran an excellent and well-researched article entitled, “As rough-surface breast implants cause more lymphoma cases, critics decry continued use.” The article is worth your read and can be found here.
And still we find ourselves another year out from action by the FDA. Can you imagine how many women have been diagnosed with AL since 2011 or even since April of 2017? After all, even the EU removed the implants from the market a full 9 months before the US FDA. See our previous blog post on this issue here.
As America continues to see the FDA act in such ways that appear to be far more corporate driven, rather than consumer-protection driven, one cannot help but to lose faith in their continued oversight.
There has never been a more critical period of time where self awareness and self-education is more important.
See our additional previous post on these implants here.