FDA’s Latest Ruling on Breast Implants

 
fda-update
 
 

The FDA released their most recent statement on Breast Implants on May 2, 2019. You can read the statement for yourself here.

My favorite part is this, “While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness. We believe women considering a breast implant should be aware of these risks.”

This is a win. Maybe some will see it as a small win, but it is certainly a step in the right direction. The FDA has acknowledged BII exists. That is no small feat. And as more of us self-report our symptoms, the evidence will grow enough for them state that they do have definitive evidence.

Here is a breakdown of the steps that the FDA has committed to taking to ensure women are actually informed and protected when it comes to breast implants:

  1. “…improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants.” This could include a boxed warning label. As a patient, the problem I see with this is that we never see the container that implants come in to see the dreaded boxed warning label.

  2. Better incorporate product ingredients into product labeling that is easy for the patient to understand. Again, when would we ever see this labeling??

  3. “We are aware that there are some health care professionals, such as gynecologists, dermatologists, internists and pathologists, who may not be fully aware of these breast implant risks, like BIA-ALCL and systemic symptoms. We are committed to doing what we can to reach them with this important information, including continuing the outreach we started with our Letter to Health Care Providers to educate the medical community about BIA-ALCL and other risks of breast implants.” I wonder how many of them will take the time to read the letter. The original letter went out in February 2019, we still have to deal with our doctors never having heard of BII.

  4. We also plan to work with the pathology community to educate pathologists about testing for this lymphoma specific to breast implants.” Many of us fight to get our implants tested only to find out that the test is a simple swab that has a 30% success rate.

  5. “We are also announcing today a change in how breast implant manufacturers file medical device reports with the FDA…the FDA has ended all summary reporting of breast implant medical device reports.” Thank the Lord. This is how our problems go unreported or snuck in with a bunch of other known problems.

While all these steps to strengthen warnings is great, what about banning implants that the FDA knows is causing cancer? Their official response is, “At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.”

Disappointing to say the least. They base their stance on the fact that textured implants only make up 5% of the total breast implant market and there are cases of BIA-ALCL in non-textured implants. They need more evidence.

So, let’s make sure we give them all the evidence they need. Please make sure that if you receive a BIA-ALCL diagnosis that you self-report through PROFILE. Please report ALL problems to NBIR.

I also strongly suggest reporting through MedWatch Voluntary Reporting Form.