Tips for Testifying at the Breast Implant FDA Meeting

Uncategorized

The National Center for Health Research is available to help patients edit their public comments before the FDA Advisory Committee. Our organization has decades of experience testifying at FDA meetings regarding breast implants and other medical devices, so we’ve seen great patient presentations and ones that were not effective at all.  For example, it’s important to keep in mind what kinds of patient experiences  the FDA will consider, and to not rush your statement.  These tips should help!

Specific Tips for Testifying at the Breast Implant FDA Meeting
  1. The patient voice is important so if you are a patient, please testify as a patient. Don’t try to testify as a scientist or medical expert, unless you are a professional in that field.  If you are both a medical professional and patient, be sure to say so in your first or second sentence.
  2. If you were in a clinical trial for breast implants be sure to say so.  Did the doctor ever follow up with you to include data on your health in the years after your surgery?  If you told your plastic surgeon of your health problems, were you no longer contacted for the study?
  3. Focus on the issues that the FDA cares about.  They have made public those 7 issues:  BIA-ALCL; Breast implant illness; Use of registries for implant surveillance; MRI screening for silent silicone gel rupture; Use of surgical mesh in breast procedures; Use of real-world data and patient perspectives in decision making; and Informed consent.
  4. Do NOT talk about how terribly your doctor treated you.  That is not the jurisdiction of the FDA, so they just won’t listen.
  5. Do NOT list all of your symptoms.  List a few and focus on how the worst ones have affected the quality of your life and health.
  6. Do NOT get into a discussion of the chemicals in breast implants unless you are a chemist.
  7. Do NOT insult FDA or doctors. If you point out that FDA and doctors need to better inform patients of the risks, etc, that would be more persuasive than insults.
  8. Did your doctor assure you that your health problems were unrelated to your implants? As a result, did you delay getting the medical care you needed?  What could FDA do to better educate doctors about implant health problems?
  9. Did your health problems start immediately or gradually over the years?  (If the latter, point out that’s why long-term studies are needed).
  10. Did your plastic surgeon ask you if you had any autoimmune symptoms or diagnoses before getting implants?  If the plastic surgeon knew you had such medical problems, did he tell you that breast implants were not studied by the implant manufacturers on women with such medical issues?
General Tips for Testimony Presentations
  • Decide on one clear message and make that message clear early and perhaps often – don’t make it a surprise at the end because they may miss it.
  • Clearly state your main points – preferably no more than 3.
  • Use simple sentence structure – it’s easier to follow.
  • Time yourself speaking out loud and make sure your statement/presentation is significantly SHORTER than the time allotted so that you WON’T need to rush and WILL have time for eye contact.  There is nothing worse than testimony that is read too quickly.

How to keep your statement short?  Take out extraneous examples, use words with fewer syllables (each syllable takes a second to say), don’t make side comments (weather, how nervous you are, etc.) that you hadn’t planned on.

 For example: Mr. Chairman, Members of the Committee, I want to thank you for the opportunity to testify today. = 29 syllables.

Thank you for the chance to speak today  = 9 syllables and just as polite.  You have thanked them and they already know who they are, you don’t have to remind them.

Opportunity = 5 syllables.   Allowing = 3 syllables.  Chance = 1 syllable.

If You Are Using PowerPoint
  • If you use PowerPoint give enough time for your audience to understand EACH Slide.  If you don’t have time to do that, take the slide out.
  • Use graphics (cartoons, photos, humorous drawings, simple graphs) to illustrate your points. A picture is worth a thousand words– that’s really what PowerPoint is for.
  • PowerPoint with lots of words is not an effective or entertaining presentation and not an effective way to share ideas.
  • Slides with words should be simple without a lot of background decoration or other distractions.
Example Format for Testimony  (Fill in the blanks)

My name is ___ and I traveled from STATE at my own expense, so I have no conflicts of interest.

Thank you for the chance to share my story with you.

I first got breast implants at the age of ___ because I ____ (very briefly mention reason).

The health issues started __ months (or years) later, but I didn’t realize it was related to my implants. [Briefly describe your symptoms in one sentence, such as “I was exhausted all the time, my hair was failing out, and I couldn’t concentrate.”]  My doctors told me ________.

I didn’t know what was wrong, but when I read about the experiences of other women online, I __________.

I got my implants out in YEAR and my symptoms [did or did not improve, gradually or immediately].  (describe briefly)

I know from experience that breast implants can harm women’s health.  Doctors and women need to be warned about the health problems that breast implants can cause.  It would help if the FDA warned them.  [Some of the women plan to say: The patients need a short, easy to read check list, like the 2-page check list that was required for Essure patients last year.]

OR:  One of the questions you’ll be voting on is ____.  I urge you to listen to my experiences and vote ____.