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Tips for Testifying at the Breast Implant FDA Meeting


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!  When you have a draft of your speech, please feel free to send it to Claudia Nuñez-Eddy, cne@center4research.org, and we would be happy to look it over and provide any tips and/or edits.

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 ____.

 

Again, if you have any questions or would like an expert pair of eyes to look over your testimony in advance, please contact Claudia by email at least one week before the meeting, cne@center4research.org.

Letter for Breast Pain

Here is our sample letter of medical necessity written for a woman who has chronic breast pain or back pain caused by the weight of her implants, but does not have capsular contracture (her breasts do not feel hard). If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click Here to download this letter as a word document that you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. [Patient name] has reported chronic breast pain. [Patient name] requires an explantation with permanent removal of both implants. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female with chronic breast pain. [Patient name] has been in my care since [date]. As a result of her pain, my patient has experienced significant deficits in her daily functioning, including [not being able to reach above her head, etc]. She has previously tried [any pain medications, including Tylenol] to relieve her pain. The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

In addition to her chronic pain on a daily basis, undergoing mammography has become too painful and the results are too inaccurate. Breast implants can interfere with the accuracy of mammography because the implant can hide breast tumors so that they are not visible on the mammogram. Inaccuracy is exacerbated when the patient has breast pain, as [Patient name] does. The lack of accurate mammograms makes it difficult to diagnose breast cancer at an early stage when it can be treated more effectively and with less radical treatments. Removal of her breast implants will allow her future mammography screenings to be much less painful and much more accurate.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has severe pain that has negatively impacted her daily functioning. Her severe breast pain keeps her from [lifting her arms above her head, getting dressed, sleep, add relevant tasks]. Surgical implant removal is the standard treatment for breast pain and capsular contracture, and is clinically appropriate for my patient’s illness. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

[RELEVANT POLICY LANGUAGE].”

[Patient name]’s severe breast pain meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of her breast implants and scar tissue surrounding them will relieve her breast pain and improve her daily functioning. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [Patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

 

Letter for Capsular Contracture

Here is our sample letter of medical necessity written for a woman with hard or painful breasts caused by capsular contracture (classified as Baker III or IV). If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click Here to download this letter as a word document you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. I have diagnosed [patient name] with [Baker III/IV] capsular contracture and severe breast pain. [Patient name] requires an explantation with permanent removal of both implants. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female with [Baker III/IV] capsular contracture and severe breast pain. [Patient name] has been in my care since [date]. As a result of her pain, my patient has experienced significant deficits in her daily functioning, including [not being able to reach above her head, etc.]. I diagnosed her with chronic pain resulting from her breast implants. She has previously tried [any pain medications, including Tylenol] to relieve her pain. The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

In addition to my patient’s chronic pain on a daily basis, undergoing mammography has become too painful and the results are too inaccurate. Breast implants can interfere with the accuracy of mammography because the implant can hide breast tumors so that they are not visible on the mammogram. Inaccuracy is exacerbated when the patient has severe capsular contracture, as [Patient name] does. The lack of accurate mammograms makes it difficult to diagnose breast cancer at an early stage when it can be treated more effectively and with less radical treatments. Removal of her breast implants will allow her future mammography screenings to be less painful and much more accurate.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has severe capsular contracture and breast pain. Her significant breast pain prevents her from [lifting her arms above her head, getting dressed, add relevant tasks]. Surgical implant removal is the standard treatment for chronic breast pain and capsular contracture and clinically appropriate for my patient’s illness. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

RELEVANT POLICY LANGUAGE

[Patient name]’s [Baker III/IV] capsular contracture and breast pain meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of both her breast implants and scar tissue surrounding is the standard treatment to relieve her severe breast pain, eliminate her capsular contracture, and improve her bodily functioning. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [Patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports

Letter for Ruptured Silicone Gel Implants

Here is our sample letter of medical necessity written for a woman with at least one ruptured silicone gel breast implant. If you would like our assistance in personalizing your letter, please take our short survey and we will email you soon.  Click here to download this letter as a word document you can edit.

[Date]

[Insurance company] Claims Department
Address Line 1
Address Line 2

RE: Letter of Medical Necessity for [patient name]
Group/policy number: [Number]
Date(s) of service: [Dates]
Diagnosis: [Code & Description]

Dear [Insurance company] Claims Department:

I am writing on behalf of my patient, [patient name], to document medical necessity for explantation of two breast implants. [Patient name] has undergone [MRI/ultrasound/mammogram/a comprehensive clinical exam] and there is clear evidence that [her right/ her left/both her] silicone gel breast implant[s] [is/are] ruptured. [Patient name] requires an explantation with permanent removal of both implants and scar capsules. On behalf of the patient, I am requesting coverage for this procedure.

[Patient name] is a [age]-year-old female who has been in my care since [date]. [As a result of her ruptured implant[s], my patient has experienced [pain] as well as significant deficits in her daily functioning, including [not being able to reach above her head, etc.]. [She has previously tried [any pain medications, including Tylenol] to relieve her pain.] She is unable to safely undergo mammography to screen or diagnose breast cancer, because the pressure of the procedure would spread the leaking silicone throughout the breast area and surrounding tissue and potentially to her lymph nodes, and from there to organs such as the lungs and liver. In
addition, even without mammography the leaking silicone [has migrated/can migrate] to her lymph nodes and from there to other organs, and [has resulted/can result] in the formation of granulomas that resemble lumps caused by breast cancer tumors. The FDA and general expert consensus have recommended explantation for all patients with both extracapsular- and intracapsular-ruptured silicone gel breast implants.

The attached medical records document [patient name]’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for the recipient that is more conservative or less costly.

According to the medical policy of [insurance company], my patient’s breast implant removal should be covered since she has [a] ruptured silicone gel implant[s]. Surgical implant removal is the standard treatment for a ruptured silicone gel implant and clinically appropriate for my patient. This surgery is not primarily for the convenience of the patient or provider.

The [insurance company] policy [policy number] states the following within the plan under the “[TITLE OF SECTION OF RELEVANT POLICY LANGUAGE]” section:

[RELEVANT POLICY LANGUAGE]

[Patient name]’s ruptured silicone gel implant[s] meets the above-stated criteria for [breast implant removal/medical necessity]. Removal of both her breast implants and intact scar tissue surrounding them is needed to prevent silicone gel leakage during the explantation surgery. Based on the language above, this procedure should be considered medically necessary.

My patient is requesting coverage for the [surgery name and CPT code #s]. Medical documentation is included.

Based on this information, I ask that you offer coverage for [patient name]’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at [phone and email contact information]. I look forward to hearing from you.

Sincerely,

[Dr. signature]
[Dr. name, title]
[Provider identification number]

Enclosures: (Attach as appropriate)
Clinic notes and lab reports