FDA & CDC - Develop a medical code for sick women suffering from breast implants.
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Breast implants have been making women sick for over 50 years.
Please help us request action to develop an ICD medical diagnostic code for breast implant illness, which will help women who are suffering from health complications caused by breast implants. Breast implants cause autoimmune diseases and cancers, including scleroderma, joint pain, muscle pain, debilitating chronic fatigue, postexertional malaise, low-grade fever, skin rashes, memory loss, multiple sclerosis-like symptoms, night sweats, headaches, chronic diarrhea, recurrent infections, melanoma, and BIA-ALCL, a cancer of the immune system.
Recently in October 2019, the FDA has announced that they are recommending a Black Box Warning label on all breast implants to ensure that patients have complete information about the benefits and risks of breast implants. This is the strictest warning label that is used by the FDA, reserved for the most dangerous and harmful drugs and medical devices. https://www.fda.gov/news-events/press-announcements/statement-agencys-continued-efforts-protect-womens-health-and-enhance-safety-information-available
An ICD-10 diagnosis code is currently not available for practitioners. Why is this code important? Without an ICD code, physicians do not have the ability to accurately document the patient’s symptoms. A code will validate the systemic symptoms of Breast Implant Illness, just as the FDA and plastic surgery societies have acknowledged that Breast Implant Illness is very real. This will help women to be able to file a claim with insurance companies to help with explant surgery costs. Breast implant removal surgery (explant) is typically more than double the cost of getting breast implants, and this can run anywhere from $6,000-$14,000. Currently, insurance companies are denying these claims, stating that it is not medically necessary to remove the toxic implants that are causing dramatic health complications.
The ICD-10 Coordination and Maintenance Committee (C&M) is a Federal interdepartmental committee comprised of representatives from the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics (NCHS). We have submitted a proposal for an ICD code for breast implant illness, a detailed request that included multiple studies on breast implants showing that they make women sick, including MDAnderson’s largest study ever done on breast implants, which concluded that breast implants are associated with autoimmune diseases and BIA-ALCL, a cancer of the immune system. One brand of implants showed a two to eight-times higher frequency of Sjogren syndrome, rheumatoid arthritis, scleroderma and melanoma compared to the general population. The other group of patients with another brand of silicone implants used for reconstruction reported scleroderma, Sjogren syndrome and dermatomyositis more than twice as often as the general public, https://www.mdanderson.org/newsroom/largest-ever-study-shows-silicone-breast-implants-associated-with-rare-diseases.h00-159227301.html
We also included statements from patients as well as plastic surgeons, MD’s, naturopaths, and nurse practitioners, all who have testified to seeing these sick women in their practice.
The ICD review committee only meets twice yearly to review ICD code proposals. We submitted for September 2019 and we were denied. We submitted again for March 2020 and we were denied. Now we have submitted once again for September 2020 and we have been denied, all stating that “the evidence is insufficient”. How much more evidence is needed? We have hundreds of studies that have been done on breast implants, dozens of which we have submitted. We have 50 years worth of sick women, over 500,000 FDA adverse event reports and even a 12 year ban on silicone breast implants after class action lawsuits against Dow Corning in the 1990’s. 170,000 women sued Dow Corning, resulting in settlement payments of $3.2 billion dollars. We currently have more than 125,000 women in online support groups who are sick and harmed by breast implants. Hundreds of thousands of women, sick for decades, yet we are told there is not sufficient evidence.
We are requesting a meeting to discuss our proposal, as we were rejected without given the opportunity to present our evidence. Please sign this petition, share and forward. Please help us to have our voices heard. Addressing breast implant illness has been long overdue, 50 years overdue, and it’s time to move forward and make a change. Please sign our petition and share with others. We are not asking for donations, just signatures, but if you choose to donate it goes to change.org to help boost the petition. Thank you for your support!
BISA - Breast Implant Safety Alliance
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