Breast Implant Victim Advocacy & Multiple Breast Implant Illness Support Groups

34,338 supporters

    Started 2 petitions

    Petitioning Center for Devices and Radiological Health

    FDA - Call to Action on Breast Implant Safety

    Patients harmed by breast implants started a petition on change.org over a year ago asking the FDA for a public meeting to discuss breast implant safety.  On March 25 and 26th of 2019, the FDA granted us our request. Over 70 harmed patients and caregivers were in attendance to give their testimonies. They made heartfelt pleas for the FDA to do more. Breast Implant Victim Advocacy presented a Call to Action to the FDA in response to the two-day meeting. We are summarizing our points below, which are also supported by the National Center for Health Research and multiple online support groups. Patients affected by breast implant illness and BIA-ALCL played a part in creating these points. We now present a petition to the FDA and CDRH to uphold these actions. We ask the FDA to uphold the following: •1) Provide breast augmentation and reconstruction patients with a mandatory, short, and understandable patient booklet and patient/surgeon checklist (checklist should be similar to Essure) to be written by a committee of harmed breast implant patients and plastic surgeons with FDA monitoring. This should include a black box warning about BIA-ALCL and describe the reports of breast implant illness. •2) The FDA should enforce requirements of pre-market and post-market large, long-term studies of thousands of women with breast implants and adopt the strategies of Ideal Implants to ensure adequate follow-up. FDA should require smaller studies aimed at determining the best diagnostic and treatment protocols for BIA-ALCL. Failure to comply with study requirements should result in a moratorium on inadequately studied implants. •3) We urge the FDA to ban Biocell textured implants and expanders and place a moratorium on other textured implants and expanders until studies are completed to determine safety. The FDA should require implant companies to pay for physicians and medical centers to notify patients with textured implants about the risk and symptoms of BIA-ALCL. •4) The FDA needs to require that breast implant manufacturers provide a list of all ingredients used in the production of each model of breast implants, and include this information on their websites for public view. •5) The FDA should require adverse event reporting for each event, rather than summary data. Companies' failure to report adverse event reports in a timely manner should result in warning letters to physicians about the companies' failure. This should include compliance in reporting cases of BIA-ALCL. •6) The FDA should provide the opportunity for harmed patient representation on the Breast Implant Advisory Team. Thousands on thousands of patients are being harmed. Adverse event reports for breast implants exceed the number reported for any other medical devices in the US. Advocates would like to thank the FDA for the increased patient engagement opportunities. We look forward to the continual collaboration with both the FDA and plastic surgery organizations. We need to work together to find common ground and move forward with actions that protect patients. We urge the FDA to move forward with the above actions. Our patients deserve better. Failed regulation and flawed studies need to be addressed. It's time to move forward.

    Breast Implant Victim Advocacy & Multiple Breast Implant Illness Support Groups
    10,441 supporters
    Victory
    Petitioning Center for Devices and Radiological Health, Binita Ashar, William Maisel, Jeffrey Shuren, Scott Gottlieb, Marsha Henderson, Isaac Chang, David Krause, Peter Hudson, Mark Trumbore

    Tell the FDA we need a hearing on breast implant illness, complications, and BIA-ALCL

    Breast implants are causing illness and harm to thousands of women. The FDA needs to hear from those of us that are sick and disabled. Our symptoms are the same as were described three decades ago despite innovations in implant manufacturing. Studies have been terminated. Women have been dropped from studies. Ladies are facing disability and struggling financially to remove their breast implants. Breast implant removal is on the rise. Other countries (South Korea, France) (http://www.straitstimes.com/asia/east-asia/safety-of-breast-implants-under-review-in-south-korea-after-silicone-gel-found-in (https://www.google.com/amp/www.dailymail.co.uk/health/article-3677858/amp/Breast-implants-linked-cancer-French-watchdog-gives-firms-year-act-face-blanket-ban.html are questioning breast implant safety and demanding more proof. Breast Implant-Associated Anaplastic Large Cell Lymphoma recently gained more media attention and women want answers. The first case was 20 years ago and still no formal definition of causality has been made. Women are being warned that textured surfaces are more prevalent in this disease, yet another textured breast implant was recently approved by the FDA. Autoimmune disorders are very prevalent among those breast implant patients who are ill. Undefined disease symptoms like fatigue, anxiety, joint pain, shortness of breath, rash, etc. are very common. We need the opportunity to tell the FDA about our struggles. Genetic testing needs to be done to see if there is a correlation among those women who are sick. A high percentage of those affected show improvement in health once the implants are removed. There are currently over 60 support groups about breast implant illness / Explantation just on Facebook. This doesn't include Facebook pages and communities, websites dedicated to the cause, and other support groups with online forums. Our groups are growing daily and we currently have at least 20,000 (Update - 50,000 as of Sept 2018) women united. We need a voice. We need to be heard. We deserve more proof that these devices are safe and more complete studies. We deserve transparency in the chemicals utilized to make these devices that we are implanting for a long duration. There is transparency in food and personal care products. Why don't medical devices require ingredient transparency? What metals are we being exposed to? What do the MSDS data sheets of these ingredients say about long term exposure? We just want the FDA to realize that we are all telling the same story - similar symptoms and the main link is breast implants. Please give us the opportunity to come speak to the FDA at our own expense and tell our stories. Thank you very much.

    Breast Implant Victim Advocacy & Multiple Breast Implant Illness Support Groups
    23,897 supporters