FDA Impedes Patient Care in Women Who Suffer from Breast Implant Complications
For over 30 years, the United States Food and Drug Administration has been asked by the patient community, doctors, researchers, and other health care providers to issue communication to all health care professionals alerting them about breast implant safety information. FDA transcripts from 2000, 2003, and 2005 show that patients were pleading for the FDA to present this information to better serve the patient population. Dr. David Kraus is current Deputy Director of the FDA CDRH (Center for Devices and Radiological Health), the division of the FDA which regulates medical devices. Dr. Kraus attended the advisory panel meetings in the early 2000’s where patients and doctors shared their testimony about the lack of communication to the medical community. Many patients who are sick from breast implants have seen dozens of medical professionals who have not been informed that breast implants can cause multiple cancers and systemic health symptoms. Additionally, many patients are not tested properly for cancers that develop from breast implants. When the medical community is unaware of this important safety information, it prevents patients from receiving proper and timely care. This may cause further health complications, or lead to a critical cancer diagnosis, or even death. In a recent survey with over 1000 responses from harmed patients, the data is alarming to see how many patients lacked appropriate care.
WHAT MEDICAL PRACTITIONERS SHOULD KNOW…
The FDA website Breast Implants: Certain Labeling Recommendations to Improve Patient Communication (2020)states
· Breast implants are not lifetime devices
· The chance of developing complications increases over time
· Some complications will require more surgery
· Breast implants have been associated with the development of a cancer of the
immune system called Breast Implant Associated Anaplastic Large Cell Lymphoma. (BIA-ALCL)
On October 27, 2021 the FDA issued an update “FDA Strengthens Breast Implant Safety Requirements and Updates Study Results.” In this update, the FDA outlines new restrictions on manufacturers and safety measures for patients, including a patient decision checklist. In early 2022, the Global Patient Advocacy Coalition (GPAC) asked the FDA for a formal public statement to explain why healthcare providers have not been informed about these new safety updates. On May 10, 2022, the FDA responded with the following statement.
We are providing the following information about FDA actions and communications relevant to the topic of your article and podcast.
The FDA is committed to making a positive impact on women’s health and we recognize that risk communication related to breast implants is essential for assuring patient safety. To this point, the FDA has posted information on our website, disseminated videos, presented before numerous groups, and held numerous press interviews, among other actions, to emphasize the need for more education and risk communication about breast implants, including systemic symptoms referred to by some patients as breast implant illness.
Since 2019, the Agency has assembled--and broadly communicated--information it has received about adverse events related to breast implants to raise awareness and to help keep an ongoing dialogue among all stakeholders on the topic. For instance, in March of 2019, we held a meeting of the General and Plastic Surgery Devices Advisory Panel to publicly discuss the long-term benefits and risks of breast implants indicated for breast augmentation and reconstruction. This meeting included a session about systemic symptoms in women with breast implants.
Our analysis of Medical Device Reports for Systemic Symptoms in Women with Breast Implants, reported to the FDA between January 1, 2008 and October 31, 2019, has been accessed more than 50,500 times since we posted this on August 20, 2020, and has been cited in clinical publications such as an article and an editorial piece in the Aesthetic Surgery Journal from the Aesthetic Society. In addition, FDA-produced videos on the topic (7 Key Things You Should Know about Breast Implants and Update on FDA's activities on breast implants) have been viewed over 50,000 times in the FDA YouTube channel.
In October 2021, the FDA announced we had issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information to help them make fully informed decisions. The FDA orders restrict the sale and distribution of breast implants to only health care providers and facilities that provide information to patients utilizing the patient brochure “Patient Decision Checklist.” This announcement was emailed to more than 220,000 email subscribers who are signed up to receive news and updates from the FDA regarding medical devices. Many of these subscribers include numerous professional societies and associations of health care providers as well as consumer and patient groups.
Although we are confident that our sweeping actions and communications over recent years pertaining to breast implant risks, including information about systemic symptoms reported by women with breast implants, have reached a broad audience of health care providers and women who are interested in this information, we are committed to continuing to communicate with patients and health care providers as new or updated information on the topic becomes available.
Once again, thanks for taking the time to contact us directly. We hope this information is helpful.
A post on the FDA website, gained 50,500 views, however the FDA failed to take action to alert medical professionals of this announcement. An announcement is only effective if it reaches the necessary audience of medical professionals who are able to provide better treatment and care to patients who are experiencing breast implant related health complications. According to the Association of American Medical Colleges and the Federation of State Medical Boards, there are 1 million active licensed physicians in the United States. The American Association of Colleges of Nursing shows that there are 3.8 million practicing nurses. For a total of 4.8 million physicians and nurses, the FDA communication only reached 50,500 people. FDA you tube channel breast implant video received 50,000 views and 320,000 subscribers received FDA email updates about breast implants. This is nowhere near the reach that is necessary to inform the medical community of nearly 5 million providers.
Recently, on September 8, 2022, the FDA issued another breast implant safety update about Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants. These are different cancers aside from BIA-ALCL (anaplastic large cell lymphoma) that prompted a worldwide recall on Allergan textured Biocell devices. There are now multiple different cancers associated with breast implants and the FDA still fails to alert the medical community. In a recent presentation about Squamous Cell Carcinoma, Dr. Scot Glasberg from the American Society of Plastic Surgeons (ASPS) stated that SCC is found to be highly aggressive, and does not respond to chemotherapy or radiation. Further, he has stated that cases of SCC have doubled since the FDA announcement in September, less than two months ago. When the FDA announcement about SCC and other cancers was released, ASPS held a meeting with board members and patient advocates. ASPS members voiced their support for a healthcare provider letter, and a call was set up to meet with the FDA, ASPS and GPAC. On November 8, 2022, the FDA made it clear that they will continue to withhold this information from the medical community, despite the request from ASPS and patient advocates. This disappointing turn of events will directly cause further harm to patients, and it will carry the potential for deadly cancers to go undiagnosed.
GPAC has launched a petition to gain support, asking for signatures to bring to the FDA to show the importance of providing this important information to the medical community. Click here to sign the petition. https://chng.it/dMFXBM6Y4Z