ISSUE 1

ISSUE 1

30 Years Ago | FDA Breast Implant Moratorium

30 years ago the FDA issued a moratorium on silicone breast implants because the manufacturers “FAILED to provide adequate safety evidence that they are marketing a safe product .” The FDA lifted the moratorium more than a decade later in 2006.

Here we are...30 years later, and the manufacturers have still FAILED to provide evidence that they are marketing a safe product. There is no scientific evidence proving that they are safe. The narrative continues due to the fact that there has not been a study showing a casual link to prove that breast implants are unsafe. However, there is mounting evidence showing the toxicity of silicone and the health complications that it causes; enough to cause the FDA to ban the practice of injecting free silicone into the body.1 Patients who experience breast implant rupture end up with free silicone migrating throughout their body. It is clear that the FDA is sending mixed messages. According to the FDA, "injectable silicone is permanent and stays in your body. It can move throughout the body and cause serious health consequences, including death." 2

In 2018, MDAnderson published the largest study of long term safety outcomes for patients with breast implants. Results showed that silicone breast implants are associated with rare diseases. According to the study, patients had a higher occurrence of Sjögren's syndrome, rheumatoid arthritis, scleroderma, and dermatomyositis than the general population.3

Each manufacturer has information in patient literature brochures stating how silicone ingredients "bleed" through an intact implant shell, this happens with both saline and silicone implants, as they are both contained in a silicone shell. There is also information on patients reporting connective tissue disease, autoimmune diseases and cancer, specifically BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma). The problem we are seeing in the patient community is that doctors are not giving this information to patients. In a survey of over 5,000 patients, 84% of patients were not given the manufacturer Patient Information Booklet and 96% stated that they do not feel they understood all of the risks, maintenance and complications associated with having breast implants.

The continued lack of transparency is unacceptable. In using alternative summary reporting, the FDA was intentionally withholding over 446,000 adverse event reports of women who were harmed by breast implants. Recently, in October 2021 the FDA issued new safety restrictions for breast implant manufacturers, including new black box labeling to outline the risks. However, the FDA has failed to issue a Health Care Provider letter to all medical professionals informing them of the health complications that are associated with breast implants. Patients are suffering for years, spending thousands of dollars on specialists, trying to determine the cause of their failing health. It is crucial for the FDA to provide this information to the medical community.

This injustice has prompted our GPAC team to work with state legislators to implement informed consent legislation for breast implant surgery. It is critical for patients to have the proper information in order to make an educated and informed decision about their health. We are proud and honored to announce that as of January 1, 2022 every patient in the state of Arizona will now have the proper information regarding breast implant safety. The patient checklist can be found on the resources tab on the GPAC website. This is a step in the right direction, but it should not have taken 30 years to get this important information to patients.

Please like and subscribe to our website and monthly newsletter to be informed of the projects that we are working on to ensure patient safety and improve the standard of care.