What is Breast Implant Illness?
Breast implant illness is a widely used term that lacks an official medical diagnosis, largely because it's understudied and little understood. It’s known to manifest as a constellation of symptoms that can include autoimmune disorders, as well as nonspecific disorders like skin rashes, brain fog, insomnia, fatigue, depression and vertigo. Even more confounding, the symptoms can appear within days or years following implant surgery.
In recent years, women have increasingly taken to social media to find answers and raise awareness about the illness. The past two years have also seen a flurry of regulatory activities in the form of warning letters to breast implant manufacturers, implant recalls and meetings between patient advocates and the U.S. Food and Drug Administration — an agency that’s been met with intense criticism for being slow to respond to implant-related health concerns.
In September, the FDA recommended a black box warning on saline or silicone gel implants, calling attention to the serious side effects linked to breast implants. Patient advocates still hope for progress on a diagnostic code from the U.S. Centers for Disease Control and Prevention that would solidify breast implant illness as a diagnosable condition.
The Summit: Why Now?
The Breast Implant Health Summit was organized to raise awareness of breast implant illness and the thousands of women who report experiencing it. Initially planned as an in-person meeting of 10 people, the summit mushroomed into a major virtual streaming event amid COVID-19 pandemic restrictions.
Valoras calls it a “one stop shop summit” to better understand the effect of breast implants on the human body. The majority of presenters have either personally experienced or treated breast implant illness and included experts in fields such as holistic medicine, nutrigenomics, plastic and reconstructive surgery, detoxification, acupuncture, herbology and physical therapy.
By centering the mission on educating physicians — rather than, for example, rebuking breast implant manufacturers — the summit focused on immediate, actionable change to help patients living with breast implant illness.
“If breast implants were to come off the market tomorrow, there would still be thousands of sick women that need medical care,” Maria Gmitro, a summit presenter and co-founder and president of Breast Implant Safety Alliance, told MedTruth in an email. “Medical professionals need to … look beyond the research that is provided by the implant manufacturers because there is a conflict of interest."
With a more informed viewpoint, physicians and health care professionals can provide better care, while acknowledging they don’t have all the answers.
Valoras, a summit co-host, told MedTruth the end goal for the effort isn’t necessarily for all women to remove their implantable devices. Instead, the focus is improving health and wellness, while ensuring patients understand the risks of breast implants before getting them
If women aren’t fully aware of the potential risks involved in living with breast implants prior to undergoing surgery, informed consent cannot possibly be achieved, she noted.
“When you buy a car, you look at a book that says ‘Don’t buy this car, it has a bad wheel.’ We can’t even get that for something that’s in our body.”
As a product engineer, Valoras has experience with the approval process of implantable devices. After becoming severely ill from her breast implants and undergoing explant surgery, she was shocked to discover all three manufacturers had been issued warning letters for compliance issues and quality concerns, little more than a slap on the wrist.
Valoras and countless other patient advocates want to see full disclosure and accountability from both manufacturers and the FDA.
“If there’s any shame or regret I feel, myself, it’s ‘how did I miss this?’” Valoras said. “Because I’m that person on the other side of the fence. How did I trust the FDA?”
Tracking the FDA
In the presentation “Tracking the FDA,” Jamee Cook, a patient advocate and co-founder of Breast Implant Victim Advocacy, highlighted the regulatory shortcomings that cost many women their good health. Cook, who has addressed FDA advisory panel hearings in the past, covered the regulatory history of breast implants at the summit.
Beyond chronicling a timeline of events, Cook outlined the similarities between women’s fight for patient justice that began in the 90s and the efforts being made today.
“The issues were exactly the same, the symptoms were the same,” Cook said. “These problems never went away. The difference today is that we have social media and technology... If strong advocates had had social media on their side at that time … would this legacy of patient harm have continued?”
The presentation also mapped out a path forward. Cook called for stronger studies and continued adverse event reporting and urged patients and doctors to report all new symptoms and diagnoses. But she made the point that patients cannot be heard if they’re dismissed by their health care providers.
The Patient-Physician Gap
Co-host Terri Diaz suffered from breast implant illness and spent years in fruitless consultation with various specialists in search of treatment for its symptoms. Her presentation, “Bridging the Gap Between the Client and Practitioner,” explored the dynamic of the patient-practitioner relationship and revealed the cracks through which women can slip when dealing with a poorly understood illness.
In her experience, many doctors either tried to convince her that her symptoms were all in her head, or were dismissive of them all together.
Diaz didn’t feel she was taken seriously.
Part of the problem stems from a lack of knowledge on the part of the practitioner. While breast implants and breast implant illness are not new, the illness and its symptoms are still widely misunderstood and viewed with some skepticism. In fact, groups like the American Association of Plastic Surgeons and the American Medical Physicians and Surgeons Advancement Alliance do not recognize breast implant illness as a true medical diagnosis at all, claiming there is no evidence of a causal relationship between breast implants and autoimmune disease.
In her presentation, Diaz touched on the disconnect that can emerge between physicians and patients.
“As any patient, we really do know our own bodies, and we do know when there’s something really wrong,” she said.
Diaz believes a mutual trust must exist between patients and practitioners. A practitioner must trust that a patient is sharing their honest experience, and a patient must be sure that their health and safety are a top priority for their doctor. It’s a collaborative effort, she noted.
Effective, judgment-free communication is an important part of this equation, Diaz said. This means finding a doctor that listens actively, uses accessible language and practices care and compassion when treating their patients. For extra support and memory bandwidth, it can also be beneficial to bring a friend or family member to appointments.
Diaz hopes to help practitioners better understand the psychology of breast implant illness patients in order to provide better care. Women are often stressed and frustrated in their efforts to determine what’s causing such discomfort, and sometimes it can be difficult for breast implant illness patients to accept that their implants are the root cause.
If a woman is experiencing life-altering symptoms, acknowledging the presence of breast implants should be a universal initial step toward healing, Diaz noted.
“The main question I would love for you to ask your patient in front of you, no matter who they are, is if they have an implantable device.”
Looking Toward the Future
Moving forward, the organizers and presenters plan to draft a consensus statement on best practices for breast implant illness, with the hope of capturing the attention of researchers to study the illness. Organizers intend to donate a portion of attendance fees to future clinical trials.
The effort to educate and advocate will continue, with the summit serving as a crucial step to build upon.
“I didn’t know the story was going to be the story until all the presenters spoke, and then you can hear the themes that came through,” Valoras said. “The foundation needed to be laid down.”