Kris Pickel, AZ Family: October 18, 2019
As the Food and Drug Administration considers issuing stronger warnings for breast implants, there is a debate brewing over the content of those warnings.
The FDA is looking at several options.
• A checklist of possible risks. Doctors would be required to go over the checklist with patients who are considering breast implants.
• Listing the ingredients in breast implants.
• A box warning, also known as a black box warning. It’s the strongest warning the FDA issues signifying there is a risk of serious or even life-threatening adverse effects.
The FDA recently updated its website, acknowledging what has become known as breast implant illness.
“Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as ‘breast implant illness (BII).’ In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms.”
The regulatory agency is reacting to pressure from a growing movement by tens of thousands of women who believe breast implants made them sick. They describe many more symptoms than what the FDA recognized.
BII is not a new problem
Women have expressed concerns about breast implants for decades. Many women say doctors discount any connection the implants and the issues they experience, often making them feel their illness and symptoms are psychosomatic.
Nicole Daruda is one of the key figures behind the growing number of women demanding stronger warnings.
With recent attention on symptoms and illnesses potentially caused by breast implants, hundreds of women are requesting to join her Facebook group, Breast Implant Illness and Healing by Nicole, every day.
Five years after getting implants, Daruda was too sick to work.
She says at that time, there was almost no information available on a possible link between breast implants and the often-debilitating symptoms that plague some women.
“I put the words together, ‘breast implant illness,’ because I didn’t know what else to call it,” Daruda said.
n March, the FDA held public meetings on the safety of breast implants.
Women showed up from across the country, demanding stronger warnings that list the chemicals and heavy metals contained in breast implants. And they don’t just want the cautions to come from the FDA. They believe the caveats should come from breast implant manufacturers, too.
When Daruda had her implants removed, she described them as “sticky,” with silicone coming through the shell. It’s a condition known as “gel bleed.”
While the FDA acknowledges that gel bleed happens, it does not list it as a known risk or complication of breast implants.
“I lost over a decade of my life and health to breast implants,” Daruda said. “After my explant, it took me four years to recover the better part of my health. I still have permanent damage to my kidney from heavy metal.”
An estimated 35 million women have breast implants. Many of them never reported negative health effects.
Cohen Tervaert says certain factors can increase a woman’s risk of having an adverse reaction to implants. Those factors include allergies (any type from hay fever to metal allergies), an autoimmune disease, and a family history of autoimmune diseases.
Large-scale studies need to be done, according to Cohen Tervaert, but how they are done needs to change.
After his presentation to the FDA, the agency asked registries that collect data on patients and the safety and performance of breast implants to start tracking information on autoimmune diseases.
While many health professionals and implant manufacturers are quick to note that the safety of breast implants has been studied extensively, Dr. Diana Zuckerman, president of the nonprofit National Center for Health Research and an expert on national health policy, says women cannot make informed decisions based on those studies.
The former senior policy advisor to the White House was vital in helping women with breast implant illness to organize and work with the FDA to secure the public meetings on breast implant safety.
“There are hundreds of studies of breast implants published in the last few decades, but almost all are so biased that they are fatally flawed,” she explained. “Almost all were paid for by the companies that make breast implants or the doctors whose salaries depend on those surgeries. The researchers asked the wrong questions and studied implants in ways that didn’t make sense. For example, they studied too few women, studied women with implants for a short period of time, and didn’t study the debilitating symptoms that women said they were experiencing. They also tended to study women with any kind of breast implants, instead of studying whether some breast implants were safer than others. And because of who was paying for the studies, even when the researchers found that implants caused medical problems, those findings were often misrepresented or completely covered up.”
When it comes to proving cause and effect between breast implants and illnesses, Cohen Tervaert believes the evidence is there.
Citing laboratory studies, he says mice prone to autoimmune diseases like lupus or arthritis developed the conditions after the implants were introduced. At the same time, mice that showed no prior sensitivity to autoimmune diseases did not develop health problems with the implants.
Another finding is that more protracted illness appears to result in more difficult recoveries.
“Proof that we have is, that if you remove the breast implant, breast implant illness can be reversible, especially if the period between implementation and explantation is very short,” Cohen Tervaert said. “You see, quite often, complete recovery of the symptoms.”
“If it’s, however, longer, than there is only partial recovery,” he continued. “And if you have developed an autoimmune disease, those autoimmune diseases can be difficult to treat until you remove the breast implants.”
A 2017 study found silicone from breast implants can migrate throughout a woman’s body — even if the implant was not ruptured — because silicone can “bleed” through the shell.
Silicone has been found not just in the tissue around the implants, but also in various organs throughout the body, including the central nervous system and brain.
Women studied had symptoms ranging from fatigue and cognitive impairment to headaches and body pain. The study found 60% to 80% of patients showed health improvements after their implants were removed.
The FDA has not decided if it will impose stricter guidelines on breast implant studies.
The agency issued warning letters to implant makers Mentor and Sientra in March, citing “low recruitment, poor data, and low follow-up rates in their required post-approval studies.”
The FDA gave the manufacturers a two-week deadline to fix the issues. Seven months later, no action has been taken against the manufacturers.
An FDA spokesperson tells CBS 5 Investigates they will not speculate on possible punitive actions.
Also in March, the FDA announced that it would hold future meetings to discusses material used in medical devices, including breast implants. They say they will focus on why some people have adverse reactions while others do not.
“The vast majority of patients implanted with medical devices have no adverse reactions,” the FDA said. “The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”
A date for the meeting has not been set.
Read the original story here.