PHOENIX (CBS 5 INVESTIGATES) -- As the Food and Drug Administration considers issuing stronger warnings for breast implants, there is a debate brewing over the content of those warnings.

[WATCH: FDA considers stronger warnings for breast implants]

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."

[FDA RESOURCE: Things to consider before getting breast implants]

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.

Symptoms for breast implant illness

[SPECIAL SECTION: Breast implant illness investigation]

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.

[RELATED: Is Facebook hiding groups dedicated to the potential dangers of breast implants?]

Healing Breast Implant Illness Facebook group

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.

[APP USERS: See photos of women before and after their explant procedures]

In 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."

Gel bleed

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."

[SPECIAL SECTION: Breast implant illness investigation]

Tests showed off-the-chart levels of vanadium in Daruda’s system.

Nicole Daruda's test results

Vanadium is a metal used to make other metals stronger for tools, engines, and nuclear plants.

Vanadium is just one of the heavy metals in breast implants. They also can contain aluminum, arsenic, platinum, cobalt, lead, and mercury, among others.

The FDA, however, only addresses one in-depth on its website -- platinum.

Findings state the metal does not pose a significant health risk. At the same time, the agency acknowledges that current studies are too small and have serious scientific flaws. It also says "toxicological significance" of exposure to platinum still needs to be determined.

To find out the possible effects of various heavy metals in the body, CBS 5 Investigates showed a list of ingredients in implants to toxicologist Dr. Daniel Brooks.

"From what I see, these levels are incredibly low," he said. "In fact, they are lower than what we ingest in some food and water sources."

Metals in Mentor breast implants

Metals in Mentor breast implants

Based on studies, Brooks says he believes the inflammatory reactions to a leak of silicone from an implant would be limited to the tissue directly in contact with the silicone.

"Downstream systemic effects? There is no evidence that that occurs," he said.

Dr. Jan Willem Cohen Tervaert, an autoimmune specialist with the University of Alberta, disagrees with Brooks' assessment.

"I'm not convinced that we can exclude heavy metals as being an important cause of the disease," he said.

He has studied links between illness and women with implants for decades.

[SPECIAL SECTION: Breast implant illness investigation]

"The immune system is attacking the breast implants."

While metals and chemicals may be a factor, research Cohen Tervaert presented to the FDA at their public meetings points to a more significant cause and effect.

A study involving nearly 125,000 women found that women who have silicone breast implants are 45% more likely to develop an autoimmune disorder.

"We know that everything you implant in a body gets an immediate reaction," Cohen Tervaert explained.

Breast implants activate surrounding cells to create scar tissue called capsules. That scar tissue formation happens in every woman with implants.

According to Cohen Tervaert, some women have a different reaction, a more extensive one.

In some cases, the cell activation around an implant cranks up the immune system, triggering it to into overdrive as the body tries to reject the foreign object.

"If the immune system is constantly active, the immune system is prone to make mistakes," Cohen Tervaert explained.

He says those mistakes can result in allergies, autoimmune diseases, and malignant lymphomas, which are cancers that start in the immune system.

Symptoms for breast implant illness

The allergies and autoimmune diseases might cause the wide range of symptoms women with breast implant illness describe.

"The immune system is attacking the breast implants," Cohen Tervaert said.

So, why do some women get sick while others don't?

"Because everyone has a different immune system," the doctor answered.

He pointed out that it's not the breast implants themselves that make women sick. It’s how each woman's body reacts to the implants.

Cohen Tervaert said it's like the flu. The virus does not make people sick. It's how the immune system reacts to the virus that causes the symptoms.

[SPECIAL SECTION: Breast implant illness investigation]

An estimated 35 million women have breast implants. Many of them never reported negative health effects.

Breast implants

Many women have breast implants with no serious complications, but there have been cases where women suffer pain and fatigue, among other health problems.

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.

Many studies into safety of breast implants are 'fatally flawed'

Dr. Diana Zuckerman Breast Implant Illness BII

Dr. Diana Zuckerman

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."

[READ: Report by the National Center for Health Research: Breast Implant Illnesses: What’s the Evidence?]

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.

[SPECIAL SECTION: Breast implant illness investigation]

What do breast implant manufacturers say?

CBS 5 reached out to breast implant manufacturers to request a list of all chemical and metals in their products. We also asked for comments on the concerns of women who believe that metals and chemicals have made them sick and studies on chemicals and metals.


While a Sientra spokesman said they would supply a statement, Arizona's Family never received an answer from the company.


Allergan, which just recalled its micro-textured breast implants due to an increased risk of the cancer BIA-ALCL, did not respond to the request.


"Thank you for reaching out to us for comment. As IDEAL IMPLANT was developed by a plastic surgeon in direct response to women's concerns over silicone gel and silent rupture, patient safety has been our primary focus from the outset. To date we have had no reports of breast implant illness from IDEAL IMPLANT patients. We did participate in the FDA hearings and listened to the women reporting these issues with other implants, and have advocated stronger long-term incident reporting on all breast implants to allow women to make more educated decisions based on the scientific data. As many medical devices, such as pacemakers, use similar silicone shell ingredients, clearly more research is needed to see why illnesses are reported relating to breast implants. As for our efforts toward patient safety, the IDEAL IMPLANT has proven to have a significantly lower risk of capsule contracture and implant rupture/deflation in FDA trial data at 8 years than silicone gel implants. In reference to your request for studies on gel bleed, we have no reports of gel bleed because it is not a silicone gel implant. Finally, the ingredients of all implants are required by the FDA to be included in the Summary of Safety and Effectiveness Data (SSED) found on our website resources page as well as We continue to stay informed on the issue and will always advocate for patient safety, education, and choice."


"Nothing is more important to Mentor than the health and safety of the women who choose our breast implants. The safety and clinical performance of Mentor breast implants is supported by completed and ongoing studies involving more than 200,000 women, including three, 10-year, prospective clinical trials.

"Materials used in the manufacture of Mentor Breast Implants can be found in Section V, Table 2, of the FDA’s Summary of Safety and Effectiveness Documents (SSED) on the FDA’s website here and here. The FDA has reviewed the list of materials and determined that Mentor breast implants are safe and effective for their intended use.

"With regard to the use of metals in breast implants, only platinum is added during the manufacturing process and the clinical evidence supports that the extremely low level of silicone and platinum that may diffuse through the shell don’t represent a significant health risk. The FDA has published a backgrounder on the topic of platinum on their website along with an overview of studies that have been conducted that you may find helpful.

"There have been a wide variety of symptoms reported that some patients believe are related to breast implants. Mentor continues to track and monitor complications through post-market clinical studies and post-market surveillance to better understand any possible connection. While to date, the overall body of scientific evidence does not support claims that silicone gel breast implants cause systemic illness, we believe that diligence in continued clinical evidence generation and the use of registries is essential to further scientific understanding of breast implant safety and Mentor fully supports this ongoing research. Patients should discuss all potential benefits and risks with their doctor prior to choosing breast implant surgery."


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