As GPB’s Ellen Eldridge reports, while some would like to see a greater acknowledgement that breast implants might make women sick, the plastic surgery industry wants more proof.
The U. S. Food and Drug Administration says breast implants now must carry warning labels on their packaging. That’s because it's known they can cause cancer.
The new warning labels also hint at other ailments. For decades, women have complained of things such as joint pain, muscle aches, chronic fatigue and even cognitive issues which they believe are tied to their breast implants.
Robyn Towt is a three-time cancer survivor who agreed to silicone breast implants after a double mastectomy.
"They make it sound easy like, 'We're just gonna give you a beautiful new set of breasts and you can go on your merry way,'" she said. "I was told they were perfectly safe."
But within four months, she felt worse than while fighting cancer. Heart palpitations and hair loss were just a few of her ailments. Towt said after surgery to remove the implants, her symptoms cleared up.
"Most of these women that have implants for reconstruction, they think all their problems are from chemo and radiation because that's what their doctors are telling them," she said.
For years, women such as Towt have believed otherwise.
From the first surgery in the early 1960s, women have shared stories linking implants to autoimmune disease.
They call the associated inflammatory reactions “breast implant illness.” The term covers everything from feeling fatigued to seeing strange rashes appear.
More recently, thousands of women with experiences like Towt’s found each other in online support groups, the largest of which, Breast Implant Illness and Healing by Nicole, has nearly 127,000 members worldwide.
Nicole Daruda's group started in 2016, and Towt eventually became one of the moderators.
Now, Towt is on the board of the Breast Implant Safety Alliance, or BISA. They say the new FDA warning on implant packaging will not be enough because the women who need to see it are under anesthesia when surgeons open the box.
The warning, however, is important to BISA because it shows that the devices are so dangerous that they warrant a black box warning, but Towt said BISA believes the warning should be a mandate and not a recommendation.
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So, BISA wants more.
"We are getting an informed consent bill passed so that surgeons are properly informing patients of the risks and complications of breast implants in layman's terms, that they can understand," Towt said.
Towt and others would like to see an outright ban on all breast implants because, Towt said, they have been in violation of their FDA approval agreements for four years and should not be on the market until they are in compliance with the FDA.
"When they comply and can prove their safety is when they should be allowed back onto the market," Towt said.
They point to a recent study in the journal The Annals of Plastic Surgery that suggests women’s symptoms improve after removing the implants.
That should be enough for stronger action, Towt said.
Doctors, patients and breast cancer survivors urged the FDA in 2003 and 2005 not to put these devices back on the market because they said they're dangerous to women's health.
But silicone breast implants were allowed back on the market in 2006, 14 years after having been pulled for safety studies in the '90s.
“Unfortunately, I believe how that happened is the FDA was listening to the science and data from the manufacturers and from these plastic surgery societies,” Towt said. “That's a huge conflict of interest.”
Breast augmentation is an almost $3 billion a year business in the United States, and the plastic surgery industry wants more proof of a link between implants and chronic illness.
"The thing about the research that exists right now is while it's compelling, it's very small," Lauren Caccavone said. "It's not peer reviewed. It's not corroborated by anybody."
Caccavone had breast reconstruction in 2012 to correct a congenital defect. Not long after, she started having headaches, vision disturbances, unexplained fevers and even night sweats.
It took years for her to figure out what was wrong. Like Towt, Caccavone’s condition improved when she had her implants removed.
While her lived experience matches what thousands of women have been saying about breast implant illness, Caccavone knows the industry requires more.
“There's not enough scientific, empirical, peer-reviewed research or evidence yet,” Caccavone said.
Caccvone's dedication to research inspired her doctor, Atlanta-based plastic surgeon Marisa Lawrence, to conduct her own study of the link between breast implants and chronic illness.
“I was patient zero for Dr. Lawrence,” Caccavone said. “She started her study when she heard my story and I kept sending her other research.”
Lawrence is using the largest grant ever from the Aesthetic Surgery Education Research Foundation for a clinical trial, she said.
Women in the experimental group will have their implants removed and the surrounding tissue examined.
"We're waiting for all of the patients to be enrolled and operated on before we can run our heavy metal testing on the capsules," Lawrence said. "So, in the two groups with breast implants, we are actually sending the capsules for microbiology evaluation, yeast, mold, bacteria and fungus."
Then, Lawrence said, the team is looking at peripheral blood for inflammatory markers.
“Preliminary reports on the blood work is interesting in terms of the inflammatory markers,” she said.
While the study is not finished, Lawrence hopes to have more complete data early next year.
The study will be published in the Aesthetic Society Journal and Lawrence will submit her personal study to the journals Plastic and Reconstructive Surgery and the Aesthetic Surgery Journal.
