Kris Pickel, CBS News: October 4, 2018.
PHOENIX (3TV/CBS 5) — The Food and Drug Administration has agreed to hold a public hearing on Breast Implant Illness. It’s a victory for women who petitioned the FDA but CBS 5 is investigating concerns the hearings will be stacked to favor implant manufacturers.
Breast Implant Illness (BII) is not recognized as a medical condition.
It is a term used by thousands of women to describe a wide range of unexplained symptoms experienced by women who believe their implants made them sick.
CBS 5 has been investigating BII for almost two years and has seen the number of women coming forward increase by the tens of thousands.
When our first investigation aired, the Facebook group Breast Implant Illness and Healing with Nicole, had 17,000 members. It now has more than 51,000.
News reports and social media are connecting women who believe they suffer from BII.
They are finding strength in numbers.
More than 21,000 women signed an online petition demanding the FDA hold public hearings.
The FDA agreed to meet privately with a small group of women who believe they suffer from BII.
Among the women who traveled to the District of Columbia for the September meeting at FDA headquarters were breast cancer survivors, women who believe implants made them sick, experts on breast implants and women who recently played a role in having the birth-control device Essure pulled off the market.
Women in the group say the FDA set the terms for the meeting: No cameras, no recording, no reporters allowed.
Following the September meeting, the FDA released a statementdisputing a study linking implants to illnesses.
Buried at the end of the statement, the FDA announced they would hold a public hearing on breast implants next year.
Daruda say some of the issues they want to address include taking textured implants the FDA has said might be linked to the potential for a rare cancer off the market, comprehensive studies and requiring surgeons to give women a checklist of potential risks at least a week before surgery.
In the FDA’s public hearing, an advisory panel will hear from industry representatives, experts, women who believe their implants made them sick and members from the public.
Following the public hearing, that advisory panel will vote on recommendations to make to the FDA. The panel does not have the power to make changes. It will only make recommendations.
Dr. Diana Zuckerman is president of the National Center for Health Research in D.C. and is responsible for a dozen Congressional investigations on a various health issues.
Zuckerman says in the past, the FDA has stacked the panels with plastic surgeons who have a financial interest in protecting breast implants.
“Having surgeons whose entire livelihood, or almost entire livelihood, is based on breast surgery, with breast implants, can’t possibly be objective,” Zuckerman said.
She says she has witnessed multiple times where plastic surgeons advocate for implants and dominate the hearings.
“I’ve seen situations where a statistician, for example, says, ‘Look at how unsafe these products are,’ and the plastic surgeon says, ‘No. No. No. We put these in all the time and they are very safe.'”
We contacted the FDA a several times during this investigation and asked if they would be looking at the panel to eliminate possible conflicts of interest.
They responded with a link to their application for panel members, which includes a section that addresses conflict of interest.
The FDA website lists the core group of eight voting members on the advisory panel.
CBS 5 was able to confirm at least two of the doctors perform breast implant surgeries and a regulatory expert who previously worked for Johnson & Johnson, which owns implant manufacturer Mentor.
Zuckerman says in the interest of ensuring an unbiased panel, people should contact their elected officials in Washington and ask them to pressure the FDA to make sure no one with financial ties to the implant industry sits on the advisory panel.
One Woman’s Story
Cancer survivor Robyn Towt was in the group of women who met with the FDA.
When diagnosed with breast cancer, Towt immediately opted for a double mastectomy.
She says her health issues, including anxiety and insomnia, started the day her implants were put in.
Having survived cancer before, radiation was not an option.
Towt chose not to do chemotherapy, leaving no explanation as to why she was getting sicker.
“I have been never been that miserable in my entire life and in that dark a place,” she said. “I feel horrible because my family suffered. My husband suffered. I was not a happy person. I was not a healthy person. I had no quality of life. I was desperate. I was sleep deprived.”
Towt says a friend in a cancer support group suggested she look into her implants as a source for her health problems.
After connecting with women on social media, Towt had her implants removed just four months after having them put in.
She says her symptoms disappeared within 48 hours.
CBS 5 Investigates has uncovered that while implant manufacturers are required to publish informational booklets that include warnings on potential risks of implants, plastic surgeons are not required to give the booklets to women.
Towt says after her implants were removed, she went back and asked her surgeon for the booklet so she could compare the warnings to the consent forms she signed.
Towt says the warnings in the booklet were stronger when it came to certain risks, including cancer associated with breast implants.
“I kind of felt duped when I was comparing them because if I had read the information in that booklet to start with, I would have never ever considered it,” she said.
Towt’s plastic surgeon did not return calls to CBS 5 inquiring when the booklets are provided to patients.
A date for the FDA’s public hearing has not been set.
The FDA says it will happen sometime in 2019.
Read the original article and watch the news segment here.