2 Massachusetts Woman Feel Vindicated After FDA Says Patients Must Be Warned of Breast Implant Risks
QUINCY (CBS) -- The U.S. Food and Drug Administration now says any woman considering breast implants must be warned the devices could make them sick. This week, the agency ordered manufacturers to include a black box warning after countless women insisted the devices poisoned their bodies.
The move is a victory for two local women who struggled to get doctors to believe their symptoms.
Meghan Sullivan of Quincy is praising the FDA's decision to issue a warning about breast implants.
"The new warning is great, it's huge," she said.
In 2017, the Hingham mom was thrilled to be able to run again after getting her implants removed.
"It got to the point where I couldn't get out of bed anymore." Sullivan said. "I was in so much pain."
She also suffered rashes all over her body and exhaustion. Sullivan blamed her implants, but doctors dismissed her concerns.
"So many trips to the doctor and being told that it's in your head, being told it's not the implants. At one point, one doctor said it was my tattoos."
Kaylee Silcox of Medway had to travel all the way to Ohio to find a doctor to remove her implants.
"The second I woke up from surgery, I could breathe better," Silcox said.
After hearing from dozens of women like Sullivan and Silcox during a hearing in 2019, the FDA issued the black box warning about the risk of a rare form of lymphoma and systemic illness. Surgeons are also required to give patients a checklist outlining the risks.
Dr. Andrea Pusic, the Chief of the Division of Plastic and Reconstructive Surgery at Brigham and Women's Hospital, said she welcomes the announcement by the FDA.
"Being very clear with patients about the risks and benefits, that breast implants are devices and they don't last forever and complications can happen. But in the right patient, they can be a very good thing," Dr. Pusic said.
Pusic also said there are a lot of doctors that don't know about breast implant illness.
"I am not questioning whether these women are experiencing these symptoms. I just don't know if we know that it's causative yet," she said. "We do know that the vast majority of women don't have symptoms."
Still Sullivan and Silcox believe others should think long and hard before having elective surgery and doctors won't dismiss patients' symptoms.
"I look back and there was so much time and energy that was wasted. And I would not never, ever want anyone to go through what I went through," said Sullivan.
The FDA also points out that breast implants are not considered lifetime devices, so the longer women have them, the greater the chance they could develop complications.
And while both of these women applaud the move, they would like to see more public information out there about the risks of implants.