FDA Orders 'Black Box' Warnings for Breast Implants

FDA Orders 'Black Box' Warnings for Breast Implants

Plastic surgeons will have to provide patients with a checklist of safety risks before performing breast implant surgery, an action the agency has been considering for years – too many years, according to some critics.

“It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist who heads the National Center for Health Research and was a member of the working group that advised the FDA on implant safety, according to a New York Times report.

“They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can cause lymphoma.’”

Breast augmentation is the most common surgical procedure in the U.S., estimated at 400,000 per year, about 100,000 of them following cancer surgery. While many patients are happy with the procedure, many others have problems they didn’t anticipate.

The so-called “Black Box” warning – the FDA’s most serious – will require doctors to give their patients a checklist detailing possible side effects of the surgery. Doctors must sign the document before surgery, confirming that the patient reviewed it.

The warning had been proposed by FDA as a voluntary measure in 2019. The latest action, which becomes effective in 30 days, makes it mandatory. Doctors and device manufacturers could face fines and other penalties if they don’t comply.

Implants blamed for problems

Although popular with patients, the implants have long troubled public health officials. Tens of thousands of patients have blamed their implants for a variety of health problems including muscle pain, chronic fatigue and rheumatoid arthritis.

Some doctors, including plastic surgeons, have also expressed concerns and at least one has had her implants removed. Dr. Amy DeRosa, a suburban Detroit surgeon, said she made the decision after years of hearing her patients complain about what’s been informally labeled “breast implant illness.”

“As I was meeting each and every one of these ladies, I was finding myself relating to a lot of their complaints and symptoms that they were experiencing,” said DeRosa in a WXYZ-TV report.

Insomnia, heart palpitations, bad headaches, ringing of the ears were a handful of symptoms her patients had expressed concerns about over the years. DeRosa said she herself had experienced “hair loss, joint pain, brain fog” before having her implants removed after 10 years. She said her symptoms cleared up quickly after the removal.

Although they are presented as a lifelong medical device, DeRosa said surgeons have come to realize the implants start causing problems after about 10 years.

“There’s basically an expiration time frame for implants as we know they are not lifelong devices, and I was approaching that – actually kind of going over that 10-year time frame,” said DeRosa.



Patients pushed for legislation

The FDA’s action follows agitation by breast surgery patients who have been pushing for state legislation to require the type of checklist FDA has now mandated.

“I realized that … trying to get anything done with the federal government would take a long time,” said Robyn Towt, co-founder Breast Implant Safety Alliance. She lobbied the legislature in her home state of Arizona because “women are in danger” and the state Senate unanimously passed a bill requiring surgeons to provide warnings to patients. Several other states are considering legislation.

The FDA said it hopes the block box warning will alert patients to the possibility of problems they might not have anticiipated.

“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”

Textured implants increase lymphoma risk

Concerns have also been raised about an apparent link between a rare cancer and a certain type of textured implant – specifically, a “textured” implant, one that has a bumpy surface.

In 2017, the FDA cited findings that the textured implants were linked to a very rare form of cancer, anaplastic large-cell lymphoma.

“All of the information to date suggests that women with breast implants have a very low but increased risk of developing anaplastic large-cell lymphoma compared to women who do not have breast implants,” the FDA said.

One study cited by the FDA looked at 231 cases of large-cell lymphoma:

  • 203 were textured implants; and
  • 28 were smooth implants.

Although no explanation has been firmly established, some surgeons believe the condition originates with a bacterial infection in the area surrounding the implants. The greater surface area of the textured implants provides more opportunity for bacteria to lodge than in a smooth implant, they speculate.