FDA approves new restrictions, orders stronger warnings for breast implants

PHOENIX (3TV/CBS 5) -- The U.S. Food and Drug Administration added new restrictions to who can sell and distribute breast implants and approved new labeling for all FDA-compliant implants. The moves come after updated study results for the cosmetic procedure and years after an Arizona’s Family investigation first exposed potential issues with the devices.

The FDA now says it will only allow health care providers and facilities that provide information to patients utilizing the patient brochure “Patient Decision Checklist.” Federal officials say the patient must initial and sign the decision checklist. The physician implanting the device needs to sign, as well.

Officials also approved stronger warnings after changes to labels were first made in September 2020. A new boxed warning should indicate that the devices can have serious side effects including injury or death. Some of those symptoms can include fatigue, memory loss, rash, “brain fog” and joint pain. The FDA is asking several manufacturers to make changes to their packaging in the next 30 days. Documents say the FDA made the change so that it can “provide a reasonable assurance of the device’s safety and effectiveness.”

Reporter Kris Pickel’s yearslong investigation

Arizona’s Family Kris Pickel first reported in 2017 about former Playboy Playmate Karen McDougal, who had her breast implants removed, saying she believed they were seriously harming her. McDougal said she battled health problems for weeks at a time and then get better, only to start another cycle of illness. Many doctors were skeptical about her claims.

“I laid in my bed and cried and I prayed every night,” she recalled. “Honestly, this was my prayer: ‘God don’t take me tonight. Give me one more day. I have a life to live. Give me one more day.’ I have those days back now,” she told Pickel during an early 2017 interview.

Heavy metals & microorganisms found inside implants

The investigation has ventured into what has become known as “Breast Implant Illness.” In 2018, a Canadian chemist, Dr. Pierre Blais, told Pickel that he thought the Canadian government was failing to protect women from the potential dangers of breast implants.

Blais claimed that microorganisms were commonly found during his research which would showcase that implants are prone to contamination. Papers he has published also listed mold, bacteria, and yeast. Other issues presented included the capsules which form around each implant. Blais also expressed concern over the calcification or mineralization that happens over time.

In March 2019, federal health officials held a two-day meeting to hear from researchers, plastic surgeons, and implant makers, as well as women who claimed they suffered from getting the implants. Shortly after, the FDA acknowledged that women with breast implants may suffer a variety of symptoms that may improve when their implants are removed. A few months later, the FDA proposed a “boxed warning.” The draft guidance suggested that breast implants are not lifetime devices and could cause cancer and/or other health problems.