AUSTIN, Texas —
It's a condition that tens of thousands of women are talking about on social media.
Yet Breast Implant Illness, or BII, is not recognized as an official diagnosis in the medical community.
The KVUE Defenders discovered the Food and Drug Administration (FDA) receives thousands of breast implant complaints per month, but that information isn’t easy for the public to obtain.
Advocates say those numbers will only increase because many women don’t know that symptoms they're experiencing could be connected to their implants.
Austinite Heidi Nichole has made it her mission to educate women about all the risks and dangers associated with breast implants after experiencing several symptoms herself.
Nichole plans to launch her public awareness campaign during South by Southwest (SXSW) in March as she works as a pedicab driver. Dressed as the iconic character "Rosie the Riveter," Nichole's outfit also includes a bikini top with breasts made of cloth.
The gimmick is designed to draw people in before she hits them with her real purpose.
"Have you heard about Breast Implant Illness?" Nichole asks as she rides past people in Downtown Austin.
The condition she's talking about relates to dozens of symptoms reported by women after breast augmentation.
Nichole said she got her implants when she was 23, in 2001. Five years later, she said her symptoms started.
"My brain just didn't want to work ... I was very fatigued ... My joints were sore," Nichole said.
Nichole said she also got bad headaches and battled depression.
She said she didn't know those symptoms were connected to her implants until more than 20 years after she got them.
In 2020, the then-45-year-old said she finally found others with similar health issues.
"I started finding the Breast Implant Illness groups," Nichole said.
A search for Breast Implant Illness (BII) on Facebook yielded dozens of support groups, the largest of which has over 187,000 members, most of whom are women sharing their pain and looking for help.
Dr. Shaher Khan, a board-certified plastic surgeon, calls it a social media phenomenon.
"So now, the patients are taking charge of their health and then realizing – very definitively and convincingly – that it is the Breast Implant Illness," Khan said.
Khan only performs explants, or breast implant removals. It was a decision he made after seeing how breast implants negatively affected patients.
Khan said BII awareness is growing, thanks in part to more celebrities removing their implants. On social media, Khan himself regularly shows what problem implants look like.
Khan said his goal is to educate more women about BII, its symptoms and how implants are linked to cancers like anaplastic large cell lymphoma and squamous cell carcinoma. The FDA linked the diseases to implants in 2022 and 2023.
"Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications," Khan said.
Even though Khan read that warning directly from a breast implant manufacturer, he said some surgeons don’t always relay that information to patients.
He's pushing for mandatory written informed consent from patients after doctors discuss the risks and dangers associated with breast implants. Khan said that goes beyond the current protocol.
Right now, plastic surgeons are required to give patients the information booklet that comes with each set of breast implants and go over a patient decision checklist.
Khan also said as BII awareness continues to grow, public pressure will eventually lead to an official medical diagnosis for BII. Right now, the medical community doesn't recognize the condition.
Dr. Scot Glasberg is the president of the Plastic Surgery Foundation, the research arm of the American Society of Plastic Surgeons.
"There's no disease entity known as Breast Implant Illness," Glasberg said.
As part of the largest group of plastic surgeons in the world, Glasberg said they’re conducting research to address testing and having ongoing conversations with patients about BII treatment.
But right now, there is no standard of care for BII.
"How do we formalize the standard of care, how do we formalize the guidelines which surgeons should be using and patients should be following," Glasberg said.
BII advocates point to another roadblock: the FDA's system that tracks problems with breast implants.
Madris Kinard, a former public health analyst with the FDA, said the system is antiquated, hard to use and doesn't give a comprehensive breakdown of all the problems surrounding breast implants.
"I think it's really kind of missing the mark," Kinard said.
The FDA keeps records on all medical device issues reported through its Manufacturer and User Facility Device Experience, or MAUDE, system.
Kinard is familiar with the database because she helped roll out the new MAUDE system before leaving the FDA in 2014.
"You can only search the last 10 years, which makes it very limiting because with breast implants. They've been on the market for so long and the problems have existed for so long," Kinard said.
Kinard said MAUDE only gives 500 results at a time and you can only search one symptom at a time, despite many BII patients reportedly suffering from as many as 10 to 15 symptoms.
"If you are trying to search for what actually happened in each of those reports, you would be sifting through data for weeks, months, maybe even longer," Kinard said. "The sheer number of reports that they have and the format that they provide makes it very difficult to know what's really going on with them."
That's why Kinard developed a medical device tracking software called Device Events, a subscription-based service that makes information about problem devices easier to access. Her database also includes product recalls.
It's information Kinard said she wants the FDA to share with all doctors.
"You know, it would be good if the FDA had a mechanism to tell the physicians about this, to do a 'Dear Doctor' letter to all types of physicians. Because when you have breast implant illness, you may not go back to your plastic surgeon," Kinard said. "You may not realize that it's even breast implant illness. You might go to your family doctor or a rheumatologist with autoimmune issues, and those physicians just haven't been notified by the FDA to even look for breast implant illness."
Kinard said the FDA gets thousands of reports each year related to breast implant malfunctions and injuries, but the data is hard to find.
According to Device Events, the FDA received:
- 36,820 breast implant complaints in 2019
- 38,285 in 2020
- 34,493 in 2021
- 44,460 in 2022
- 39,564 in 2023
- 3,113 in January 2024
But on the FDA website, the agency claimed it reviewed medical device reports between January of 2008 to June of 2023 and only identified 9,458 reports related to breast implant illness.
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KVUE reached out to the FDA for an interview. A spokesperson declined the request but answered a number of questions via email.
When asked if the FDA had any plans to improve MAUDE for the public, a spokesperson provided the following comment:
"The public MAUDE database is one of the tools the FDA uses to provide device performance information to the public. Reports in MAUDE are redacted for personal health and other non-disclosable information. While reports are investigated by the FDA, they are not modified to reflect any additional or supplemental information obtained can result in limited information.
"The FDA is working with the National Evaluation System for Health Technology (NEST) to develop an initial medical device active surveillance system for safety signal identification. To establish a fully functioning active surveillance system for medical devices will require additional and ongoing resources. A fully functioning system would provide a supplemental post-market surveillance tool complimentary of the information obtained through mandatory Medical Device Reporting requirements and provided to the public in MAUDE. Such a system will help improve the quality of real-world evidence that healthcare providers and patients can use to make better-informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access.
"The FDA continues to widely monitor clinical journals for published research on breast implants. We also evaluate results from ongoing FDA-mandated post-approval studies and national registries such as PROFILE and NBIR. In addition to considering studies involving Breast Implant-Associated Anaplastic Large Cell Lymphoma and other cancers, we also consider studies referring to “breast implant illness” and studies citing associated systemic symptoms, including fatigue, memory loss, rash, "brain fog" and joint pain.
"In addition, we often consult with breast implant patients, scientific and clinical experts and experts with specialized knowledge from federal agencies such as the CDC and the NIH. As significant new information becomes available, the FDA also updates its website with data, adverse events, post-approval study results and other critical information to help inform patients and healthcare providers, including colleagues across the federal government, of our findings."
When asked about the FDA's role in approving a future BII diagnostic test, the spokesperson said:
"The FDA considers in vitro diagnostics (IVDs) or “tests” to be medical devices, which generally are subject to FDA oversight. IVDs are intended for use in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue. IVDs can be used to measure or detect substances, analytes or markers in the body, such as proteins, glucose, cholesterol or DNA, to provide information about a patient’s health, including to diagnose, monitor or determine treatment for diseases and conditions."
In the meantime, Heidi Nichole is getting help from other BII survivors to raise awareness.
For 14 years, Cecily Henderson said no one could figure out what was causing her symptoms.
"So I was experiencing like, brain fog, muscle fatigue. My eyes were really dry. I couldn't really function very well," Henderson said. "I was too tired all the time. And I'm like, something's wrong … I went to the doctor, and they told me nothing was wrong. They took all the tests. 'Nothing's wrong with you.' Told my family, 'It's all in your head. You're a hypochondriac.' And you know, not having that support was really hard."
Henderson said she found a plastic surgeon who listened to her and ran tests. Not long after, Henderson had her implants removed.
Henderson subsequently went back to school to study functional medicine to help heal herself. Now she’s helping others.
“I decided to put my efforts into creating educational courses on breast implants and their free courses for women so they can understand everything that the implant is made of, the risks, the potential illnesses and cancers that can come along with that,” Henderson said.
Lisa Haskins-Pearson got her breast implants in 2004. She said she immediately knew something was wrong
“I had pain under my left implant from day one,” Haskins-Pearson said.
Her symptoms continued to get worse.
“My spine was deteriorating; I was tested and I had [a] cognitive disability,” Haskins-Pearson said.
Haskins-Pearson said she ultimately ended up getting cancer and had the implants removed.
“It was triple invasive ductal carcinoma,” Haskins-Pearson said.
Further complications of the disease nearly killed her.
Like Nichole and Henderson, Haskins-Pearson said she doesn’t want anyone else to go through what she did.
“We're getting autoimmune diseases, neurovascular disorders, we're getting many illnesses at a higher degree than the normal population," Haskins-Pearson said. "And that is our intro to being able to start showing this illness does cause disease and death. So let's recognize it and let's start figuring out how to heal people. And, ideally, that would be protocols in traditional medicine with functional medicine working beside it."
In January, Haskins-Pearson, Nichole and Henderson started a GoFundMe in hopes of raising money to further their advocacy.
They also have support from Robyn Towt, the co-founder of the Global Patient Advocacy Coalition. Towt helped pass a 2022 Arizona law that requires plastic surgeons to get written informed consent.
"Our mission is to continue to raise awareness and to continue to pass not only state legislation but federal legislation that protects patients and informs patients," Towt said. "And just to make sure that you know, we're holding the medical community accountable and the FDA accountable for making sure that breast implant manufacturers have proper labeling and proper informed consent."
Days after this investigation, the FDA sent KVUE a new statement on Feb. 28th from Binita Ashar, an MD, MBA, FACS, Director of the Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality (OPEQ) and CDRH.
"(The) Center for Devices and Radiological Health (CDRH) is committed to protecting the public health and providing information to patients and providers to better understand the safety risks of breast implants, and to help strengthen the evidence generated to inform regulatory actions in this space.
CDRH would like to acknowledge the article published recently in the Plastic and Reconstructive Surgery journal. The article describes evidence regarding the risk, diagnosis and management of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the link to textured breast implants. It also discusses prophylactic explantation (removal) and the potential for risk reduction in certain cases, and emphasizes that explantation should be a shared decision between the patient and surgeon.
CDRH welcomes thoughtful, scientific and transparent public dialogue concerning breast implant safety and effectiveness, and we continue to evaluate all available information about BIA-ALCL and other breast implant-related illnesses. Given that the occurrence of BIA-ALCL is uncommon, prophylactic removal of textured implants is not recommended in asymptomatic patients. However, individual patients should discuss possible benefits and risks of removal with their healthcare providers to make an informed decision about their health.
Textured breast implants overall are less common in the U.S. compared to other countries. Prophylactic surgery presents a range of risks depending on individual patient risk factors including history and anatomy. Additionally, there are different types of breast implants currently marketed in the U.S. and risks vary by type of implant and patient characteristics.
In most cases, BIA-ALCL is found in the scar tissue and fluid around the implant. However, in some cases, it can spread throughout the body. While uncommon, a BIA-ALCL diagnosis is serious and can lead to death if not diagnosed early and promptly treated. We encourage patients and providers to report any issues related to breast implants to the FDA’s Adverse Event Reporting Program.
In recent years, CDRH has taken a number of steps to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. In 2019, we convened the General and Plastic Surgery Devices Advisory Panel to publicly discuss the long-term benefits and risks associated with breast implants indicated for breast augmentation and reconstruction.
In 2021, we issued new orders restricting sales and distribution of breast implants and approved new labeling to ensure consumers are equipped with the information they need to make informed decisions. The orders restrict sale and distribution of breast implants to only healthcare providers and facilities that provide information to patients utilizing the Patient Decision Checklist to ensure they understand the risks, benefits and other information about the device. In 2022 and 2023, we provided new information on breast implant safety, including information on Squamous Cell Carcinoma, various lymphomas other than BIA-ALCL, and various malignancies of the breast in patients with breast implants.
We continue to meet with patient and provider stakeholders and regularly update our breast implant-related communications. Additionally, we continue to closely monitor and analyze all information regarding risks associated with breast implants, and remain committed to communicating publicly when we receive any new or significant information so that patients, together with their providers, can make thoughtful and informed decisions. Our continuous work serves to strengthen the evidence that is generated regarding breast implant safety and inform our regulatory actions in this space."