Delayed Reporting or Late FDA Warning on Breast Implant Cancer, Patient Advocates Say

Breast implants can trigger a rare but aggressive cancer, and U.S. regulators may have failed to warn the public about the risk in a timely manner — a view shared by doctors and patient advocates who have been reporting related risks for years.

The U.S. Food and Drug Administration (FDA) said earlier this month that, against the backdrop of more than 300,000 breast augmentation surgeries in the U.S. each year, squamous cell carcinoma — a potentially aggressive tumor that can form in scar tissue around implants — has been detected in at least 19 patients. According to clinical literature reports compiled by the FDA, three of those cases have resulted in death.

The FDA added that the cancer may not appear until up to 20 years after surgery.

Maria Gmitro, president of the patient advocacy group Breast Implant Safety Alliance, wrote in an email that advocates have "been sounding the alarm for years." She said the public might have been warned sooner if the FDA had enforced post-market study requirements for implants.

In 2006, when the FDA approved silicone gel-filled breast implants from Allergan and Mentor Worldwide, it required large-scale post-market studies to better understand rare events and long-term outcomes. But by 2011, manufacturers acknowledged losing track of many patients after implantation. In 2019 and 2020, the FDA sent warning letters to Mentor, Sientra, and Allergan for failing to complete patient follow-up in post-approval studies.

"If post-market studies had continued and patient symptoms had been followed, the public could have had better data and information, and this missed opportunity directly affects patient safety today," Gmitro said in a statement. Gmitro herself had her breast implants removed in 2017, after experiencing what she described as "ongoing health complications" for three years.

One of the first reports of squamous cell carcinoma associated with breast implants appeared in 1992, when plastic surgeons at Saint Louis University School of Medicine noticed that a woman had developed the cancer 15 years after breast augmentation. Since then, case reports have continued to accumulate, and even Facebook groups have emerged: one group dedicated to breast implant-associated squamous cell carcinoma dates back to 2020.

The FDA first issued a warning on this issue last September, when 10 cases were reported. At that time, the FDA said there was not enough information to determine whether breast implants directly cause the cancer, or whether certain implants carry higher risks than others.

An FDA spokesperson wrote in an email that the agency's review stems from its "ongoing post-market safety review of breast implants, including manufacturers' compliance with post-market studies, and collaboration with external stakeholders."

The agency added: "As we stated when we issued our first safety communication about squamous cell carcinoma in September, although we still believe that squamous cell carcinoma in the capsule around a breast implant may be rare, its cause, incidence, and risk factors remain unknown."

Challenges in case counting

Reporting challenges for squamous cell carcinoma make it difficult to determine the true number of cases. The FDA said it has received 24 medical device reports of squamous cell carcinoma associated with breast implants to date, but these numbers do not necessarily represent the actual incidence due to possible duplicate reports or underreporting.

Dr. Scot Glasberg, president-elect of The Plastic Surgery Foundation, said he has learned of 16 cases of squamous cell carcinoma from the literature, with another 23 from de-identified data. "While this is a rare tumor, what is concerning is that it is quite aggressive," Glasberg said.

A recent review published in Clinics in Plastic Surgery counted 20 reported cases of squamous cell carcinoma associated with breast implants. The review found that 43% of those affected died within six months.

Dr. Mark Clemens, the corresponding author of the article and a professor of plastic surgery at MD Anderson Cancer Center in Houston, believes the actual number of cases may exceed the 19 recently disclosed by the FDA. "It may not be exponentially more, but I do think there are more cases," he said, adding that he is aware of about 10 additional cases.

The number of implant-associated squamous cell carcinoma cases is smaller than that of other breast implant-related cancers. For example, there are more than 1,300 known cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system, Clemens said. According to the review, there are also about 30 reported cases of B-cell lymphoma.

Until recently, patient registries only collected data on breast implant-associated anaplastic large cell lymphoma. The National Breast Implant Registry, established through collaboration among The Plastic Surgery Foundation, the FDA, patients, and implant manufacturers, only began including data on squamous cell carcinoma and other lymphomas at the end of last year. Gmitro noted that even so, data currently comes only from plastic surgeons, while these cases may first be identified by oncologists, gynecologists, general practitioners, or other physicians.

Additionally, because squamous cell carcinoma cases are detected on average 20 years after implantation, the original surgeon may no longer be practicing, and patients may seek follow-up care from other doctors. Or, the implant brand name may have changed, Gmitro said, which also adds to the difficulty of tracking.

She added that the first step in determining the scope of the problem is to require all doctors and medical practitioners to report any implant-associated cancer cases directly to the FDA.

Recent regulatory scrutiny

Breast implants were last under strict scrutiny in 2021, when the FDA required implant manufacturers Allergan, Ideal Implant, Sientra, and Johnson & Johnson subsidiary Mentor to add boxed warnings to device labels informing doctors and patients of the risks of cancer and other complications, and clarifying that implants are not lifetime devices.

The FDA also said that healthcare providers and facilities selling these devices must review a decision checklist with patients before surgery, which includes information on the incidence of breast implant-associated anaplastic large cell lymphoma related to the devices. However, this requirement currently does not cover squamous cell carcinoma.

Some people with implants may also experience breast implant illness — a term used by the FDA to describe systemic symptoms such as fatigue, brain fog, and joint or muscle pain.

Despite these concerns, the number of breast augmentation surgeries has increased in recent years.

According to data from the Aesthetic Society, a professional organization of plastic surgeons, in 2021, despite the ongoing pandemic, surgeons performed 365,000 breast augmentation surgeries, and 148,000 people had implants removed and replaced. In comparison, breast augmentations totaled 280,692 in 2019.

Additionally, in 2021, 71,000 people had implants removed without replacement, an increase from 2019.

The Aesthetic Society reported that breast augmentation alone generated $1.54 billion in revenue for U.S. plastic surgery practices in 2021.

Diagnosis and treatment

Anaplastic large cell lymphoma is associated only with textured implants, while squamous cell carcinoma cases have been reported across all types of breast implants. Mark Clemens of MD Anderson said a potential cause may be local immunosuppression related to inflammation around the implant.

The prognoses for the two cancers differ significantly: most patients with localized anaplastic large cell lymphoma achieve complete remission, while according to Clemens's review, nearly half of squamous cell carcinoma patients die within six months.

Scot Glasberg of The Plastic Surgery Foundation said these cases are related to implants, noting that "the pathology of the capsule (the scar tissue around the implant) seems to indicate that the tumor originates from the capsule."

According to the article published in Clinics in Plastic Surgery, patients with breast implant-related cancers experience symptoms such as pain, swelling, fluid accumulation, and redness, but squamous cell carcinoma is more likely to present as a mass and spread beyond the scar tissue around the implant.

Jennifer Cook, director of BIA-ALCL advocacy at the Breast Implant Safety Alliance, wrote in an email statement that while signs of these cancers may appear on routine screenings or mammograms, these signs are not specific to cancer and may overlap with benign implant complications.

Cook said that if the radiologist reading the images is not up to date, or believes the cancer risk is too remote to warrant a biopsy or expensive follow-up tests, the cancer could be missed. She added that MRI or ultrasound is often better than mammography at detecting signs of cancer.

The American Society of Plastic Surgeons recommends that surgeons send biopsy samples for testing for squamous cell carcinoma as well as BIA-ALCL when making a diagnosis, Glasberg said, who is a past president of the society. Before planning implant removal, the society also recommends an MRI to determine whether a tumor is present in the scar tissue near the chest wall, so that surgeons can be prepared if more extensive surgery is needed.

According to the review, even when breast implant-related cancer is found, many patients discover that while insurance companies cover implant removal and replacement for patients undergoing breast reconstruction, only 17% of insurers cover these costs for cosmetic breast augmentation patients, and many insurers explicitly refuse to pay for cancer treatment for patients with a history of cosmetic surgery.

"They are denied diagnosis and treatment," Clemens said, adding that clinical societies are lobbying to change this.

Informed consent

The FDA appears to take the cancer risk seriously enough to have required manufacturers to add information about the risk of squamous cell carcinoma to device labels. While this is not yet mandatory, "I suspect it will become a requirement soon," Glasberg said.

An FDA spokesperson said via email that the agency hopes increased awareness of the issue "may lead to more cases being reported, so that the FDA can further evaluate the issue and better understand the risk." "We will continue to inform the public as new and important information becomes available."

Gmitro of the Breast Implant Safety Alliance also hopes that patients will be informed in the informed consent checklist they receive before surgery that implants can cause squamous cell carcinoma.

"We remain concerned about how this information is presented to patients, because there is currently no mandate or accountability mechanism," Gmitro said. "Additionally, when safety issues arise, there is still no mechanism to warn patients, and BISA believes this should also become a requirement."

"If you have a car and something goes wrong, they find you. Why can't this be done for devices implanted in our bodies?" she asked.