Breast implants can cause a rare but aggressive cancer, and U.S. regulators may have failed to warn the public about the risk in a timely manner—so say doctors and patient advocates who have been reporting the risk for years.

The U.S. Food and Drug Administration reported earlier this month that, against the backdrop of more than 300,000 breast augmentation surgeries annually in the U.S., at least 19 cases of squamous cell carcinoma—a potentially aggressive tumor—have been found in the scar tissue around implants. According to clinical literature reports compiled by the FDA, three of those cases resulted in death. The agency added that this 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 patient advocates have "been sounding the alarm for years." She said that if the FDA had enforced post-market study requirements for implants, the public might have been warned sooner.

In 2006, when the FDA approved silicone gel 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 admitted they had lost track of many patients after implantation. In 2019 and 2020, the FDA sent warning letters to Mentor, Sientra, and Allergan for failing to maintain follow-up with patients in post-approval studies.

"If post-approval studies had continued and patient symptoms had been followed, the public could have had better data and information—this was a missed opportunity that 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 three years of "ongoing health complications."

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 accumulated, and even Facebook groups have emerged: one group about breast implant-associated squamous cell carcinoma dates back to 2020.

The FDA first issued a warning about this issue last September, when 10 cases were reported. At that time, the agency said there was not enough information to determine whether breast implants 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-approval studies, and collaboration with external stakeholders." The agency added: "As we said when we issued our first safety communication about squamous cell carcinoma in September, while we still believe squamous cell carcinoma in the capsule around implants may be rare, its cause, incidence, and risk factors remain unknown."

Statistical challenges

The challenges of reporting this cancer make it difficult to know the true number of cases. The FDA says it has received 24 medical device reports of squamous cell carcinoma associated with breast implants to date, but because of possible duplicate reports or underreporting, these numbers may not represent the actual incidence.

Dr. Scot Glasberg, president-elect of the Plastic Surgery Foundation, said he knows of 16 cases of squamous cell carcinoma from the literature, with another 23 from de-identified data. "Although 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 be higher than the 19 disclosed in the FDA's recent report. "It may not be exponentially more, but I do think there are more," he said, adding that he is aware of about 10 additional cases.

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

"When we started studying BIA-ALCL at MD Anderson, there were only 65 known cases. Now it has just passed 1,300," Clemens said. "Awareness of these diseases is key to ensuring patients receive timely and appropriate treatment."

Dr. Mark Clemens
Professor of Plastic Surgery, MD Anderson Cancer Center

Until recently, patient registries only collected data on anaplastic large cell lymphoma associated with breast implants. The National Breast Implant Registry, established through a collaboration of the Plastic Surgery Foundation, the FDA, patients, and implant manufacturers, began including data on squamous cell carcinoma and other lymphomas at the end of last year. On Wednesday, the FDA informed healthcare providers that case reports of squamous cell carcinoma and other implant-associated cancers can be submitted to the PROFILE registry—a system originally created to track cases of breast implant-associated anaplastic large cell lymphoma.

Gmitro noted that even now, data is only collected from plastic surgeons, but these cases may be discovered 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 need to seek follow-up care from other practitioners; or the implant brand name may have changed, Gmitro said, which also makes cases difficult to track. 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 review

Breast implants were last under intense 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 do not last a lifetime.

The agency 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 device. However, that requirement does not yet cover squamous cell carcinoma.

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

Despite these concerns, the number of surgeries is still increasing. According to data from the Aesthetic Society, a professional organization for plastic surgery, in 2021, despite the pandemic, surgeons performed 365,000 breast augmentations, and 148,000 people had implants removed and replaced. In comparison, in 2019, there were 280,692 breast augmentations. Additionally, 71,000 people had implants removed without replacement, an increase from 2019. The Aesthetic Society reported that breast augmentation alone brought in $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 with all types of breast implants. Dr. Clemens of MD Anderson said a potential cause may be local immunosuppression around the implant related to inflammation.

The prognoses for the two cancers differ significantly: most people 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. Glasberg of the Plastic Surgery Foundation said these cases are implant-related, noting that "the pathology of the capsule (scar tissue around the implant) seems to indicate that the tumor originates from the capsule."

"Any tumor that may be device-related and has a high mortality rate should be considered a significant event, even if the number of cases reported to date is very rare."

Dr. Scot Glasberg
President-Elect, Plastic Surgery Foundation

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 that spreads 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 these cancers 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, 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 in addition to BIA-ALCL, said Glasberg, a past president of the society. Before planning implant removal, the society also recommends an MRI to detect tumors in 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 will cover implant removal and replacement for patients undergoing breast reconstruction, only 17% of insurers cover the cost for breast augmentation cases, 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 that it is asking manufacturers to include information about the risk of squamous cell carcinoma on device labels. Although this is not yet mandatory, "I suspect they will do so soon," Glasberg said.

The agency said it hopes that increased awareness of this issue "may lead to more case reports, allowing the FDA to further evaluate the issue and better understand the risks," the spokesperson wrote in an email. "We will continue to inform the public as any new important information becomes available."

Gmitro of the Breast Implant Safety Alliance also wants patients to be informed in the pre-surgery informed consent checklist that implants can cause squamous cell carcinoma. "We are still concerned about how this information is presented to patients, because there is no mandate or accountability. Additionally, there is still no mechanism to warn patients when safety issues arise, and BISA believes this should also be a requirement," Gmitro said. "You have a car. When something goes wrong with the car, they find you. Why can't we do the same for devices implanted in our bodies?" she asked.

This article has been updated to include the FDA's statement about the registry system for tracking breast implant-related cancers.