There are new safety warnings from the FDA regarding breast implants.  Here’s what we know: ScienceAlert

There are new safety warnings from the FDA regarding breast implants. Here’s what we know: ScienceAlert

The US Food and Drug Administration (FDA) now warns that silicone or saline-filled breast implants can, on rare occasions, cause cancer in the scar tissue around the breast implants.

The safety advisory was released this month and is based on a thorough review of emerging literature on breast implants. The results, although limited, reveal a small number of cases of squamous cell carcinoma (SCC) and lymphoma in people with breast implants.

SCC is the second most common form of skin cancer. Other types of cancer previously associated with breast implants include T-cell lymphoma, which involves immune cells that directly destroy pathogens in our body, and B-cell lymphoma, which involves cells that produce antibodies against the disease.

Both of these cancers appear to involve the immune system, and although they are not breast cancers per se, new evidence suggests that they can affect the tissues around the breast when an implant is present.

Unlike T-cell lymphomas, however, B-cell lymphomas and SCC do not show up on mammograms, meaning they have eluded our detection methods for much longer.

To date, no cases of SCC associated with breast implants have been reported in the UK, but in the US other cases are being reported. FDA researchers have now identified nearly 20 cases of SCC in the scar tissue around breast implants, as well as fewer than 30 cases of various lymphomas.

The actual incidence rate remains uncertain, but is probably quite rare. Signs reported by patients include swelling, pain, bumps, or skin changes.

Unless you have any of these symptoms, experts say there’s no need to rush to have your implants checked or removed. Cancer risk remains very low, but that doesn’t mean it’s not worth keeping an eye on.

In 2018, a review initially identified 5 cases of SCC associated with breast implants and, on average, these cases were diagnosed around 23 years after the implants were first implanted. Two of these cases ultimately proved fatal.

At the time, researchers suspected chronic inflammation was to blame, and the new review confirms the connection to the immune system.

“In all documented cases of B-cell lymphomas we have seen the presence of the Epstein-Barr virus, so it would appear that there is a viral mediator contributing to the pathogenesis,” said oncologist Mark Clemens. The Lancet.

Chronic inflammation is known to trigger CTS, but at this time experts say we don’t have enough information to know whether breast implants directly cause the inflammation or the associated cancers.

The current review can only point to a correlation, but given the possible risks, FDA Director for Surgical Devices and Infection Control Binita Ashar said the committee “wanted to provide clear and understandable information to the public as soon as possible”.

Going forward, any reports of cancer developing in scar tissue around breast implants should be reported to FDA officials, so they can determine who is most at risk and why.

(Those outside the United States should report to their own country’s governing body.)

Nigel Mercer, a health products regulator in the UK, told The Lancet he was not surprised to learn that another type of cancer associated with breast implants was coming to light.

For many years, those who opted for surgical breast augmentation received virtually no safety information. In fact, during the first three decades of breast implant surgery, no clinical trials were performed. Even now, long-term research is limited.

It wasn’t until 2011 that the FDA identified a possible cancer associated with breast implants, called anaplastic large cell lymphoma (ALCL) – a cancer also triggered when the immune system goes awry.

In 2016, the World Health Organization followed suit, designating breast implant-associated ALCL (BIA-ALCL) as a T-cell lymphoma that can sometimes develop as a result of breast implants.

Other than that, we don’t know much else.

By early April 2022, the FDA had counted 1,130 global cases of BIA-ALCL, including 59 deaths. In the UK, the incidence rate of these cancers is estimated at 1 in 15,000.

Rare or not, patients have the right to know about the possible risks associated with their breast implants. In fact, in many ways, patient demands have spurred breast implant research.

Over the years, patients have reported many side effects related to their breast forms, including brain fog, inflammation and fatigue.

Collectively, these symptoms are known as breast implant disease (BII), a poorly understood and understudied set of complaints from thousands of people around the world who have received breast implants, either for cosmetic purposes, for gender affirmation or breast cancer purposes.

The FDA has been warning for years that breast implants aren’t lifelong prostheses, but the message isn’t often heard by the public. Early research suggests that the longer a breast implant stays in the body, the more likely it is to cause complications, such as infections, inflammation, rupture, or localized pain. In rare cases, cancer can also be a risk factor.

The FDA currently recommends that people with breast implants undergo regular screening five or six years after initial implantation and then again every two or three years thereafter to ensure that their implants are in good working order. functioning. But to date, research suggests that less than 6% of patients actually do.

To address this issue, in 2020 the FDA recommended that manufacturers use a boxed warning to inform patients that breast implants are not meant to be lifetime devices. This suggestion, however, is not legally binding and its effectiveness is unclear.

While we await more evidence, FDA officials say they will continue to work with the American Society of Plastic Surgeons to collect more detailed information on specific implant cases where cancer has been reported.

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