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

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

The US Food and Drug Administration (FDA) is now warning that breast implants filled with silicone or saline can, in rare cases, cause cancer in the scar tissue surrounding the breast implants.

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

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 bodies, and B-cell lymphoma, which involves cells that produce antibodies against disease.

Both types of cancer appear to involve the immune system, and although they are not breast cancers as such, emerging evidence suggests that they can affect the tissue around the breast when an implant is present.

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

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

The actual incidence rate remains unclear, but it is probably quite rare. Signs reported by patients include swelling, pain, lumps, 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. The risk of cancer is still 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 prostheses were first implanted. Two of these cases ultimately proved fatal.

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

“In every documented case of B-cell lymphoma, we’ve seen the presence of 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 SCC, but at this time, experts say we don’t have enough information about whether breast implants directly cause the inflammation or the associated cancers.

The current review can only point to a correlation, but given the potential risks, FDA director of infection control and surgical devices Binita Ashar says the committee “wanted to get clear and understandable information to the public as quickly as possible.” .

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

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

Nigel Mercer, a UK health care products regulator, told The Lancet he’s not surprised to hear another cancer associated with breast implants comes to light.

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

It was only in 2011 that the FDA identified a potential cancer associated with breast implants called anaplastic large cell lymphoma (ALCL), a cancer that is also triggered when the immune system fails.

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

Other than that, we know little else.

As of early April 2022, the FDA had counted 1,130 global cases of BIA-ALCL, including 59 deaths. In the UK, the incidence rate for these cancers is thought to be 1 in 15,000.

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

Over the years, patients have reported numerous side effects from their breast prostheses, including brain fog, inflammation and fatigue.

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

The FDA has warned for years that breast implants are not prosthetics for life, but the public often doesn’t hear the message. Initial research suggests that the longer a breast implant remains in the body, the more likely it is to cause complications, such as infection, inflammation, rupture, or localized pain. In rare cases, cancer can also be a risk factor.

Currently, the FDA recommends that people with breast implants have regular screening five to six years after initial implantation and then again every two to three years to make sure their prostheses are working properly. But to date, research suggests that less than 6 percent of patients actually do this.

To address this, in 2020 the FDA recommended that manufacturers use a boxed warning to let patients know that breast implants should not be lifelong devices. This suggestion, however, is not legally binding and it is not clear how effective it has been.

While we wait for more evidence, FDA officials say they will continue to work with the American Society of Plastic Surgeons to gather more detailed information about specific implant cases in which cancer has been reported.

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