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 either silicone or saline can, in rare cases, cause cancer in the scar tissue around the breast implants.

The safety alert was published this month and is based on an extensive 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 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 includes the immune cells that directly destroy pathogens in our bodies, and B-cell lymphoma, which includes the cells that make antibodies against the disease.

Both of these cancers appear to involve the immune system, and while they are not breast cancers per se, emerging evidence suggests that they can affect the tissue 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 screening methods for much longer.

To date, no breast implant-related SCC cases have been reported in the UK, but in the US, more cases are being seen. FDA researchers have now identified nearly 20 cases of SCC in the scar tissue around breast implants, as well as under 30 cases of various lymphomas.

The true incidence rate remains unclear, but it is probably quite rare. Patient-reported signs include swelling, pain, lumps, or skin changes.

Unless you have any of these symptoms, experts say there’s no need to rush to get your implants checked or removed. The risk of cancer remains very low, but that doesn’t mean it’s not worth paying attention to.

In 2018, a review initially identified 5 cases of SCC associated with breast implants and, on average, these cases were diagnosed approximately 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 supports the immune system connection.

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

Chronic inflammation is known to cause SCC, but as of now, experts say we don’t have enough information about whether breast implants directly cause the inflammation or related cancers.

The current review can only suggest an association, but given the potential risks, the FDA’s director of surgical devices and infection control, Binita Ashar, says the committee “wanted to provide clear and understandable information to the public as quickly as possible.”

From now on, any reports of cancer developing in the scar tissue around breast implants should be reported to FDA officials so they can figure out who is most at risk and why.

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

Nigel Mercer, the UK’s healthcare products regulator, told The Lancet that he was not surprised to hear of another type of cancer linked to breast implants coming to light.

For many years, those choosing breast augmentation surgery received little to no safety information. In fact, in the first three decades of breast implant surgery, there were no clinical trials. Even now, long-term research is limited.

It was only in 2011 that the FDA identified a possible cancer associated with breast implants, called anaplastic large cell lymphoma (ALCL) – a cancer also caused when the immune system goes awry.

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

Beyond 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 of these cancers is thought to be 1 in 15,000.

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

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

Collectively, these symptoms are known as breast implant illness (BII), a poorly understood and understudied collection of complaints from thousands of people around the world who have received breast implants, whether for cosmetic reasons, gender confirmation, or breast cancer. breast.

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

The FDA currently recommends that people with breast implants have regular checkups five or six years after the initial implantation and then every two or three years after that to make sure their implants are in working order. But to date, research shows that less than 6 percent of patients actually do this.

To correct this, in 2020 the FDA recommended that manufacturers use a boxed warning to inform patients that breast implants are not supposed to be lifetime devices. This proposal, however, is not legally binding and it is unclear how effective it has been.

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

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