Breast Implant Risks Withheld From Women By Manufacturers, Regulators: “Implant Files” Report

This is part of a series of “Implant Files” stories, which are based on the findings of an international coalition of journalists that raise serious concerns about the safety of certain medical devices. 

Many more women may be experiencing problems with breast implants than the public realizes, with mounting evidence suggesting that concerns about breast implant lymphoma and autoimmune disorders may have been known for years, yet were not shared with women receiving the devices.

In an investigative report by the International Consortium of Investigative Journalists (ICIJ), known as The Implant Files, researchers suggests that health regulators in the U.S. and Europe have allowed medical device manufacturers to keep a number of breast implant risks hidden from the public.

Breast implants have been placed in the bodies of more than 10 million women across the globe over the last decade, and the FDA’s own data acknowledges that as many as 20% will get them removed in less than 10 years, due to complications that include rupturing, scar tissue problems and deflation.

However, what’s not as commonly known is the risks of breast implant-associated cancers and growing scientific evidence suggesting breast implants can cause autoimmune disorders, which could result in rheumatoid arthritis and even stillbirths.

These risks may be more common, and more serious, than has been previously reported. The ICIJ report indicates that the regulators have largely allowed manufacturers to hide these potential side effects of breast implants from the public in prior years.

Before 2016, there were fewer than 200 suspected breast implant injuries reported every year, according to the report. However, in 2017, the FDA deployed more stringent medical device reporting rules, which no longer allowed manufacturers to report “routine events” without making them public. In 2017, the number of reports jumped to 4,567, and there were more than 8,200 reports in the first half of 2018 alone.

The report indicates that regulators worldwide allow breast implant manufacturers to get away with violating reporting rules. The investigators found that the European Union allowed all 10 manufacturers to continue to sell breast implants in its member countries even after all of them failed to submit complete regulatory compliance reports. They failed to track patient safety data, failed to give doctors and patients clear instructions, and even failed to demonstrate that the implants were compatible with the human body.

Breast Implant Safety Concerns

The investigation comes amid increasing concerns about problems with silicone breast implants reported by women nationwide.

Women have reported experiencing a variety of complications often referred to as “breast implant illness”, describe chronic side effects, such as fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues. In many cases, the problems have led women to have their breast implants removed, and concerns about the risk have become a factor many are questioning when deciding whether to undergo breast enhancement or reconstruction surgery.

While the FDA and the medical community have acknowledged the risk of breast implant ruptures and leaks, and, more recently, a form of lymphoma found to develop in the tissue surrounding breast implants, the larger breast implant syndrome risk has not yet been recognized.

Most doctors still do not review the potential risk of breast implant health side effects with patients, since it is not a recognized medical condition and there have been no studies to establish that it exists. However, science often takes time to catch up with the fast pace of emerging health risks that may appear on the internet and social media.

Recently much of the FDA’s focus regarding breast implants has been on the link to a rare form of cancer, known as anaplastic large cell lymphoma (ALCL), which has been found to develop in the tissue surrounding certain implants.

Last year, the FDA issued warnings about breast implant lymphoma rates, long after concerns about the risks first emerged. A number of subsequent studies have confirmed that the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is real, suggesting that the risk appears to be linked specifically to the use of certain textured breast implants with larger surface areas.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

In October 2017, a study published in the medical journal JAMA Surgerywarned that many breast implant cancer cases worldwide have likely not been reported, and noted that many doctors continue to be unaware of the BIA-ALCL risk.

As awareness of the problem increases, many experts have warned that the number of diagnosed breast implant ALCL cancer cases is likely to increase. As a result of manufacturers’ failure to adequately research the risks associated with their devices, a number of women are now pursuing potential breast implant lymphoma lawsuits, and it is possible that breast implant illness claims may also be pursued if independent scientific evidence emerges to support the claims.