Breast Augmentation that can be Fatal – What did the Industry Know? | Levin Papantonio - Personal Injury Lawyers

Breast Augmentation that can be Fatal – What did the Industry Know?

A type of medical device used in breast augmentation and restoration surgery, known as the textured breast implant, has been linked to a rare form of cancer known as anaplastic cell lymphoma (ACL). This is a variant of non-Hodgkin's lymphoma, a cancer that attacks the immune system and is strongly associated with exposure to glyphosate and other toxins. It has raised serious questions about what the manufacturers may have known about the risks of their product.

In March 2015, researchers at Birmingham (UK) City Hospital reported that breast implant-associated ACL affects approximately 300 out of every 100,000 women annually. However, the authors of another study from Baylor University Medical Center believe this figure may be a “gross underestimation,” due to the number of breast enlargement surgeries that are carried out across the world and the fact that the disease is not always diagnosed correctly. The disease can present symptoms similar to breast cancer, including lumps in the breast, pain and tenderness, and unusual swelling. However, the pathology of ACL is much different – and not always well understood.

Textured breast implants are just that. Unlike other types of breast implants, these devices have a textured surface that is designed to cause irritation and scarring on the inner tissues of the breast. This build-up of scar tissue is supposed to hold the implants in place, making them less likely to fall out of place. While medical science is not altogether certain how this results in ACL, it is believed that because the formation of scar tissue is a response to irritation, chronic inflammation may be a contributing factor.

A report from the International Consortium of Investigative Journalists published in November, 2018 says that for several years diseases attributed to breast implants were considered “routine” – and therefore, there was no obligation on the part of medical device manufacturers to say anything to the general public. Then, in 2017, the FDA tightened its enforcement of reporting requirements. Significantly, there was a spike in the number of reports. Yet, despite this rise in the number of breast implant-related illnesses, the FDA has not issued a ban on the devices as has been done in France and is under consideration in other countries.

Breast implants have been controversial among medical scientists for many years. Surgeons began experimenting with breast augmentation in the late 1880s. Over subsequent decades, use of substances such as paraffin, ivory, glass balls, rubber, cartilage taken from animals and other materials were used – usually, with devastating consequences to the patient's health.

Silicone implants were introduced in 1962, but 30 years later the FDA put a moratorium on their use due to reports of leaks and associated illnesses. In 1995, lawsuits from women who had taken ill because of silicone implants drove one manufacturer, Dow-Corning, into bankruptcy. Nonetheless, the FDA lifted its moratorium on silicone implants in 2006, contingent on the completion of post-marketing studies and monitoring. Saline-filled implants were approved in 2000, but even these have had complications.

Are we seeing history repeating itself with textured breast implants?