The long-term safety of breast implants; a topic widely thought to have been resolved over the decades, is receiving renewed interest from medical communities around the world and is now on the radar of the U.S. Food and Drug Administration. What started as concern over a type of cancer predominantly tied to textured breast implants has led to new questions being raised over the long-term safety of all breast implants and how well that safety has been tracked over the years.
Discussions of a condition known as breast-implant-associated anaplastic large-cell lymphoma began back in 2011 when women, mostly in Europe, began developing a particular type of cancer. The cancer was almost exclusive to women who had received a textured breast implant rather than a smooth implant with no texture. Textured implants were designed to stay in place better than smooth-surfaced implants. It was later discovered, however, that the texture on the surface of the implant could cause abrasions in the breast tissue which could, over time, lead to cell damage.
The medical community, citing no actual medical value in textured implants over smooth implants, reacted by widely rejecting the devices and would eventually see to the complete removal of textured breast implants from the European market earlier this year.
The United States remained largely insulated from the fallout over textured breast implants because the overwhelming majority of US breast augmentations and reconstructions are performed using smooth implants. “No one can prove any benefits to texturing,” says one surgeon. “If you remove the products, the risk goes to zero. To me, it’s a no-brainer. Personally, I think they shouldn’t be on the market.”
The risk, however, may not actually be zero and the situation may not be nearly that simple. In a statement released by the FDA, the agency says that “a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices” leading to “inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.” Silicone – a material widely used throughout breast implant applications – is among those now being scrutinized over its potential long-term side effects.
Women have brought complaints and concerns over the safety of breast implants of all types for decades. The impact of these renewed investigations; especially over products long thought to be safe, may ripple through medical and legal communities for years to come.