Tuesday, 25 February 2020

Are Breast Implants Safe?



by Rohrich, Rod J.; Kaplan, Jordan 

Plastic and Reconstructive Surgery: February 2020 - Volume 145 - Issue 2 - p 587-589

Breast implants are among the most well-studied implantable medical devices placed in humans. They have been used in both reconstructive and aesthetic breast surgery for more than 60 years. The safety of the device has been affirmed repeatedly through extensive long-term studies and further research continues to take place in order to ensure patient safety.1 Recent scientific studies have shown an infrequent correlation between textured breast implants and anaplastic large cell lymphoma (ALCL), which has resulted in a specific subset of textured breast implants to be removed from market secondary to a higher incidence of this disease.2 Such action reaffirms the importance of ongoing research in all aspects of plastic surgery as we always place patient safety first and foremost.
As physicians who took a Hippocratic oath to do no harm, we must adhere to these same scientific standards if we are to meaningfully define the wide range of symptoms that have collectively become known on social media as “breast implant illness.” This condition has been attributed to any and all types of saline and silicone breast implants and their surrounding silicone shells. It has been postulated that the implant shell itself may have toxins or other yet-to-be-defined elements that cause a myriad of symptoms yet to be articulated in a scientific manner.3 A 2006 study published in the Annals of Chemistry evaluated the total platinum concentration in both patient tissue and breast implant samples. The authors concluded that women with silicone breast implants have platinum levels that exceed that of the general population.4 However, a critical analysis highlighted that platinum concentrations in blood and urine samples showed no statistically significant difference and that both the control and implanted groups were shown to have platinum levels comparable to those in platinum industry workers. Furthermore, the study design was deemed nonreproducible.5,6 Pinpointing a material explanation for breast implant illness symptoms has been impeded by poor data collection and lack of science and dissemination of misinformation on social media, which places patients with breast implants at risk of making improperly informed decisions.
This is not to say that breast implant illness does not exist—both patient advocacy groups and the U.S. Food and Drug Administration recognize various symptoms as being risks related to breast implants7—but rather that there is no current scientific evidence to support such claims. It is therefore the responsibility of plastic surgeons to advise patients who may present with symptoms associated with breast implant illness to seek full evaluation by our medical and rheumatology colleagues to ensure we are not missing any type of disease process; the American Society of Plastic Surgeons is taking the lead in working with patients and with the Food and Drug Administration to investigate these widely reported symptoms in an effort to supplant speculation with data and science.