Silicone gel breast implants were introduced in 1962 by Cronin and Gerow. Within a year, there were already complaints of various symptoms from implanted patients, leading Miyoshi to coin the term “human adjuvant disease” in 1964. Unfortunately, these complaints were not taken seriously by neither their Plastic Surgeons nor the implant companies, who both argued that breast implants were perfectly harmless. Patients were often told “It’s all in your head”. The texturing of implants (making the outside shell somewhat rough) began in the 1970s, in an effort to decrease the incidence of capsular contracture following breast augmentation.
Patients continued to develop what were called “connective tissue disorders” which they felt were caused by their breast implants. This led to the FDA’s withdrawal of gel implants in 1992 because of a lack of data proving the safety of these implants. Confusing the issue were numerous studies showing that breast implants were completely safe, despite a similar number of studies confirming quite the opposite. The problem is that these studies that demonstrated breast implant safety were usually either funded by breast implant companies or performed by consultants that were paid by breast implant companies. It’s not very difficult to understand that a Plastic Surgeon who is paid by a breast implant company or makes a lot of money with breast implants cannot be relied upon to study breast implant safety in a neutral fashion. We call that CONFLICT OF INTEREST. Although such studies were accepted in the past, studies with such conflict of interest are no longer considered valid in the scientific communities. In fact, presenters at national meetings now must begin their presentations by addressing possible personal conflicts of interest as they may pertain to the topic of their presentation.
Given the numerous studies showing breast implant safety as well as a huge push from the breast implant industry, the FDA allowed the return of gel implants in 2006. Still, numerous patients continued to experience problems, once again being told “It’s all in your head”.
By 2011, several cases of a rare lymphoma called Anaplastic Large Cell Lymphoma (ALCL) were reported in patients with textured implants. By 2016, the association between textured implants and Breast Implant Associated (BIA)-ALCL became undeniable and widely known. With the recognition of BIA-ALCL secondary to textured breast implants, it became apparent that breast implants were not so harmless after all. Hence our slogan: “It’s NOT in your head… it’s in your BREASTS”. With social media, these many thousands of patients rallied together to make their voices heard. Breast Implant Illness (BII) is now recognized by the FDA as well as Plastic Surgery associations throughout the world, although it is yet to be fully understood.
Given this lack of knowledge regarding breast implant illness, Dr. Nicolaidis has now focused his practice on making patients FEEL better with explantations as well as LOOK better with simultaneous breast lifts, all the while trying to better understand this complex, multifactorial illness.