My name is Susan Dorsey, I live in Mount Juliet, TN and I am here to share with you my experience as a participant of Allergan’s Adjunct trial for silicone breast implants.
I have always been very healthy and physically active. When I turned 40, in 1995, I had saline breast implant surgery. I enjoyed those implants for ten years. Then, in 2005, I decided to have them replaced for cosmetic reasons. I met with Dr. Kenneth Hagan, at Vanderbilt, who recommended that I enroll in the silicone implant trial there. I paid my $6,000 and enrolled.
Recovery for this breast surgery was much the same as my saline surgery in 1995. However, about a month post-surgery while getting ready for a Christmas party, I remember having difficulty raising my arms over my head. Later in December, my family spent the holidays in the Caribbean. While there, I experienced flu-like symptoms and spent most of the time in my room believing that I had swallowed some of the water or eaten a food that wasn’t agreeing with me.
January brought more new symptoms. The neck and shoulder pain that I had felt in December had worsened to the point that I was going to physical therapy three times a week. My vision had become blurred and I was experiencing loud buzzing in my ears. Every day seemed to bring new health issues. These included: severe joint pain, dizziness, anxiety, tingling hands/feet, heart palpitations, insomnia, depth perception problems, loss of appetite, metallic taste in my mouth and others.
Over the course of the next nine months, I had 24 doctor’s appointments, including neurologists, orthopedic surgeons, and others. I also had 31 physical therapy appointments, 2 MRI’s, 2 spinal epidural procedures and an admission to Vanderbilt’s emergency room. In all, there were 63 medical appointments in the nine months following my joining the research trial. Six months into the study, I felt close to death and called my daughter who was in college in Kentucky. I asked her to take care of my 12-year-old son if anything happened to me. I prepared my will, expecting I would not wake up one morning. During the year before getting silicone implants, I had only routine doctor appointments limited to annual physicals and a stomach bug.
Ten months into the study, I met with Dr. Hagan and advised him about the deterioration of my health since being in the study. I asked to have the silicone implants removed and replaced with the saline implants I had prior to the study. I was advised that there was no exit strategy from the study and that the implant removal would be done only if I had the money to pay for their removal. He added that for my trouble, he would throw in a free breast lift and that he would contact Allergan to see if they would provide the saline implants cost-free. They would not. I paid the $3,500 and was dropped from study on September 29, 2006 when my silicone implants were removed and replaced with saline implants. During the time I was enrolled in the study, I had no contact from Vanderbilt or Allergan. I called Allergan and left a phone message stating I had some health problems due to the silicone research trial and requested a return call. I followed that with an email. I received no return call and the email response from Allergan read: Thank you for your inquiry. We are a leading manufacturer of plastic surgery products and we are happy to provide you with information that may assist in answering your questions. Your inquiry has been received and will be responded to in a timely manner. Due to FDA regulations that apply to manufacturers of plastic surgery products, we cannot comment on any particular medical condition, surgery or physician opinion.
On April 16, 2007, seven months after the silicone implants were removed from my body, I sent Allergan a certified letter advising that my medical problems were subsiding and that Vanderbilt’s Dr. Hagan told me that the study implants were returned to them for testing. I attached a copy of the Device Identification Forms requesting the test results be mailed to me. I heard nothing back.
I believe that most of this horrific period in my life could have been avoided had I been monitored during the time following my enrollment in the study. Not only was there no follow-up, but matters were made much worse when my requests for help were ignored. It was clear that no one was interested in hearing about my adverse reactions. Vanderbilt’s Dr. Hagan wrote in my chart that my newly-diagnosed fibromyalgia was most likely a coincidence. What kind of research is that?
During my participation in this pseudo-research trial, I had over $100,000 in medical expenses, along with suffering lost wages of over $400,000. Fortunately, I had the mental and physical strength and the financial resources to get through the past six years. I know of several other women who were not as fortunate. I wonder if the kind of research conducted by Allergan would have identified or evaluated the kinds of serious health reactions I had to the silicone implants. I was forced out of the study when I made to decision to remove the silicone implants in order save my life. All records about my medical problems were deleted as though I never existed. Despite my repeated efforts, Allergan was not interested in learning about how their silicone implants harmed me, or how my health improved when they were removed.
At the very least, the FDA must make sure that safety studies by implant companies should be conducted in an ethical manner. Problems should be reported and injured participants should receive appropriate medical care. It is your job to make sure this situation changes immediately.
Susan testified at the FDA Advisory Committee Meeting on breast implants on August 30, 2011.