California
I am Beatrice R. I had hoped to be there in person, but my flight was canceled due to the hurricane. Thank you for showing this video instead.
I am currently a single mother, a photographer, and a multimedia consultant. I speak four languages and I was raised in Europe. I live in San Diego.
In 2005, I wanted a minor nipple procedure, to correct a cosmetic problem caused by breastfeeding. Two surgeons advised implants. Dr. Minniti in Beverly Hills convinced me that the implants were safe and that once they were in, I would never have to worry about them for the rest of my life, unless of course I had a capsule, and in that case he’d break it, a minor office visit.
The study documentation was presented to me for signing for the first time at the pre-op. appointment. I had no time to read the over a dozen pages, but I was reassured that all women were part of the trial and it was a mere formality. This is the Adjunct study referred to by the FDA.
Please note that no one ever followed up at any time, despite my sending many emails regarding my ailments to both FDA and Mentor.
Because I am the athletic type, I chose small implants. Without my consent, the surgeon implanted me with the whopping 450cc, about twice the size I wanted. I was a teacher and felt ridiculous and deformed after the surgery. I stopped going to the gym because even with two sports bras I could no longer run and men were obsessing with my chest size. My chest muscles were deformed because they were cut deeply to adjust to these enormous implants. I can never do any sports that put strain on my chest, which is most sports.
This is a point I’d love the FDA to pay attention to, as surgeons may use implants that are not the ones agreed on, but these details are not in writing.
The larger implant size was a problem, but not as big as a problem as the severe immune reaction I had to the implants.
Within days after the surgery, the skin on my arms and forearms felt very sore and sensitive, and a strange pain seemed to come and go at different locations in my body. Ankles and knuckles were the worst. The pain would take my breath away, and never stopped, day or night. The pain killers, anti inflammatory and muscle relaxant, prescriptions, nothing helped.
Nights were exhausting, trying to get comfortable and get more than 3 hours of sleep at a time. I had to lay down in bed either on my back or sideways and having to rotate continuously because the arms would go numb. After only a few hours of sleep I’d be awake and pacing around at home.
I had a burning sensation on my upper lip at all times. My eyes were dry in the morning and feeling like sand and very painful. Some days one eye would go completely blurry and a few hours later it seems like I had perfect vision. My hair started to fall off and I gained 15 pounds in just a few months.
I saw many specialists, who ran every possible test. One year after getting the implants I had a sinus infection that developed into bronchitis and lasted for months. I did three rounds of antibiotics and developed staph on my neck, which triggered an asthma attack and sent me to the emergency room. This is all documented with my doctors. The school wanted to fire me because I kept missing work.
One day the pain in my left ring finger was so strong that I had to go to the emergency room to get X-rays. They couldn’t figure out what was wrong. At times, pain would shoot in my right foot, and this was very dangerous while I was driving.
At times the gums in my mouth were pulsating at the root of my teeth. It felt like removing teeth would be relief. My labia were painful, my feet arches would get stiff and I’d feel a throbbing pain at the joints. Then the symptoms got worse. My vertebrae started to make loud popping noise upon waking up.
My immune system was completely out of control but none of the doctors could figure out what to do to help me. Then the brain. Driving home from L.A. one night, I no longer knew if I was in Italy, in France, or in the United States. This was incredibly scary, I was losing my mind. Everything was getting worse. Soon, I had to systematically walk up and down every row of cars in a parking lot to find where I had parked.
Over the next 20 months, I visited 12 specialists and met with three surgeons to discuss getting my implants removed. Waking up in the morning, I would look at my front door and feel completely overwhelmed, in tears, by everything I needed to do to get ready for work — simple steps as showering and getting dressed, brushing my hair, my teeth, and out into the world. This was like climbing the Kilimanjaro.
I felt like a woman in her 80s, at the end of her life. A vaginal ultrasound revealed I had three ovarian cysts, two fybroids and a mass that had to be operated right away. So now I had to postpone getting my implants removed until that surgery was completed.
Fearing the worse, I made a video on Youtube telling my unfortunate guinea pig experience, for other women to find support and stay away from the damaging silicone. To my surprise dozens and dozens of women responded to my video. Women from all over the country and the world told me of the exhausting suffering, health deterioration and complications, lack of funds to see doctors and run tests, and the frustration of their families not being able to help them.
I am angry that the FDA allowed these potentially dangerous implants on the market, with studies that were not really aimed at collecting scientific evidence of safety. The silicone gel includes heavy metals and potentially dangerous chemicals, and each label should include all the ingredients, just like with the food industry. The FDA should also require that the labels should also include examples of the patient’s potential expenses for lab testing, the loss of time from work, and harm to one’s quality of life.
At today’s meeting you are supposed to decide what research needs to be done. The FDA has stated that serious health problems are rare with breast implants, but I can tell you that is not true. Based on my experiences, neither the plastic surgeons nor the implant companies can be trusted to do this research objectively. Certainly, neither reported my serious health problems to the FDA.
Beatrice submitted her story to be read at the FDA Advisory Committee Meeting on breast implants in August 2011.