Testimony of Shannon Scott during the Public Comment of the FDA Advisory Panel for Silicone Gel Breast Implants in April 2005.
My name is Shannon Scott. I have no conflict of interest.
In 2002, I received silicone gel implants through Mentor’s adjunct study. To be in the study, a patient must have a deformity, have had a mastectomy, or a problem with implants that need to be replaced. The goal of the study is to evaluate short-term complications. I wanted implants for augmentation. Dr. Deniz Gocken of San Diego stated that I was eligible for reconstructive surgery in the adjunct study, even though my only deformity was a nearly invisible blemish on my left breast.
I was in perfect health prior to augmentation. Three months after I began developing pain within my breasts, the implants started to harden. A plastic surgeon performed a procedure in which he squeezed them to break up the scar tissue.
In January of 2005, I was told by Mentor’s patient service representative that closed capsulotomies are not to be performed. This procedure can cause the implants to rupture.
Dr. Gocken is still a part of the adjunct study. He has refused to provide me with any future medical care. I was told that I would receive monitoring and medical treatment as needed through the adjunct study for the next five years. This has not happened.
Since the implants, I have had muscle, joint aches, severe chest pain, limited range of muscle motion, migraines, rashes, swollen lymph nodes, fatigue, sensitivity to light, and considerable memory loss.
I am now bedridden approximately 95 percent of the time. And due to the pain, I need assistance in even the most minor aspects of my life, such as brushing my hair or even getting dressed. I cannot afford the thousands of dollars it will take to have my implants removed.
This study is supposed to be monitored by the FDA. I did not receive informed consent. The doctor did a forbidden procedure that could have ruptured my implants, and now I can’t afford to get them taken out.
I question how the FDA can allow this to happen to women. Dr. Gcoken’s medical records in my case are incomplete and inaccurate. If Mentor is not provided data, such as in my case, you can assume that the clinical trial study data is also incomplete and inaccurate.
How many cases like mine occur? How many people are too ill or have been misdiagnosed or ended up committing suicide? Is the statistical data in these studies?
It is my hope to prevent other young women, young healthy women, from experiencing this nightmare. Thank you for your time.