[83608851]
On (b)(6) 2017, a patient contacted a representative of sofregen via phone and reported issues she had experienced with the seri surgical scaffold. She provided the following information via email on (b)(6) 2017: "this is a follow up email from our phone conversation today, on (b)(6) 2017, involving my emergency surgery on (b)(6) 2017. As a result of being greatly infected from the seri silk that was covered in "biofilm". I have medical reports confirming that and i am currently recovering from surgery. On (b)(6) 2017 i had surgery in (b)(6) performed by dr. (b)(6). After having problems with capsule contracture in the past, dr. (b)(6) recommended the seri silk to be placed with my implants to reduce the risk of a capsule contracture to reoccur. In early (b)(6) 2017, less than 6 months after surgery, i noticed my left breast changing and becoming more firm. After consulting with dr. (b)(6), he confirmed i had a grade iv capsule contracture. Shortly after my appointment he prescribed singular to help reduce the capsule contracture. By the middle of june, i experienced more pain associated with my left breast, i thought it must be the singular breaking down the capsule contracture. At that time, i asked my employer if i could be moved to an office job and not be on my feet working constantly with my arms and hands, as well as working on up to 20 clients at a time. My director said they did not have any openings at that time in the administration or admissions office. I asked her to let me know if you anything opens up. Meanwhile the schedule and physical aspects of my job caused me to resign, my last day was (b)(6) 2017. Just three days later, as i was leaving for (b)(6) to visit my family and friends, my daughter (b)(6) noticed my breast was red and warm to the touch. She said "mom i think you have an infection". Upon my arrival to (b)(6), i contacted dr. (b)(6), he advised me to seek medical attention from a plastic surgeon in (b)(6) and try to get on an antibiotic. I looked on my (b)(6) health insurance and found dr. (b)(6). I was able to get in with him on (b)(6) 2017 and he put me on the anabiotic cephalexin. On (b)(6) 2017, exactly one week later, the pain was unbearable and the infection started draining, i became very scared and drove myself to the emergency room at (b)(6) medical center in (b)(6). Once i got there, the medical staff was great and informative. I became more aware how dangerous the infection could have gotten if it became toxic and gotten into my bloodstream. After taking blood for growing cultures, they put me on an intravenous anabiotic and fluids. Then they admitted me and got in touch with dr. (b)(6). Dr. (b)(6) contacted me as soon as i was admitted and informed me that the implant and infection needed come out right away. I was quickly prepped for surgery. My insurance would only pay for the infected implant to come out. I was kept overnight at the hospital and released on (b)(6) 2017. Then a drain tube was placed and it had been draining for almost two weeks when removed on (b)(6) 2017. I was supposed to fly home on (b)(6) 2017, however i had to postpone my flight until (b)(6) 2017. I was placed on 750 mg of levofloxacin/ levaquin for 2 weeks. It makes me dizzy and sick to my stomach. I am currently trying to get short-term disability, until i can feel better and can get back to work. My left breast looks very deformed and i am devastated, find myself crying and depressed. This has been life changing in the worst way. Having had this result of using seri silk, i would have never made that choice and put my life at risk by having it placed in my body. I hope you make your consumers aware that they could risk their lives by using your product. Please contact me as soon as possible, as i would like to file a formal complaint. " no additional information is available at this time. We are still attempting to contact the patient. On (b)(6) 2017, the patient provided additional information. On (b)(6) 2017, she had a second surgery to remove the breast implant and the seri from her right breast. She stated she would send medical records with additional information.
Patient Sequence No: 1, Text Type: D, B5