Sientra Silicone Breast Implants:
- Approval Date: March 9th, 2012
- Medical Device Recall Search
- FDA Overview – Sientra
- FDA Consumer Information
- FDA PMA P070004
- Approval Order (Post-Approval Study Conditions)
- Summary of Safety & Effectiveness (Heavy Metals, pgs. 6-7)
- Labeling Pamphlet #1 (for augmentation patients, from 2012)
- Labeling Pamphlet #2 (for reconstruction patients, from 2012)
- Labeling Pamphlet #3 (mini brochure, from 2012)
- Labeling Pamphlet #4 (for physicians, from 2012)
- Post-Approval Study
- Supplements: S001, S002, S003, S004, *S006, S007, S008
Sientra was the North American distributor of Brazilian Silimed breast implants. Silimed breast implants were banned by the EU, U.K., and Australian regulators after inspectors found contamination of unknown particles that were later identified as cotton and silica at the company’s facility in Brazil.
Sientra breast implants were voluntarily pulled from the U.S. market in October 2015 by the company. They were put back on the market on March 1, 2016. In 2018, Sientra announced a site-change to a US manufacturing facility to its contract manufacturer, Vesta.
2019 Update – FDA Issues Warning Letter to Sientra:
“We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies.” – FDA Commissioner Scott Gottlieb, M.D.
“The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.”
Sientra Post-Approval Studies (5):
1. Core Cohorts Study: A requirement is for Sientra to conduct Device Explant Analyses for all the devices retrieved from the women enrolled in this study and report the findings.
2. US Post-Approval Study: Intended to follow women for 10 years, commencing in 2012.
3. Case-Control Study: To evaluate the association between Sientra Silicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. This study will be conducted in Brazil. Note: The latest four year report due on 3/8/16 is overdue.
4. Continued Access Study: The follow-up rate was 48.5% at year 5. This study was to collect additional safety and effectiveness data from women who received these implants prior to approval but outside of the Core Cohort Study. A requirement was for Sientra to conduct Device Explant Analyses for all the devices retrieved from the women enrolled in this study and report the findings.
5. Focus Group Study: To evaluate the augmentation and reconstruction patient labeling through an independent group obtaining responses from patients on the format and content of labeling. This study used 37 patients.
“Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.” – FDA
If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for the Post-Approval Studies program. Her email is [email protected] and phone number is (301) 796-6134.
FDA MAUDE – Adverse Reaction Reports – Inclusive of Sientra Silicone Pre and Post Approval Studies:
I had silimed smooth cohesive gel silicone implants put in (b)(6) 2006. I was put on a 10 yr study by the company, but was told they didn’t need to follow me after about 4 yrs. By the 1st year of being followed, i had developed joint pain. Although mild at first my symptoms over the past 9 yrs have progressed significantly. The past 3 or 4 years, i have suffered with debilitating joint pain and stiffness, muscle pain, joint swelling, horrible insomnia, extreme fatigue, dry eyes, constant diarrhea, anxiety, brain fog, muscle weakness, raynauds disease. Right sided chest pain and right sided abdominal pain just under the right implant. I have been to multiple specialists including 3 rheumatologists and had hundreds of labs, xrays and other testing. Always to be told everything is normal. I feel like my body is attacking itself with no explanation. I did test positive for a gene called hla b27, but everything else is “normal. ” a few weeks ago, i had a natural healing woman tell me she was pretty sure it’s my implants and i have since been researching it a lot! i was amazed to read of thousands of other women with the exact same unexplained symptoms. I am currently working on getting all my records from the past 10 years and seeing a plastic surgeon for explantation. I have had to take narcotic pain medications daily for the past 2 years just to be able to work, and have been on so much prednisone for the joint pain that i now have bilateral avascular necrosis in both hips that may require surgery to fix. I have spent (b)(6) of dollars with no answers, have suffered greatly and now need to figure out how i am going to come up with thousands more to get them out. More research has got to be done. Thousands of women are suffering and going broke and destroying relationships. Link.
FDA MAUDE – Adverse Reaction Reports – Inclusive of Sientra Silicone Breast Implants:
Note: Parentheses represent redacted information to protect privacy.
Breast implants, capsule contracture, fluid in breasts, rashes, brain fog, depression. I have had depression since the implants and very bad eczema, dry hair and skin and other health symptoms. Link.
Breast implants, sientra making me ill. Hair loss, fatigue, memory loss, brain fog, blurry vision, joint pain, and sleep disturbance. Link.
Two months after implant i had severe sores appear all over body, intense fatigue, swallow and breathing problems, chronic cough, hair loss, vision problems, eye pain, atheistic pain, pain in chest. Link.
I got sientra silicone gel breast implants on (b)(6) 2017 and i immediately got severely sick. I had severe dizziness, shortness of breath, chest pain, chronic fatigue, heart paliptations, blurry vision, passing out, difficulty swallowing, and many other symptoms. I removed my breast implants on (b)(6) 2017 and my symptoms are improving already. I was perfectly healthy before implants. I had to visit the er several times as well as several doctors appointments since implanting. I believe that breast implants are not safe and need to be taken off the market as they ruined mylife. I was put on disability from work as i was bed ridden before explanting. Dates of use: (b)(6) 2017. Diagnosis or reason for use: cosmetic. Link.
Sientra implants on (b)(6) 2014. Since implants i have had biotoxin illness symptoms including but not limited to visual disturbances, vertigo, hair loss, nutritional deficiencies, memory loss, brain fog, pain in joints, migraines, fatigue, reynards syndrome, low ferritin levels, immune system lowered, increase food allergies, scleredema, candida overgrowth, bacterial infections in vagina, cold hands and feet, numb and tingling hands and feet, pain in shoulders, inability to concentrate. Link.
I was implanted with silicone gel textured implants. I began experiencing neurological problems one month following mammogram. My implants were voluntarily removed from the us market in (b)(6) 2015 for “quality concerns at the manufacturing plant in (b)(4)”. I was explanted on (b)(6) 2017, i had abnormal cells growing within the scar capsule around one implant and a seroma. My surgeon said my entire chest cavity was terribly inflamed. I had a second surgery in (b)(6) to remove affected axillary lymph nodes and began a detox protocol for mold and chemical toxicity by my surgeon. Beyond the fact that this has affected my quality of life, i have been left with a huge financial burden. And then to have a mainstream medicine refuse to believe my implants were the source of my problems is hard. I have never notified by sientra that there were problems with my implants. Link.
I had textured silicone breast implants surgery (b)(6) 2014. After about one year my left breast starting swelling up. Finally i went to the doctor and under ultrasound they removed 3 large containers of blood tinged fluid from my left breast. Unfortunately the fluid all came back and more. So my plastic surgeon said we need to remove the implant and i agreed. At my request he removed both implants this time. After the surgery my doctor told me it was a good thing he took that out. He said it was a mess, seroma, blood clots and capsulated. He said he had to do a lot to clean it all out. I suggested he test for cancer that was associated with textured implants and seromas. He said the test came back negative for cancer. Ever since the swelling started i have been dealing with autoimmune issues. Link.
I had sientra implants on (b)(6) 2015. After getting my implants in, the next day my face was swollen. I had real bad thrush. I couldn’t even swallow. It burned all the way down my throat. My iron was really low. I had chest pains shooting to my back on my left side for the whole time period i had my implants in which was 10. 5 months. As the weeks went by, i had upper back pain. After two months, i began having capsular contracture on both boobs especially my left. By the third month my surgeon said yes i did have capsular contracture. I had grade iv capsular contracture by the fifth month of having my implants in. I was sent to the emergency room for sharp intense pain in my mid level back, which they took ct scan. They said they didn’t see anything and kept me in the hospital over night. I have been to e. R. Several times over sharp pains in my back i have had fatigue, exhaustion, anxiety, sore muscles, weak muscles, joint pains, tension headaches, locked up arm on my left side, muscle cramps throughout my body, red painful eyes, muscle burning on my ankle and wrist, neck pain. I was told by my primary doctor i had chronic pain all over my body, fibromyalgia, unusual large lymph nodes under my arm pits, which were very tender, my chest felt heavy, hard to breathe. Link.
After implants in (b)(6) 2015 my health started going downhill. Right after implants i had severe thrush, throat burned very bad. I could not eat without having very bad pain in throat. I had very bad, sharp, shooting pains in my left side of chest which shot to my back side immediately after implants put in. The sharp pains did not go away. Face swollen the very next day after implants put in. Immediately had back, spine pain, lower back pain, shoulder pain, upper back pain after implants put in, in (b)(6) of 2015. Two months after implants put in i had capsular contractions in both breasts from implants. Still sharp pains shooting from left breast to my left side of back. Upper back pains even more at this time, “misformed” shaped breast. Now was getting neck pains. Three and a half months after implants i now have eye pains in both eyes, breast getting more uneven shaped. Six months after implants in, very hard to breathe at times. I now have joint and muscle pains throughout my body, in my feet, calves, hands, back, neck, shoulders, inflamed lymph nodes under my armpits. Still shooting pains from left breast to my left back. By nine months out, i am very weak, fatigued, exhausted, can barely work at my job. At 10 months i am now getting burning, inflamed, red spots/patches throughout body, so painful it feels like i had sprained a body part. Eyes blood shot red and in pain and very sensitive to light. Link.
After two months of switching saline to seintra “gummies”, i have become very sick. Link.
I received sientra silicone breast implants on (b)(6) 2015. The serial number of the implant was (b)(4). A week after receiving the implants the implants i developed a bumpy rash covering the whole breast area that is red and purple in color. The symptoms are still persisting in the area and have not gotten any better. I saw the news about sientra’s contamination in their factories and the (b)(6) medicines and healthcare products regulatory agency suspension of sales of sientra implants. I would like to be informed if the fda has any updates regarding possible contamination of the products in the u. S. And whether these rash symptoms are a byproduct of the implants. Link.
In 2010 i experienced a hematoma in the lower inside of my left breast accompanied by great pain. Gradually the breast developed a painful capsular contracture and a mass in my left armpit lymph nodes which was treated by the (b)(6) with an asthma medication that did not work. I then received a letter about alcl which alarmed me even further and saw several doctors of which none knew how to test for alcl. I began experiencing a sensation in my chest that felt like an abscess that was spreading through my ribcage into my lung which makes it incredibly hard to sleep at night. I am in constant pain. Recently, my office at (b)(4)was closed, so i was forced to go into a field technician or lineman position. As i have progressed in my training for the last 6 months, i have experienced an unbelievable amount of pain, lack of sleep and uber fatigue. I went to the (b)(6) did not automatically provide insurance this last year and asked for an mri. I finally got the mri and the radiologist stated the implant was possibly ruptured and there was evidence of 2 leaks (exact wording subject to interpretation). Since i received that information 2 weeks ago, i have researched the internet and found that (b)(4) is providing explant money under certain conditions. Unfortunately, the conditions or stipulations are extremely subjective, for example, the explant money is only allotted if the implant was not subject to or exposed to some sort of stress or accident. Also, the lifetime warranty in some cases will not be applicable. This brings up the question of when that determination will be made. In my own case, if the implants are not under warranty, i would choose not to have them replaced. So what are the dynamics of an explant surgery? will (b)(4) provide breast implants in the case that my explant fits into their perfect little box they have created and will my surgeon be compelled to go through this checklist in the middle of surgery to det. Link.
Silimed/sientra sent out expired implants that we double serilized (dry heat then chemically) for dr’s to implant into pts. I previously had implants for 9 yrs, had a child and needed a lift and new implants. I specifically asked for mentor implants but dr (b)(6) ignored my request and through 14 surgeries, i got expired, double sterilized silimed/sientra implants. I suffered from severe scar tissuing pushing my implants through my skin at least 3 times, (b)(6) in my chest wall 3 times, 14 disfiguring surgeries, seroma and permanent numbness in both breast and my left implant fell through again in 2011. I no longer have an implant on one side, however the right one is giving way as well. I no longer have nay energy and am constantly sick since these were implanted. I was notified from sientr when they bought silimed in (b)(6) 2008 and about what had been done to my implants and asked to participate in a study which i declined. I just want to be normal again and these bad implants removed, but due to all of my medical costs, and my health, my credit is ruined and i can’t get them fixed. Date: before implantation. Serial: can provide at later date. Dates of use: 2006 – 2007. Reason for use: lift and new implants after child. Link.
Patient had bilateral breast implants inserted (b)(6) 2015. Returned to surgery for revision on left breast. Clinically per surgeon stated, “breast had indentation, “concave” appearance. Upon removal implant was “white and cloudy” and “more dented than usual”. Possible manufacture defect. Link.
Implant has folded inside my body creating significant ripping, deformity and pain. Link.
Silicone gel breast implant – patient reported rippling visible on right side. Device removed and replaced. Link.
Silicone gel breast implant – patient diagnosed with baker grade iii capsular contracture – left side. Device scheduled to be removed and replaced with identical dev. Link.
Silicone gel breast implantation – primary augmentation. Patient diagnosed with baker grade iii capsular contracture in left breast. Patient is scheduled for device removal and replacement with identical device. Link.
Silicone gel breast implantation – primary augmentation. Pt diagnosed with baker grade iv capsular contracture in left breast. Pt is scheduled for device removal and replacement with identical device. Link.
Silicone gel breast implant – patient reported seroma and capsular contracture resulting in device removal. Link.
Bilateral breast reconstruction surgery performed on (b)(6) 2012. One implant removed and replaced on (b)(6) 2012 due to seroma. Link.
Silicone gel breast implant – mri indicated device rupture. Device removed and replaced with identical device. Link.
Reported rupture of silicone gel-filled breast implant. Link.
Reports of Infections:
Silicone gel breast implant – suspected rupture diagnosed by mri. Operative finding not ruptured. Second diagnosis of periprosthetic infection/fluid collection. Device replaced with identical size and style device. Link.
On (b)(6) 2015, sientra, a mfr of breast implants, notified (b)(6) plastic surgery ((b)(6)) that breast implants from one of their factories could be contaminated. Those breast implants were only sold in europe, and did not impact the u. S. Supply. We alerted our pts of this issue, but were not concerned because our sientra rep, (b)(6) told us that only the european supply had potential problems. After being informed of the sientra issue, one of our pts elected to continue with her breast augmentation with sientra implants (style 107) on (b)(6) 2015. Dr. (b)(6) performed the breast augmentation surgery using sientra style 107 gel implants. Two days later on (b)(6) 2015, sientra voluntarily stopped selling implants in the u. S. Our pt seemed to be doing fine the first week, but then had issues with the implant. She had developed increasing symptoms of pain and tenderness in her chest and breasts. On (b)(6) 2015, dr. (b)(6) removed both implants. He saw creamy yellow pus on each breast side, removed both implants, and had cultures tested. (b)(6) surgery center submitted a product complaint report form to sientra on 10/20/2015. (b)(6) plastic surgery reported the incident to the sientra rep. On 11/05/2015, the epic lab confirmed that the pt had developed bilateral polymicrobial infections. (b)(6) of sientra sent (b)(6) an explant kit on 10/20/2015 to retrieve the implants for sientra testing. The implants were sent back to sientra for their own testing. At an (b)(6) 2015 office visit, the pt was feeling much better and was continuing to improve. Sientra was supposed to report this infection to the fda. (b)(6) followed the proper channels in notifying sientra and providing pt care. As of 02/23/2016, sientra denies any bacterial infection from any implants in the u. S. This is incorrect, as this case demonstrates. (b)(6) is notifying the fda of our instance of bacterial infection from sientra breast implants. Link.
Had a breast implant surgery in (b)(6) 2015. It was to replace my older implants in which i had no problems. This was just a routine breast revision surgery. The implants were made by sientra. At 2 weeks after surgery got very ill, dizziness, fever, chills, extreme fatigues, loss of appetite, and pain on my left side. It went undiagnosed for another week, they thought i had contracted the flu. The plastic surgeon referred me to an infectious disease dr. Exactly one month after surgery, i started iv antibiotics under care of. Begun a 4 week round of vancomycin and azithromycin. Infection levels dropped some, still very ill and skin on breast was redder, more hard, and very painful. At week 8, noticed some discharge from nipple where the stitches had been. I went to plastic surgeon, he made a small hole, fluid came gushing out. He said the implant was on top and was visible, rather than under the muscle; it was pushing its’ way out. Scheduled the surgery of explant of the left side in which i had the infection. My right brest appeared fine, no pain or redness, stitches normal on the right side. In doing a culture of the tissue, it was determined the infection was caused by mycobacterium fortuitum. When the infectious disease dr. Informed me of what this was, he said it was very rare in the us. He had only seen this infection once before, 10 yrs. Prior on a breast implant surgery on someone who had been in the marines. I then started the antibiotic clarithromycin for another 4 weeks. The dr. Has felt that a protocol somewhere was missed and believed was on the implant to start. In gathering second opinions, as i was concerned, going back to the original surgeon, numerous comments from plastic surgeons were they assumed i had gone out of the country to have my surgery. I have never been out of the country and had surgery in (b)(6). I contacted the county health dept. , but they don’t keep record or report this type of bacteria i was told. Currently have disfigured left side due to lots of tissue damage and lots of scar tissue. Sientra – left side (infected side) (b)(4), serial #(b)(4) smooth round, mp on (b)(6), was at a plastic surgeons office for a consultation. He mentioned he hoped that sientra implants would be back available in the spring of 2016 to his nurse. This made me curious as i had not heard they were off market. Saw an article from (b)(6) 2015, that there were some problems with plant in (b)(6). I thought it was important to report since the infection may have come from this plant; would not want people to go through the last few months of what i did and the reconstructive surgery yet to come. I have asked the original doctor a few times if he reports to sientra the lot number as i was curious if anyone else experienced these problems, he said no, as if it wasn’t something to report to them. I went online to the sientra website in (b)(6) to see if they spoke of any problems and there wasn’t a recall or further info. Link.
Right silicone gel breast implant explanted due to suspected infection. Patient also reported ‘popping’ sound from breast a few days before a scheduled doctor visit. Device was removed and replaced with another silicone gel breast implant. Link.