Breast Lymphoma Lawsuit Filed Over Sientra Silicone Implants

Dozens of women are pursuing breast implant lawsuits after developing a rare type of cancer in the surrounding tissue. While most of the claims involve problems with Allergan’s recalled Biocell line of textured breast implants, a recent lawsuit suggests that silicone implants by Sientra may also result in a similar risk.

In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Tennessee, Kelly Painter-Hart indicates that she was diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) from Sientra silicone implants.

Painter-Hart underwent bilateral mastectomies in November 2013, as a preventative measure against breast cancer. At that time, she was implanted with Sientra textured oval-shaped silicone gel implants manufactured in Brazil.

By September 2019, she was suffering from acute swelling of her right breast, and was diagnosed with the breast lymphoma in October of that year. A month later, in November 2019, she had the implants surgically removed.

“Mrs. Hart chose to undergo double mastectomies in order to avoid the risk of developing cancer,” her lawsuit states. “Had she been informed of any increased risk of developing cancer associated with Sientra textured implants manufactured in Brazil, she would not have chosen to use that product and/or would have opted out of reconstruction.”

Concerns about the risk of BIA-ALCL emerged a few years ago, and researchers determined that the problems appeared to be linked to certain breast implant designs that featured large textured surfaces, which may result in persistent inflammation that produces lymphoma in the breast.

In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of “Biocell” textured breast implants, after the FDA determined the design was linked to more than 500 cases of BIA-ALCL diagnosed worldwide, including at least 33 deaths.

In a recent update, the FDA indicates it has identified an additional 160 new cases since July 7, 2019, as well as three new deaths. That brings the total cases to 733 BIA-ALCL diagnoses worldwide, and a total of 36 patient deaths globally.

At least 620 of those breast implant lymphoma cases were specifically linked to Allergan design, and in another 47 cases the manufacturer was unknown.

A recent study by Columbian researchers found only seven out of 18 cases of BIA-ALCL diagnosed in that country were linked to Allergan breast implants, with the rest caused by other designs.

11 Comments

  • JenniferFebruary 12, 2022 at 5:09 pm

    4/2013 I had Sierra teardrop implants ( unsure if textured) I do have the device identification & warranty card. I had implants after stage I breast cancer surgery in 2012. In 2014 I was diagnosed with stage IV breast cancer. Went back to the surgeon in 2016 because the left breast is much larger than the right breast. He refused to do anything given my current diagnosis. Did not mention any recal[Show More]4/2013 I had Sierra teardrop implants ( unsure if textured) I do have the device identification & warranty card. I had implants after stage I breast cancer surgery in 2012. In 2014 I was diagnosed with stage IV breast cancer. Went back to the surgeon in 2016 because the left breast is much larger than the right breast. He refused to do anything given my current diagnosis. Did not mention any recalls nor did I receive anything from the company. To date, and the reason I found this, I started having numbness, pain and tingling sensations around my left breast, under my left armpit, left back shoulder blade area and shooting down my arm. I was looking up what it would feel like if my implant had ruptured. Given my disease and the medication I’ve been on for the past 8 years I suffer from arthritis and many other symptoms but it leaves my to wonder what’s happening to me now and or 8 years ago?

  • ClaudiaJanuary 26, 2022 at 7:49 pm

    I had Sientra Gummy Bear Textured implants put in in Sept. 2015. Major health problems followed, including a massive rupture. How can I find out if my 2015 impants from Sientra were manufactured inthe Silimed Factory in Brazil?? I have all the serial #s etc. I can not fins anything about manufacturing location.

  • E.January 8, 2022 at 7:33 pm

    I had a Sientra gummy bear implant after mastectomy in 2015 after being ensured it was safe from the surgeon upon my asking, when I had heard that silicone implants had caused cancer. He told me there was no truth to it. My implant was painful since it was put in. I also developed capsular contracture early on. I also learned I had a Seroma. My breast also developed a rash on that breast only and[Show More]I had a Sientra gummy bear implant after mastectomy in 2015 after being ensured it was safe from the surgeon upon my asking, when I had heard that silicone implants had caused cancer. He told me there was no truth to it. My implant was painful since it was put in. I also developed capsular contracture early on. I also learned I had a Seroma. My breast also developed a rash on that breast only and discomfort in the armpit. A test was performed on the breast saying it was negative for alcl. I requested it be removed due to the pain and learning of the increasing numbers of alcl and my symptoms. My surgeon denied any reason for concern of my implant. I do not no if proper protocol was followed on removal and proper pathology was performed for testing of alcl. Some of my capsule had to be left due to inability to remove due to risk. I will have to be concerned for the rest of my life if I will develop it. Alcl cases are rapidly increasing and the Dr’s are not concerned. The plastic surgeon denied any Sientra cases being reported when he removed it in 2021.

  • MicheleJanuary 3, 2022 at 8:51 am

    I was diagnosed with stage IV Breast implanted associated anaplastic large cell lymphoma. Had surgery April, 2021 and 6 cycles chemo after. Had sientre textured implants in 2014 after having mastectomies for DCiS.

  • ChristiAugust 12, 2021 at 5:45 pm

    In November 2014, I had textured Sientra implants implanted. In January 2019, I was diagnosed with Hodgkin's Lymphoma in the left axillary. In August 2019, my left breast engorged, and upon removal of the implants and biopsy of two swollen lymph nodes, from the same left axillary that the Hodgkin's Lymphoma was in, it was diagnosed that I had anaplastic large cell lymphoma caused by the breast im[Show More]In November 2014, I had textured Sientra implants implanted. In January 2019, I was diagnosed with Hodgkin's Lymphoma in the left axillary. In August 2019, my left breast engorged, and upon removal of the implants and biopsy of two swollen lymph nodes, from the same left axillary that the Hodgkin's Lymphoma was in, it was diagnosed that I had anaplastic large cell lymphoma caused by the breast implant. I underwent treatments from January 2019 trough to December 2019.

  • jenniferJuly 7, 2021 at 10:26 pm

    I also had sientra silimed implants and explant surgery with numerous illness. I also was in the study they didnt complete. the gummies you can cut in half wont leak. PLEASE. i would have never gotten these if I only knew. not to mention they we recalled and no one contacted me

  • PirieMay 24, 2021 at 7:22 am

    How can we reach Sientra and file a complaint or lawsuit against them for their horrible implants that have made us sick? I just had an explant surgery because of 2 ruptured implants and pain behind both of my breasts. I know Allergan is helping patients, but what about Sientra? Thanks!

  • EDecember 29, 2020 at 7:32 pm

    My mom got Sientra textured implants in 2013 or 2014, and began showing signs and symptoms of autoimmune complications but we didn't make the connection. A year later, a spot on her upper left lung was discovered on an xray when she had pneumonia, but she was told it was nothing to worry about. In Sept of 2019, she thought she had pneumonia again and was coughing up blood so she had another xray d[Show More]My mom got Sientra textured implants in 2013 or 2014, and began showing signs and symptoms of autoimmune complications but we didn't make the connection. A year later, a spot on her upper left lung was discovered on an xray when she had pneumonia, but she was told it was nothing to worry about. In Sept of 2019, she thought she had pneumonia again and was coughing up blood so she had another xray done, which led to the discovery of late stage lung cancer in her upper left lung that spread so quickly that we never got time to do any real treatment before it spread to her other lung, her breast, and her liver (all found upon her autopsy). She died on Jan 3, 2020 and the autopsy did not find evidence of BIA-ALCL. However, once I started researching textured implants, I found plenty of links to lung cancer. Her cancer spread very quickly, which was abnormal for the kind she supposedly had. She was never warned of any cancer risks by her surgeon. I found a Sientra product packet that had general cancer risks buried in the fine print and written off as "rare". Her surgeon did not tell her to do yearly cancer screenings, especially because her age bracket had the highest risk. Before these implants, my mom was a vibrant and healthy woman with decades of life left. She hit the gym regularly, and danced in shows, and was very capable and full of life. She was my best friend. She was also a nurse and had she been warned of cancer risks, she would never have gone through with the surgery. She was also never warned of a Sientra implant recall after hers were put in- never contacted by anyone about that to check and see if she was effected by that batch. I only found that out while she was dying. My mom seemed okay, and then in three long months, she suffered greatly and died without a chance. And because it was lung cancer and not officially bia-alcl, I can't find a lawyer to pursue a case against Sientra, or her surgeon for failing to inform consent. Nobody should die because they were trying to feel beautiful, and nobody should have to helplessly watch that happen to their mom.

  • KimberlyOctober 31, 2020 at 10:33 pm

    In 2013 I had a breast Augmentation. Sientra textured tear drop implants were used and no cautions were spoken of this implant. A week into my recovery I had issues and went to ER. I followed up with Surgeon who ordered an ultrasound and was told all was ok after several complaints of severe pain. Left breast has always showed pain from time of surgery. A majority of my health issues started in 20[Show More]In 2013 I had a breast Augmentation. Sientra textured tear drop implants were used and no cautions were spoken of this implant. A week into my recovery I had issues and went to ER. I followed up with Surgeon who ordered an ultrasound and was told all was ok after several complaints of severe pain. Left breast has always showed pain from time of surgery. A majority of my health issues started in 2018 until today’s date. After many ER visits, blood tests, scams, tests for auto-immune disease, I am not looking at my decline in health as being a result of Sientra implants. I was never notified of a recall my my surgeon or by Sienna . At this time, I am bed ridden, on a feeding tube, and not able to function on a daily basis . Here are my symptoms today with no other explanation as to the cause Hair loss Shakiness Verdigo Heart palpitations Nausea Feeling of acid/poison running through veins Anxiety Dry eyes and mouth Eyes sometimes get very red, bloodshot and hurt/burn Sudden Sensitivity to allergens Phlegm in throat High pulse Bloating Constant gas Gastroparesis Acid reflux Bad blood circulation Sinuses filling up at night while sleeping or while laying down Raynaud’s phenomenon that comes and goes Chills Hot flashes Bruising that doesn’t go away or takes a long time to go away Fatigue Intermittent Achy joints Brain fog Extremely dry skin Insomnia Intermittent breathing problems/ wheezing Waking up multiple times during the night Trouble concentrating Constipation Back pressure/upper backache over lung area Headaches that start behind eyes Blurred vision Headaches

  • LibeOctober 15, 2020 at 6:52 am

    I have been harmed by silimed textured siretra implants ... tested positive for autoimmune. Left capsular contractor with fluid surrounding it and right ruptured. Was not warned of recall in 2015 to Australia and not told can cause problems by destination beauty cosmetic company

  • JaniceOctober 2, 2020 at 7:13 pm

    I had Seintra silicone implants put in 5 years ago and have had all sorts of issues. I’m in a lot of pain and waiting for an appointment to have them removed. I’m very upset about this article. I’ve been complaining to my Drs about inflamed under arm issues, pain, burning and more.

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