Allergan Biocell Class Action Lawsuit Says Manufacture Should Replace Breast Implants, Provide Medical Monitoring
According to allegations raised in a recently filed class action lawsuit brought by women who received Allergan Biocell breast implants, which were recalled worldwide last month due to a risk of cancer linked to the textured design, the manufacturer should be forced to provide funding to allow women to have the breast implants removed and replaced, as well as medical monitoring to detect cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that may develop in the future.
The complaint (PDF) was filed by two women identified only as “Jane Doe 1” and “Jane Doe 2” on August 16, in the U.S. District Court for the District of New Jersey. The lawsuit names Allergan Inc, as well as its former incarnations, Inamed Corporation and McGhan Medical Corporation, as defendants.
The women are from Arizona and Illinois, and each indicates that they were implanted with Allergan Biocell breast implants, which features a micro-textured design that has been linked to reports of a rare lymphoma that may develop in the tissue surrounding the implants.
Although neither of the plaintiffs indicate that they have developed BIA-ALCL from the Allergan Biocell implants, they indicate that they now live in perpetual fear of developing the cancer, and claim that Allergan should have to pay for all women who received the implants to have them removed and replaced and should pay for medical monitoring for the women for life.
To date, Allergan has only offered to pay for the replacement breast implants themselves, not the surgery to remove and replace its current implants, nor medical monitoring for cancer.
The Allergan Biocell class action lawsuit comes several weeks after the FDA announced that the manufacturer had agreed to issue a worldwide breast implant recall for all of products featuring the microtextured design.
The announcement came following similar recalls for Allergan breast implants in Canada, Australia and France.
“Allergan received a substantial benefit from selling thousands of the recalled Biocell products from 2006 through July 14, 2019 at the expense of Plaintiffs and the Class who are exposed to the risk of developing BIA-ALCL, a serious and deadly disease,” the lawsuit states. “Plaintiffs and the Class will be forced to expend substantial sums for the removal of the recalled implants, surgical and diagnostic fees, and/or medical monitoring and invasive diagnostic procedure required as a result of their exposure to the risk of contracting BIA-ALCL.”
The plaintiffs present claims of failure to warn, negligence, unjust enrichment, medical monitoring, and violation of the Illinois Consumer Fraud Act, and the case joins a growing number of both individual and class action breast implant cancer lawsuits filed against Allergan by women throughout the United States.
Biocell Breast Implant Concerns
The FDA indicates that there are at least 573 known cases of BIA-ALCL worldwide, including 33 deaths. Of those, 481 have been linked to Allergan breast implants. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
The FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
Those with questions regarding the safety communication can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
Cases of BIA-ALCL or other complications should be reported to the FDA MedWatch Adverse Event Reporting Program.
13 comments
I agree and I’m going to see a lawyer as well. My husband passed away a year ago from Non-Hodgkins Lymphoma and now I’m expected to live in fear that my children could loose their mother too. Allergan needs to be held accountable.
I am a breast cancer reconstruction patient. These implants were put in my chest at the recommendation of my surgeon. This was in 2014. They knew about the risk of ALCL in 2011! I was never given disclosures if I had known I never would have let them be put in my chest. Now I have to have them removed, I have seen two surgeons in the last two weeks. Both of them said remove them. I have two clinical symptoms and have had theses symptoms for four of the five years that I have had them. I am so pissed off that no one informed me, no one wants to be responsible. I have to take off of my job for 8 weeks to recover from another surgery! Who pays for that?! Me!
I got my implants in Jan 2018 after having a double mastectomy in November of 2017. I also had the Allergan now recalled tissue expanders. I cannot believe I now have to undergo a 7th surgery on October 3 to replace my implants and do the painful fat transfers all over again. Why isn’t Allergen offering to at least pay for this surgery? If I understand it correctly, the textured implants were used primarily on cancer patients who have already been through so much. I had a double mastectomy because I didn’t ever want to worry about cancer again. So ironic.
I am a breast cancer reconstruction patient. After undergoing a double masectomy in 2014, the Allergan textured implants were used in my reconstruction. I was never informed of any issues with the implants until now. I have had issues with them with swelling, sharp pains and several other issues, so I am having them removed in two weeks. It is overwhelming and I am terrified of what might be inside me.
I am a 5 year cancer survivor. I had these implants put in me due to cancer . I had a double mastectomy with reconstructive surgery. And these were the implants my surgeon used . I was never told anything about the implants causing any kind of cancer . If I did I would not have used them . I have to be out of work for 6 wks due to surgery to remove them . Who is going to pay me for being out of work . Someone. Needs to help us women .
I’m so devastated. I had to request my own surgical records after I received the recall letter this month. I had Allergen implants inserted when cancer cells were detected in both breasts in 2012. One year after they knew they were defective! I’m having hardening issues too.
I cannot believe this is happening. The pain and absolute torture I endured from metastatic breast cancer, chemo, radiation, and 6 surgeries. My reconstruction had to be done twice!! Now I understand why they look so horribly uneven, the stabbing pain and lumps. I just knew this wasn’t normal. I want Allergan to replace these implants and make sure that I get my medical bills covered. And they should be responsible for punitive damages for the pain and misery their product has put me through. I already had to pay 20% of all my cancer treatments including my reconstructions. I shouldn’t have to pay for their negligence as well.
November 2015 the recalled Allergan expanders were put in after diagnosis of triple negative breast cancer and double mastectomy. The expanders were there through chemotherapy, last infusion was March 2016. Then the Allergan recalled implants were put in April 2016. Less than one year later I had a red swollen left breast literally twice the size of the other. Breast surgeon did ultrasound said not enough fluid around implant to worry about must be infection and I was given and antibiotic. This didn’t take care of the problem and I was given antibiotics three more times. The redness went away, the swelling has never gone away…is now different shape and some days has little fatty looking lumps on it and aching pain everyday. Have had MRI and was told not enough fluid around breast to be tested or worry about. EASY for them to say. I want the implants out, smooth implants in, tissue and fluid tested for cancer. I do not believe this should be at my expense. Then maybe..just maybe I wont worry.
When there is recall on my vehicle I take it to the shop and the manufacturer pays for the repair….why is Allergan not responsible for this repair?
All of this is still coming to light for me. I have currently with extreme swelling in one breast with pain that started out similar to that I’d pulled a muscle in my chest. Within a week my breast size had doubled. I’ve had multiple tests with a breast aspiration to be done on Monday. I was sent home from hospital yesterday to find my paperwork that proves I have Allergan BIOCELL implants for now 3 years. I’m so scared. Does anyone know if there’s a law suit group fighting for compensation expenses in Australia and if not how would I find out?
This is ridiculous and Allegran needs to be held responsible!! I as well am a breast cancer survivor. I was diagnosed when I was 36 years old – I was lead to believe that reconstructive surgery was my best option being I was young! They put these horrible implants in me that now can possibly cause cancer again- I spent the last 6 years of my life hoping this day would never come again! These implants have doubled in size and I had to take off work and go in for more screening! Ultrasound showed in fact that I have a ton of fluid behind both breasts- so then the biopsy was ordered and here I am waiting in fear for results once again! My whole life is at a standstill- I have 4 young children and a husband who need their mom and wife! If I would have known there were any chances of these things causing cancer I wouldn’t have put these ticking time bombs in my chest- they need to pay
In 2015, after an Allergan saline rupture, the Allergan Natrelle textured implants that are part of the FDA’s safety notice were inserted. I have MS, an autoimmune disease, and take medication to suppress my immune system, both increasing my risk of lymphoma. Last week, a breast MRI revealed a mass below my left breast which has changed shape and is painful. I want these implants removed and believe Allergan is responsible for surgical costs.
I had them in 2005/2006. I had one rupture and ended up paying the labor to put it back in. So I feel they should pay for everything plus monitoring plus reimbursement me for my time and labor payment for the rupture. This is a nightmare. I should not have a constant worry about this. The sad part is most women don’t even know that have these. No letter has been sent or anything. When automobiles are recalled for a defective part-owners are informed with letters. The manufacturer pays for parts and labor and compensation if already done. We are human beings and the “part” was recalled by FDA but they will only pay for implant when people are literally dying from these implants. They should have to pay for full implant job, time off work, monitoring and reimbursement for previous problems such as cancer, autoimmune, ruptured, etc. I am praying for this and I hope everyone effected by this does as well.
I too am double mastectomy patient. Had my surgery 5 1/2 years ago. Once got the letter about the recall I check for lump under my arm and sure enough I had one on my left side. I had an MRI that was originally read that my implants were intact and not leaking but needed an ultra sound and then biopsy of the lump. Turns out the lump is silicone. Back up a little, I thought I had saline until all this came up. So back to the resuls, I questioned how I could have silicon deposit of the implant was not leaking. So they re-read the MRI to find this time that it is actually leaking. So now I have to have my implants removed and replaced. The reason they used these implants is because they work best when you have no breast tissue for the implant to adhere to. So since I now have to have smooth implants that do not hold their shape when you don’t have breast tissue and the doctor will have to take tissue from other parts of my body to shape them. I too feel that Allergan should have to pay for any monies I have and will have to put out for this. I also feel that they should pay us for pain and suffering for having to go through this again. Not to mention the fact that we have to worry about possibly developing cancer again! I believe that God will protect me from it , but there is always that thought in the back of yoy mind. What can we do to get help with this?