Breast Implant Surface Texturing Process Causes Lymphoma, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed recently against Allergan, the texturing process used to manufacture its now-recalled Biocell breast implants increased the risk of women developing a rare type of cancer, now commonly known as breast implant anaplastic large cell lymphoma (BIA-ALCL).

Michelle Forney and her husband, John, filed a complaint (PDF) in the U.S. District Court for the District of New Jersey on April 23, claiming that Allergan failed to warn consumers about the known risks and problems linked to the Biocell line of breast implants.

The lawsuit also accuses the manufacturer of recklessly and continually failing to meet the FDA’s Premarket Approval Application requirements with the implants, blaming the surface texturing process for creating the unique cancer risk associated with the breast implants.

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Women may face a risk of Anaplastic Large Cell Lymphoma (ALCL) from certain breast implants.

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Forney, of California, received McGhan Biocell saline-filled breast implants in 1999. McGhan was later acquired by Allergan, Inc.

“In 2015, Mrs. Forney started to develop strange symptoms including horrible itching and pain in her right breast,” the lawsuit states. “She went to 6 medical providers to try to determine the problem and received multiple mis-diagnoses, including capsular contracture, mastitis, herpes, shingles, and various infections.”

Her condition was not properly diagnosed until 2018, when she got her right breast implant removed. Surgeons found “dozens of tumors” on the capsule around the implant, and pathology results tested positive for BIA-ALCL.

Allergan was forced to issue a worldwide breast implant recall last year, removing all products from the market that featured the macrotextured design, after federal regulators in the United States determine nearly all reported cases of BIA-ALCL were linked to the design.

The breast implant cancer involves a type of non-Hodgkins lymphoma that may develop in the tissue surrounding the implant. As a result of the risk, dozens of women nationwide have filed claims against the manufacturer, alleging that they may have avoided a cancer diagnosis if the manufacturer had not intentionally covered up the problems and misled patients and the medical community.

According to the lawsuit, the manufacturing process led to variable roughness in the texture of the implants, due to a process known as “salt loss.”

This lawsuit, and other recently filed complaints, have pointed to the use of salt crystals and scrub brushing of the implants, in a process meant to abrade the implant shells after curing with salt and remove any remaining salt, as a potential cause for increased breast implant cancer risks. Forney’s lawsuit suggests that the manual scrubbing results in variable results which can leave behind randomly-arranged cubic indentations, ruptured silicone domes and torn silicone fragments.

Forney’s complaint joins dozens of other breast implant ALCL lawsuits, as well as a growing number of claims presented by women who did not develop the cancer, but indicate that they either had the implants removed or plan to do so, in order to protect their safety.

In the federal court system, at least 50 complaints over the breast implant cancer problems have been consolidated as part of a multidistrict litigation (MDL) in the District of New Jersey, where U.S. District Judge Brian R. Martinotti is presiding over all pretrial proceedings to reduce duplicative discovery into common issues in the claims, avoid conflicting schedules and orders, and serve the convenience of common witnesses, parties and the judicial system.

As more women undergo procedures to have breast implants removed due to the cancer problems, or receive a diagnosis of BIA-ALCL, the size and scope of the litigation is expected to continue to expand over the coming months.

2 Comments

  • CAWSMay 20, 2021 at 1:05 pm

    Your doctor lied. Saline implants are way more dangerous than advertised.The product package insert states that they EXPIRE in 36 months when stored at room temperature! Then they put them in a 98.6 degree body for 10-20 years and expect us to be ok. Fact is it is the VALVES that fail; they begin to AUTOINFLATE, squiring out a little bit of sterile saline water when squeezed and then sucking in yo[Show More]Your doctor lied. Saline implants are way more dangerous than advertised.The product package insert states that they EXPIRE in 36 months when stored at room temperature! Then they put them in a 98.6 degree body for 10-20 years and expect us to be ok. Fact is it is the VALVES that fail; they begin to AUTOINFLATE, squiring out a little bit of sterile saline water when squeezed and then sucking in your body fluids. These then grow in a warm ,dark, moist ecosystem just about an inch from your lungs & heart. The body forms a scar capsule in an attempt to protect the body; but after a while the silicone bag breaks down and leaks out. By this time the bags are teaming with bacteria,virus,fungus and /or parasites. These flood your system and depending on how toxic [and your immune system strength] can do serious damage including paralysis & death. Telling a patient to leave broken implants in is malpractice and very dangerous. If possible the remaining one should be explanted whole for analysis and THE CAPSULE SHOULD ALWAYS BE REMOVED as it is always full of pathogens. I nearly died from pneumonia & pleurisy twice. Once at the 37 month mark when valves began to fail and again at the 16 year mark right before the right on broke. Five surgeons told me it was ok to wait while my shoulder became immovable. It took TWO surgeons 2.5 hours to dig the textured under the muscle saline implants & capsules out of my chest without puncturing my lungs. I lost a pint of blood and had to wear drains for 5 days. I shipped the devices off to Dr Pierre Blais; world's leading expert on implant failure , for analysis. They were piss yellow inside and full of pathogens especially fungus which has been a particular problem for me. I have now been diagnosed with "mild" interstistal lung disease which they can't attribute to smoking or asbestos ; though I am loath to let them invade my lungs to prove it is from the silicone seeping into my lungs as there is no cure for this anyway. Blais has been fighting the Canadian FDA for 50 years trying to warn them about the dangers of breast implants & even won in court against them but the industry is too powerful and money too great. Please tell anyone thinking of doing this the real story.

  • PamelaMay 1, 2020 at 2:53 am

    I had Mentor, Textured Implants,Saline Under Muscle. I had a rupture during a mammogram. I went to my P.S. and he refused to remove it. He told me he had known women to just bust the other one to match it. He said he would replace two,but I could not afford it. I had a warranty. I was implanted in 1999, explanted in 2018. I can not find a lawyer. I am going to die from this. He told me it wou[Show More]I had Mentor, Textured Implants,Saline Under Muscle. I had a rupture during a mammogram. I went to my P.S. and he refused to remove it. He told me he had known women to just bust the other one to match it. He said he would replace two,but I could not afford it. I had a warranty. I was implanted in 1999, explanted in 2018. I can not find a lawyer. I am going to die from this. He told me it would not hurt me if left in, because it was Saline. I did not know it was incapsuled in silicone. It was my left breast. It affected my lungs. When I explanted the P.S. then stabbed the one that was not ruptured inside me. Well that side got huge. Had a bad infection, had green coming out of me.I did not go back to him. I immediately got all the surgical records. I had to go back to hospital and have another surgery.I was told by Dr. Chen he did care how long it takes to remove textured implant, you get it out in one piece. One layed on left side ruptured for 14 yrs. Then he did that on explant. He called me at my home wondering why I did not go back. I told him I had a very interesting conversation with another P.S. about a situation. Never said it was me,to the other P.S.'s.I just asked what the proper way to remove a textured under muscle implant. They told me all in one piece due to bacteria buildup in the crevices. So I told him he improperly removed my implant,and most likely caused the second operation. He disagreed. He said after stabbing it he scrubbed my chest wall with a scrubber. Dr. Chen said I will most likely need another operation. Because there was no way he got it all. But I now have a lung disease. Systemic Sclerosis with Anti,RNA polymerase 111 Both lungs are shot. I also had a hair test done ,showed aluminum toxicity poisoning. The doctor told me I had silicosis, caused from silicone. Also had ANA test ran. Complete blood work up. It's all in my system. Renal failure, I live on oxygen. I have all my records from beginning to the end. That includes the explant records. I asked the P.S. before explant to keep my implants ,that I wanted them. He did not tell the hospital. I talked to them. They said they only keep them for 30 days. If you can help me or advise me please let me know, thank you

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