Allergan Breast Implant Lawsuits

Allergan breast implant lawsuits claim Allergan Inc. and its subsidiaries did not properly warn women that their textured breast implants carried a risk of a type of cancer called breast implant–associated anaplastic large cell lymphoma, or BIA-ALCL.

Allergan Textured Breast Implant
Breast Implant Lawsuit Facts
  1. Injuries in Lawsuits A type of lymphatic cancer called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL)
  2. Defendants Allergan plc, Allergan Inc., Allergan USA Inc., Inamed Corporation (an Allergan subsidiary formerly known as McGhan Medical Corporation)
  3. Related Lawsuit Defendants Mentor Worldwide (a subsidiary of Johnson & Johnson)
  4. Litigation status Initial stages, no settlements or trials yet

On July 24, 2019, the Food and Drug Administration announced that it had found evidence that Allergan textured breast implants had a higher risk of BIA-ALCL than other textured implants.

The manufacturer issued a worldwide recall for several brands of its Biocell textured breast implants after the FDA requested the company pull the devices from the United States market. Allergan’s subsidiaries Inamed and McGhan manufactured some of the recalled devices.

The FDA has not linked smooth Allergan breast implants to cancer, and these are not involved in the recall.

Regulators in France, Australia, the United Kingdom and Canada have taken actions similar to those of the FDA.

So far, more than a dozen women have filed lawsuits in federal and state courts in the United States and in provincial courts in Canada, according to Allergan’s 2018 annual report.

Allergan Textured Breast Implants and Cancer

The main injury claimed in Allergan breast implant lawsuits is a rare type of cancer called breast implant–associated anaplastic large cell lymphoma, or BIA-ALCL. So far, the majority of reported cases worldwide involved Allergan’s textured implants, according to the FDA.

BIA-ALCL is not breast cancer. It is a type of non-Hodgkin lymphoma. These cancerous cells develop in scar tissue and fluid near the implant, and in some cases it can spread and lead to death.

Infographic showing how BIA-ALCL develops in the fluid or scar tissue
Expand
BIA-ALCL develops in the fluid or scar tissue surrounding the implant, not in the breast tissue like breast cancer does.

Treatment requires surgery to remove the implant and affected tissue. In some cases, patients require radiation and chemotherapy. Although, the disease is treatable, it can still cause trauma in patients.

“We cannot allow women to be unnecessarily harmed while we collect data,” Dr. Eric Swanson wrote in a February 2019 article in the Annals of Plastic Surgery. “Capsulectomies, positron emission tomography and computed tomography, the cost of medications (brentuximab is very expensive), and the emotional and financial impact of BIA-ALCL take a heavy toll on affected women, even if the disease is seldom fatal.”

Swanson wrote that some plastic surgeons feel it is time to abandon textured implants. He cited data from non-industry funded studies showing Allergan’s Biocell textured implants have more complications.

“The emotional and financial impact of BIA-ALCL take a heavy toll on affected women, even if the disease is seldom fatal.””

Dr. Eric Swanson, plastic surgeon, Swanson Center for Cosmetic Surgery

In addition to the BIA-ALCL risk, these implants also had greater incidences of seromas, or fluid pockets, compared to other implants. They also carried a greater risk of performance failure, pain, rupture and scar tissue around implant known as capsule.

Symptoms of Breast-Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Symptoms of BIA-ALCL mainly include persistent swelling or pain around the breast implant. These symptoms can occur several years after receiving the implant.

A doctor may find evidence of fluid collection around the implant or capsular contracture, which occurs when scar tissue squeezes the implant. Some women have reported lumps in their breasts.

When Did the FDA First Know About the Cancer Risk?

The FDA first identified a possible association between breast implants and anaplastic large cell lymphoma in 2011. But the agency said there were too few cases at the time to properly gauge the risk.
In 2016, the World Health Organization classified the disease as a type of T-cell lymphoma that developed after receiving breast implants.

In 2017, the FDA announced BIA-ALCL was primarily associated with textured implants.

The FDA held a public advisory committee meeting in March 2019 to discuss risks. Initially, the agency declined to recommend a recall. Then new data in July 2019 showed a spike in BIA-ALCL cases.

This data led to the July 2019 Allergan textured implant recall.

How Many Women with Allergan Implants Have Been Affected?

Of the 573 cases of BIA-ALCL reported worldwide, 481 (83.9 percent) were linked to Allergan implants, the FDA said.

Out of the 33 deaths reported, 13 were tied to specific manufacturers. Twelve of those 13 deaths were associated with Allergan’s implants.

American Women Affected
The FDA estimates hundreds of thousands of American women have Biocell breast implants.
Affected Allergan products include certain styles of:
  • McGhan BioDimensional Silicone-Filled Biocell Textured Breast Implants
  • McGhan Magna-Site Tissue Expander
  • McGhan Style 134 Croissant Shaped Tissue Expander
  • Natrelle 133 Plus Issue Expanders
  • Natrelle 133 Tissue Expanders with and without suture tabs
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
  • Natrelle Inspira Silicone-Filled Breast Implants
  • Natrelle Saline Breast Implants
  • Natrelle Silicone-Filled Breast Implants
  • Style 133 Biospan Tissue Expander

If you are unsure if you have a Biocell textured implant, check with your plastic surgeon.

Plaintiffs: Manufacturer Failed to Warn About Cancer Risk

Plaintiffs in Allergan’s textured breast implant lawsuits allege the devices caused women to develop BIA-ALCL. They further allege that the defendants failed to adequately warn against this risk and failed to promptly and properly report the results of the post-marketing studies relating to these products, according to Allergan’s 2018 annual report.

Two of the women who have filed lawsuits are Vivian Skelton and Sandra Rush.

Vivian Skelton’s Allergan Natrelle Silicone Breast Implant Lawsuit

Vivian Skelton filed her lawsuit against Allergan and its subsidiaries in March 2018 in California. She had Allergan Natrelle Silicone Breast Implants implanted in May 2014.

After the surgery, she experienced pain, discomfort, fatigue and swelling in her left breast. Throughout the two years that followed, she suffered constant pain and fluid buildup. She went through several MRIs and ultrasounds and two revision surgeries.

“[Allergan] disseminated false information, in that they engaged in false and misleading sales and marketing tactics, touting the aesthetic beauty of breast augmentation and minimizing the risks.”

Skelton v. Allergan Inc. et al.

Ultimately, an MRI in February 2016 revealed skin thickening, swelling and cysts up against the implant. Doctors diagnosed her with BIA-ACLC and removed the implant. She underwent several rounds of chemotherapy and suffered several complications, including cognitive dysfunction that required her to stay in a rehab facility.

Skelton’s lawsuit claims Allergan “disseminated false information, in that they engaged in false and misleading sales and marketing tactics, touting the aesthetic beauty of breast augmentation and minimizing the risks, which reached physicians, the medical community, and the public with knowledge that the information was, in fact, false and misleading.”

Sandra Rush’s Lawsuit Involving McGhan Textured Saline Implants

Sandra Rush filed her lawsuit against Allergan and its subsidiaries in May 2019 in New Jersey. Rush had had McGhan textured saline implants implanted in 1995. In 2017, she noticed her left breast had become swollen and sore.

After a mammogram and biopsy, doctors diagnosed her with BIA-ALCL. She had surgery to remove the implant and additional surgery to reconstruct her breast with her abdominal fat.

The cancer had spread, and she had to undergo treatment for stage 4 BIA-ALCL. Tests showed she had cancer cells in her spine, pelvis, jaw, bone marrow and skin.

She had five cycles of chemotherapy as well as a bone marrow transplant, and she had to leave her job. As a result, Rush suffered from depression, nausea and insomnia.

“Despite Defendants’ knowledge of an association between breast implants and ALCL dating back to the 1990’s, Defendants purposefully failed to comply with their clearly established post-market surveillance obligations and in doing so have exposed many hundreds of thousands of women to life-altering and avoidable cancer,” Rush said in her lawsuit.

Is There an Allergan Breast Implant Class Action?

So far, no class action lawsuits have been filed on behalf of women diagnosed with BIA-ALCL after receiving Allergan textured implants.

But according to the International Consortium of Investigative Journalists, investors have filed a class action lawsuit claiming Allergan plc headquartered in Dublin, Ireland, concealed the link between its textured implants and the rare type of lymphoma. The suit also claims Allergan failed to inform investors that the safety findings threatened regulatory approvals in Europe.

Shareholders Accuse Allergan of Fraud
Thomas F. Cook’s lawsuit claimed Allergan “employed devices, schemes, and artifices to defraud” shareholders and mislead them about its textured breast implants.

Thomas F. Cook filed the class action in New York on Dec. 21, 2018.

“Allergan misled investors by boasting about various ‘pharma and device approvals,’” Cook’s lawsuit claims. “The truth was revealed on December 19, 2018, when the Company announced that it had suspended the sale of [textured breast implants and tissue expanders] and that it was withdrawing all remaining supplies from European markets.”

The lawsuit came after Allergan announced it had lost its textured implant CE Mark, a European safety certificate needed to sell its devices in 33 European countries.

The French accredited certification firm LNE G-MED did not renew the company’s CE Mark because of it wanted to see further data from Allergan before re-issuing the safety certificate, the International Consortium of Investigative Journalists reported.

Meanwhile, French regulator Agence Nationale de Sécurité du Médicament asked Allergan to recall batches of affected products from all French hospitals.

“Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and this action, is not based on any new scientific evidence regarding these products,” Allergan said in a Dec. 19, 2018, press release regarding its decision to suspend sales and withdraw textured breast implants in Europe.

Please seek the advice of a medical professional before making health care decisions.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

17 Cited Research Articles

  1. Allergan. (2018, December 19). Allergan Suspends Sales and Withdraws Supply of Textured Breast Implants in European Markets. Retrieved from https://www.allergan.com/news/news/thomson-reuters/allergan-suspends-sales-and-withdraws-supply-of-te
  2. Allergan. (2018, December 19). FAQ on CE Mark Non-Renewal of Textured Breast Implants and Textured Tissue Expanders. Retrieved from https://www.allergan.com/getmedia/c305b7a3-f3c8-46e6-9ff0-378247d23184/FAQ-on-CE-Mark-Non-Renewal-of-Textured-Breast-Implants-and-Textured-Tissue-Expanders-121918.aspx
  3. Allergan. (2018, December 31). Form 10-K for Year Ended December 31, 2018. Retrieved from https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allerganinvestors/financial-information/proxy-materials/2018_10-k.pdf
  4. Allergan. (2019, August 2). Withdrawn Affected Product Names and Styles. Retrieved from https://www.allergan.com/getmedia/a39a1e7c-ef2d-4054-9bd0-0fb05bf69402/BIOCELL-styles-recall.aspx
  5. Associated Press. (2019, July 24). Allergan recalls textured breast implant tied to rare cancer. Retrieved from https://www.statnews.com/2019/07/24/allergan-recalls-textured-breast-implant-tied-to-rare-cancer/
  6. Bowers, S. & Boland-Rudder, H. (2018, December 19). Allergan Textured Breast Implant Sales Halted in Europe Amid Safety Controversy. Retrieved from https://www.icij.org/investigations/implant-files/allergan-textured-breast-implants-recalled-in-europe-pending-safety-review/
  7. Chavkin, S. (2019, January 9). Allergan Faces Fresh Woes As Investors Sue. Retrieved from https://www.icij.org/investigations/implant-files/allergan-faces-fresh-woes-as-investors-sue/
  8. Cook et al. v. Allergan PLC et al. (2018, December 21). Class Action Complaint for Violation of the Federal Securities Laws. Retrieved from http://securities.stanford.edu/filings-documents/1068/Ap300_03/20181221_f01c_18CV12089.pdf
  9. Fox, M. (2017, March 21). Breast Implants Can Cause Rare Form of Cancer, FDA Says. Retrieved from https://www.nbcnews.com/health/health-news/fda-affirms-breast-implants-can-cause-rare-form-cancer-n736551
  10. Lim, D. (2018, December 20). Allergan loses CE mark for textured breast implants, opening EU market. Retrieved from https://www.medtechdive.com/news/allergan-loses-ce-mark-for-textured-breast-implants-opening-eu-market/544885/
  11. Rush v. Allergan et al. (2019, May 10). Complaint and Demand for Jury Trial. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-5-10-bia-alcl-rush-complaint.pdf
  12. Skelton v. Allergan et al. (2018, March 2). Complaint for Damages, Demand for Jury Trial. Retrieved from http://securities.stanford.edu/filings-documents/1068/Ap300_03/20181221_f01c_18CV12089.pdf
  13. Swanson, E. (2019, June). The Textured Breast Implant Crisis: A Call for Action. Retrieved from https://journals.lww.com/annalsplasticsurgery/Fulltext/2019/06000/The_Textured_Breast_Implant_Crisis__A_Call_for.1.aspx
  14. The American Society for Aesthetic Plastic Surgery. (n.d.). BIA-ALCL Frequently Asked Questions. Retrieved from https://www.surgery.org/sites/default/files/BIA-ALCL-FAQ-3.pdf
  15. U.S. Food and Drug Administration. (2019, August 7). The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
  16. U.S. Food and Drug Administration. (2019, July 24). FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
  17. U.S. Food and Drug Administration. (2019, July 24). Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
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