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.
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.
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.””
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.
- 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.”
Ultimately, an MRI in February 2016 revealed skin thickening, swelling and cysts up against the implant. Doctors diagnosed her with BIA-ALCL 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.
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.