Silicone breast implants have been reported to rupture, leak and fail over time, and have been linked to severe health complications including a rare type of cancer, according to the U.S. Food & Drug Administration (FDA).
Free Confidential Lawsuit Evaluation: If you or a loved one has been diagnosed with cancer or had a doctor suggest breast implant removal because of a predisposition of cancer, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
Silicone breast implants were a huge problem back in the 1990s. While manufacturers of the implants maintained that their products were completely safe, many women were convinced their implants were causing a wide range of serious health complications.
Silicone implants became so problematic that they were banned by the U.S. Food & Drug Administration (FDA) from 1992 until 2006. Most of the manufacturers either went out of business, abandoned the market, or filed for bankruptcy in an effort to insulate themselves against lawsuits. Despite lingering doubts by many, FDA actually allowed silicone implants back onto the U.S. market in 2006.
Breast Implant Lymphoma FDA Warning
In January 2011, the FDA issued a warning which advised women with breast implants to notify their doctors of any changes in their breasts because of a potential association with a rare type of cancer known as anaplastic large cell lymphoma (ALCL). In breast implant recipients, ALCL has occurred in the scar capsule adjacent to the implant.
FDA’s warning was based on a review of scientific literature which found at least 34 cases of ALCL in women with both saline and silicone breast implants. The agency said it was aware of about 60 cases of the disease in breast implant recipients worldwide.
Signs and symptoms of anaplastic large cell lymphoma include:
- Breast Pain
- Lump in the breast
- Asymmetry that develops after breast implant surgery sites were fully healed
J&J Sued Over Leaking Mentor Breast Implants
A lawsuit has been filed against Johnson & Johnson’s Mentor Worldwide unit for allegedly selling defective breast implants that are causing health problems for some women, including muscle pain and nausea. The suit, which was filed in California on February 2, 2017, accuses Mentor of failing to conduct government-mandated studies on the potential health risks of its silicone implants. Leaks from the implants are causing a variety of ailments for Plaintiff Rexine Mize and other women, according to the lawsuit.
Breast Implant Problems
- Implant Rupture
- Capsular Contracture (implant too tight)
- Leaking Implant
- Toxic shock syndrome
- Implant failure
- Removal surgery
- Revision surgery
- Anaplastic Large Cell Lymphoma (ALCL)
- Lung Cancer
- Neurological Diseases
- Rheumatological Problems
- Autoimmune Diseases
- Chronic Fatigue Syndrome
- Esophageal Motility
- Raynaud’s Syndrome
- Multiple Sclerosis
- Connective Tissue Diseases
- Systemic Fungus
- Sjogren’s Syndrome
- Breast pain
- Upper or lower back pain
- Chemical sensitivity
- Muscle pain and/or stiffness
- Hair loss
- Achy or swollen joints
- Sensitivity to sunlight
- Kidney problems
- Rheumatoid arthritis
- Difficulty swallowing and/or breathing
- And more
- 1895 – Austrian-German surgeon Vincenz Czerny performs the first breast reconstruction on a woman at the University of Heidelberg.
- 1945 – Japanese prostitutes catering to U.S. military men begin injecting industrial silicone directly into their breasts.
- 1962 – Thomas Cronin and Frank Gerow invent the silicone breast implant.
- 1976 – FDA begins regulating silicone breast implants.
- 1982 – FDA classifies breast implants as Class III Medical Devices amid “reports of adverse events in the medical literature.”
- 1991 – Jean-Claude Mas establishes Poly Implant Prothese (PIP) in southern France.
- December 1991 – Mariann Hopkins awarded $7.3 million settlement from Dow Corning over health issues linked to ruptured breast implants.
- January 1992 – FDA calls for a voluntary moratorium on the use of silicone gel breast implants until safety has been reviewed.
- March 1992 – Several major medical manufacturers including Dow Corning, Bristol-Myers Squibb (BMS) and Bioplasty withdraw from the silicone implant market.
- April 1992 – FDA recommends that silicone breast implants should only be used for reconstruction after surgery or to correct congenital deformities.
- May 1995 – Facing a massive number of lawsuits, Dow Corning files for Chapter 11 bankruptcy; litigation was halted by the filing.
- 1996 – PIP begins selling saline implants in the U.S., but its failure to gain pre-market approval from the FDA in 2000 cuts off that key market.
- 2000 – France lifts its ban on silicone implants.
- December 2000 – The UK bans PIP hydrogel implants after finding that the manufacturer’s biological safety assessment is inadequate.
- 2006 – FDA lifts restrictions on silicone breast implants, approving them for cosmetic use in women aged 22 years and older.
- 2010 – Breast implantation is the most popular form of plastic surgery in the U.S. with 318,123 augmentations performed, 62% of which used silicone implants.
- March 2010 – France’s health regulator, AFSSAPS, orders the withdrawal of silicone breast implants manufactured by PIP. The company subsequently files for bankruptcy.
- December 2011 – France’s health minister announces that the 30,000 French women with PIP implants should have them removed and it will pay for the operations.
- January 26, 2012 – Mas and CEO Claude Couty are arrested.
Based on the relatively small body of research conducted to date on anaplastic large cell lymphoma, frequency of the disease ranges anywhere from 1 in 3,000 women with breast implants to 1 in 30,000. About 1.5 million women in the U.S. get breast implant each year, according to People.
BIA-ALCL is not classified as a cancer of the breast tissue, but the disease almost always appears on or near the implant site. Physicians are asked to watch cautiously any patients with new swelling, lumps or pain around breast implants.
Implants are manufactured with either smooth or textured exteriors and saline or silicone gel interiors, FDA said. Most cases of anaplastic large cell lymphoma have been diagnosed in women with textured breast implants. However, it’s important to note that the lymphoma has been found in women who were implanted with the smooth variety as well.
Most women who go on to be diagnosed with BIA-ALCL are tipped off to the presence of the cancer due to symptoms such as pain, lumps, swelling, or asymmetry in the boobs that developed after they were fully healed.
The condition manifests similar to chronic fatigue syndrome, with aches and breathing problems, and there’s little speculation and even less research into what about the implants may be causing the disease.
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” said Dr. Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.
Are Lawsuits Being Filed?
Yes. There are currently a number of lawsuits pending against breast implant manufacturers:
- In 2012, an Arizona woman filed a lawsuit (PDF) against Allergan, alleging that she suffered a number of complications from Natrelle silicone breast implants, including neurological problems and vision loss. Plaintiff received the implants in 2009 and was subsequently required to undergo a bilateral mastectomy due to breast cancer. She alleges that Allergan Natrelle breast implants were defectively designed and also claims that she was unwittingly enrolled in a safety study without consent.
- A Seattle woman filed a lawsuit (case no. 2:16-cv-07316-DMG) in September 2016 against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging that the companies failed to follow requirements imposed by the FDA in connection with Mentor’s premarket approval application. The suit also accuses the manufacturers of failing to warn of the potential health risks of breast implant surgery.
- A product liability lawsuit filed in California in February 2017 alleges that breast implants sold by Johnson & Johnson’s Mentor subsidiary are defective and prone to leaks. The complaint was filed by Plaintiff Rexine Mize, who claims that leaking breast implants caused her severe muscle pain, nausea and other health problems.
What is Breast Implant Illness?
Breast Implant Illness (BII) is a complication of breast implants in which the woman experiences a variety of symptoms, including (but not limited to):
- Chest pain
- Hair loss
- Chronic pain
- Body odor
- Brain fog
- Sleep disturbance
- Neurologic / hormonal problems
Can I Participate in a Class Action?
There are currently several class action lawsuits pending on behalf of victims of defective breast implants. Settlements are currently being handled for Dow Corning breast implants for Class 5 claimants, in addition to cases involving implants that contain silicone gel for Class 7 claimants. Our lawyers will be able to explain the requirements needed to participate in each of these class action lawsuits.
Do I Qualify to File a Claim?
You may be eligible to file a breast implant lawsuit if you had an illness or a loved one died after receiving a breast implant made by:
• Dow Corning Corporation
• McGhan, Mentor, CUI or Bioplast
• Baxter Health Care
• 3M Corporation
• Bristol-Meyer Squibb
Breast Implant Surgery Leaves Teen With Brain Damage
Dec. 20, 2019 – A Colorado family is suing a doctor and a nurse anesthetist, claiming that their daughter suffered 2 cardiac arrests and brain damage during breast implant surgery in Greenwood Village, according to CBS 46. The patient, 18-year-old Emmalyn Nguyen, was left unattended for 15 minutes after being given anesthesia by nurse anesthetist Rex Meeker, according to the lawsuit. During that time, Nguyen went into cardiac arrest and was revived, but then went into cardiac arrest a second time. The staff failed to call 911 for more than 5 hours, leaving Nguyen in a “minimally conscious state” — unable to speak, walk, eat or take care of herself, a condition she will likely be in for the rest of her life.
“To me it’s a miracle she pulled through all that and she is still fighting this,” said Sonny Nguyen, Emmalyn’s father. “I don’t know how they can sleep at night knowing they did this to her. They ruined Emmalyn’s life, not just hers but all of ours.”
Illinois Woman Sues Allergan for Not Recalling Breast Implants Sooner
September 24, 2019 – A woman from Illinois on Friday filed a class action lawsuit against Allergan Inc., alleging that the company knew about the risk of cancer with its textured breast implants long before it recalled the devices, according to Law360. Plaintiff Lana Tauben further claims Allergan used an FDA loophole to bury adverse event reports associated with the implants, and it wasn’t until 2017 when the agency tightened its requirements that many of the injuries were made public.
“The FDA even acknowledges there was a ‘transparency issue’ until recently with the reporting of adverse event reports,” Tauben said. “The FDA said the increase in adverse event reports reflected the FDA’s implemented change in reporting requirements in 2017 and not ‘a new public health issue.’”
Plaintiff is seeking to represent a class of women in Illinois who received Allergan breast implants. Her suit alleges damages of negligence and violations of the Illinois Consumer Fraud and Deceptive Business Practices Act.
The lawsuit is: Tauben v. Allergan PLC, Allergan Inc and Allergan USA. U.S. District Court for the Central District of Illinois. Case Number 1:2019cv02257.
Allergan Won’t Pay for Breast Revision Surgery After Failing to Warn About Textured Implants, Class Action Alleges
August 29, 2019 – A new class action lawsuit is claiming that Allergan Inc. used regulatory loopholes to hide a link between its textured silicone implants and breast-implant-associated anaplastic large-cell lymphoma (BIA-ALCL), and is now refusing to pay for surgery to remove the implants following a worldwide recall. The complaint, filed in California federal court, alleges that Plaintiffs “A.B.” and “C.D.” were diagnosed with BIA-ALCL after receiving Allergan textured breast implants, and are now being forced to pay out of their own pockets to have the implants removed.
According to the class action, there are 573 cases of BIA-ALCL known in the medical literature, and 84% of them have been linked to Allergan textured implants. Of the 33 patients who died, 12 had received Allergan Biocell implants, the complaint states.
Furthermore, Allergan used an antiquated FDA loophole to avoid publicly disclosing the risk of ALCL for years, even after issuing a worldwide recall for its Biocell implants, according to the class action.
Allergan Recalls Breast Implants Linked to Cancer
July 24, 2019 – Allergan Inc. issued a worldwide recall on Wednesday for its textured breast implants over concerns the devices may increase the risk of anaplastic large cell lymphoma (ALCL), according to an FDA News Release. The agency said it asked Allergan to issue the recall after new data indicated that the company’s Biocell breast implants with a textured surface account for a higher incidence of ALCL compared to smooth breast implants. The move follows similar recalls in France, Australia and Canada.
Canada Bans Allergan Breast Implants
June 3, 2019 – Health Canada, the federal department responsible for helping Canadians maintain and improve their health, has suspended sales of Allergan Biocell breast implants due to an increased risk for breast cancer, according to CBC.
The agency initiated the recall following results of a 2017 safety review on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which found at least 26 confirmed Canadian cases of BIA-ALCL (85% of which involved Biocell breast implants).
Based on the cumulative data, Health Canada estimates that the risks of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.
Dozens More Lymphoma Cases Linked to Breast Implants, FDA Warns
February 7, 2019 – February 7, 2019 – At least 457 women in the U.S. have been diagnosed with anaplastic large cell lymphoma, FDA said in its warning. Of these, 9 died as a result of complications from the disease. ALCL is a rare cancer that affects cells in the immune system, and can be found around the breast implant.
FDA first warned about the risk of lymphoma with breast implants in 2011, saying there was a small but significant risk of developing the cancer after getting breast implants. It asked doctors whether they’d noticed changes in their patients and urged women to check for symptoms such as fluid buildup or a mass around their implants
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants,” FDA said.
Along with its most recent warning, FDA also issued a separate letter to medical professionals discussing the link between breast implants and anaplastic large cell lymphoma.
“We want all healthcare providers to be aware … particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy,” the agency said. “We are also asking health care providers to report to the FDA cases of Breast Implant Associated – Anaplastic Large Cell Lymphoma. (BIA-ALCL) in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.”
Most cases of ALCL occurred in women who had received implants with textured surfaces, rather than smooth surfaces. The cancer is slow-growing and treatable when diagnosed early.
“When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle,” FDA said.
Most people are diagnosed with ALCL at an advanced stage (stage 3 or 4), which means the cancer has likely spread to other parts of the body. Symptoms depend on the stage of the disease, but in general consist of:
- Swollen lymph nodes (glands)
- Night sweats
- Weight loss
FDA Update on Breast Implant ALCL Link
March 21, 2017 -The FDA has updated its understanding on the risk of anaplastic large cell lymphoma (ALCL) with breast implants, stating that the cancer is more likely to occur in women whose implants have textured surfaces.
According to an FDA Safety Alert issued Tuesday, most data suggests that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) occurs more frequently in women with textured breast implants compared to those with smooth implants.
ALCL is a rare form of non-Hodgkin’s lymphoma that occurs when white blood cells called lymphocytes grow out of control. The condition typically occurs in patients undergoing implant revision operations for late onset, persistent seroma, according to the FDA.
As of February 1, 2017, FDA has received at least 359 medical device reports (MDRs) of BIA-ALCL, including 9 deaths. There were 231 reports that included information on the breast implant surface.
Of these, 203 reports involved textured implants and 28 involved smooth implants. Most of the reports contained no information about the surface textures of any previous implants.
Additionally, 312 of the 359 reports included information on implant fill types. Of these, 186 involved silicone implants and 126 involved saline implants.
Signs and symptoms of anaplastic large cell lymphoma include:
- Breast pain
- Lump in the breast
- Asymmetry that develops after breast implant surgery sites were fully healed
FDA is advising women who are considering breast implants to talk to their doctor about the potential benefits and risks of textured-surface vs. smooth-surfaced implants before undergoing surgery.
Do I Have a Breast Implant Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in breast implant lawsuits. We are handling individual litigation nationwide and currently accepting new breast implant complications cases in all 50 states.
Again, if you or a loved one has been diagnosed with cancer or had a doctor suggest breast implant removal because of a predisposition of cancer, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our attorneys can help.