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Breast Implant Lawsuit

Breast Implant Lawsuit

Two decades ago, $4 billion was paid in a massive class action settlement to approximately 450,000 women who got sick from toxic breast implants leaking silicone. Lawsuits now accuse manufacturers of failing to test the implants for safety after the FDA lifted a 14-year ban in 2006.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting breast implant induced injury cases in all 50 states. If you or somebody you know has been diagnosed with side effects of silicone breast implants, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Breast Cancer Survivors at Risk of Lymphoma

Breast cancer survivors often undergo a double mastectomy to reduce the risk of their cancer returning. When implants are used in reconstructive surgery, there is a low risk of developing lymphoma as a result of the implants. One breast cancer survivor from Missouri said:

“My whole world came crumbling down again. I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer.”

Breast Implants Linked to 400+ Reports of Lymphoma

In March 2017, the FDA confirmed that breast implants are associated with Anaplastic Large-Cell Lymphoma (ALCL), a rare but fast-growing type of non-Hodgkin lymphoma. The agency received over 350 reports of ALCL in women with breast implants, including 9 women who died. Textured implants have the highest risk of ALCL.

A few weeks later, health officials in Australia reported 51 cases of ALCL in women with breast implants since 2007, including 3 deaths. All of the cases involved women with textured or polyurethane breast implants.

Problems With Textured Breast Implants

Recent studies have found that bacterial coatings (biofilm) on textured breast implants may trigger low-level infections, inflammation, and seroma (fluid buildup around the implant). The symptoms of ALCL may include:Breast Implant ALCL Lawyer and Lawsuits

  • Breast pain
  • Swelling or lumps
  • Asymmetry of the breast
  • Fever
  • Loss of appetite
  • Tiredness
  • Night sweats
  • Weight loss
  • Painless swelling in the armpit, neck or groin
  • Enlarged lymph nodes

Breast Implant Lawsuit Update 2017

In January 2017, a lawsuit was filed in Los Angeles by a woman who suffered health problems when her Mentor MemoryGel breast implants leaked silicone in her body. Her lawyer told Bloomberg, “We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women. This suit may be just the tip of the iceberg.”

Mentor MemoryGel Lawsuit Filed in California

In September 2016, another lawsuit (PDF) was filed by a woman from Seattle who experienced fatigue, nausea, skin rashes, heavy metal poisoning, and other health problems that she blames on “systemic toxicity due to her body’s reaction to the toxic elements contained within the gel of the implants.”

$4 Billion Breast Implant Class Action Settlement

Breast implant lawsuits are nothing new. Around 450,000 women who were injured filed lawsuits and joined class action lawsuits in the 1980s and 1990s after studies found evidence of tissue disease. After several multi-million dollar jury awards, Dow Corning Corporation offered a $4 billion settlement and went bankrupt in 1995.

Breast Implant Lawsuit Settlement Amounts

In 1998, $3.2 billion in lawsuit settlements were paid to thousands of women who were injured by silicone breast implants. The payouts averaged $26,000 (or roughly $20,000 for a ruptured implant and $5,000 for surgery) plus between $10,000 and $250,000 for diseases.

FDA Lifts 14-Year Ban on Silicone Breast Implants

The FDA banned silicone breast implants in 1992 due to concerns about side effects and a lack of long-term safety data. In 2006, under pressure from the industry, the FDA agreed to lift the 14-year ban — but required manufacturers to complete several massive studies.

What Happened With the Safety Studies?

Mentor Worldwide became the first company allowed to sell silicone breast implants 2006. In exchange, Mentor was required by the FDA to enroll 80,000 women in 6 long-term safety studies lasting 10 years.

Only 3 years into the 10-year study, Mentor “lost track” of 79% of women who signed up when the study began. As a result of the massive dropout rate, the entire study was essentially meaningless.

Other manufacturers had similar problems. Allergan “lost track” of 40% of women with silicone breast implants just 2 years into a 10-year safety study. Low participation makes the studies completely useless for detecting rare side effects like cancer.

Studies do not show evidence that silicone gel-filled breast implants cause connective tissue disease, reproductive problems, or breast cancer. Low follow-up rates and other study limitations may limit interpretation of the data and preclude the detection of very rare complications.

What are Silicone Breast Implants?

Silicone gel-filled breast implants have an outer shell of silicone that is filled with silicone gel. They may contain toxic chemicals or heavy metals left over from the manufacturing process. This is also true for “cohesive gel” or “gummy bear” silicone implants that have recently become popular because they are advertised as leak-resistant.

List of Silicone Breast Implants

  • Allergan Natrelle
  • Allergan Natrelle Cohesive Silicone Gel Implants
  • Mentor MemoryGel
  • Mentor MemoryShape
  • Sientra Silicone Gel Breast Implants

“Ticking Time Bomb” in Millions of Women

Breast implants are advertised as safe and permanent — but the reality is they are NOT lifetime devices. Nearly all of them will eventually rupture and leak. Even intact implants commonly “sweat” out silicon or platinum through the shell (called “gel bleed”). Breast implants can also pop open or break suddenly without causing any symptoms. This is called a silent rupture and it is why the FDA recommends MRI screening at 3 years post-implant and every 2 years afterward.

Symptoms of Leaking Breast Implants

  • Decrease in breast size
  • Change in breast shape
  • Hard lumps over the implant or chest
  • Pain or tenderness
  • Tingling
  • Swelling
  • Numbness
  • Burning sensation

What Happens When Breast Implants Leak?

Silicone is thicker than saline (salt-water), so when a silicone gel-filled breast implant ruptures, the gel may stay in the shell or the capsule of scar-tissue surrounding the implant. This is the best-case scenario.

The worst-case scenario — and far more common — is that silicone leaks outside the capsule surrounding the implant and is absorbed by the body. The leaked silicone may travel (migrate) away from the breast and create lumps in the lymph nodes, chest wall, or armpit. It is usually impossible to remove all silicone gel in other parts of the body.

What is Silicone Sickness?

“Silicone sickness” is a whole-body illness that occurs when toxins trigger an immune response. Leaking breast implants are known to cause tissue inflammation and foreign body reactions when the body rejects the implant. Silicone leaking out of breast implants might also cause life-threatening tissue diseases like scleroderma or systemic sclerosis — but without adequate safety studies, no one knows for sure.

What is the Risk?

Dr. Edward Melmed, a plastic surgeon in Dallas, Texas, spoke at a 2-day meeting when the FDA was considering recalling all silicone breast implants due to a lack of long-term safety data in 2011. He called silicone an “industrial toxin” and also warned that 50% of silicone breast implants rupture by 10 years, 72% by 15 years, and 92% by 20 years.

FDA Warning Links Breast Implants and Cancer

The FDA issued a warning about a possible risk of Anaplastic Large-Cell Lymphoma (ALCL) from breast implants in 2011. The risk was low, with about 60 cases worldwide out of millions of women with breast implants. The FDA updated this warning in 2017 after 350 cases of ALCL were reported. ALCL is an immune system cancer that occurs in cells that attack toxins. It is a fast-growing subtype of Non-Hodgkin Lymphoma.

Signs & Symptoms of Silicone Sickness

  • Fatigue and weakness
  • Breast pain
  • Connective Tissue Disease (CTD)
  • Lupus
  • Joint or muscle pain
  • Rheumatoid arthritis
  • Cognitive dysfunction (brain fog, memory loss)
  • Toxic Shock Syndrome
  • Fibromyalgia diagnosis
  • Systemic sclerosis
  • Non-Hodgkin’s Lymphoma
  • Anaplastic Large Cell Lymphoma (ALCL)
  • Swollen lymph nodes
  • Skin rash or hives
  • And more

New Wave of Breast Implant Lawsuits?

Breast implants are Class III (“high risk”) medical devices that must go through a rigorous protocol called Premarket Approval (PMA) before they are allowed on the market. In 2008, the U.S. Supreme Court ruled in Rigel vs. Medtronic that manufacturers of PMA-cleared medical devices are immune from lawsuits involving injuries.

That means breast implant injury lawsuits would normally face an impossible legal battle. However, there are exceptions — such as when a manufacturer violates requirements of PMA. In the case of silicone gel-filled breast implants, a new wave of lawsuits accuse manufacturers of inadequately testing the implants for safety and failing to warn about side effects.

Do I have a Breast Implant Lawsuit?

The Schmidt Firm, PLLC is currently accepting breast implant induced injury cases in all 50 states. If you or somebody you know has been diagnosed with side effects of silicone breast implants, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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