Breast implants lawsuits accuse manufacturers of failing to test silicone breast implants for safety after the FDA lifted a 14-year ban in 2006, about a decade after $4 billion was paid to 450,000 women in a class action lawsuit settlement.
Need a Texas Breast Implant Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with side effects, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
FDA Links Breast Implants and Cancer
In January 2011, the FDA warned that breast implants may increase the risk of an immune-system cancer called Anaplastic Large Cell Lymphoma (ALCL). The FDA reported a total of 60 breast implant ALCL cases worldwide. This cancer is a rare but often aggressive type of Non-Hodgkin’s Lymphoma.
Breast Implants Linked to 400+ Reports of Lymphoma
In April 2017, Australian health officials reported 51 cases of ALCL in women with breast implants, including 3 women who died since 2007. All of the cases involved women with textured or polyurethane breast implants.
In March 2017, the FDA updated their warnings after confirming 359 cases of ALCL in women with breast implants, including 9 women who died. The FDA said the risk was “very low,” but warned that symptoms may include pain, swelling, lumps, and seroma (fluid buildup around the implant). According to the FDA:
Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.”
Textured Breast Implants Linked to Highest Risk of Cancer
Textured breast implants were significantly more likely to be linked to ALCL. Recent studies suggest that bacterial coatings (biofilm) on the textured surface may contribute to low-level infections, inflammation, scar-tissue, and immune system cancers like ALCL. Silicone breast implants were also linked to more cases of ALCL than saline-filled breast implants.
Risk of Breast Implant Rupture
Dr. Edward Melmed, a plastic surgeon in Dallas, Texas, called silicone breast implants an “industrial toxin” at an FDA meeting in 2011. He warned that 50% will rupture by 10 years, 72% by 15 years, and 92% by 20 years. He told CNN:
“Why is the FDA continuing to allow a device to be placed in young women that is guaranteed to fail 80% in 10 years? Would they allow that in hip replacements? Would they allow it in men?”
Mentor MemoryGel Breast Implant Lawsuits
In September 2016, a lawsuit (PDF) was filed by a woman from Seattle who experienced a wide range of health problems from Mentor MemoryGel breast implants leaking silicone.
In January 2017, another lawsuit was filed by a woman who says her silicone breast implants leaked and caused chronic pain, nausea, fatigue, skin rashes, and other side effects. 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.”
$4 Billion Breast Implant Lawsuit Settlements
Around 450,000 women filed lawsuits in the 1980s and 1990s for “silicone diseases” caused by breast implants. Several multi-million dollar jury verdicts and a $4 billion class action settlement put Dow Corning Corp. into bankruptcy in 1995. The settlement amounts averaged $26,000 per plaintiff (or around $20,000 for a ruptured implant and $5,000 for implant removal surgery) plus payouts of between $10,000 and $250,000 depending on disease symptoms.
List of FDA Approved Silicone Breast Implants
- Allergan Natrelle
- Allergan Natrelle 410
- Mentor MemoryGel
- Mentor MemoryShape
- Sientra Silicone Gel Breast Implants
“Ticking Time Bomb” In Millions Of Women’s Bodies
Breast implants are not lifetime devices. The risk of rupture increases over time. When a silicone breast implant bursts open, silicone gel leaks out and travels away from the breast. This can cause lumps to form in the breast, lymph nodes, chest, or armpit. It may be impossible to remove silicone from the body.
Breast Implant Silicone Poisoning
Silicone leaking out of breast implants is associated with “silicone sickness,” a toxic illness that occurs when the body absorbs silicone and triggers an immune system reaction. Leaking breast implants are known to cause local tissue inflammation. They might also increase the risk of a life-threatening connective tissue disease called scleroderma.
Symptoms of Leaking Breast Implants
- Breast pain
- Tissue hardening
- Breasts change size or shape
- Chronic fatigue, weakness
- Skin rash or hives
- Swollen lymph nodes
- Night sweats
- Memory loss or confusion
- Immune system dysfunction
New Wave of Breast Implant Lawsuits?
All silicone breast implants are Class III (“high risk”) medical devices that require Premarket Approval (PMA) from the FDA. In 2008, the U.S. Supreme Court gave manufacturers of PMA-approved devices immunity from lawsuits in Rigel vs. Medtronic Inc..
That means lawsuits involving silicone breast implant injuries are generally preempted by federal law. Lawyers have a few ways to get around this rule. One way is by showing that a manufacturer violated terms of the PMA by misleading the FDA about a device’s safety.
FDA Lifts 14-Year Ban on Silicone Breast Implants
In April 1992, the FDA banned silicone breast implants after lawsuits raised safety concerns and manufacturers failed to provide safety data. The FDA lifted the 14-year ban in 2006, after manufacturers promised to complete several massive long-term safety studies in exchange for bein allowed to return silicone breast implants to the market.
Safety Studies Are Essentially Worthless
Mentor Worldwide, Allergan, and Sientra were each required by the FDA to complete six safety studies with 10 years of follow-up as a condition of PMA approval in 2006 — but the studies were so bad that the data is all but useless and rare complications were likely missed.
For example, Mentor was supposed to track 80,000 women who received their silicone breast implants for 10 years — but just three years into the study, Mentor “lost track” of 79% of women with silicone implants, making the study’s conclusions essentially worthless.
In comparison, Allergan enrolled over 57,000 women in a 10-year study — but just two years later, they “lost track” of 40% of women with silicone breast implants. According to the FDA:
“Studies to date 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.”
FDA Rejects Breast Implant Recall
The FDA became concerned about the studies in 2010 and proposed a recall due to the lack of long-term safety data and known complications. However, the recall was rejected in 2011 after the FDA had a meeting with plastic surgeons and industry leaders.
List of Breast Implant Complications
- Uneven breasts
- Breast or nipple pain
- Tissue disease
- Hard lumps
- Skin rash
- Mammogram misdiagnosis
- Surgery complications
- Enlarged lymph nodes
- Necrosis (dead tissue)
- Breast sagging
- Implant rupture
- Hematoma or seroma
- Implant is visible, wrinkled, or rippled
- Toxic Shock Syndrome
- Systemic sclerosis
- Additional surgery
Need a Breast Implant Lawyer in Texas?
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