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 suffered complications with a breast implant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: 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. As of February 1, 2017, the agency has received at least 359 medical device reports (MDRs) of BIA-ALCL, including 9 deaths. The vast majority of these incidents occurred in women with textured breast implants, according to the FDA.
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.
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.
Free Case Evaluation: Again, if you had breast implants and suffered one or more of the above problems, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.