On March 21, 2017 the FDA issued a new warning about breast implants and the dangerous link to a rare form or cancer called anaplastic large cell lymphoma (ALCL). The risk was first identified in 2011, but the agency cited the need for more information at that time before it could characterize the disease.
The FDA stated the new warning came after it received more than 350 reports of ALCL diagnosis, and 9 deaths, among breast implant patients in recent years. However, they cautioned that the overall risk is still rare, since more than 300,000 women undergo breast augmentation surgery each year.
The reported cases of ALCL were more common in those with textured implants, as well as those with silicone implants, but was present in smooth and saline-filled versions as well.
Anaplastic large cell lymphoma (ALCL) is a rare form of non-Hodgkin's lymphoma characterized by the rapid multiplying of abnormal white blood cells. Despite being located around the breasts, it is not breast cancer.
The current risk is estimated to be 1 in 30,000 for those in the U.S. and Europe with breast implants, and as high as 1 in 1,000 for those in Australia and New Zealand.
ALCL can take approximately 8-10 years to develop after breast augmentation. Unlike normal non-Hodgkin’s lymphoma, however, which concentrates in the neck, armpits or groin, ALCL typically remains in the area of the implant.
The World Health Organization and FDA have stated ALCL is highly treatable if discovered early. Left untreated, however, it can spread quickly with fatal results. ALCL is usually treated by removing the affected implant and capsule, as well as chemotherapy or radiation in some cases.
The symptoms of anaplastic large cell lymphoma (ALCL) include:
While the FDA says women with breast implants do not need to change their medical care, they should monitor for and report any symptoms to their doctor.
The breast implant industry, worth nearly $650 million each year, has been linked with health concerns for decades. In 2006, the FDA lifted a 14-year ban on many of these devices, and companies have increased sales since.
Doctors first identified a link between breast implants and ALCL cancer in 1997. In 2011, the FDA and World Health Organization identified a more definite risk. However, none of the products have been recalled since that time.
The treatment costs, pain and health risks of cancer such as anaplastic large cell lymphoma can be substantial for those affected.
Due to the manufacturers’ continued sales of these dangerous products, and failure to properly warn patients of the risks, they are liable to those affected. Lawyers are currently helping those diagnosed with ALCL file lawsuits.
Anyone who has been diagnosed with anaplastic large cell lymphoma (ALCL) after undergoing breast implant surgery, or survivors of someone who has died from the disease, may qualify.
In both cases, potential claimants should learn their legal options as soon as possible before the expiration of their statute of limitations. Those who qualify may be entitled to substantial compensation. A lawyer can review your case and find out if you qualify at no cost to you. Contact DrugNews today in order to speak directly with a lawyer.
No. So far, no one has filed a class action lawsuit for breast implant cancer. Instead, lawyers are filing individual cases for those injured in different court districts. Since the FDA warning could affect thousand of patients, a large number of claims are expected.
Lawyers expect hundreds or even thousands of women who have been diagnosed with ALCL may come forward to file lawsuits. In this case, the claims are usually moved to one dedicated court venue, called a multidistrict litigation (MDL) court, for faster handling.
MDL courts have many of the benefits of class action lawsuits, without binding plaintiffs to one law firm that they didn’t choose. Also, victims can make more decisions on their individual cases, and often receive more compensation than participants in a class action.
Like any lawsuit, the value of each breast implant lawsuit is different. It can depend on many factors like the stage of cancer, the extent and duration of treatment needed, the patient’s age, whether surgery, chemotherapy or radiation is necessary, and whether they pass away.
Based on the severity and risk of death associated with any cancer, lawyers expect these lawsuits will seek compensation into the millions of dollars in some cases.
Finding out if you qualify and filing a claim is much easier than you may expect. You can contact DrugNews by live chat, email or phone, and be talking to a lawyer today at no cost. They will ask a few simple questions to see if your case qualifies for further investigation.
After you have agreed to let a lawyer specializing in breast implant litigation represent you, they will obtain your medical records and other pieces of evidence to file a lawsuit. The time to prepare your case for trial or settlement can take 12-24 months, and is subject to dates set by the court.
However, your lawyer will in most cases appear for you so no travel is necessary. And, there is no cost to you unless you receive compensation.
A suit filed on February 2, 2017 by Rexine Mize of Los Angeles, CA alleges she suffered severe pain, nausea, skin rashes and fatigue due to leaks in her silicone breast impants made by Mentor and Johnson & Johnson.
Ms. Mize claims the company failed to properly test the risks of leaks as required by the government.
This lawsuit was filed in September of 2016 by Sara Ebrahimi, a resident of Seattle who claims her MemoryGel silicone breast implants made by Mentor and Johnson & Johnson caused her skin rashes, extreme fatigue and metallic poisoning in her bloodstream.
The suit claims the silicone from the implants leaked into the patient’s bloodstream.
In 1992, the Dow Corning Corporation, facing public and governmental pressure, discontinued 5 models of its silicone-based breast implants. However, they continued producing 45 other silicone medical products. Dow eventually faced over 200,000 lawsuits alleging sickness from breast implants. The company filed for bankruptcy in 1995.
The FDA issues the latest warning about the link between breast implants and anaplastic large cell lymphoma (ALCL) after receiving more than 350 reports of ALCL diagnosis or death among breast implant patients in recent years.
Australia’s Therapeutic Goods Administration estimates as many as 1 in 1,000 women in the country with breast implants will develop anaplastic large cell lymphoma (ALCL), after 46 cases are diagnosed.
The French Medicines Agency gives breast implant manufacturers 12 months to prove their products are safe or have them banned, after stating there is a “clear link” between breast implants and cancer.
The FDA reports approximately 20% of women who received cosmetic silicone breast implants, and 50% of those who received them after a mastectomy, will need to have them removed within 10 years.
The FDA first identifies a possible link between breast implants and the rare cancer anaplastic large cell lymphoma (ALCL), but states more information is necessary.
The FDA approves silicone breast implants from Mentor, Allergan and Sientra after a 14-year ban on the devices.
Doctors first describe breast implant-based anaplastic large cell lymphoma as a concentration of seroma fluid between the implant and surrounding fibrous capsule.
Facing hundreds of thousands of lawsuits from women claiming sickness or cancer from its breast implants, Dow Corning Corp. files for Chapter 11 bankruptcy.
Dow Corning withdraws from the silicone breast implant market, but continues to sell silicone to other breast implant companies.
The FDA orders the stop of all production and selling of silicone-filled breast implants in the United States due to “inadequate information to demonstrate that breast implants were safe and effective”.
The FDA begins an investigation into breast implant failures and side effects, and reclassifies the products as Class III medical devices. Manufacturers are subsequently required to submit data showing the safety and efficacy of their breast implants.
French company Laboratoires Arion develops and begins selling the first saline-filled breast implant.
The Dow Corning Corporation, along with American doctors Frank Gerow and Thomas Cronin, develop the first self-contained silicone breast implants.
The first recorded breast augmentation through implant placement is performed by surgeon Vincenz Czerny, who used body fat to repair a breast affected by tumor.
It is estimated that worldwide, there are between 5 and 10 million women with breast implants. At present, there are around 13 companies that supply this multi-billion dollar market. In the United States, the majority of implants are sold by Allergan, Mentor and Sientra.
Other breast implant brands include:
If you or someone you know has developed anaplastic large cell lymphoma after receiving breast implants, it is important to speak with a lawyer about your rights. You may be eligible for substantial compensation.
Anaplastic large cell lymphoma (ALCL) is a rare form of non-Hodgkin's lymphoma that causes rapid multiplying of abnormal white blood cells around the breasts. It can take from 8-10 years to develop after breast implant surgery. Although ALCL is highly treatable if discovered early, it can spread and be fatal if left untreated.
Lawyers are now pursuing lawsuits against several breast implant manufacturers due to their failure to properly identify the cancer dangers or warn patients. These cases are likely to be consolidated in special courts, therefore, it is important to select a lawyer with substantial experience in mass tort defective device litigation.
DrugNews works only with lawyers that specialize in medical device injury cases such as these, and have handled thousands nationwide. Contact us today to speak with a lawyer at no charge.