The U.S. Food and Drug Administration (FDA) recently issued a report about the risk for anaplastic large-cell lymphoma in women with breast implants. The FDA issued the alert, noting that almost all cases of implant-caused lymphoma have involved implants with textured rather than smooth surfaces. The implant texturing, which is used to help anchor the implants, is said to cause constant inflammation, and later lead to cancer.
Of the 359 global cases of breast implant-caused cancer reported to the FDA, there have been at least 12 deaths. The cancer and death toll is likely much higher, as the statistics only rely on voluntary reports from patients and doctors.
The FDA said they have known about this rare cancer occurrence since 2011, and have since strengthened their understanding of the condition. The World Health Organization (WHO) has also expressed concern over breast implant-associated T-cell lymphoma that can develop following breast implants.
Allergan has recalled textured breast implants due to added BIA-ALCL risk.
Joe Lyon is a highly-rated Cincinnati product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.
Roughly 400,000 women receive breast implants each year in the United States. An estimated one in 30,000 women with textured implants will develop the cancer. The material of the implant—silicone or saline—has not been found to affect one’s risk. The cancers from textured implants have been diagnosed anywhere from two to 28 years after implantation, with a median diagnosis of eight years.
As breast implants have gained in popularity over the years, medical experts fear the breast implants lymphoma risk could encompass thousands of women across the country. In the years 2000 to 2016, the number of breast augmentation surgery rose 37 percent in America.
The FDA first learned of the risk in 2011 and implant product labeling was added. The label warnings on Allergan and Mentor implant packaging however, are listed among several other less severe complications and can get lost in the small print.
Implanting surgeons are encouraged to warn patients of the breast implant lymphoma risk, but it is estimated that only around 30 percent of doctors discus the risk of cancer with patients.
The FDA has proposed a risk assessment checklist and boxed warning after hundreds of reported cancer cases came to the attention of the agency. Many patients say they had clue there were risks associated with implants before having surgery.
The FDA wants a boxed warning that tells patients that breast implants do not last a lifetime, and that the chances of developing complications increase the longer they have the implants. The warnings should also highlight the link to anaplastic large cell lymphoma, and describe some symptoms of cancer patients should be aware of.
The checklist could warning women that if they smoke or have diabetes or autoimmune disease, they may have additional risks after surgery, including chronic pain or loss of sensation.
Lymphoma is a common cancer of the blood—the two main forms of lymphoma being Hodgkin lymphoma and non-Hodgkin lymphoma. Lymphoma occurs when cells of the immune system, types of white blood cells, multiply uncontrollably.
It is not known entirely why breast implants cause T-cell lymphoma in the breast, though some medical professionals surmise that bacteria attached to the textured implant creates an immune system reaction within the body of a woman.
Symptoms of this rare form of lymphoma include, pain, a swelling around the breast and a buildup of fluid around implants. If detected early on, the cancer is generally treatable.
Affected patients are encouraged to remove their implants immediately along with the other damaged tissue in the breast. About 85 percent of cases are resolved after surgery. If the cancer has spread, however, chemotherapy and radiation may be necessary.
The FDA recommends that women consider a few things before undergoing breast implant or breast augmentation surgery, including:
In 2019, the FDA requested that Allergan recall their BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system.
The FDA (U.S. Food and Drug Administration) requested that the Allergan recall include all BIOCELL textured breast implants and tissue expanders currently marketed.
Worldwide Medical Device Reports (MDRs) have indicated an increasing number of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) cases and related deaths, which are closely associated with the breast implants. At least 573 cases of anaplastic large cell lymphoma related to breast implants have been reported to the FDA, along with 33 patient deaths
Allergan Natrelle 133 and 133 Plus tissue expanders have not yet been associated with BIA-ALCL, but the devices have the same Biocell texture, which is why they were recalled. Tissue expanders are only indicated to be used for 6 months maximum, but experts do not know what duration of exposure to the Biocell texture may lead to cancer.
The FDA says the risk of BIA-ALCL with Allergan BIOCELL textured implants is around 6 times the risk of BIA-ALCL with other textured implants on the market. Macro-textured implants, like the kind being recalled, represent less than 5 percent of all breast implants in the United States. The recalled textured breast implant products include
To be clear, BIA-ALCL is not breast cancer, but rather a far less common form of non-Hodgkin’s lymphoma. BIA-ALCL is commonly found in the scar tissue and fluid near breast implants, and can potentially spread to other parts of the body.
If not diagnosed and treated promptly, patients may suffer from complications and severe cancer-related conditions, including death. Patients are encouraged to speak to their implanting surgeon and a product liability attorney. Even though the overall chance of developing BIA-ALCL is low, the Allergan textured breast implant recall indicates the serious nature of potential related health problems.
Allergan has said they are taking precaution due to recent reports of an increased cancer risk. Tens of thousands of women have been implanted with such devices over the years and may be at risk. Doctors and the FDA have urged women to consider a number of health risks before deciding on breast implants.
There may be safer ways to protect yourself against breast implant lymphoma, and may discuss with your doctor. Any women who have developed lymphoma or another cancer due to defective breast implants can contact a medical device recall attorney to discuss your legal options. Settlements and awards are likely following any injury caused by a defective medical device.
The FDA and Allergan will continue to monitor BIA-ALCL cases linked to textured breast implants and tissue expanders. The FDA also announced recommendations for label changes for breast implants to include a boxed warning indicating specific risks.
According to the American Society of Plastic Surgeons, breast augmentation was the most popular cosmetic surgical procedure performed in 2018. Millions of women have breast implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or for reconstruction after a mastectomy.
Over 310,000 breast augmentations were performed in 2018 alone. But thousands of women with breast implants have reported developing cancers and other illnesses, including several symptoms some experts call “breast implant illness.”
Some of the illnesses resemble connective tissue disease like lupus, rheumatoid arthritis and other serious autoimmune conditions. Most women with breast implants have no serious complications, but as many as 20 percent of women with implants have their implants removed within 10 years, usually due to complications.
Doctors have said implants are not meant to be lifetime devices. The FDA would like implant manufacturers to list the ingredients in implants, as reports of heavy metals have been concerning in the devices. Metals may include mercury, lead, arsenic and platinum, and dangerous chemicals.
New implant screening recommendations for those who already have silicone gel implants say women should undergo imaging scans to look for ruptures beginning five years after the surgery.
Boxed warnings are the strongest form of warning required by the FDA for product labeling. The FDA suggests warnings that may include: “breast implants are not considered lifetime devices.”
Experienced medical device attorneys are now filing claims against implant makers like Allergan and Mentor for manufacturing defective products that have not been properly tested long term, and cause deadly diseases like cancer. The companies producing implants that cause cancer must be held responsible for the damage they cause.
Thus far, not many implants have been recalled. As seen in the past from many medical device corporations, legal action is the only deterrent to putting defective devices to market, and the only way to protect consumers from further injury.
The Lyon Firm specializes in representing plaintiffs in product liability and personal injury lawsuits, filed against negligent medical device companies to recover rightful compensation.
Many product liability cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove products and change designs and warnings as a result of litigation.
Product liability lawsuits often contain causes of action for strict liability, negligence, and breach of warranty. Strict liability applies to different factors than negligence-based claims.
In negligence cases, the actions of the defendant are the focus. In strict liability claims, the focus is on the condition of a product at the time it left the manufacturer. If a product is determined to be defective, the company is liable for any foreseeable injuries that are in-part caused by the defective condition of the product.
A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:
(1) Manufacturing/ Construction Defect:
These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).
As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.
(2) Defective design and/or formulation:
Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.
Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)
(3) Failure to warn or inadequate warning or instruction associated with the product:
All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.
Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.
The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.
The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.
Risks: The following factors are considered under Ohio law when determining the risks associated with the design of a product: (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation.
Benefits: The following factors are considered under Ohio law when determining the benefits associated with product design: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c)
Defenses for Defective Design: (1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).
A manufacturing defect is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.
Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design.
The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care. Ohio Revised Code 2307.74.
Manufacturing Defect Examples:
In determining whether a product is defective due to inadequate warning or instruction, evidence must be presented to prove:
Defenses to Failure to Warn Claims: (1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).
Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.
Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.
Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:
The listed government agencies, however, may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product.
Our Firm will help you find the answers. The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered.
Experience: Joe Lyon is an experienced Cincinnati Product Liability Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Product Liability lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.
Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.
Results: Mr. Lyon has obtained numerous seven and six figure results in personal injury, automotive product liability, medical negligence, construction accidents, and auto dealership negligence cases. The cases have involved successfully litigating against some of the largest companies in the world
Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products have a duty to foresee potential injury and properly design and test products before they are released.
Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.
(Pikeville, Kentucky): Confidential settlement for Plaintiff who suffered spinal cord injury resulting in paraplegia due to defectively designed seat belt. Four passengers with three-point (lap/shoulder) belts walked away from the accident, and the only passenger wearing a two-point belt (lap only) suffered a debilitating spinal cord injury. The settlement assisted with home improvements to assist in daily living. GM entered federal bankruptcy during the process and no longer manufactures two-point lap belts for vehicles.
(Hillsboro, Ohio): Confidential Settlement for the family of elderly man who was catastrophically burned while operating a propane wall heater. The burns resulted in his unfortunate death. The heater, manufactured and sourced from China, was alleged to allow the flame to reach outside the grid area in violation of ANSI standards. The Defendant resolved the case following discovery and mediation. The recovered funds were paid to the victim’s surviving spouse and children. The company no longer manufactures this type of heater.