The U.S. Food and Drug Administration (FDA) has ordered all manufacturers of surgical mesh products used for the transvaginal repair of pelvic organ prolapse to stop selling the devices immediately. Boston Scientific and Coloplast are the last two companies currently making the transvaginal mesh products.
Defective vaginal mesh devices can lead to serious injury and painful revision surgeries in patients. Chronic pain, infection, mesh migration, and other complications. Lawsuits have been filed on behalf of injured patients and large settlements have been reached.
The FDA stated the companies have not demonstrated “reasonable assurance of safety and effectiveness” for the pelvic mesh devices they market and distribute. The FDA has warned patients before about the risks of mesh implants. The safety agency classified transvaginal mesh as “high-risk” in 2016. Pelvic Mesh injury and transvaginal complications include the following:
The FDA notes women with transvaginal mesh implants should continue with routine follow-ups with their physician. Revision surgeries are often necessary when complications occur, though can present a number of health risks. Consumer safety lawyers can discuss legal action following transvaginal mesh injuries.
Joe Lyon is an experienced Cincinnati Medical Device Recall Lawyer reviewing Transvaginal Mesh Implant Injury Lawsuits for plaintiffs nationwide.
Numerous product liability and personal injury lawsuits have been filed over vaginal mesh injury and mesh defects. The transvaginal mesh produced by medical device companies is a synthetic implant meant to strengthen weakened pelvic muscles. But the mesh implants have been known to lead to serious health issues and revision surgeries.
Johnson & Johnson, Boston Scientific and Coloplast have been up against consumer protection attorneys and medical device lawsuits that allege the companies knew of the risks of their defective surgical mesh products and still sold the products to patients. In fact, several medical device manufacturers are currently paying nearly $8 billion to resolve injury claims of more than 100,000 implanted women.
For many years, women implanted with pelvic mesh devices have suffered various injuries such as mesh erosion, infection, mesh migration, organ perforation, and chronic pain. The FDA has decided the risks of transvaginal mesh products outweigh the benefits and is halting the sales of pelvic mesh devices for repairing pelvic organ prolapse. Some mesh products will still be on the market for other operations.
Gynecologists have used surgical mesh to repair pelvic organ prolapse since the 1970s. The surgical mesh is implanted in the vaginal wall, and has caused bleeding, severe pain and infection. Many women have required revision surgery to deal with mesh injury complications.
Transvaginal mesh implants used in pelvic organ prolapse surgery tends to be larger and pose more risks than other mesh products. Even the smaller mesh devices have a complication rate of 5 to 15 percent, which is unacceptably high. The FDA received over 10,000 injury complaints as of last year.
Injured plaintiffs have settled lawsuits against device manufacturers, and litigation continues for those affected by defective pelvic mesh devices. The Lyon Firm can assist in recovering rightful compensation related to medical expenses, pain and suffering, and long-term disability.
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Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.
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 Defective Device 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. Defective device 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
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against medical device companies due to a defective or recalled mesh product to obtain just compensation under the law.
United States Court for the Northern District of West Virginia
Mr. Lyon has represented and continues to represent numerous women across the country who suffered from complications and adverse events associated with the implantation of pelvic mesh. The mesh was implanted to treat pelvic organ prolapse and stress urinary incontinence.
The manufactures included Bard, J&J (Ethicon), Boston Scientific & AMS. The complications included mesh erosion, pain with intercourse, permanent pelvic pain, additional infections, and pelvic scaring.