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Transvaginal Mesh

FDA Regulations on Transvaginal Mesh Products Increased

By | Defective Medical Devices, Medical Malpractice, Medical Products Lawsuit, Transvaginal Mesh, Transvaginal Mesh Lawsuit, Transvaginal Mesh Products | No Comments

Regulations on Transvaginal Mesh Products Increased by the FDA

Transvaginal mesh products have been used since the early 1990s with very little regulatory oversight. In the more than twenty years that followed, thousands of patients suffered unanticipated complicated and injuries due to the implant. As of January 4th of 2016 the FDA has announced that there are increased regulations for transvaginal mesh devices.

This has been a slow process for the FDA to take action. Studies conducted throughout 2008-2010 showed that the devices were becoming progressively dangerous for their recipients. The FDA even found that other natural means may be more effective than these artificial implants. Despite this information, manufacturers have knowingly continued to sell these dangerous implants. According to Boca Raton defective medical device attorneys, this knowing endangerment of consumers creates a great deal of potential liability for people that have received these transvaginal mesh implants.

These new regulations do not mean that consumers are out of danger. Some components of the regulations do not really impact the device manufacturers until 2018. Our leading Boca Raton medical device liability attorneys are concerned there will be many more innocent victims who receive these dangerous implants and suffer injuries as a result before the FDA protects them. Your only recourse is taking legal action to hold the manufacturers financially accountable.

There are 34 transvaginal mesh manufacturers in the United States. There are tens of thousands of potential victims that are suffering injuries from these faulty implants. Anyone that has one of these devices, even without current complications, is encouraged to speak with both a medical doctor and a products liability attorney to learn about their rights and options for ensuring their well-being.

You should be proactive if you have had a transvaginal mesh product implanted. At Osborne & Francis Law Firm PLLC, our Boca Raton transvaginal mesh device attorneys have already successfully recovered millions of dollars in compensation for these victims. Call us at 561-293-2600 or contact us online to schedule a free initial consultation to discuss your legal options.

Filing a Transvaginal Mesh Lawsuit

By | Transvaginal Mesh, Transvaginal Mesh Lawsuit | No Comments

Proven Legal Guidance to Help You Navigate the Process of Filing a Transvaginal Mesh Lawsuit

Transvaginal mesh has been used since the mid-to-late 1990s to treat common medical conditions such as Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Several large manufacturers and pharmaceutical companies have entered the market with transvaginal mesh products. The most prevalent makers of transvaginal mesh include

  • Boston Scientific
  • Ethicon, Inc. (Johnson & Johnson)
  • R. Bard, Inc.
  • American Medical Systems
  • Coloplast Corporation

Collectively, these companies are facing more than 100,000 lawsuits filed by patients that have experienced serious health complications following mesh implantation. Thousands of women have been required to undergo additional surgical procedures in an attempt to correct or remove transvaginal mesh, but many are left with permanent side effects that greatly reduce quality of life.

If you’ve experienced complications following a transvaginal mesh procedure, you may be able to recover damages for your medical expenses, lost wages and pain and suffering. It is important to seek legal advice as soon as possible after you become aware of a potential problem to ensure that you are still eligible to file a lawsuit. Generally, you have two years from the date the injury occurred or the date you became aware of the problem to file a lawsuit. In most transvaginal mesh cases, the statute of limitations does not start until you have complications attributable to the mesh. There are several steps that must be taken throughout the process and your case may go on for several years.

If filing a lawsuit is in your best interest, the Florida transvaginal mesh attorneys at Osborne & Associates work diligently to fully evaluate your medical history, gather evidence to support your claims as well as expert medical testimony to substantiate and prove the extent of the health complications you’ve experienced. We work with all parties involved to negotiate your case and reach a full and fair settlement. If a settlement cannot be reached, we are ready to take your case to trial to achieve the maximum compensation you deserve.

The complications associated with transvaginal mesh have the potential to negatively impact your personal and financial well-being for many years to come. Hiring an experienced transvaginal mesh lawsuit attorney with significant litigation experience is your best chance at receiving the restitution you deserve. To discuss your options during a free, initial consultation, contact our Boca Raton office at 561-293-2600 or contact us online.

Transvaginal Mesh Lawsuit Update

By | Transvaginal Mesh, Transvaginal Mesh Lawsuit | No Comments

Record-Breaking Transvaginal Mesh Verdict Awards Victim $100 Million

Currently, it is estimated that there are more than 100,000 lawsuits pending against transvaginal mesh manufacturers including Boston Scientific, Ethicon, Inc. (Johnson & Johnson) and C.R. Bard, Inc. Just this past May, a Delaware jury handed down a $100 million verdict against Boston Scientific.

The plaintiff, a 51-year-old woman, sued the company after having the Pinnacle and Advantage Fit mesh implanted in 2009 to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Following the initial implantation, she experienced serious side effects including pain, urinary tract infections and painful intercourse. She also underwent two additional unsuccessful corrective surgeries. The $100 million is comprised of $25 million in compensatory damages and $75 million in punitive damages.

Following the trial, the jury found that Boston Scientific was negligent in the design and manufacturing of the mesh products and fraudulently failed to adequately warn doctors and patients about potential risks associated with mesh implantation. In July 2014, a Texas jury awarded a $73 million verdict to a similar plaintiff. This award was later reduced to $34 million due to Texas’ specific punitive damages cap.

The FDA has issued warnings about the use of transvaginal mesh and potential complications including

  • Pain
  • Infection
  • Mesh erosion
  • Pain during sex
  • Organ perforation
  • Urinary tract infections

At Osborne & Associates, our Florida transvaginal mesh attorneys have handled numerous transvaginal mesh cases and were personally involved in securing a $26.7 million verdict in November, 2014. While each case is different and presents its own challenges, our transvaginal mesh attorneys are ready to explore any and all legal options that may be available for you. To discuss your case, call 561-293-2600 or send an email.