Mesh Lawyers in Las Vegas
Is the FDA Protecting Consumers from Hernia Mesh Dangers? They Should Be.
With over 100,000 patients undergoing hernia surgery each year in the United States, medical professionals have over 50 different hernia mesh devices to choose from before the procedure, manufactured by varying medical device companies.
Since 2000, nearly 90% of all hernia surgeries have included mesh implantations. These devices have been widely criticized by patients, physicians, and regulating or informational agencies, including the US National Library of Medicine, National Institutes of Health from the time when the critical injuries began being reported, including life-changing occurrences of:
- Abdominal pain
- Bowel obstruction and/or perforation
- Bowel irregularities, including constipation or diarrhea
- Inability to walk
- Infections and non-healing wounds
- Leg, groin, and testicular pain
- Liver abnormalities
- Loss of testicle
- Pain during intercourse
- Renal Failure
- Subsequent surgeries
The larger question became, how is the US Food and Drug Administration (FDA) been policing these devices to ensure the public’s safety is paramount to manufacturer profits?
Serious Oversights: Patients are Suffering the Consequences
Of the fifty hernia mesh implant devices available, at least ten have been associated with serious patient injuries, yet have not been recalled by the FDA to provide public safety measures across the board.
One broadly covered example that medical experts, attorneys, and now judges are underscoring as an ongoing defective product case follows the Physiomesh device manufactured by Ethicon, a division of Johnson & Johnson.
Physiomesh Device Timeline
- December 2009
- Physiomesh Medical device was received under the FDA’s 510(k) Premarket Notification for approval, with “submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.”
- April 2010
- The FDA approves Physiomesh for use in patients, without a clinical trial, through the premarket notification submission
- January 2013
- Complaints of serious injuries begin to emerge in patients who had Physiomesh implanted
- April 2016
- The FDA acknowledges the dangers of hernia mesh devices on their website, stating the most common complications (were) associated with recalled mesh
- May 2016
- Ethicon withdraws Physiomesh from the market, denounces the assertion that a recall has ever taken place
- January 2018
- First Physiomesh lawsuit goes to trial in Illinois
Although Physiomesh has been identified in court records as the alleged cause of some of the most severe hernia mesh injuries in patients throughout the country, to date the FDA has not posted any information regarding that specific device. In fact, to date, the FDA has not recalled a single hernia mesh device.
How to stay informed: Search the FDA database for a specific medical device recall or stay up to date with all FDA Medical Device Approvals, Recalls, and Updates.
Manufacturing Unreasonably Dangerous and Defective Products
When defective products endanger the public’s health, the FDA should take notice. Current lawsuits assert that manufacturers are allegedly releasing “unreasonably dangerous” and “defective” products to physicians and consumers without the proper warnings regarding their side effects.
In another widely covered hernia mesh lawsuit, reports alleged the manufacturer, C.R. Bard, Inc., used a polypropylene, also known as a resin plastic, in its device’s composition. According to court documents, it was known by company officials that this material could be harmful to the health of humans.
A material warning for polypropylene has been registered with US Occupational Safety and Health Administration. The warning stated polypropylene should not be used in medical applications in humans. Even ones involving brief or temporary implantations in the human body, in contact with fluids or tissues. The result? Patients are suffering from serious bodily harm from a product replete with warning that was still implanted during a medical procedure.
The medical device companies that are producing unsafe or defective hernia mesh implants are now defending their products in courtrooms for negligent actions, including:
- Failure to adequately test hernia mesh devices
- Negligent design, manufacturing, and marketing of unsafe devices
- Deliberate and reckless concealment of information regarding defective devices
- Intentional misrepresentation of the hernia mesh’s safety and quality
- Failure to warn the public of the risks associated with the device
The Reality of the Domino-Effect in Hernia Mesh Implant Patient Health
The result of these negligently manufactured devices leaves patients dealing with life-changing injuries that are not corrected quickly, or sometimes at all.
Hernia mesh implantations can:
- Erode into nearby organs, including the bowel
- Require multiple, lengthy surgeries to correct
- Lead to extended hospitalization periods
- Involve partial bowel removal and colostomy procedures
Updated Studies + Latest Information = Successfully Fighting for Your Rights
At BBBC Law, our Las Vegas, NV attorneys are standing by to hear your hernia mesh experience today by calling 702-228-2600. Together, we will combine the medical evidence of your injuries with the realities of the hernia mesh device manufacturer’s negligence, and pursue the financial recovery you deserve to not only get the medical treatment you need but the peace of mind you deserve. Call us now for a free, confidential consultation.