Injured by a defective Product?
Hernia Mesh Attorneys 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
- Adhesions
- Bowel obstruction and/or perforation
- Bowel irregularities, including constipation or diarrhea
- Fevers
- Headaches
- Inability to walk
- Infections and non-healing wounds
- Leg, groin, and testicular pain
- Liver abnormalities
- Loss of testicle
- Pain during intercourse
- Rash
- Renal Failure
- Subsequent surgeries
- Death
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
Suffering From Hernia Mesh Surgery Complications? You Are Not Alone.
According to the FDA, more than one million surgeries occur every year in the United States to repair hernias. Of those, nearly 800,000 are performed to repair an inguinal hernia which occurs in the inner groin.
Other types of hernias and their locations can include:
- Ventral
- The general abdominal or ventral wall
- Hiatal
- Inside the abdomen, upper stomach/diaphragm
- Femoral
- Upper thigh/outer groin
- Umbilical
- Belly button
- Incisional
- Incision or scar in the abdomen
These painful injuries occur from tissue, organ, or intestine being forced through a weakened area in the connecting tissue or surrounding muscle.
Hernia Treatment Options: Surgery
Surgery is the only way to repair hernias. Not all treatment options require surgical mesh, but since 2000, non-mesh procedures comprised less than 10% of hernia repair techniques, including:
- Laparoscopic surgery
- Small incisions in the abdomen that allow a minimally invasive approach to inserting the hernia mesh to reinforce the herniated area
- Open repair
- The incision made near a hernia and weak muscle area to implant the mesh for support and to strengthen the location
The uptick in mesh-implant surgeries has caused a significant increase in painful side-effects associated with hernia surgeries throughout the country. If you have had hernia surgery in the last twenty years, chances are you have a mesh implant. Were you sufficiently warned of the dangers of your surgical mesh implant?
Hernia Mesh Warnings: Were You Informed Properly?
Thousands of patients have exhibited serious side effects from surgical mesh implants and have turned to lawsuits to recover fully from their pain and suffering.
As of November 2017, approximately 350 lawsuits have been combined into two new multi-district litigations in federal court, opening the door for patients across the United States to join the fight against the hernia mesh, manufacturers.
Updated Studies + Latest Information = Successfully Fighting for Your Rights
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