What a Manufacturer Recall Could Mean for Your Hernia Mesh Implant
In June of 2016 parent company Johnson & Johnson issued a global recall of their Ethicon Physiomesh product. Commonly used in laparoscopic surgery for ventral hernia repair, it is also used for other fascial tissue applications. However, after implanting the product, multiple surgeries were required afterward to address issues that developed from the initial surgery. This conclusion was drawn after the review of two unpublished hernia surgery studies for Denmark and Germany.
The analysis revealed patients implanted with Ethicon Physiomesh had a higher recurrence for surgery or further operation than patients cited in the studies using other products. The exact cause of the discrepancy is unknown as the issue is believed to be multi-faceted. The recall only extends to the Ethicon Physiomesh product. Other Ethicon hernia mesh products remain unaffected. Johnson & Johnson also agreed to provide medical staff with treatment information for patients who are currently implanted with an Ethicon Physiomesh device.
Hernia Mesh Recall, Too Little Too Late
The recall could be too late however. Law suits have started rolling in and their numbers are only expected to increase. Here is a brief sample of legal actions, product notices and company actions taken to date:
- In 2013, Matthew Huff underwent hernia repair surgery. Physiomesh was used to repair his ventral hernia. He began to develop severe pain in his abdomen in July of 2015. Those pains were accompanied by chills, fever, nausea and redness at the surgery site. Ultimately, he was treated for infection, as well as two abscesses alongside an intestinal fistula. His case is currently scheduled for January 22, 2018 in the state of Illinois.Case No. 3:16-cv-00368.
- A product liability lawsuit found it way to the U.S. Middle District of Florida on September 22nd. This case claims the hernia mesh is defective and caused the patient persistent abdominal pain, accompanied with diminished bowel motility as well as bowel obstruction.
- This adverse event report was submitted to the FDA after the mesh was discovered to have pulled away from the interior abdominal wall resulting in the patient’s need for a second surgery.
- In June of 2012, Ethicon voluntarily removed four transvaginal mesh products from the market. Products affected by the voluntary recall were Prolift, ProliftM+, TVT, Prosima Pelvic Floor Repair System and Secur. The company stated the product removal was conducted for reasons of business.
More legal action is imminent which means John & Johnson’s Physiomesh recall could be too little too late. Part of the problem for them could be how the FDA granted approval for their product. Typically, products undergo various rounds of clinical trials to check for product effectiveness and safety. Physiomesh was marketed under the FDA’s 501k process which does not require the usual clinical product trials to ensure the safety or efficacy of the product. With no trials, and a blanket pass from the FDA, the product was rolled out en masse and ultimately became a staple for ventral hernia surgery.
Do You Have a Physiomesh Claim?
If you were implanted with an Ethicon Physiomesh device for a ventral hernia surgery or fascial tissue repair, you may have a claim. It is important to make sure of a few things first. Take a look at the points below.
- Verify. Contact the hospital where you hernia surgery was conducted. Ask for the records department and verify that Phyisomesh was used for your surgery.
- Get Checked. If you have experienced problems since surgery, get checked by your doctor. In order for a claim to occur it must be proven that the hernia mesh product used during your surgery is responsible for complications you experience afterward.
- Contact us for a risk free review. We have a team of experienced lawyers waiting to assist you. It costs nothing but your time, and could pay dividends in the long run. Isn’t your health worth a call?
It’s time to take control of your health if you or someone you know has been experiencing problems after a hernia surgery. The voluntary recall by Johnson and Johnson speaks volumes. It is a preemptive move on their part to stave off any more damage that could result in potentially faulty products being used for patients during hernia surgery.
The FDA offers no real help either. They are completely out of touch to the point that there is still no information posted on their site regarding the Physiomesh recall. This is an issue that must be handled by you. Don’t wait for the pain to get better or something worse to happen. We can help you decide whether or not you have a claim. Get in touch with us today. Let’s start a conversation.