Physiomesh: Holding Ethicon Liable for Patient Harm
Many people have medical needs that make surgery necessary. One such medical need is a hernia, a painful condition in which an organ squeezes through connective tissue. In the most serious of cases, a hernia can be fatal, and the need for surgery is pressing.
To treat a hernia, surgeons will often use a mesh to hold the organ in place and prevent the hernia from recurring. Physiomesh is one such product. Unfortunately, however, physiomesh has been linked to a number of adverse events and cases of patient harm. If you have undergone surgery for hernia repair and suffered harm, here is what you need to know–
What Is Physiomesh?
Manufactured by Ethicon, a subsidiary of Johnson & Johnson, Physiomesh is a flexible composite mesh that is used in hernia repair surgeries. Made from polypropylene, the mesh is also used to reinforce the abdominal wall to prevent hernia. Hernia repair surgeries are very common, and the use of a mesh patch, which is stitched over the hernia – which is a condition in which the organ is displaced and protrudes through the abdominal wall – to prevent protrusion is a common remedy.
Despite the fact that hernia repair surgeries may be common, as may require the use of composite mesh, Physiomesh has proven to be defective. In fact, the mesh has caused so many complications that in 2016, Ethicon issued a market withdrawal of the product.
Market Withdrawal of Physiomesh
In May of 2016, Ethicon and Johnson & Johnson issued a worldwide recall of Physiomesh. The recall was based on the fact that the medical product was associated with a high number of complications, including the need for a secondary surgery. The recall came six years after the product was introduced to the market; unfortunately, six years was far too much time – numerous patients who underwent hernia repair surgeries that used Physiomesh experienced adverse events.
Dangers of Physiomesh
The dangers associated with Physiomesh are many, and countless patients have been harmed as a result of this medical device. These adverse events included:
- Abdominal pain;
- Necessary revision surgery to remove Physiomesh;
- Recurrence of hernia;
- Device failure;
- Bowel obstruction;
- Mesh migration;
- Mesh contraction;
- Intestinal fistulae;
- Diarrhea; and
- In the most severe of cases, complications associated to defective Physiomesh mesh have been serious enough to result in death.
How Has the FDA Reacted?
Reports of adverse patient event began trickling in soon after Ethicon’s Physiomesh was approved for the market. Consider the November 2010 report, accessible on the website of the U.S. Food and Drug Administration (FDA), in which “tears, rips, holes in device” are reported, leading to “minimal adhesion” and removal of the mesh. Or, the February 2012 report in which a patient, who underwent hernia repair surgery that used Physiomesh, returned one week post-surgery with complaints of vomiting, constipation, and abdominal pain and distention. The physician determined that the patient’s symptoms were a result of an adverse reaction/irritation to the Physiomesh.
Despites these reports, and many more like them, it took years for the mesh to be officially recalled by Ethicon. The recall that Ethicon did issue was voluntary, and was not mandated by the FDA.
Litigation Emerging Against Ethicon
Due to this year’s official recall of Physiomesh, as well as the mounting number of adverse patient conditions, litigation is emerging against the company. There have been at least two lawsuits filed against Ethicon: One in September of 2016, which was filed by a Floridian woman who experienced adhesion of Physiomesh in her abdominal wall, preventing removal, and one in April of 2016, filed by an Illinois who suffered infection and two abscesses.
If you have undergone hernia repair surgery and have experienced any symptoms of a secondary hernia or mesh failure, you too may have a case against Ethicon. It is important to meet with an experienced defective medical device and product litigation attorney if you think that you may have a case.
Case Criteria – Do You Have a Case Against Ethicon?
When you meet with our team at Edward A Smith Law Offices, our attorneys – including myself personally – will need to ask you a number of questions about your condition, your medical history, and whether or not Physiomesh was used in your hernia repair surgery. If I believe that you have a case, we will help you to build that case and pursue litigation against Ethicon to recover compensation for the harm that you have suffered. Review the following case criteria and questions you will be asked to determine whether or not you may have a case against Ethicon–
Implant Specific Information
Our lawyers will need information that is specific to the implantation of the Physiomesh. These questions include, but are not limited to:
- Was the mesh actually implanted?
- By whom was the mesh implanted?
- For what specific purpose did implantation occur? What was the medical need?
- Were there any alternative options offered? (Were there potentially remedies outside of mesh implantation?)
- Did you present any hesitation to the implantation of mesh?
- Did you give your informed consent? Was the implantation your own choice?
- Did you you have any other prior surgeries that were relevant to this one, such as former hernia repair surgeries or surgeries that utilized mesh implantation?
- What type of hernia repair surgery did you require and undergo?
- In which manner was hernia mesh implanted (i.e. staples, stitches, etc.)?
- Was the procedure open or laparoscopic?
- Did you present any risk factors associated with mesh failure?
- Did you know of adverse patient events associated with Physiomesh prior to your surgery?
Damages – Injuries Resulting from Implanted Mesh
In addition to implant specific information, our law firm will also need information about your injuries and damages resulting from the implanted mesh. These questions can be intimate and personal; however, it is very important that we collect honest answers in full in order to determine the value of your claim.
- Have you experienced any adverse conditions associated with the mesh? Adverse conditions include, but are not limited to, fever, pain, need for secondary or subsequent surgery, diarrhea, constipation, secondary hernia, bowel obstruction, and sepsis.
- What happened after you experienced these symptoms? Did you see a doctor? Was a secondary surgery pursued? Was mesh replaced? How were you initially diagnosed post-surgery following pain or other complications? We need all details about post-operative care and management of post-surgery complications.
We may also need to ask you other questions about your relationship with your doctor and your interaction with any medical professionals. We will also need to obtain critical information regarding:
- Whether or not your doctor had knowledge of the risks of Physiomesh and the fact that it was recalled prior to your surgery;
- Pathology reports;
- The specific complication of the mesh (i.e. adhesion, separation, migration, etc.) and appearance of mesh after removal;
- Operative notes;
- Records of follow-up stays; and
- Details of product used.
I Will Help Guide You
The above can be a lot to take in for a patient. I will guide you through the questioning and support you along the way. If I believe that you have a case, my law firm and our team will immediately open an investigation to gather all necessary documentation and evidence for building your case.
What Damages Are Recoverable?
If I determine that you have a case, our law firm will get to work on building your case. We will work hard to prove that:
- Physiomesh was defective and Ethicon had a responsibility to manufacture a product free from defects, and recall the product as soon as a defect was known;
- You underwent a surgery that relied on a defective medical device – Physiomesh – and you were unaware of this device defect; and
- The use of Physiomesh was the direct cause of your complications and damages.
Proving Ethicon Owed you a Duty of Care
By proving that Ethicon owed you a duty of care which was violated, and you suffered harm and losses as a direct result, we can improve your chances of recovering your full damages amount. This includes compensation for:
- Medical expenses, including the expenses of a secondary surgery and future treatment costs;
- Lost wages or future lost wages; and
- All other economic and noneconomic damages associated with your losses.
You Need to Act Quickly
If you have suffered an adverse reaction and you believe that that reaction is a result defect Physiomesh, you need to act quickly. Under California law, you have two years from the date of cause of action to file a claim to recover damages. If you wait longer than two years from the date of cause of action, you can be permanently barred from recovering compensation at all. For personal injuries, the two year date begins two years from the date of injury, or one year from the date of discovery.
Sacramento Physiomesh Hernia Injury Attorneys
I’m Ed Smith, a Sacramento Physiomesh Hernia Injury lawyer. If you or your loved one has suffered an injury like the type described in this article, please call me promptly at (916) 921-6400 or toll free at (800) 404-5400 for free, friendly advice. I care about you and your future, and will do everything I can to improve your chances of a successful suit against Ethicon for damages related to defective Physiomesh.
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Source of Physiomesh: Holding Ethicon Liable for Patient Harm – Edward A Smith – Products Liability Attorney