Hernia Mesh Device Used In Surgeries Voluntarily Withdrawn Due To Alarmingly High-Rates of Complications
What To Do If You Had Hernia Surgery Between 2010 and June 2016
From the desk of:
Andy Bederman, Managing Attorney
If you or a loved one had complications or suffered a hernia recurrence in the time period after a hernia repair procedure, this may be the most important message you will ever read...
Here is why...
Ethicon®, a subsidiary of Johnson & Johnson®, has voluntarily withdrew from the market a commonly used hernia repair product, called Physiomesh® Flexible Composite Mesh.
Physiomesh® was voluntarily pulled off the market in May 2016 due to studies showing Physiomesh® had alarmingly high-rates of complications, hernia recurrences and revision surgeries in patients.
What is Physiomesh®?
Physiomesh® is a flexible composite mesh that is used to repair hernias and reinforce weaknesses in the abdominal wall which could cause hernias.
Surgeons implant the Physiomesh® device over an opening or weak spot on the abdominal wall -- creating a strong barrier to prevent your internal organs from squeezing through.
Physiomesh® was introduced to the market in 2010 and voluntarily withdrawn on May 26th, 2016.
Why Was Physiomesh® Pulled Off The Market?
Recent studies and data clearly demonstrated increased complications and mesh failures with Physiomesh®, compared to competing mesh products on the market.
Ethicon® (the Johnson & Johnson® subsidiary that makes Physiomesh®) was alerted to the Physiomesh® problems from data provided by the HerniaMed German Registry and the Danish Hernia Database.
Upon being alerted to these findings, Ethicon® released an "URGENT Field Safety Notice" to operating room supervisors and chiefs of surgery.
This "URGENT Field Safety Notice" set forth an immediate product withdrawal for Physiomesh® -- stating, EFFECTIVE IMMEDIATELY -- DO NOT USE OR DISTRIBUTE Ethicon® PHYSIOMESH®.
Why Is Physiomesh® Unsafe?
While Ethicon® (manufacturer of Physiomesh®) stated they have not been able to fully understand the reasons behind the high-rate of complications and failures with their product, many medical professionals have voiced their opinions and concerns.
Many believe Physiomesh® has increased risks because it was defectively designed with a lower level of elasticity compared to competing mesh products on the market.
This serious design flaw may cause poor attachment to the interior abdominal wall which could lead to retraction/contraction, ripping and failing -- leading to significant health consequences for the patient.
Did the surgeon use Physiomesh® in your hernia operation?
If you had surgery to repair a ventral or inguinal hernia between the years of 2010 and 2016 your surgeon could have used Physiomesh®, as it was widely used before the voluntary product withdrawal.
Your medical records would clearly state if your surgeon used Physiomesh® for your hernia repair.
And due to the seriousness of the Physiomesh® withdrawal, you may have received (or will soon receive) a letter from your doctor stating the withdrawn mesh product was implanted during your surgery.
But since doctors are not obligated to notify their patients, many doctors do not. In fact, most doctors probably won't... so you need to find out for yourself and take your health into your own hands!
What The Physiomesh® Withdrawal Means For You...
If you are still reading this, it means you likely fall into one of three categories...
WHICH SCENARIO DESCRIBES YOU?
- I underwent a hernia repair but am unsure if I received Physiomesh® -- I have had zero problems thus far.
- I underwent a hernia repair and am currently experiencing potential complications from it (see list of possible complications below)
- I underwent a hernia repair and in the time after, suffered a mesh failure or other complication which required revision surgery (ie. re-operation) or additional medical treatment.
Our Law Office is currently investigating cases for ALL THREE SCENARIOS -- Including cases with and without complications. Due to the high failure rate of Physiomesh®, you are eligible to contact us even if you have not had any complications or problems thus far.
If you are unsure if you received Physiomesh®, you can easily find out by retrieving your medical records, or by inquiring with your surgeon.
Our law firm is assisting individuals with finding out if they received Physiomesh®. We are able to pull your medical records and confirm whether the withdrawn product was used in your operation.
I Have Experienced Complications Or Required Additional Treatments & Surgeries After My First Hernia Repair...
After a hernia repair surgery, where Physiomesh® may have been used, you may have experienced any of the following negative effects related to Physiomesh®:
- Revision surgery
- Recurrence of hernia
- Intestinal complications
- Formation of a mass / lump / bulge
- Adhesions (internal scar tissues)
- Vomiting / Nausea
- And more...
AND PLEASE NOTE: Even if you had a hernia repair operation and NEVER experienced any negative effects, you are still eligible for a case evaluation because Physiomesh® failure rate is so high.
So please continue reading because it is critically important for you to understand not only the medical aspects of all this, but also the LEGAL aspects behind your safety and well-being.
Your Rights As A Patient May Have Been Violated... And How Protecting Your Rights Is Equally Important As Protecting Your Health
If you or a loved one had a hernia operation before May 26th and you suspect a mesh product may have been used, there is something you can do today to greatly benefit yourself and your family.
As hard as it might be to imagine, you may have been a victim of a product that was defectively designed.
As such, your health may have been put at risk, or worse, negatively affected by a defective medical product -- one that is alleged to be unreasonably dangerous and not suitable for its intended use.
Ethicon® Chose To Skip Rigorous Pre-Market Research That Could Have Uncovered The Serious Risks of Physiomesh®
Ethicon® (the manufacturer) chose to bring Physiomesh® to market WITHOUT the typical FDA-required pre-market research that gives doctors and patients confidence a medical product is safe to use.
Instead, Ethicon® sought FDA approval via the highly controversial 510(k) exemption process -- which allows "low risk" devices to bypass the rigorous pre-market research and trials.
However, the FDA's 510(k) exemption requires Physiomesh® to offer a reasonable assurance of safety and effectiveness, and per the FDA's website...
"510(k) exempt devices must be suitable for their intended use"
Sadly, many doctors and patients now feel that Physiomesh® is not safe, and never was effective or suitable for its intended use!
You May Be Eligible For Financial Compensation Having Been Affected By A Defective Medical Device
Medical device manufacturers are subject to STRICT guidelines and rules by the FDA. The FDA puts rules in place that require medical device manufacturers to conduct extensive testing, research and clinical trials before their device can be used in hospitals.
...this is done so doctors and patients like YOURSELF can weigh the benefits of using a particular medical device against the possible dangers and consequences it may pose.
And it gives doctors the ability to make an informed decision about which brand hernia mesh to use, based on available safety data gathered in pre-market testing and trials.
When A Manufacturer Doesn't Adequately Test The Safety of A Medical Device, Doctors & Patients Become Victims -- And All You're Left With Is A Dangerous Device Stuck Inside You...
As a result of Ethicon® not conducting the rigorous pre-market research and trials by using the controversial 510(k) exemption, you or a loved one may have suffered negative health consequences, emotional pain, lost wages due to time off work, significant medical expenses, and more.
You may be entitled to what are called "damages", which is just a legal term for money awarded in individual lawsuits, settlements and class action lawsuits.
Because Physiomesh® has such a high-rate of hernia recurrence, revision surgery and other complications, patients often find themselves burdened with substantial medical expenses, lost wages, decreased quality of life from all the emotional strain, and more.
What Your Next Step Should Be If You Had A Hernia Operation Between 2010 and 2016
Our legal team has reviewed the available evidence and research, and our experience in medical device liability cases tell us, that we are in prime position to effectively help patients who are victims of the Ethicon® Physiomesh® voluntary withdrawal and any subsequent injuries suffered.
We are offering a free legal consultation and case evaluation to patients who believe they may be affected.
If you'd like to learn more and speak with a hernia mesh lawyer free of charge, this is your opportunity to discover the help that is available to you.
Getting started is simple and easy...
Fill out the contact form below or call us at 888-245-5497 for a free case evaluation and legal consultation. We will personally speak with you about your case.
Speaking to an attorney, you will get answers to the following...
- How do I find out if my surgeon used Physiomesh® (if you don't already know)
- Am I eligible to pursue a hernia mesh lawsuit?
- What is involved and how does it work?
- Should I file a lawsuit or seek a settlement?
- How do I get started?
- ...And more
This consultation with an attorney does not cost you anything and is 100% free and confidential. That means you have nothing to lose and everything to gain.
You will speak to our attorneys -- lawyers with years of experience getting successful legal outcomes for victims like yourself.
We are currently accepting cases nationally in the U.S., so you are eligible to speak to us for free -- no matter what state you live in.
You should contact our firm if:
- You underwent a hernia repair but are unsure if you received Physiomesh® -- even if you have had zero problems thus far
- You underwent a hernia repair and are currently experiencing potential complications
- You underwent a hernia repair, and after suffered a mesh failure or other complication which required revision surgery (ie. re-operation) or other medical treatments
And know this...
If at any point you do not believe we are the most qualified to help you get the money you rightfully deserve, you are not obligated in any way, shape or form to pay us or work with us. This is a NO-PRESSURE consultation.
We are confident you will see the extraordinary value we can offer you. Our law firm works strictly on a contingency basis -- meaning patients we represent only pay if they are awarded by settlement or from a Physiomesh® lawsuit.
You must act quickly because there is a only a small window of time that hernia patients can file a mesh lawsuit or seek a Physiomesh® settlement. This is called the "statute of limitations" -- and it is different for every state.
So act now and fill out the contact form at the bottom of the page. Or simply pick up the phone and call us right now at 888-245-5497.
We stand ready to help you win your case.
Andy E. Bederman
Law Offices of Greenberg & Bederman, LLC
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