Physiomesh Failure Started at the FDA

Medical Devices Such As The Ethicon Physiomesh Were Brought To Market Using The FDA's Flawed, Outdated 501 (K) Fast Track Approval Procedure

Monday, August 13, 2018 - Dr. David Kessler was appointed by President Bush as the chairman of the food and drug administration (FDA) and considers the agency to be "the most important consumer protection agency in the world". According to Dr. Kessler, "Americans rightfully expect public health decisions to be made in their best interest, and to be based on the best science and medicine." (Netflix documentary "The Bleeding Edge")

It was the original charter of the medical devices branch of the FDA to require all medical devices to go through a process called pre-market approval (PMA), a regiment of human testing of medical devices the results of which must be approved by a panel of FDA scientists before a medical device can be offered to the public. As medical technology progressed and medical devices flooded the market the PMA process became untenable. In order to speed up approval, the FDA created the 501 (k) fast-track approval process. Under the 501 process, a medical device can bypass PMA if the manufacturer can show that the new device is substantially similar to one already approved and on the market, even if the device was itself fast-tracked, to begin with. In addition, a device can pass the fast-track process by being similar to a device that has malfunctioned and taken off the market. The only criteria are that the device was once approved. According to Dr. Kessler "the 501 process was designed to be the exception, not the rule." Today approximately 98% of all medical devices seeking approval bypass PMA by using the 501K fast-track process.

What has resulted is that medical devices such as Ethicon Physiomesh may have been approved by being similar to the company's other mesh devices, the transvaginal mesh which, has proven to be an abject failure and cost tens of thousands of women immeasurable pain and suffering. Ethicon and its Parent company Johnson and Johnson voluntarily withdrew Physiomesh due to an exceptionally high failure rate requiring revision surgeries. Surgeons performing revision surgery are now required to preserve Physiomesh as evidence to demonstrate the device's deterioration. Expert's site the body's rejection of Physiomesh's polypropylene component as the root cause of the device's failure, similar to that of the Transvaginal mesh.

Hernia repair patients suffering from the symptoms requiring revision surgery can consult with an experienced and knowledgeable Physiomesh attorney to see if they qualify to seek compensation for their medical expenses, lost wages, and pain and suffering. Physiomesh patients are holding Ethicon and Johnson and Johnson accountable for their negligence in rushing a faulty medical device to market without sufficient human test.

The FDA needs to do more to crack down on medical device manufacturers like Ethicon and Johnson & Johnson that abuse the 501 (k) fast-track approval process given the higher than expected rate of failure of Physiomesh and other medical devices.

More Recent Ethicon Physiomesh Lawsuit News:

• Hernia Mesh Repair Patients Should Know the Risks | 8/4/2020
• Think Twice Before Agreeing To Laparoscopic Hernia Repair Surgery | 7/31/2020
• Leading Hernia Repair Doctor Answers Hernia Repair Questions | 7/22/2020
• Update For Physiomesh Hernia Mesh Patients and Plaintiffs | 7/16/2020
• Hernia Mesh Trials May Focus On Similarities To Recalled Vaginal Support Mesh | 7/2/2020
• Patients Postponing Elective Hernia Mesh Surgery Due To Covid-19 | 6/18/2020
• Lawsuits Are Being Finalized For Hernia Repair Mesh Victims | 6/8/2020
• Bellweather Hernia Repair Mesh Failure Trials Are Scheduled to be Heard in September | 5/29/2020
• French Study Finds Fewer Hernia Mesh Revision Surgeries Within Two Years | 5/21/2020
• Hernia Repair Mesh Failure Can be Life-Threatening | 5/14/2020
• Hernia Mesh Strategy For Filing a Lawsuit | 4/29/2020
• A Natural Tissue Hernia Repair Surgeon Thinks Hernia Mesh Surgeons May Be Covering For One Another | 4/21/2020
• Five Physical Indications of Hernia Mesh Failure | 4/10/2020
• Hernia Mesh Lawsuits On Course To Begin This Fall | 3/30/2020
• Hernia Repair Mesh Lawsuits Require Thorough Preparation | 3/16/2020
• Hernia Mesh Preservation is Essential To Identify Its Manufacturer | 3/13/2020
• The Number of Hernia Repair Mesh Complaints is Increasing Every Day | 3/5/2020
• Plastic Hernia Repair Mesh May Not Do Well Long-Term When Used Inside The Human Body | 2/27/2020
• Bellweather Hernia Repair Mesh Trials To Begin This Year | 2/10/2020
• Ethicon's Physiomesh Composite hernia repair device was quickly recalled by Johnson & Johnson. | 2/4/2020
• Hernia Repair Mesh Problems Include Auto Immune Disorders | 1/29/2020
• Hernia Patients Should Question Their Surgeon's Experience With Laparoscopic Equipment | 1/2/2020
• Hernia Repair Mesh Could Be a Time Bomb That Is Ready To Explode | 12/26/2019
• Hernia Repair Mesh Surgeons Will Not Admit Hernia Mesh Failure | 12/17/2019
• Hernia Mesh Surgeons Lie to Their Patients That Return With Unbearable Pain | 12/11/2019
• Hernia Mesh Should Taken Off of the Market Worldwide | 11/19/2019
• Doctors Opinions Differs When Asked Which Type of Hernia Repair Surgery Is Best | 11/12/2019
• Consumer Advocate Ralph Nadar Speaks About Hernia Repair Mesh Malpractice | 11/5/2019
• Hernia Mesh and Vaginal Support Mesh Are The Same Things | 11/1/2019
• Vaginal Mesh IS Hernia Repair Mesh Re-purposed | 10/15/2019
• Avoid Doctors That Use Hernia Repair Mesh And Consider Natural Tissue Hernia Repair Instead | 10/9/2019
• The FDA Should Take Another Look At Their Hernia Mesh Classification | 10/7/2019
• Doctors Should Take Their Patient's Hernia Mesh Complaints Seriously | 10/1/2019
• Hernia Repair Mesh Can Cause Lifelong Medical Complications | 9/16/2019
• Doctors Are Divided As To Hernia Repair Mesh Safety | 9/12/2019
• Doctors Debate Using Hernia Repair Mesh Or Natural Tissue Hernia Repair | 9/6/2019
• Millions May Require Multiple Hernia Mesh Revision Surgeries Worldwide | 8/30/2019
• Hernia Mesh Failures In Europe Mirror Those In the US | 8/26/2019
• Open Hernia Repair Techniques Versus Laparoscopy | 8/15/2019
• Hernia Repair Mesh Contains Plastics That May Eventually Fail | 8/12/2019
• Doctors Are Divided As To Hernia Repair Mesh Safety | 8/2/2019
• The Number of Hernia Repair Mesh Lawsuits is Staggering | 7/29/2019
• Polypropylene Plastic Used to Make Hernia Mesh Is Making Patient Ill | 7/23/2019
• Experienced Surgeons Admit Hernia Mesh Can Cause Years of Pain | 7/16/2019
• Europe Is Concerned That Hernia Mesh Can Cause Severe Side Effects | 7/12/2019
• Physicians Are Split On Hernia Repair Mesh Benefits Versus Complications | 7/2/2019
• Hernia Repair Mesh Seems To Be Failing After a Number of Years | 6/27/2019
• Ethicon To Pay $80 Million In Pelvic Mesh Verdict | 6/18/2019
• Hernia Repair Mesh Is Similar to The Transvaginal Mesh Which Was Subject to Recall | 6/13/2019
• Laparoscopic Surgery Can Increase the Rate of Hernia Mesh Revision Surgeries | 6/7/2019
• Hernia Repair Doctors Are Ignoring The Risks of Using Hernia Mesh | 6/3/2019
• Hernia Repair Surgeons Are Divided Over Natural Tissue Versus Surgical Mesh Hernia Repair Techniques | 5/27/2019
• Hernia Repair Mesh Sales Continue In Spite of Requiring Revision Surgeries | 5/21/2019
• Over 200 Deaths Due To Faulty Hernia Repair Mesh Have Been Uncovered By An FDA Whistleblower | 5/15/2019
• Hernia Mesh Could Soon Follow Pelvic Mesh And Be Banned In The US | 5/6/2019
• Laparoscopic Hernia Mesh Removal Can Break Hernia Mesh Into Pieces If Performed Improperly | 4/30/2019
• Hernia Repair Mesh Results May Not Be Living Up To Expectations | 4/24/2019
• The FDA Bans Pelvic Surgical Mesh | 4/18/2019
• Hernia Repair Mesh Was A Really Bad Idea | 4/15/2019
• The World's Leading Hernia Repair Hospital Questions Laparoscopic Hernia Repair Techniques | 4/8/2019
• More and More Hernia Patients Are Avoiding Surgeons That Insist On Using Hernia Repair Mesh | 3/27/2019
• Australia and England Are Devastated By Pelvic and Hernia Repair Mesh Failures | 3/22/2019
• More and More Hernia Surgeons Also Remove Failed Hernia Mesh Devices | 3/19/2019
• Doctors in Great Britain Are Concerned Over The High Rate of Hernia Mesh Failures | 3/15/2019
• Hernia Repair Mesh Can Lacerate The Bowels Releasing Feces Into The Body Cavity | 3/12/2019
• A Strangulated Hernia Can Lead to Death | 3/7/2019
• Ethicon Physiomesh Trials Delayed Until 2020 | 3/3/2019
• Doctors May Require Special Training To Remove Failed Hernia Repair Mesh | 2/28/2019
• Hernia Repair Mesh Failures to Increase In The Years to Come | 2/22/2019
• Johnson & Johnson To Pay $41 Million To Injured Pelvic Mesh Patient | 2/15/2019
• The world's leading hernia repair hospital will not touch hernia mesh with a ten-foot pole | 2/11/2019
• Little is Known Why Ethicon Withdrew Physiomesh Composite Hernia Repair Mesh From the Worldwide Market | 2/5/2019
• Australian Hernia Institute Downplays Hernia Mesh Failure | 1/29/2019
• Hernia Repair Mesh Plaintiffs Are Gathering For Fall 2019 Trials | 1/24/2019
• Senator Rand Paul Chooses a Canadian Hospital Specializing in Non-Mesh Hernia Repair | 1/19/2019
• Hernia Mesh Patients Fear Comparisons To Failed Pelvic Mesh Devices | 1/15/2019
• England Health Ministries Are Concerned Over A Large Number of Hernia Mesh Failures | 1/10/2019
• University Hospital Continues to Use Hernia Mesh | 1/8/2019
• Hernia Repair Physicians Are Dealing With Hernia Repair Mesh Failures | 1/1/2019
• Hernia Repair Doctors Are Shunning Repair Mesh And Returning To Traditional Hernia Repair Methods | 12/20/2018
• Hernia Mesh Failure Symptoms Should Be Addressed Immediately | 12/18/2018
• Hernia Repair Mesh Patients Are Coming Forward With Their Stories | 12/11/2018
• Record Number of Hernia Mesh Failures Predicted in England | 12/7/2018
• Examples of Hernia Mesh Failure | 11/30/2018
• Europe's Hernia Mesh Scandal | 11/20/2018
• Think Twice Before Accepting A Doctor's Hernia Mesh Recommendation | 11/9/2018
• Hernia Mesh Devices - A History of Failure | 11/2/2018
• Physiomesh Problems Are Certain To Occur For Many Years To Come | 10/30/2018
• Ethicon Physiomesh Hernia Mesh Problems and Consumer Complaints | 10/25/2018
• Doctors Trusted the FDA to the Detriment of Physiomesh Patients | 10/16/2018
• Hernia Repair Is One of the Most Frequently Performed Surgeries in the World | 10/12/2018
• Doctors should not be blindly trusted to do what is best for their patients | 10/3/2018
• Physiomesh Substantially Similar to Other Failed Medical Devices | 10/1/2018
• Physiomesh Can Degrade and Break Into Pieces During Attempted Revision Surgeries | 9/28/2018
• Ethicon Physiomesh Polypropylene May Not be Biocompatible | 9/27/2018
• Ethicon's Physiomesh Composite Mesh Joins the Transvaginal Mesh as Recalled Failures | 9/22/2018
• Patients Can Report Their Medical Device Problems to an FDA Online Database For Everyone to See | 9/20/2018
• The Problem With The FDA's 501 (k) Fast-Track Approval Process Is That It Bypasses The Testing Usually Required Of A New Medical Device | 9/18/2018
• Johnson & Johnson Could Have Been More Forthcoming in Withdrawing Physiomesh | 9/14/2018
• Ethicon Will Not Reintroduce Physiomesh | 9/10/2018
• While Hernias Are Thought To Be A Men's Health Issue, Women Also Get Them And Can Be Adversely Affected By The Malfunctioning Physiomesh | 9/5/2018
• Doctors Are Surprised With Lax FDA Approval Requirements | 8/27/2018
• Polypropylene In Physiomesh May Have Never Been Tested | 8/24/2018
• Ethicon Fails To PinPoint the Reason for Physiomesh Failures | 8/21/2018
• Physiomesh May Have Been Compared With Transvaginal Mesh to Receive FDA Fast-Track Approval | 8/14/2018
• Herniamed Registry Data Convinced Ethicon to Pull Physiomesh | 8/9/2018
• Similarities Between Ethicon’s Physiomesh and Transvaginal Mesh Medical Devices | 8/7/2018
• Physiomesh Failures Could be Ongoing Nightmare | 8/2/2018
• The US National Institute of Health's Physiomesh Polypropylene Warning | 7/30/2018
• Physiomesh is Voluntarily Withdrawn From The Market | 7/27/2018
• Ethicon and Johnson & Johnson Inc. Fear a Flood of Physiomesh Litigation | 7/25/2018
• Traditional Hernia Repair Doctors Think Physiomesh May Be Unnecessary | 7/23/2018
• One Hernia Repair Expert Would Never Use Physiomesh | 7/19/2018
• Scientific Studies of Physiomesh Polypropylene | 7/17/2018
• Human Body May Reject Plastic-Based Medical Devices | 7/12/2018
• Ethicon Will Not Reintroduce Physiomesh | 7/9/2018
• Ethicon Physiomesh Lawsuits Pile Up | 7/5/2018
• Physiomesh Withdrawn From Market to Limit Ethicon's Liability | 6/30/2018
• Court Orders Surgeons to Preserve Physiomesh After Removal | 6/27/2018
• Thousands of Physiomesh Patients Are Left With Constant Pain | 6/22/2018
• Physiomesh Hernia Repair Trial Underway | 6/18/2018
• Polypropylene Rejection by the Human Body May Causes Physiomesh Failure | 6/13/2018
• Ethicon Withdraws Physiomesh From The Market | 6/8/2018
• Ethicon Takes Physiomesh Taken Off The Market ... Permanently | 6/5/2018
• Ethicon Physiomesh Trial Scheduled To Proceed | 5/28/2018
• Polypropylene Could be The Cause of Physiomesh Failure | 5/24/2018
• Ethicon Pulls Physiomesh From the US Market | 5/21/2018
• Ethicon Physiomesh Migration Issue | 5/16/2018
• Physiomesh Patients Subjected to Revision Surgery | 5/13/2018
• A Market Withdrawal of Physiomesh Heads Off Total Recall | 5/8/2018
• Market Withdrawal or Compulsory Recall | 5/5/2018
• Johnson and Johnson Pulls Physiomesh From the Market | 5/1/2018
• Lawsuits Against Ethicon Consolidated in Multi-District Litigation | 4/30/2018
• Do You Qualify to File a Physiomesh Claim | 4/27/2018
• Polypropylene in Physiomesh Causes Device Failure | 4/25/2018
• Facts Pertaining to Hernias and the Ethicon Physiomesh Hernia Repair Composite Mesh | 4/23/2018
• Ethicon Physiomesh Was Not Adequately Tested Before Being Allowed on The Market | 4/16/2018
• Ethicon Physiomesh Pulled From The Market | 4/13/2018
• Ethicon Physiomesh Flexible Composite Mesh Recalled | 4/9/2018
• The Ethicon Physiomesh Pulled From The Market | 4/3/2018
• A Summary of Physiomesh Hernia Repair Mesh Negligence | 8/21/2017
• People are Suing Ethicon, Maker of Physiomesh and Johnson & Johnson Subsidiary | 8/14/2017
• Urgent Field Safety Notice for Physiomesh Hernia Repair Mesh | 8/7/2017
• Ethicon Physiomesh Legal Questions | 7/28/2017
• Ethicon Physiomesh Hernia Repair is Flawed | 7/21/2017

Lawyers for Ethicon Physiomesh Lawsuits

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.