Ethicon unfortunately fast tracked regulatory approval of Physiomesh™ utilizing the lawful, controversial yet unsettling Federal drug Administration’s (FDA) 510k Premarket Notification process. Ethicon was able to evade more stringent Federal Drug Administration clinical trials with this controversial tactical maneuver! Pathetically, large medical device manufacturers regularly, willfully and deviously evade FDA scrutiny by utilizing the flawed 510k process.
Rather then force Johnson and Johnson’s subsidiary, Ethicon to recall Physiomesh™, the empty suits at the FDA allowed Ethicon to not only steal people’s lunch money but to spit in their face at the same time. Ethicon, was allowed to have it both ways, remove Ethicon’s allegedly defective hernia mesh from the market place while at the same time Ethicon denies that Physiomesh™ is dangerous and defective.
Many victims of Physiomesh are looking into filing a hernia mesh lawsuit. The best hernia mesh law firms are filing mesh lawsuits in Federal and State Courts across the nation and in other countries. If you did not file a hernia mesh lawsuit 2017, should you file a hernia mesh lawsuit 2018? Many victims are reaching out to surgical mesh attorneys and defective hernia mesh lawyers asking about mesh settlements and whether they will qualify for a hernia mesh settlement 2018. Other victims are merely seeking an Ethicon mesh lawsuit update.
Is Ethicon Physiomesh™ surgical hernia mesh defective?
“Physiomesh™ was marketed after clearance under the FDA’s 510(k) process in April 2010, which does not require clinical trials for safety and efficacy.” MeshNews desk It has been alleged that Johnson and Johnson’s corporate subsidiary, Ethicon put profit motive over safety. Medical device companies have shamelessly utilized the FDA 510k premarket approval process to dump defective hernia mesh into the open market. This has caused untold pain and suffering among mesh victims. This has also lead to thousands of hernia mesh revision surgeries.
Should Johnson and Johnson settle the mesh causes of action?
Ethicon Physiomesh™ hernia mesh was introduced in 2010 into the hernia mesh medical device marketplace. This was the beginning of a sad and disturbing course of events. This course of events culminated in Ethicon’s voluntary removal of Physiomesh from the marketplace in 2016. Some people are wondering: if Ethicon implicitly admits to the dangerous of this medical device, shouldn’t Ethicon open their pocketbook and reach a global mesh settlement 2017 or 2018. Sadly, Ethicon has decided to engage in scortched earth litigation rather than reaching a settlement with the victims.
Physiomesh™ withdrawn and removed from United States Markets- Recall in Canada
On May 26th 2016, Ethicon uncharacteristically issued an “urgent” field safety notice. Ethicon’s actions were technically not a recall. In some other countries such as Canada, Ethicon recalled PHYSIOMESH™.
Has the FDA been asleep at the wheel concerning Ethicon Physiomesh™ hernia mesh?
“In December 2009, Ethicon submitted to the United States Food and Drug Administration (“FDA”) a Section 510(k) premarket notification of its intent to market PHYSIOMESH. By a letter dated April 9, 2010, the FDA cleared Physiomesh as a Class II prescription device on the basis that it was at least as safe and effective as—that is, substantially equivalent to—Ethicon’s PROCEED Mesh, ULTRAPRO Mesh, and ULTRAPRO Hernia System, all of which had been previously cleared by FDA under the 510(k) process. Thereafter, Ethicon began marketing Physiomesh™ to surgeons. Ethicon decided to withdraw Physiomesh™ from the global market in May 2016.” DEFENDANTS’ RESPONSE IN OPPOSITION TO PLAINTIFFS’ MOTION FOR TRANSFER PURSUANT TO 28 U.S.C. § 1407
The FDA determined that “ETHICON PHYSIOMESH, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.” Approval letter from FDA to Ethicon dated April 9, 2010
The FDA’s decision in 2010 was that the device ETHICON PHYSIOMESH was “Substantially Equivalent (SESE)” to previous Ethicon hernia mesh products.
On April 9th, 2010, the DEPARTMENT OF HEALTH & HUMAN SERVICES, food and drug administration (FDA) approved Ethicon’s pre-market notification. “We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce…” Id.
What mesh did Ethicon claim was the predicate device that PHYSIOMESH was substantially similar to?
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Many adverse event reports were submitted to the FDA prior to the device being removed from the United States Markets
- Event Date 11/08/2010 MAUDE Adverse Event Report: ETHICON, INC. PHYSIOMESH MESH, SURGICAL – “It was reported that a pt underwent a primary incisional anterior abdominal wall hernia repair procedure on (b)(6) 2010 and mesh was placed using intraperitoneal onlay mesh technique. The pt developed severe pain with a visible recurrence and bulging. The pt underwent a second laparoscopic procedure on (b)(6) 2010. The surgeon discovered that the mesh came loose partially. The mesh was frayed especially where the tackers were placed. Minimal adhesion were removed and the mesh was removed. The surgeon used tension technique to close.” Catalog Number PHY1520R Device Problem Tears, rips, holes in device, device material
- Event Date 05/20/2011 MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC- “It was reported that a patient underwent an open ventral/incisional hernia repair procedure on (b)(6) 2011 and mesh was used. On (b)(6) 2011, the patient presented with abdominal pain and a high white blood cell count. The patient developed an intrabdominal infection that was (b)(6). The patient underwent reoperation on (b)(6) 2011 and seroplueralant fluid on the visceral side and parietal side of mesh was observed. The mesh was explanted. Currently, the patient is intubated in icu with sepsis. The surgeon opines the cause of the patient and (b)(6) event was renal failure at time of reported symptoms on (b)(6) 2011.” Catalog Number PHY0715R, Report Number: 2210968-2011-00780
- Report Date:08/03/2012 MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL, POLYMERIC “It was reported by a patient that the patient underwent a hernia repair procedure on an unknown date and mesh was used. Approximately one year after the procedure, the patient experienced a relapse. A second procedure was performed on an unknown date and the mesh was removed. The surgeon reported that the mesh was not incorporated in the abdominal wall and was adherent to the small intestine. Additional information was requested.” Report Number2210968-2012-04287 , MDR Report Key2707404
- Report Date: 08/04/2011 MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC”It was reported that a patient underwent an incisional hernia repair on an unknown date and mesh was used. The patient developed an ileus. During reoperation, heavy ingrowth of the mesh and bowel was noted. The bowel could only be separated from the mesh with sharp instrument. The mesh was removed. The ileus was repaired by skin closure and no new mesh was placed. An additional surgery for hernia repair with mesh is planned after four to six weeks.” MDR Report Key2217482, Report Number: 2210968-2011-01135d
- Report Date04/04/2011 MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC- “It was reported that a patient underwent a laparoscopic surgical procedure on (b)(6) 2010 to repair a ventral hernia and mesh was implanted. The patient experienced a recurrent hernia on an unknown date. The patient underwent an open hernia repair procedure (b)(6) 2011. During the procedure, the mesh was very easily removed because it was hardly attached to the peritoneum with almost no ingrowth. A different mesh was used complete the repair procedure.” Catalog Number PHY1520V, Report Number2210968-2011-00517
- Event Date 04/15/2011 MAUDE Adverse Event Report: ETHICON ETHICON PHYSIOMESH ETHICON HERNIA MESH “Laparoscopic ventral hernia repair with ethicon mesh. Mesh pulled away from abdominal wall resulting in 2nd surgery laparoscopic & open (laparotomy) removal of mesh, repair of recurrent ventral hernia using bard mesh.” Report Number 2069574
What is MAUDE – Manufacturer and User Facility Device Experience
“The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1(manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
“Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm