There are currently 716 Physiomesh cases filed in Federal court nationwide. In March of 2017, consolidation for an MDL was requested. The Judicial Panel on Multidistrict Litigation “JPML” heard consolidation arguments on May 25, 2017. On June 2, 2017, all Physiomesh cases filed in Federal court were consolidated into the Northern District of Georgia under the Honorable Richard W. Story.
The Physiomesh lawsuit is against Ethicon, a subsidiary of Johnson & Johnson. The Physiomesh is made from polypropylene and is intended for hernia repair. Ethicon has been battling lawsuits for years against its transvaginal mesh products, which are also made from polypropylene. Ethicon continues to deny the life-threatening complications that polypropylene causes. However, Ethicon issued a market withdrawal on the Physiomesh in May of 2016.
The US FDA has NOT Recalled the Physiomesh
Contrary to popular belief, the US FDA has not recalled the Physiomesh. Below is an excerpt that the Hollis Law Firm received in September of 2016 from Ethicon’s legal counsel, Butler Snow. A full version of the letter from Butler Snow can be viewed here.
Apparently Ethicon didn’t recall the Physiomesh in the United states, because the FDA didn’t require them to. Instead, the FDA allowed Ethicon to perform a market withdrawal. Ethicon “voluntarily withdrew” the Physiomesh after independent studies revealed high rates of complications associated with the Physiomesh. The previous high rates of patient and surgeon complaints were never enough to sway Ethicon or its parent company Johnson & Johnson into removing the Physiomesh from the market. Ethicon and Johnson & Johnson did not want to recall the Physiomesh and lose all of the profits that the Physiomesh was generating. Prior to removing the Physiomesh from the market, Ethicon created the Physiomesh Open in an attempt to fix the defects of the original Physiomesh. Ethicon submitted a 510(k) application for the Physiomesh open on June 12, 2014, and received clearance on October 23, 2014. Ethicon gave the Physiomesh Open about half a year to gain market traction before they finally decided to “voluntarily withdrawal” the regular Physiomesh from the market.
What is the Difference Between a Recall and a Market Withdrawal?
A recall is to be issued by the company on its own initiative, by FDA request, or by FDA order under statutory authority when the product may cause adverse health consequences. A market withdrawal is appropriate only when there is no evidence of manufacturing or distribution problems. Additionally, safety alerts are sent to hospitals, physicians, and patients to notify them of the potentially dangerous side-effects of a product when it is recalled, but not when a product is simply “withdrawn from the market.”
The FDA has three different classification for recalled medical devices. The FDA’s recall definition page can be viewed here and the excerpts are below. Read the definitions below, then the adverse events later in this article, and determine if the FDA was justified in allowing Johnson & Johnson and its subsidiary Ethicon to conduct a market withdrawal instead of a recall.
Was a Medical Device Safety Alert Issued in the United States for the Physiomesh?
No, a medical device safety alert was never issued in the United States for the Physiomesh. The FDA notes that a medical device safety alert should be issued if a device may present an unreasonable risk of substantial harm.
Ethicon, Johnson & Johnson, and the FDA didn’t think that the American public deserved to be made aware of the substantial risk of injury associated with the Physiomesh. However, an urgent field safety notice was issued in Switzerland on May 25, 2016, noting that reoperation and recurrence rates after laparoscopic ventral hernia repair using the Ethicon Physiomesh Composite Mesh were higher than the average rates. Ethicon even believed that the higher rates of reoperation and recurrence could be do the the characteristics of the Physiomesh. Unfortunately, Ethicon admitted to physicians that they were unable to instruct how to reduce the failure rate of the Physiomesh. A full version of the Switzerland urgent field safety notice can be viewed here.
After Ethicon withdrew the Physiomesh, the Getinge Group (parent company of Atrium Medical Corporation) sent a letter trying to convince doctors to start using Atrium’s C-Qur Hernia Mesh. Atrium has already faced several lawsuits from the FDA and consumers regarding the C-Qur hernia mesh. Having the Physiomesh off the market is great, but replacing it with another defective hernia mesh does no good.
FDA Clearance of Ethicon’s Physiomesh
The FDA originally cleared Ethicon’s Physiomesh on April 9, 2010. Ethicon used the FDA 510(k) clearance program for the Physiomesh. The 510(k) clearance program allowed Ethicon to skip rigorous pre-market research and studies, which are required for PreMarket Approval (PMA). Ethicon claimed that the Physiomesh was substantially similar to the Proceed hernia patch, which Ethicon also manufactures. Ethicon submitted a modified version of the Physiomesh (Physiomesh Open) for FDA 510(k) clearance on June 12, 2014. The FDA approved a second model of the Physiomesh on October 23, 2014. However, the FDA noted that 510(k) clearance did not mean that the Physiomesh complied with any Federal statutes, regulations, acts, the FDA or other regulatory agencies.
Ethicon utilizes a light-weight polypropylene (plastic) to manufacture the base layer (middle) of the Physiomesh. Polypropylene is the same material that Ethicon makes their trans-vaginal mesh and bladder slings from. Ethicon has faced thousands of lawsuits over its trans-vaginal mesh and bladder slings made from polypropylene. Ethicon added an absorbable film coating to each side of a polypropylene sheet to create the Physiomesh. The coating on each side of the Physiomesh is made of polyglecaprone, which is intended to be absorbed by the body after implantation. The polyglecaprone coatings alone are not able to adhere to the polypropylene. A polydioxanone film is utilized on each side of the polypropylene to bond the polyglecaprone coatings to the polypropylene mesh. In total, there are 5 layers to the Physiomesh. Every layer except the polypropylene in the middle of the Physiomesh is intended to be absorbed by the body after implantation.
Physiomesh: A Defective Design
The Physiomesh is one the most defect hernia meshes that the Hollis Law Firm has investigated to date. Ethicon has been aware that the Physiomesh was defectively designed and dangerous to implant in patients since its creation. There are numerous defects that physicians have been reporting to Ethicon (Johnson & Johnson) and the FDA since the product was released! Below are several design defects of the Physiomesh, backed up by Physician FDA adverse event reports.
The Physiomesh is Too Weak, Resulting in Mesh Rupture
The Physiomesh utilizes a lighter weight polypropylene than Ethicon previously used it its hernia mesh products. A “light-weight” polypropylene mesh simply means that less polypropylene is utilized to make the mesh. Manufacturers started using less polypropylene in hopes that there would be less complications associated with hernia mesh. The “light-weight” polypropylene is also significantly weaker than the old “heavy-weight” polypropylene. As a result, many patients have experienced the Physiomesh tear apart inside of them. Physicians frequently report patients experiencing their bowels blowing through the middle of the Physiomesh! Somehow, the United States Food and Drug Administration still has NOT recalled the Physiomesh!
Is the FDA Aware that the Physiomesh is Too Weak?
- Mar 2017: Physiomesh FDA Adverse Event Report MDR# 6396745 “When the surgeon drew the mesh from the sterile packaging, the mesh began to disintegrate.”
- Jan 2017: Physiomesh FDA Adverse Event Report MDR# 6218326 “The surgeon found that there was a hole in the center of the mesh.”
- Oct 2016: Physiomesh FDA Adverse Event Report MDR# 6027276 “Post-operatively, the mesh was broken into pieces and the hernia was formed through the sack and reduced during previous surgery.”
- Aug 2016: Physiomesh FDA Adverse Event Report MDR# 5866715 “It was also reported that the initial mesh was disintegrated.”
- Jun 2016: Physiomesh FDA Adverse Event Report MDR# 5758664 “It was found that recurrence of hernia occurred before the patient was discharged form the hospital. Reoperation was performed soon after the recurrence was first noted. In the reoperation, the mesh which had been used in the initial operation was not found inside the patient and the size of hernia was quite large.”
- Jun 2016: Physiomesh FDA Adverse Event Report MDR# 5724175 “When the surgeon entered the abdominal cavity, he saw where the hernia had forced its way through the center of the mesh and it split in the middle.”
- Apr 2016: Physiomesh FDA Adverse Event Report MDR# 5613331 “Patient experienced mesh rupture that resulted in hernia recurrence.”
- Mar 2016: Physiomesh FDA Adverse Event Report MDR# 5471668 “During the procedure, the mesh appears to have fractured in the middle of the mesh.”
- Jan 2016: Physiomesh FDA Adverse Event Report MDR# 5344417 “After 4-5 weeks, the patient experienced violent pain which occurred after sex. The patient underwent reoperation and during the procedure it was found that half the mesh had torn and the other half adhered to the colon. The ingrown mesh part also showed adhesions. While disconnecting the mesh from the colon, the bowel was injured.”
- Oct 2015: Physiomesh FDA Adverse Event Report MDR# 5141887 “Surgeon reported the hernia had pushed right through the center of the mesh.”
- Oct 2015: Physiomesh FDA Adverse Event Report MDR# 5118197 “The mesh that had contact with the strap was absorbed by the visceral peritoneum and intestinal fibro saram.”
- Sept 2015: Physiomesh FDA Adverse Event Report MDR# 5071991 “The implant showed damages (fraying mesh filaments) at the margins and 1 hole near the margin.” “One side of the mesh had broken free of the suture line and was no longer connected to the fascia. The sutures were found to be intact to the muscle and fascia. The mesh was reported to have torn away, was balled up and was near the bowel.”
- Jul 2015: Physiomesh FDA Adverse Event Report MDR# 4908850 “The patient underwent a hernia repair [sic] and a mesh was implanted due to a linear tear in the midst of previously implanted mesh.”
- May 2015: Physiomesh FDA Adverse Event Report MDR# 4779125 “It was discovered by the surgeon that the mesh had ripped right down the middle.”
- Apr 2015: Physiomesh FDA Adverse Event Report MDR# 4726748 “Patient experienced bowel adhesions to the mesh and presented with bowel obstruction… the surgeon opined that they felt this was a product failure. It was reported that the surgeon will remove the mesh which had a distinct 3 cm hole in mesh through which bowel is protruding.”
- Apr 2015: Physiomesh FDA Adverse Event Report MDR# 4672635 “During the surgery, it was found that the mesh was not visible nor could the surgeon feel the mesh. The surgeon opined it was like it was melted and torn apart.”
- Mar 2015: Physiomesh FDA Adverse Event Report MDR# 4571551 “Patient underwent a hernia repair procedure about one year ago and mesh was implanted. The patient recently underwent a hernia revision because the mesh split in half.”
- Feb 2015: Physiomesh FDA Adverse Event Report MDR# 4520210 “Following the procedure, the mesh had given way at the hernia defect site resulting in a recurrent hernia.”
- Dec 2014: Physiomesh FDA Adverse Event Report MDR# 4287046 “Approximately ten days later, the patient presented with a small bowel obstruction… It was noted there was a hole in the center of the mesh and that a loop had come through.”
- Nov 2014: Physiomesh FDA Adverse Event Report MDR# 4262657 “The patient experienced recurrent hernia with a report of feeling a burst at the place of the original hernia… the mesh was found to be properly incorporated with a tear in the top right quadrant.”
- Oct 2014: Physiomesh FDA Adverse Event Report MDR# 4206060 “The patient returned with a hernia recurrence and the physician found that the mesh had given way where the defect was. The mesh effectively had a hole in it. The hole was visible straight through the middle of the mesh, it hadn’t stretched.
- Oct 2014: Physiomesh FDA Adverse Event Report MDR# 4148916 “The patient experienced central mesh rupture, detected after tissue dissection, and heavy adhesions to the small intestine… The surgeon opines the hernia recurred because the mesh was too weak.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4126076 “The patient complained of increased pain over the next 4 months, she was treated with antibiotics and a ct scan [sic] revealed an increase of liquid over the hernia repair area. The patient was diagnosed with diverticulitis and a bowel obstruction [sic] and an incarcerated small bowel obstruction… There was a hole noted in the mesh.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4115333 “The surgeon found that the implanted mesh was damaged with holes in different positions.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4099678 “The surgeon opined that the mesh appeared to have incorporated surrounding the umbilicus, but the mesh was ruptured at the umbilicus.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4085408 “It was noted patient experienced wound dehiscence with signs of central fraying of the mesh but mesh was not broken.”
- Jun 2014: Physiomesh FDA Adverse Event Report MDR# 3889137 “Several small holes were seen near the margin of the hole.” “During the re-operation it was noted that there was a hole in the middle of the mesh. The small bowel was obstructed inside the hole of the mesh with necrosis. Some adhesions were noted. The patient was septic and required hemodynamic support. The mesh was removed and due to the resection of the small bowel.”
- May 2014: Physiomesh FDA Adverse Event Report MDR# 3812512 “The patient returned because the hernia had come back. The patient underwent a second laparoscopic surgery which revealed that the mesh had burst at the site of the defect. The solution was to dissect the damaged part of the mesh.”
- Apr 2014: Physiomesh FDA Adverse Event Report MDR# 3733591 “During the procedure, it was noted that the perimeter of the mesh was intact with sutures in the fascia and the majority of the middle of the mesh was dissolved. The surgeon removed the mesh.”
- Jan 2014: Physiomesh FDA Adverse Event Report MDR# 3595668 “The patient experienced a recurrent hernia and underwent a reoperation. During the reoperation, the surgeon found the mesh was broken.”
- Dec 2013: Physiomesh FDA Adverse Event Report MDR# 3523058 “Now the mesh is torn apart in the middle and the patient has heavy adhesions.”
- Dec 2013: Physiomesh FDA Adverse Event Report MDR# 3510809 “The surgeon cleared adhesions and ommentum from the hernia defect. The mesh had incorporated well into the abdominal wall but the mesh was torn under pressure of the abdomen, allowing the viscera to re enter the former defects.”
- Nov 2013: Physiomesh FDA Adverse Event Report MDR# 3523648 “Patient underwent a hernia repair procedure on an unknown date about one year ago. Currently, the mesh is torn apart in the middle.”
- Oct 2013: Physiomesh FDA Adverse Event Report MDR# 3397512 “A 4 cm rupture was found at the median of the mesh… mesh was ruptured in the middle.”
- Sept 2013: Physiomesh FDA Adverse Event Report MDR# 3327998 “The patient underwent a re-operation. During the procedure, the surgeon noted that there was a hole in the mesh.”
- Aug 2013: Physiomesh FDA Adverse Event Report MDR# 3300946 “The patient underwent a second surgery because the hernia reoccurred. During the re-operation, the surgeon noted a defect similar to a small hole or tear in the center of the mesh.”
- Jul 2013: Physiomesh FDA Adverse Event Report MDR# 3214452 “During the surgery, it was noted that there was a rip in the middle of the mesh.”
- May 2013: Physiomesh FDA Adverse Event Report MDR# 3135192 “The patient presented to the surgeon [sic] with a bowel obstruction. Bowel incarceration was discovered by diagnostic laparotomy [sic] and the surgeon saw a hole in the center of the mesh. Also, part of the mesh was densely adhered to the bowel. The surgeon partially removed the mesh.”
- Apr 2013: Physiomesh FDA Adverse Event Report MDR# 3058421 “Approximately four months post operatively, the patient experienced a recurrent hernia. A re-operation was performed. During the surgery it was noted that the mesh was torn in the middle.”
- Mar 2013: Physiomesh FDA Adverse Event Report MDR# 3023523 “During a re-operation on an unknown date it was found that there was a large amount of exudate and a hole in the mesh. A fistula was also discovered at the time. The hole int he mesh was repaired and the fistula was surgically treated.”
Dual-Sided Coating Prevents Adequate Incorporation
Unlike all other coated hernia meshes, the Physiomesh has a thick coating on both sides of the polypropylene. If the Physiomesh is not coated on both sides, the coating easily slides off of the polypropylene. Utilizing a dual-sided coating enabled each coating to stick to the other coating and not just the polypropylene. The coating is intended to prevent the bowel from being exposed to the underlying polypropylene. Polypropylene will essentially stick or adhere to any tissue or organs in the human body. If the polypropylene sticks to the bowel, it can cause severe injuries such as a bowel obstruction. However, if a mesh is coated on both sides, the mesh will not properly incorporate into the abdominal wall. The inability of the Physiomesh to properly incorporate results in the mesh free floating and moving around in the patient’s abdominal cavity. Hernia recurrence, severe pain, and even bowel complications are common in patients in which the Physiomesh fails to incorporate.
Is the FDA Aware that the Dual-Sided Coating Prevents Incorporation?
- Jan 2017: Physiomesh FDA Adverse Event Report MDR# 6218126 “Two months after the procedure, the patient returned to the doctor, complaining the hernia had returned… A re-operation was performed and it was discovered the mesh pulled away from the fixations and stay sutures and migrated into a ball in the omentum.”
- Dec 2016: Physiomesh FDA Adverse Event Report MDR# 6168117 “Following the procedure, the patient underwent a revision procedure due to recurrent hernia and the mesh was found in half down the middle where bowel was. It was also reported that abdominal wall in-growth was low compared to other mesh.”
- Jul 2016: Physiomesh FDA Adverse Event Report MDR# 5782201 In a randomized trial “Patients experienced post-operative pain, seroma, hematoma, trocar hernia, cellulitis, hernia recurrence and mesh migration into the small bowel. As a result of the mesh migration, the patient was readmitted to the hospital with an enterocutaneous fistula. The patient was treated with mesh extraction and segmental small bowel resection.”
- Jun 2016: Physiomesh FDA Adverse Event Report MDR# 5717602 “Incorporation of the mesh into the abdominal wall was poor, and the mesh was easily detached. The patient also experienced pain postoperatively at seven days, one month, three months, and/or six months.”
- Apr 2016: Physiomesh FDA Adverse Event Report MDR# 5612626 “The mesh fell off into abdominal cavity and adhered to bowel loop.”
- Dec 2015: Physiomesh FDA Adverse Event Report MDR# 5305994 “Ten days post-op, the patient returned with bowel obstruction and revision surgery was performed. During the re-operation, the surgeon used the tip of suction to swipe across the adhesion/omentum, the mesh fell easily into the abdominal cavity and was removed.”
- Nov 2015: Physiomesh FDA Adverse Event Report MDR# 5250319 “During the re-operation, the doctor noticed that the mesh was completely unfixed in the patient and essentially balled up. The surgeon opines that the coating on both sides of the mesh is inhibiting tissue in growth.”
- Sept 2015: Physiomesh FDA Adverse Event Report MDR# 5071911 “The surgeon states his patient experienced rupture, no integration and severe adhesions.”
- Aug 2015: Physiomesh FDA Adverse Event Report MDR# 5029640 “The physician opined that fascia side of mesh had zero incorporation.”
- Jun 2015: Physiomesh FDA Adverse Event Report MDR# 4859872 “The patient underwent a hernia repair procedure and the mesh was found to be sitting between the tissue layers, not incorporated into the tissue.”
- May 2015: Physiomesh FDA Adverse Event Report MDR# 4805703 “Following the procedure, the mesh did not incorporate on the abdominal wall. The patient underwent re-operation and explantation of the mesh.”
- Apr 2015: Physiomesh FDA Adverse Event Report MDR# 4650179 “The mesh was not grown in and could be easily removed and retrieved. It was only still fixed at a small point to the abdominal wall.”
- Dec 2014: Physiomesh FDA Adverse Event Report MDR# 4330398 “Following the procedure, the patient experienced a recurrent hernia, sliding of the mesh and lack of integration.”
- Nov 2014: Physiomesh FDA Adverse Event Report MDR# 4224037 “The surgeon removed the mesh except for a small amount of the mesh that remained implanted and attached to the abdominal wall. The surgeon opines that something occurred and the mesh had pulled away from the tissue on one side.”
- Oct 2014: Physiomesh FDA Adverse Event Report MDR# 4173408 “The patient underwent a re-operation and it was discovered that mesh edge had come loose and was able to be pulled off.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4115784 “During reoperation, dense adhesions were noted with poor incorporation of the mesh into the abdominal wall. The mesh was easily detached.”
- Aug 2014: Physiomesh FDA Adverse Event Report MDR# 4042157 “The surgeon opines that the coating on the mesh does not allow adequate incorporation into the fascia and when the fixation dissolved the mesh subsequently migrated.”
- May 2014: Physiomesh FDA Adverse Event Report MDR# 3815110 “The surgeon noted during the procedure that the mesh was intact but appeared to have torn off of the peritoneum.”
- Apr 2014: Physiomesh FDA Adverse Event Report MDR# 3769395 “Mesh was easily removed… The surgeon opines that because the mesh has absorbable material on both sides, it causes a problem with timely integration.”
- Mar 2014: Physiomesh FDA Adverse Event Report MDR# 3714557 “During the reoperation, the surgeon noted that the mesh was not integrated in the abdominal wall but inside the defect.”
- Dec 2013: Physiomesh FDA Adverse Event Report MDR# 3499336 “The mesh was easily removed from the abdominal wall during the procedure and it was noted that the mesh was ruptured approximately 1 cm above the defect, and it had migrated into the defect. Adhesions were present.”
- Nov 2013: Physiomesh FDA Adverse Event Report MDR# 3481456 “Post operatively, the mesh showed no ingrowth although the whole surface of the mesh had contact to the peritoneum.”
- Oct 2013: Physiomesh FDA Adverse Event Report MDR# 2405475 “The patient underwent removal of the mesh [sic] because the mesh was not grown in, it was only adhered slightly on the outer edges and the patient had inflammation.”
- Sept 2013: Physiomesh FDA Adverse Event Report MDR# 3367067 “During the procedure, the surgeon saw big sheets of the mesh layer were hanging in the pneumoperitoneal cavity and were detached form the mesh.”
- Aug 2013: Physiomesh FDA Adverse Event Report MDR# 3272675 “The mesh was no longer anchored in place and had become loose. The sutures were in place but the mesh had ripped out on the right hand side.”
- Jul 2013: Physiomesh FDA Adverse Event Report MDR# 3214337 “The surgeon noted that there was little in growth after one year.”
- Jun 2013: Physiomesh FDA Adverse Event Report MDR# 3177490 “The patient experienced a recurrent hernia. During the reoperation, it was noted that there was little ingrowth into the abdominal wall and was easily removed.”
- May 2013: Physiomesh FDA Adverse Event Report MDR# 3133999 “During the reoperation, the surgeon noted that the previous mesh had not grown in and it was detached very easily.”
- Apr 2013: Physiomesh FDA Adverse Event Report MDR# 3073046 “The right side of the mesh did not incorporate and the straps looked like they had torn through the mesh… The bowel was coming through the right side.”
- Mar 2013: Physiomesh FDA Adverse Event Report MDR# 2992243 “During the procedure it was noted that there were adhesions to the intestinal wall. The mesh was folded and there was not sufficient tissue ingrowth.”
Coating Does Not Protect the Bowel from Adhesion Formation
Our hernia mesh lawyers learned something very significant from the Physiomesh; it takes less inflammation/irritation for adhesions to form between the mesh and the bowel than it does for the mesh to incorporate into the abdominal wall. Adhesions and incorporation are describing the same process, the development of internal scar tissue, occurring on opposite sides of the mesh. The bowel is much more sensitive than the abdominal wall, and as a result, scar tissue forms easier between the mesh and bowel than the mesh and abdominal wall. This was something that initially surprised both our hernia mesh attorneys and our medical experts. It intuitively makes sense that the bowel would be more sensitive to scar tissue formation, but somehow it’s something that’s not been previously studied. Regardless, the physician adverse event reports to the FDA supply all the necessary evidence.
Is the FDA Aware that the Physiomesh’s Coating is Ineffective?
- Apr 2017: Physiomesh FDA Adverse Event Report MDR# 6465145 “Six weeks later the patient was sent to pain management due to continuing serious pain. In 2014 the patient was rushed to er due to incarcerated loop of small bowel within ventral hernia and the mesh… Patient has been on disability since 2012 and had to go to pain management for seven years.”
- Jan 2017: Physiomesh FDA Adverse Event Report MDR# 6264418 “Within a week or two after the procedure, the patient was seeing a doctor for abdominal pain. In 2016, the patient developed severe abdominal pain after eating and ct scan of abdomen showed a partial small bowel obstruction. The patient was admitted for observation and treatment with hydrated iv antibiotics. Five days later the patient required exploratory laparotomy. Surgical findings were acute and chronic inflammation, multiple adhesions, hemorrhage and ischemia in the small bowel. During the open bowel resection, ninety centimeters of small bowel was removed. The patient was on pca dilaudid for four days. Weight loss was twenty five pounds…. The patient is still not feeling well with episodes of vomiting.”
- Oct 2016: Physiomesh FDA Adverse Event Report MDR# 6057564 “Hospitalization was prolonged for the patient who possibly developed severe complications requiring operation. During reoperation, loose adhesions of the greater omentum to the upper edge of the mesh and tangential to its surface were found.”
- May 2016: Physiomesh FDA Adverse Event Report MDR# 5650261 “Six months after surgery, the patient experienced severe stomach pains… it was noted that the small intestine was stuck to the mesh.”
- Apr 2016: Physiomesh FDA Adverse Event Report MDR# 5585136 “An inflammatory exudate, gelatinous in appearance, was noted to be hanging from the mesh implant during the laparoscopy. It was also reported that beneath this exudate there was a small bowel with adhesions.”
- Feb 2016: Physiomesh FDA Adverse Event Report MDR# 5419904 “Patient experienced serious adhesions, partly impossible to remove, particularly those with ingrowth of the small intestine, left side mid-abdomen. Approximately three cm long dense adhesions was found between jejunum loop and mesh with kinking and stenosis. The defect size was off site of the mesh with clear mesh shrinkage. The was solved by segment resection and partial mesh resection. The patient underwent resection of the small intestine and terminal colostomy reconstruction.”
- Nov 2015: Physiomesh FDA Adverse Event Report MDR# 5204983 “The re-operation revealed adhesion of bowel on the previously implanted mesh.”
- Oct 2015: Physiomesh FDA Adverse Event Report MDR# 5166167 “During the procedure, the omentum majus was found firmly adherent on the mesh. Relatively low adhesions were found to the peritoneum… mesh was detached form the omentum and the coating from the mesh was partially separated, because it strongly adhered to the omentum.”
- Jul 2015: Physiomesh FDA Adverse Event Report MDR# 4894918 “Multiple adhesions in loops, adherence and perforation of the small intestine in two places. The mesh was removed… The patient was sent to the ICU…receives daily dressing changes, is fasting and on total parenteral nutrition and antibiotics. There is no forecast for hospital discharge… The surgeon opined that the patient had a generalized infection and died.”
- Jun 2015: Physiomesh FDA Adverse Event Report MDR# 4841461 “In the beginning of 2014, the patient became severely ill with symptoms of a bowel obstruction, severe nausea, vomiting, abdominal pain, cramping and bloating. The patient experienced numerous hospitalizations and weight loss of 45 pounds as of 2015.”
- Feb 2015: Physiomesh FDA Adverse Event Report MDR# 4528325 After 12-18 months “the patient experienced significant pain, over and above what was expected immediately post op and for the following 4 days, before being released from the hospital… the majority of the mesh was covered with adhesions.”
- Nov 2014: Physiomesh FDA Adverse Event Report MDR# 4242516 “In 2013, the patient presented with severe abdominal pain out of proportion to the exam and erythema over the anterior abdominal wall. A ct scan confirmed an incarcerated small bowel with obstruction. The patient underwent a procedure for a mildly ischemic bowel within an incarcerated hernia severely stuck to mesh, resulting in a enterotomy requiring resection.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4115778 “The second day after the surgery the patient developed adhesions to the intestinal loops and was admitted with septic shock and a distended abdomen with a peritoneal reaction. A laparotomy was performed. The surgeon found corrosion of the loops and perforation of the small intestine… The intestinal fistula was surgically closed and the patient was hospitalized in the intensive care unit… the patient is currently in a coma… septic shock, possibly originated by the fistula and the patient passed away.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4076714 “During this open procedure, the previous mesh was found adhered to the small bowel. The surgeon removed parts of the mesh, lysed the adhesions and then removed the bowel from the mesh. The enterotomy was performed as the adhesiolysis created a defect in the jejunum intra-operatively.”
- Sept 2014: Physiomesh FDA Adverse Event Report MDR# 4060962 “Small bowel obstruction which the surgeon opined was caused by adhesions of the mesh. The surgeon took down the adhesions with blunt and sharp dissection.”
- Aug 2014: Physiomesh FDA Adverse Event Report MDR# 3979789 “Four months following the procedure, the patient experienced enterocutaneous fistula and bowel perforation which drained fecal matter without exposure of mesh.”
- Feb 2014: Physiomesh FDA Adverse Event Report MDR# 3633903 “Three weeks later, the patient underwent a re-operation to remove the mesh because it was joined to the bowel loops.”
- Jan 2014: Physiomesh FDA Adverse Event Report MDR# 3546474 “Patient underwent a revision surgery because the mesh had grown into the intestines.”
- Dec 2013: Physiomesh FDA Adverse Event Report MDR# 3526920 “The mesh was removed due to incarceration of the bowel.”
- Nov 2013: Physiomesh FDA Adverse Event Report MDR# 3467114 “The surgeon noticed that the mesh was completely into the bowel with extremely severe adhesions and fistula.”
- Oct 2013: Physiomesh FDA Adverse Event Report MDR# 3434975 “A lap-assisted small bowel resection of a piece of small bowel adherent to devascularized omentum which was adherent to the abdominal wall near the left edge of the mesh was performed.”
- Sept 2013: Physiomesh FDA Adverse Event Report MDR# 3335298 “During the surgery, the surgeon noted that the mesh was adhered to the bowel.”
- Aug 2013: Physiomesh FDA Adverse Event Report MDR# 3300504 “The patient had to undergo a second operation and it was noted that a dense amount of adhesions had formed in the center of the mesh. The adhesions were removed and the mesh was replaced.”
- Jul 2013: Physiomesh FDA Adverse Event Report MDR# 3216551 “Patient experienced a recurrence of the hernia with massive adhesions.”
- Jun 2013: Physiomesh FDA Adverse Event Report MDR# 3159978 “It was also noted that there were strong adhesions present. The adhesions were dissected.”
- May 2013: Physiomesh FDA Adverse Event Report MDR# 3097130 “Mesh was adhered to the bowel loops. The mesh was removed at the time and a jejunostomy was done.”
Prone to Folding Over After Center Stripe Degrades
Medical device manufacturers are also obligated to inform the FDA when studies or literature reveal complications or defects in their products. In November of 2015, Ethicon reported a literature review to the FDA. In the study, a patient experienced bowel complications after being implanted with the Physiomesh and “adhesions were found on the majority of the mesh surface. Recurrence presented in the long [axis] of the mesh in the line of the stripe built into the mesh… It was opined by the study authors that recurrence occurred at the time point the stripe underwent degradation. It was also opined by the study authors that stiffness of the mesh in the long [axis] could be an independent factor causing recurrence.”
Packaging Prone to Micro Perforations and Tears
The Physiomesh utilizes a foil package to keep the hernia mesh sterile. The foil packaging of the Physiomesh is prone to excessive wrinkling, which weakens the sterile packaging and allows micro perforations to form. The small holes that form in the sterile packaging of the Physiomesh are extremely hard to detect and greatly increase the risk that a surgeon implants a contaminated medical device. As a result, high rates of infection have been observed with the Physiomesh. As can be seen in the photos, the holes in the packaging of the Physiomesh are difficult to detect until the packaging is held up to a light source. With the packaging defect being so hard to detect, it’s surprising that so many adverse events have been reported on this specific defect.
Is the FDA Aware that the Packaging of the Physiomesh is Prone to Micro Perforations?
- May 2016: Physiomesh FDA Adverse Event Report MDR# 5685709 “The product was removed from the box and a tear was noticed in the packaging.”
- May 2016: Physiomesh FDA Adverse Event Report MDR# 5634666 “During the procedure it was found that the mesh foil was open and not sterile.”
- May 2016: Physiomesh FDA Adverse Event Report MDR# 5634021 “When the package was opened and outside of its storage-box, a hole was discovered in the inner package.”
- Mar 2016: Physiomesh FDA Adverse Event Report MDR# 5476131 “During the procedure, the foil package had two holes in the package when removed from the box.”
- Oct 2015: Physiomesh FDA Adverse Event Report MDR# 5141758 “When the mesh was opened, it was noticed that the foil was pierced; the mesh was not used in the procedure since the sterility was compromised.”
- Apr 2015: Physiomesh FDA Adverse Event Report MDR# 4689813 “When the circulating nurse open[ed] the sealed mesh box, the mesh was missing inside the box, was only left with the IFU [Instructions For Use] booklets.”
- Nov 2014: Physiomesh FDA Adverse Event Report MDR# 4220845 “When opening the device, a hole was found in the tyvek package in the left middle of the front side.”
- Apr 2014: Physiomesh FDA Adverse Event Report MDR# 3761462 “As the mesh was opened, a hole in the packaging was noted.”
- Feb 2014: Physiomesh FDA Adverse Event Report MDR# 3648350 “A hole was found in the cellophane package. No holes were found in the outer carton.”
- Feb 2014: Physiomesh FDA Adverse Event Report MDR# 3606753 “While opening the package, the scrub tech felt that the device was not sterile.”
- Oct 2013: Physiomesh FDA Adverse Event Report MDR# 3423160 “The outer pouch of the mesh was wrinkled and crumpled with small holes.”
- Sept 2013: Physiomesh FDA Adverse Event Report MDR# 3335359 “It was noted that the inner foil pouch was not seal[ed].”
- July 2013: Physiomesh FDA Adverse Event Report MDR# 3202361 “When the device was opened it was noted that there was a hole in the inner package.”
- Apr 2013: Physiomesh FDA Adverse Event Report MDR# 3782195 “Cover of the mesh was damaged.”
- Apr 2013: Physiomesh FDA Adverse Event Report MDR# 3037969 “The surgeon starting to secure the mesh with sutures when it was noted by the OR nurse that there was a hole in the packaging of the mesh. The surgeon removed the mesh from the patient.”
- Mar 2013: Physiomesh FDA Adverse Event Report MDR# 3015448 “Inner sterile pouch had a hole in it.”
The Physiomesh has been associated with high rates of bowel obstructions, seromas, fistulas, infections, rashes, pain, hernia recurrence, mesh shrinkage, and mesh failure. The hernia recurrence rate is high with the Physiomesh due to poor incorporation and the mesh tearing easily. Subsequent surgeries are typically required due to complications related to the Physiomesh.
Scientific Articles on Ethicon’s Physiomesh:
Data from the Herniamed German Registry, one of two large independent hernia registries that found high rates of complications associated with Ethicon’s Physiomesh. The analysis compares the 1-year follow-up data collected for all patients with incisional hernia who had undergone elective laparoscopic intraperitoneal only mesh repair either with Physiomesh (n=1380) or with other hernia meshes (n=3834). Patient’s implanted with the Physiomesh were approximately 250% more likely to suffer a hernia recurrence. The study authors concluded by noting “The importance of real-world data for postmarketing surveillance of surgical meshes has been demonstrated in this registry-based study. Randomized controlled trials are needed for premarket approval of new devices. The role of sponsorship of device studies by the manufacturing company must be taken into account.
Physiomesh was compared to two other composite hernia mesh products. The Physiomesh resulted in the development of more seromas and less tissue integration than the other studied hernia mesh products.
A study comparing various techniques utilized to close a hernia defect with Physiomesh. Many patients experienced hernia recurrence regardless of the technique utilized.
25 patients were implanted with Physiomesh. Within 6 months of hernia mesh implantation, 20% of those implanted with Physiomesh had experienced a hernia recurrence in the first 6 months and then the study was terminated. The authors of the study concluded that “Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the [Physiomesh] system associated with significantly greater hernia recurrences and postoperative pain…”
Physiomesh was compared to two other new hernia mesh products. Physiomesh demonstrated significantly lower incorporation strengths than the other hernia mesh products. Fractioning of the the Physiomesh coating was also observed over time, which lead to scar plate formation, but little to no abdominal wall adherence.
The mechanical properties 13 hernia mesh products were evaluated, including Physiomesh. Significant differences were observed depending on which mesh was implanted and how it was secured. The authors noted that hernia mesh materials are currently utilized as if they are uniform and interchangeable, when that is simply not the case. Additional instructions and training from Ethicon could have resulted more successful hernia repairs.
5 animals were implanted with Physiomesh and 5 animals were implanted with Ventralight. Animals implanted with Physiomesh exhibited significantly more inflammation, fibrosis, and hemorrhage.
The Physiomesh was found to be the least comfortable of the six hernia meshes.
Should the FDA Recall the Physiomesh?
After reviewing all of the above information, what do you think? Was the FDA justified in allowing Johnson & Johnson and Ethicon to conduct a market withdrawal instead of recalling the Physiomesh? Remember, a market withdrawal is only appropriate if there is no evidence of a defect. If you think that the FDA should have recalled the Physiomesh, let us and everyone else know by sharing this page on social media and commenting that the FDA should recall the Physiomesh on our Physiomesh YouTube video. Additionally, call your state representatives and other elected officials, and ask them why the FDA is protecting Johnson & Johnson instead of the public. The FDA must be reformed or the American public will lose even more faith in our medical industry.
The hernia mesh device tags are necessary to prove which hernia mesh was utilized during an operation. It is not uncommon for an operative report to use a generic name instead of the brand name when describing a hernia mesh. Many surgeons use the name of a company’s original polypropylene mesh to describe any hernia mesh made by that company. For instance, some surgeons will call all Ethicon hernia meshes “prolene” and all Bard Davol hernia meshes “marlex.” There are so many new hernia meshes constantly coming to the market that many surgeons can’t even remember which one they are implanting.
Device tags are not always easy to locate. Some hospitals do not maintain or include device tags as part of the medical record chart. At times, it is necessary to contact the surgical department directly. Obtaining medical device tags can be a frustrating and time consuming process, luckily the Hollis Law Firm has staff trained and experienced in tracking down medical device tags.
Device tags are also known as “product stickers” and the “Product Traceability Label.” The device tags note that Ethicon is the manufacturer of the Physiomesh. This particular Physiomesh was 15x20cm. The PHY1520V is the catalog number (also known as the reference number), which is used for when ordering a particular Physiomesh. The expiration date for this Physiomesh was October, 2014. This Physiomesh’s LOT number was EM8DDQA0. The LOT number corresponds to a group of Physiomeshes that were manufactured at a particular location at a particular time. LOT numbers are useful in determining if a product defect is an isolated incident or a systemic problem. The Physiomesh’s defects are a systemic problem.
Johnson and Johnson’s subsidiary Ethicon withdrew all LOT numbers of the Physiomesh from the market. The Hollis Law Firm’s Physiomesh lawyers are reviewing injuries associated with all Physiomesh LOT numbers.
Physiomesh: Ethicon Hernia Mesh Lawsuit
Please call us to speak to one of our trained hernia mesh team members. An attorney and a medical professional will look over your Physiomesh case and let you know what they believe the best course of action is for you. The specific facts of your lawsuit will determine if your lawsuit is compensable and to what amount. The Hollis Law Firm represents hernia mesh victims nationwide. All case evaluations and consultations are FREE, CONFIDENTIAL, and carry NO RISK or OBLIGATION. Call 1-800-701-3672 for an Ethicon Physiomesh lawsuit evaluation.
Physiomesh lawsuits are starting to mount across the nation. Many attorneys have finally realized that the Physiomesh is a defective hernia mesh. The hernia mesh lawyers at the Hollis Law Firm understand that the problem is larger than just Physiomesh. Visit our general hernia mesh lawsuit page for more information on other hernia meshes. Follow our Physiomesh Lawyer FaceBook page to stay up-to-date on everything Physiomesh.
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