Proceed Lawsuit: Who is the FDA Protecting?

Proceed Hernia Mesh Logo

Proceed Hernia Mesh Lawsuit

The Proceed lawsuit is against Ethicon, a subsidiary of Johnson & Johnson. The Proceed hernia mesh utilizes a light-weight polypropylene. Ethicon knew that the polypropylene used to make the Proceed hernia mesh was not inert or fit for human implantation. Ethicon added a layer to the Proceed in an attempt to lessen the injuries caused by the polypropylene. However, the protective layer on the Proceed mesh is completely ineffective. After a period of time, the layer goes away and only bare polypropylene remains.

Proceed Surgical Mesh Folded

Proceed Components

The base of the Proceed hernia mesh is Ethicon’s Prolene Soft Mesh, a light-weight polypropylene mesh. Ethicon then added a resorbable coating made of Oxidized Regenerated Cellulose (ORC) to the Prolene Soft Mesh when creating the Proceed hernia mesh. To make the cellulose layer stick to the polypropylene of Prolene Soft Mesh, Ethicon utilized Polydioxanone (PDS). The polypropylene side of the Proceed hernia mesh is indicated with blue stripes. The blue striped polypropylene side of the Proceed mesh is intended to be placed against the parietal side (abdominal wall), while the tan cellulose side is to be placed against the viscera (underlying organs).

What is Oxidized Regenerated Cellulose?

First, let’s start with what Cellulose is. Cellulose is an organic polysaccharide, most often known for being the primary component of the cell wall in green plants. Cellulose is a very cheap product to produce, and there are numerous ways to produce cellulose. However, the coating of the Proceed hernia mesh can not be made out of regular cellulose, because regular cellulose is NOT resorbable in the human body. For cellulose to be resorbable in the human body, the cellulose must first be oxidized. A quick and cheap solution for oxidizing large quantities of cellulose at once is to hit the cellulose with radiation. Properly irradiated cellulose should turn into Oxidized Regenerated Cellulose (ORC). Ethicon utilizes radiation in an attempt to turn the cellulose of the Proceed hernia mesh into oxidized regenerated cellulose. However, Ethicon doesn’t just irradiate the cellulose of the Proceed hernia mesh. Ethicon waits until the sterilization process and then hits the entire Proceed hernia mesh with radiation, including the polypropylene.

Literature on Oxidized Regenerated Cellulose

“Oxidation, however, is the only process that renders cellulose bioabsorbable in man. Complete oxidation of cellulose yields carbon dioxide and water. Partial oxidation of cellulose results in a biomaterial with controlled degradation characteristics that are used to advantage by the biomedical industry. Since the oxidation process is complex, it often results in non-homogenous materials.” “Due to the availability of many carboxyl groups, oxidized cellulose has a low pH.”

Sterilization of the Proceed

Proceed Hernia Mesh Sterilized via Gamma Irradiation
R = Radiation

Radiation is a cheap and effective sterilization method, which many types of medical devices utilize. However, Johnson & Johnson’s Proceed is the only polypropylene hernia mesh to utilize radiation. Radiation will degrade, weaken, and embrittle polypropylene, which is why polypropylene hernia meshes are traditionally sterilized with Ethylene Oxide. Even Johnson & Johnson sterilizes their other polypropylene hernia meshes with Ethylene Oxide. Polypropylene doesn’t just weaken and degrade at the time it’s exposed to radiation, a chain reaction is set off that continues to degrade the polypropylene months and even years after radiation exposure. It is well known that polypropylene should not be sterilized using irradiation techniques such as gamma or beta irradiation, as the polymers will be significantly degraded.

Proceed Irradiated with Cobalt
Cobalt 60 = Radioactive Isotope

Studies on Radiation Impacting Polypropylene

“Radiation, where mostly the effects of [gamma] rays has been investigated in the past, induce chain scission and degradation effects, resulting in a reduced melt viscosity and severe embrittlement. Parallel to that oxidized phenolic antioxidants results in discoloration; the material becomes yellow. What makes this radical reaction so critical is the fact that it continues for long times after the actual sterilization process, making long-term studies necessary for studying the effects.”

How sterilization via high-energy radiation embrittles various formulations of polypropylene.

Proceed Hernia Mesh Design Defects

The Proceed hernia mesh is an unbelievably defective hernia mesh, just like Johnson & Johnson’s other coated hernia mesh, the Physiomesh. However, many of the defects associated with the Proceed hernia mesh are completely different than the design defects of the Physiomesh!

Prone to Degradation and Disintegration

Proceed Torn to PiecesPolypropylene of the Proceed is exposed to radiation, setting off a prolonged chain reaction that significantly degrades and weakens the plastic. Doctors have submitted numerous reports to the FDA and Johnson & Johnson regarding the Proceed breaking apart and disintegrating! It doesn’t appear that the FDA or Johnson & Johnson care though, maybe because degradation is expected when polypropylene is hit with radiation?

Proceed Same Polypropylene as Prolene

Ethicon Claims the Proceed’s Polypropylene is Identical in Composition to that used in Sutures. Prolene Sutures are NOT Exposed to Radiation.

IFU Claiming Polypropylene Doesn't Degrade or Weaken

From Within the Instructions for Use (IFU) for the Proceed Hernia Mesh

Is the FDA Aware the Polypropylene of the Proceed Disintegrates?Remaining Pieces of Proceed Mesh

Mar 2017: Proceed Ventral Patch FDA Adverse Event Report 6449428 “During reoperation, it was found that the mesh was disintegrated into multiple small pieces.”

Mar 2017: Proceed Ventral Patch FDA Adverse Event Report 6428177 “Prior to the procedure, when removed from the packet, the mesh was disintegrating and it was not implanted in the patient.”

Feb 2017: Proceed Ventral Patch FDA Adverse Event Report 6356389 “Pt returned and required mesh to be removed which was disintegrated into multiple small 2 mm pieces which was removed from [patient].”

Feb 2017: Proceed Ventral Patch FDA Adverse Event Report 6333715 “Following the procedure the patient experienced a recurrent ventral hernia and underwent a re-operation. During re-operation, it was found that the mesh had pulled loose and was broken into pieces inside the patient. It was also reported that the mesh had completely pulled away from abdominal wall and crystal /plastic like pieces were observed on top of the mesh in the space around the mesh.”

Oct 2016: Proceed Ventral Patch FDA Adverse Event Report 6027082 “As the surgeon was inserting the product into the patient, the product was “disintegrating” or coming apart.”

Oct 2016: Proceed Ventral Patch FDA Adverse Event Report 6026994 “The mesh was coming apart and the patient developed a recurrent hernia.”

3 Pieces of Broken Proceed MeshFeb 2016: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5401708 “The patient was scheduled for an exploratory procedure an an abscess was discovered. During the operation, the mesh was found disintegrated and cut into the patient’s small intestine. The mesh was removed; the part of small intestine was removed and re-attached. It was also reported that the additional plastic surgery was performed to repair the wound area around the hernia. The patient is still in the hospital.”

Sept 2013: Proceed Rectangle Mesh FDA Adverse Event Report 3350415 “He required additional surgery on [sic] to remove fragments of the mesh.”

May 2013: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3134439 “The surgeon stated that only parts of the mesh remained in the patient.”

May 2013: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3092369 “The patient required additional surgery on [sic] in order to treat an infection and unspecified complication caused by the disintegration of the mesh.”

Polypropylene Fragments

Jul 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2671342 “The patient began experiencing issues immediately. The mesh has fallen apart and there are holes in the mesh. The patient has abdominal pain and has begun developing a cyst.”

Jun 2012: Proceed Ventral Patch FDA Adverse Event Report 2623145 “A reoperation was performed [sic]. A large defect was found in the mesh having completely fallen apart and being separated into multiple pieces.”

Dec 2011: Proceed Ventral Patch Mesh FDA Adverse Event Report 2387598 “Upon examination, the surgeon noted a unresolved umbilical hernia. The surgeon noted that the mesh was disintegrated. The mesh was explanted. The physician opined that the cause of the event was due to the mesh being disintegrated and balled up.”

Blue polypropylene stripe of the Proceed
Close Up of Blue Indicator Stripe

Jun 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2119079 “The patient presented with redness, secretion, local edema and skin erosion. The patient was hospitalized for six days to remove the mesh fragments that were exposed, resuture the skin, and for antibiotic treatment. The patient left the hospital and returned home, however, still needed medical care. The surgeon opines that the mesh caused the rejection and suture dehiscence.”

Apr 2011: Proceed Ventral Patch FDA Adverse Event Report 2071326 “While positioning mesh for closure, mesh broke into 2-3 pieces.”

Mar 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2042579 “Upon exploration, the surgeon discovered the device was completely adhered to the bowel. The suture line was intact and the edges were intact, but the center of the device was disintegrated and broken. The surgeon attempted to remove it but could only remove a couple of small pieces which were discarded.”

Feb 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1985582 “The pt came back with a recurrence 1 year later. The pt had a reoperation on [sic] and the surgeon felt that there was little mesh remaining in the site. The surgeon opines that the mesh may have broken down or disintegrated from the time it was implanted a year ago until now.”

Apr 2010: Proceed Ventral Mesh Patch FDA Adverse Event Report 1656429 The physician stated that the Proceed mesh “disintegrated – causing hernia repair to fail – secondary surgical intervention needed to repair hernia.”

Sept 2009: Proceed Ventral Patch FDA Adverse Event Report 1493475 “One month post-op, the [patient] was brought back to surgery to remove the mesh. The surgeon discovered the only part of the mesh left was the outer plastic ring, but the mesh had disintegrated and there was small plastic type shards of 2-3mm left. The surgeon irrigated the area and removed all shards that could be located.”

Feb 2007: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 814502 “Pt was returned to surgery five days following device implant. The surgeon noted during the reoperation that the device was broken.”

Prone to Shrinking and Contracting

Polypropylene degrades, shrinks, and contracts after being implanted in the human body. The Proceed hernia mesh degrades, shrinks, and contracts even faster than other polypropylene hernia meshes, because the Proceed is sterilized with radiation. The Proceed hernia mesh shrinks and contracts shortly after implantation, because the polypropylene has been irradiated. Again, the FDA and Johnson & Johnson have been notified by physicians nationwide regarding complications stemming from the Proceed shrinking after implantation.

Studies on the Proceed Shrinking

Massive mesh shrinkage was also observed for the polypropylene mesh coated with Oxidized Regenerated Cellulose (Proceed): after a 12-week period only 22% of the residual mesh surface was preserved.

The study found that those implanted with the Proceed hernia mesh exhibited higher mesh “shrinkage and there was a predominance of acute inflammatory process in the PCD (Proceed) group.”

The Proceed hernia mesh shrunk the most of all tested hernia meshes, shrinking 25% in just 4 months!

Is the FDA Aware the Polypropylene of the Proceed Shrinks?

Shrinking of Proceed MeshJan 2014: Proceed Ventral Patch FDA Adverse Event Report 3576335 “During the reoperation, the initial hernia defect had remained the same and the mesh had shrunk in size. The surgeon opines that the shrinking of the mesh led to the recurrence of the hernia.”

Dec 2013: Proceed Ventral Patch FDA Adverse Event Report 3537924 “The mesh had not integrated appropriately on the parietal side and had significant adhesions on the visceral side. It shrunk considerably. The patient required additional surgery.”

Jul 2013: Proceed Ventral Patch FDA Adverse Event Report 3257141 “The hernia has recurred and the mesh has contracted leaving the defect open for the omentum to enter.”

Jan 2013: Proceed Ventral Patch FDA Adverse Event Report 2894259 “The surgeon found that the device was crimped up.” “The histological examination shows an excised peritoneum tissue sample with embedding of alloplastic mesh tissue. ” Ethicon stated “No conclusion of the shrinking could be determined.”

Oct 2012: Proceed Ventral Patch FDA Adverse Event Report 2772504 “During the procedure it was noted that the mesh had shrunk and was no longer covering the defect.”

May 2012: Proceed Ventral Patch FDA Adverse Event Report 2588604 “The patient experienced a recurrent umbilical hernia. It was also noted that the patient had developed adhesions and the mesh was contracted.

Polypropylene side of the Proceed hernia mesh
Blue Stripes = Polypropylene Side

June 2011: Proceed Ventral Patch FDA Adverse Event Report 2145857 “The surgeon opines that excessive shrinkage caused the recurrence. By doing so, the overlap disappears and recurrences can arise around the previous mesh.”

May 2011: Proceed Ventral Patch FDA Adverse Event Report 2084888 “During the surgery, the surgeon found that the mesh was retracted and two small intestinal loops were in contact with the mesh which was being absorbed by the small intestine loops. The surgeon cut the intestinal wall to retrieve the mesh.”

Dec 2010: Proceed Ventral Patch FDA Adverse Event Report 1942571 “The [patient] experienced a recurrent hernia. Upon re-operation, the surgeon reported that the mesh was the size of a nickel.”

Oct 2010: Proceed Ventral Patch FDA Adverse Event Report 1874118 “The patient presented with recurrent hernia on [sic] with symptoms of swelling and slight discomfort. Recurrent hernia was confirmed with ultrasound… Extreme mesh contraction and some small bowel adhesions were noted during the repair procedure.”

Oct 2010: Proceed Ventral Patch FDA Adverse Event Report 1858918 “Five month after the initial procedure, the patient developed an asymptomatic recurrence of the umbilical hernia… Some omental adhesions at the umbilicus covering the mesh were noted… The mesh was found to have shrunk and folded up.”

May 2009: Proceed Multi-Layer Laminate Mesh Adverse Event Report 1392886 The patient was implanted with a 10 x 15 cm Proceed mesh in 2008. “The 10 x 15ccm original mesh, which had “shrunk” to a 3 x 7 cm mesh, was removed, as reported by the cytology report.”

Too Weak: Prone to Tearing

Proceed Surgical Mesh Tearing
Proceed Torn Down Middle

Ethicon utilizes it’s Prolene Soft Mesh, a light-weight polypropylene mesh, as the base layer of the Proceed and the Physiomesh. The hernia mesh industry shifted to light-weight polypropylene meshes due to complications caused by polypropylene. The thought was less polypropylene = less complications. Unfortunately, this theory was not properly tested before the devices were launched. A review of physician reported adverse event reports reveal that both the Proceed and the Physiomesh are prone to ripping and tearing. Unlike the Physiomesh and the Prolene Soft Mesh, the polypropylene of the Proceed has been exposed to radiation, making the Proceed even more likely to tear.

Is the FDA Aware the Proceed is Prone to Tearing?Proceed Ripping Down Middle

June 2017: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 6677821 “During the procedure, the surgeon found the device difficult to handle and reported that it stuck to the underlying tissue. The mesh turned black with minimal contact with blood, and ripped in a few places where the absorbable straps were used to fixate the mesh”

Mar 2017: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 6449618 “During the procedure, the mesh was torn from the middle.”

Sept 2016: Proceed Ventral Patch FDA Adverse Event Report 5976672 “The mesh easily tore apart during the procedure.”

May 2016: Proceed Ventral Patch FDA Adverse Event Report 5643344 “The mesh tore along the edges intra-operatively during implantation.”

Apr 2016: Proceed Ventral Patch FDA Adverse Event Report 5441419 “The mesh ripped while the surgeon was suturing.”

Dec 2015: Proceed Ventral Patch FDA Adverse Event Report 5275131 “During the placement, it was noticed that the mesh was torn down.”

Proceed Hernia Mesh Torn to the CenterJul 2015: Proceed Ventral Patch FDA Adverse Event Report 4953590 “In 2013, the patch tore the patient’s bowel. On [sic], the patient was hospitalized for septic shock. A drainage tube was placed to remove the excess. It was removed later.”

Apr 2014: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3724960 “The mesh pulled loose from the sutures.” The manufacturer that there were “holes present in the mesh with damage consistent with the  mesh having been torn. The force required to tear the mesh could not be determined.”

May 2013: Proceed Ventral Patch FDA Adverse Event Report 3124889   “Dr. put the mesh in the abdomen and the mesh ripped.”

Feb 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2467413 Proceed Mesh implanted in 2008 and patient experienced a “recurrent hernia and underwent another surgery… surgeon could see that the mesh had failed, it was torn inferiorly.”

Sept 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2252037 “The patient returned to the facility due to complication. On [sic] a second procedure was performed and the suture pulled through the mesh and left holes in the mesh. The mesh was removed and discarded.”

Proceed Mesh Starting to Delaminate While TearingJul 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1757810 “Within 48 hours post procedure, the patient coughed resulting in a re-herniation… Upon removal, the mesh appeared to have torn from the suture line at approximately the 12 o’clock position extending left laterally and down… Also, there were similar holes in the mid section of the mesh approximately 13mm.

Jun 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1739588 “The patient felt something “pop” and developed a bulge in [sic[. A ct scan was done in the emergency room showing the mesh tore. A follow up appointment was scheduled to determine the next plan of action.”

Nov 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1546207 “It was noted that the mesh had torn right in the middle.”

Oct 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1519847 “It was noted when the [patient] was opened that the mesh had split down the middle.”

July 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1420808 “Upon re-operation, it was determined by the surgeon that the mesh was torn down the middle.”

May 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1391761 “The patient vomited ten days post-operatively and she heard a cracking sound. An hour later, the patient saw blood at the surface of the skin. On the following month, a re-operation was performed and the mesh was found to have split in torn down the middle from top to bottom.”

Proceed Tearing and DelaminatingJan 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1300412 “The mesh device was split down the middle.”

Nov 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1244227 Eight weeks after implantation “the surgeon reports finding the mesh torn in the middle.”

Sept 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1174148 “The surgeon reports that the mesh was split/torn down the middle.”

Aug 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1102494 “Patient presented with an asymetrical abdomen five days following an open incisional hernia repair. The patient was returned to surgery at which time the surgeon observed that a portion of the device was torn at two suture points… The surgeon opines that the event is related to excessive tension placed on the device.” The manufacturer noted that “The cause and circumstances of the tear could not be determined.”

Jul 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1074525 “Pt presented with a recurrent hernia three weeks following an open ventral hernia repair. The [patient} was returned to surgery. The operating surgeon reports that the mesh tore the sutures on one side of the defect.”Proceed Ripped in Half

Jun 2008: Proceed Mesh FDA Adverse Event Report 1064272 “Later that day, the patient developed nausea and vomiting… A ct scan demonstrated a loop of small bowel incarcerated in the incisional ventral hernia repair. The patient was brought back to surgery. The physician noted that the etiology of the incarceration was due to the fact three of the eight transfascial sutures had broken on the left lateral side of the repair. The sutures were intact, but pulled through the mesh.”

Dec 2007: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 965107 “Pt developed a recurrent hernia within 24 hours of a previous repair. The pt returned to surgery for repair. Surgeon reports observing small tears along the edge of the mesh.”

Aug 2007: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 905151 “Device tore while pulling on the device with graspers during implant.”

Jun 2007: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 867686 “Bowel obstruction twelve days following a multiple hernia repair procedure. The patient was returned to surgery for laparotomy at which time the surgeon reports observing the mesh “torn into two pieces.” The mesh was removed.” Ethicon concluded that “the deformation damage indicates that the mesh was under excessive stress when it eventually tore.

Feb 2007: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 820202 “[Patient] was returned to surgery six months following device implant. The surgeon noted that the device was fully reperitonealized yet torn down the middle.”

Too Weak: Prone to Blow Outs

Hole in Center of Proceed Hernia MeshEarlier it was demonstrated that the light-weight polypropylene utilized in Proceed is too weak an will easily tear. The light-weight polypropylene utilized in the Proceed also makes the mesh prone to “blow outs” or having loops of bowel push through parts of the mesh. The Proceed hernia mesh is too weak to provide the necessary support that the human abdominal cavity requires. As the Oxidized Regenerated Cellulose fabric and the polydioxanone layer of the Proceed dissolve, the mesh becomes even weaker. Within 6 months of implantation, it is expected that both the polydioxanone and cellulose layers will not longer be attached to the polypropylene. The center of the Proceed hernia mesh is typically where the bowel will slowly start to breakdown the polypropylene, creating a small hole, and eventually pushing all the way through the mesh. Bowel strangulation and bowel obstructions are common after the bowel has pushed through the Proceed mesh. Additional surgeries and even bowel resections are frequently required to fix the associated complications of a mesh blow out. Patients frequently re-herniate through the middle of the Proceed hernia mesh, similar to what has been observed with the Physiomesh. The FDA and Johnson & Johnson have been aware for over a decade that the light-weight polypropylene utilized in the Proceed hernia mesh is too weak.

Studies on the Proceed Blowing Out

A case study of a 42-year-old man with hernia recurrence 4 years after being implanted with a polypropylene mesh coated with Oxidized Regenerated Cellulose (Proceed). A segment of small intestine herniated through a central defect in the mesh.

Is the FDA Aware That the Proceed is Prone to Blow Outs?

Central Mesh WeakeningNov 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5198633 “The patient had to return to the operating room 16 days later, as the hole in the mesh had caused a richter hernia, which required repair.”

Feb 2013: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2958877 “Approximately one year later, the patient required surgery for an intestinal obstruction. During the procedure it was noted that there were three holes in the mesh, where the bowel passed the mesh.”

Dec 2012: Proceed Ventral Patch FDA Adverse Event Report 2858133 “During the re-operation, the surgeon noted that the mesh had remained in place and was not broken or folded. There was just an impression in the center along with some bulging.”

May 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2582402 “During the following year, the patient experienced nausea and was treated several times for an ileus. During [sic], an abdominal ct scan revealed an incarcerated bowel and was treated with total parenteral nutrition. On [sic], the patient had surgery where it was noted that there was a large hole where the bowel was incarcerated and a small hole in the mesh. A twelve inch section of the bowel was removed and a portion of the mesh was explanted.”

May 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2108260 It was reported that “The patient experienced an acute onset of severe abdominal pain and drainage of succus entericus. The patient underwent reoperation on [sic]. During the reoperation, a small bowel herniation with strangulation was noted and a two centimeter hole or rip was found in the mesh. The mesh was removed.”

May 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2105049 “The patient experienced a recurrent hernia…During the second surgery to repair the hernia recurrence, the surgeon noted a five centimeter defect through the middle of the mesh, with the remainder incorporated well. A piece of the mesh was removed from the patient.”

Nov 2010: Proceed Ventral Patch FDA Adverse Event Report 1889958 “The operative report states “it was evident that there was giving-way of the mesh at the superior aspect of the defect and omental attachments were noted at the site.”Central Mesh Breakdown

Apr 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1659550 Proceed hernia mesh was implanted in 2008. “When the surgeon reoperated on [sic], he stated that the recurrent hernia protruded through a 3cm “defect” in the center of the mesh which was not noticed at the time of the original surgery.”

Mar 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1640077 “During the procedure, the pt was found to have a hernia where the mesh pulled away from the fascia and a hole was found in the center of the mesh. Additionally, there were dense adhesions between the mesh and intra-abdominal contents.”

Feb 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1611369 “A few months later the pt developed a bulge at the hernia site. It was fluid build-up (ascites) and the pt required a re-operation on [sic]. The surgeon said the mesh had incorporated everywhere except in the center which allowed fluid build-up. During the re-operation, the surgeon used sutures to close the fascia to prevent fluid from passing through. The surgeon opines that the pt’s fatty liver progressed from the initial operation. In portions of the mesh where the hernia recurrence was felt, there were small perforations in the mesh through which the ascites traveled into the hernia sac.”

Hole in Proceed MeshOct 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1525545 “On post-operative day four, the pt returned to the emergency department with abdominal pain and was found to have a small bowel obstruction… a circumferential mesh defect was found, not related to the mesh-fascial sutures. This was deemed a mesh failure/defect.”

Aug 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1442259 “The patient underwent a second hernia repair procedure on an unknown date. A small well delineated defect was noted in the mesh with a small bowel incarceration and small bowel obstruction. The operating surgeon reported that the hole in the mesh was a perfect circle…”

Aug 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 144258 “In approx five months later, the patient presented with nausea and vomiting and small bowel obstruction from adhesions… During the second procedure, there apparently was a hole in the mesh at the umbilicus through which a loop of small bowel had herniated causing an obstruction.”

Apr 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1367974 “The surgeon observed during the reoperation that the mesh had a hole in the center.”

Feb 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1328982 “Reported that a patient developed a recurrent hernia 2.5 years following an initial hernia repair. The patient has returned to surgery for repair. Surgeon reports a hole in the center of the mesh was observed upon reoperation.” 

Feb 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1304598 “The surgeon reports that there was a hole in the mesh.”

Jan 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1295109 “The patient presented 10 days later with a massive disruption of the mesh.”Hole in Proceed Mesh

Jan 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1292036 “Pt presented with abdominal pain 11 days following a hernia repair with  mesh implant. The pt was returned to surgery. The operating surgeon reports observing a hole in the center of the previously implanted mesh. The mesh was removed and the pts’ bowel was found to be compromised. The pt was repaired with the creation of a bowel stoma.”

Dec 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1273897 “The pt presented six months later with a recurrent hernia. An open hernia repair was performed at which time the surgeon reports a hole was observed in the center of the mesh at the site of the initial defect; the outer edges of the mesh were intact.”

Dec 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1252798 “Pt presented with a recurrent hernia about one year following an initial repair with mesh implant. The pt returned to surgery and the previously implanted mesh was explanted. The surgeon reports that the mesh appeared weakened in the center with the presence of a hole.”

Oct 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1197676 “It was reported that in less than 12 months, the pt’s hernia recurred and required a subsequent surgical repair in 2007. During the surgery, it was reported that on the right side, the mesh had disrupted in the mid portion, with herniated tissues through the mesh.”

Feb 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1001093 “Pt reported the development of pain following an initial ventral hernia repair. A new hernia was diagnosed approx 2 yrs following the original repair. The pt was returned to surgery for repair. It was found that the new hernia was through a hole in the original mesh.”

Feb 2007: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 813247 “Pt presented with a recurrent hernia. The pt was returned to surgery. The surgeon reports that the pt’s bowel came through the mesh. A bowel resection and repair was performed.”

ORC Layer Prone to Delamination

Proceed Layers SeparatedCellulose is intended to protect a patient’s bowel and other underlying organs from the polypropylene portion of the Proceed. If polypropylene comes in contact with the bowel or other underlying organs, the polypropylene will attach to the underlying organs, forming what is known as adhesions. Bowel adhesions cause pain, nausea, diarrhea, constipation, vomiting, bowel obstructions, bowel strangulation, and bowel perforations. Surgeons frequently report having to remove segments of patient’s bowels due to the Proceed mesh densely adhering their intestines. Ethicon has previously issued recalls on the Proceed Surgical Mesh on December 21, 2005, and again on October 19, 2010, due to the ORC layer delaminating and increasing the risk of adhesions and bowel fistulization. The Proceed hernia mesh delaminates due to a design defect in the mesh that cannot be fixed. The cellulose fabric of the Proceed will not stick or adhere to the polypropylene, which is why polydioxanone is utilized to bond the cellulose to the polypropylene. However, polydioxanone quickly loses it’s bonding properties in the presence of moisture.

Proceed Hernia Mesh Recall December 21, 2005

Proceed Surgical Mesh Voluntary Recall 2010

The last recall on the Proceed delaminating was in 2010, yet surgeons continue to experience the ORC layer of the Proceed delaminating to this day! The adverse event reports below demonstrate that this defect isn’t fixed.

Is the FDA Aware that the Proceed is Still Delaminating?Proceed Starting to Delaminate

Jun 2017: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 6625555 “Prior to the procedure, the ORC and polypropylene mesh separated when out of the package.”

Jun 2017: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 6619113 “During the procedure, the orc barrier of the mesh was flaking off.”

Mar 2017: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 6440499 “During the procedure, the mesh delaminated with layers separating. There was no evidence that the seal or packaging had been compromised.”

Mar 2017: Proceed Ventral Patch FDA Adverse Event Report 6376360 “During the procedure, the screen of the mesh was crumbling.” The adverse event was classified as “Delamination.”

Jul 2016: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5827881 “A defect was noticed in the periphery of the mesh. It appeared the oxidized regenerated cellulose (orc) component was defective or torn, like there was a tear or defect in the product. The defect was not in the area of the hernia opening that was being repaired, but outside of that area, so the doctor still used the product for the procedure.”

Jul 2016: Proceed Ventral Patch FDA Adverse Event Report 5806489 “During the procedure, the first layer of the device disassembled, preventing the procedure of the installation of the mesh on the spot of the defect.”

Cellulose Peeling Away From PolypropyleneFeb 2016: Proceed Ventral Patch FDA Adverse Event Report 5438582 “During the procedure, the surgeon noted that the top and bottom of the mesh separated during fixation.”

Nov 2015: Proceed Ventral Patch FDA Adverse Event Report 5217619 “During the procedure, the mesh fell apart when stitched.” The adverse event was classified as “material separation.”

Nov 2015: Proceed Ventral Patch FDA Adverse Event Report 5243607 “Upon placement, a piece of mesh was disintegrating. As soon as the mesh hits a tissue, the bottom ring falls apart.” The adverse event report was classified as “Material separation.” Ethicon claimed that there were “clear signs of re-sterilization by autoclaving and the product packaging was compromised, exposing the device, which was subsequently degraded.”

Sept 2014:Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 4078083 “During the procedure, it was noted that the inner layer of the mesh was separated from the outer layer that was against the abdominal wall. The inner layer clumped and disintegrated, disengaged from outer layer and was removed. Remaining mesh was against the omentum”

Feb 2014: Proceed Rectangle Mesh FDA Adverse Event Report 3626588 “After the mesh was wet and before entering into the abdomen, the mesh was delaminating.”

Feb 2014: Proceed Rectangle Mesh FDA Adverse Event Report 3604576 “At the end of the procedure the surgeon noted that the mesh had delaminated.”Cellulose Separating from Polypropylene

Feb 2014: Proceed Rectangle Mesh FDA Adverse Event Report 3626665 “The mesh was delaminating when it was inside the patient…The orc component was separated and stained with blood and/or tissue remains. The soft mesh component was separate with small fragments of the pds film layer attached.” The manufacturer noted that the “circumstances and force required to cause the delamination could not be determined.”

Nov 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2821845 “During the procedure the mesh delaminated.”

Jun 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2650794 “During the procedure the mesh delaminated.”

May 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2571145 Mesh was pulled through the trocar and it delaminated.

May 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2570032 “When the surgeon opened the package, it was noted that one side of the mesh was delaminated. The surgeon inserted the mesh and tried to fixate the mesh with straps and the mesh delaminated completely. Two additional hours of surgery were required to remove the mesh.”

Feb 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2436876 “The smooth side of the mesh was oriented down to the bowel. The patient had a delamination of the mesh in late 2011 and will be having a removal surgery in the near future.”

Oct 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2296608 “During fixation of the mesh the orc layer delaminated.” Four sections of the Proceed mesh that were cut were found to have delaminated.

Proceed Separated to the EdgeOct 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2296326 “It was reported that the mesh started to delaminate when inserting into the patient… The orc layer was delaminated but presents as small brown fragments. The pds film layers appeared relatively intact.” The manufacturer noted that “considering the state of the orc, it could not be determined if the product had delaminated during the procedure or from degradation after use.”

Jun 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2146668 “During the procedure, the orc layer of the mesh detached from the mesh while placing the fixating sutures.”

May 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2082224 During the procedure it was noted that “the coating was damaged and it had to be removed.” The manufacturer noted that “The orc layer was dried and cracked along the folds and at numerous sites along the edge.”

May 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2074248 Two rectangular pieces of Proceed mesh were stitched together and then implanted into the patient. It was later reported that “Both mesh sections were delaminated with no orc present. The 6″ x 1″ strip had three holes or tears, but non appeared associated with the sutured sites binding the 6″ x 1″ strip to the 6″ x 4″ section.”

Apr 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2063302 “The patient experienced bleeding of the abdominal wall twelve hours after the initial procedure. A second procedure was done. During the second procedure, the physician noted that the cellulose layer of the mesh had separated. When the physician went to suction the blood, the cellulose stuck to the suction device and it disintegrated into pieces.” The manufacturer noted that “no conclusion can be drawn at this time.”Proceed Delaminating

Apr 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2048401 “During the procedure, the orc separated form the polypropylene mesh during suturing.”

Dec 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1934434 “During the procedure, delamination of one corner of the mesh was noted when fixation was 3/4 of the way completed. The surgeon continued to implant the mesh and suture the mesh in place.”

Nov 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1910805 “During the procedure, a very small area of the orc layer became separated from the mesh. This was noted after the mesh had been fixated. The surgeon used suture to combine the 2 layers.”

The ORC Layer of the Proceed is Ineffective at Protecting Underlying Organs

Green Background Visible Through Large Pores of Cellulose Fabric
ORC Layer on Green Background

Delamination isn’t the only problem with the Proceed’s cellulose layer. Even when the ORC layer of the Proceed hernia mesh stays attached, it doesn’t protect the underlying organs from adhesion formation. The ORC layer of the Proceed hernia mesh is ineffective at protecting underlying organs, because the ORC layer is not a continuous barrier, it has pores… very large pores. The ORC layer of the Proceed is a fabric that feels and looks very similar to pantyhose. The large pores of the ORC layer allow adhesions to form to the Proceed as if it were a bare polypropylene mesh. The ORC layer of the Proceed is a gimmick so that Johnson & Johnson can sell more hernia meshes.

Proceed IFU Warning: Don't Implant Near Blood or Fibrinous Exudate

From the Instructions For Use (IFU) for the Proceed Hernia Mesh

Patents Related to Oxidized Regenerated Cellulose (ORC) and Adhesion Formation

Unknown How ORC Fabric Works

Johnson & Johnson Patent from 1985 for an ORC Fabric Adhesion Barrier. Patent US5002551

Ethicon Patent for ORC Fabric

Ethicon Patent from 1997 for an ORC Fabric Adhesion Barrier. Patent US6500777 

Studies on the Effectiveness of the Proceed Preventing Adhesion Formation

The study concluded that in the case of impaired intestinal peritoneum Proceed does “not provide significant adhesion prevention.”

Polypropylene mesh coated in Oxidized Regenerated Cellulose (Proceed) was associated with significantly more extensive adhesions than polypropylene mesh coated with ePTFE. Additionally, the polypropylene mesh coated with Oxidized Regenerated Cellulose (Proceed) induced a significantly more pronounced inflammatory response and foreign body reaction.

The study results found that adhesion formation from 3 days to 6 weeks was significantly greater for Proceed Ventral Patch compared to Ventralex ST or Parietex Composite.

The results found that the adhesion score was significantly higher in the Ethicon Proceed and Bard Composix L/P.

The Proceed hernia mesh exhibited high rates of adhesion formation to the greater omentum.

Is the FDA Aware that the ORC Layer of the Proceed is Ineffective at Protecting Underlying Organs?Oxidize Regenerated Cellulose Fabric

Dec 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5318321 “The mesh has eroded into the small bowel. It was reported that the patient is scheduled for surgery to remove the mesh.

Dec 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5261653 “Postoperative complications included pulmonary embolus on a second postoperative day with hospitalization for 37 days, respiratory complications with hospitalization for 54 days, uncomplicated pneumonia with a quick recover, intraabdonimal bleeding with a hemoglobin drop which was conservatively treated with hospitalization for two days, small bowel perforation during a stomal hernia repair with re-laparotomy and removal of the mesh…”

Dec 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5257616 “It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that following insertion the patient experienced dyspareunia, and neuromuscular problems. It was reported that the patient has undergone multiple surgeries and revisionary procedures.”Cellulose of the Proceed

Nov 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5210540 “The surgeon found excessive adhesions for which he was not able to operate laparoscopically and the surgery was converted to an open procedure. when the surgeon opened the abdomen, it was found that the mesh implanted for repair of ventral hernia three years prior was stuck in the small bowel. Anastomosis had to be performed to correct the defect.”

Sept 2015: Proceed Ventral Patch Mesh FDA Adverse Event Report 5054138 “Upon investigation, it was found there were several adhesions to the mesh area causing a twist and restriction to the small bowel. On [sic], the patient underwent exploration of the bowel to take down adhesions and a section of the bowel was cut out.”

Aug 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 5028109 “A few months following the procedure, the patient could not swallow. On [sic] the patient underwent a surgical procedure. During the procedure, it was noted the mesh was adhered and “strangling” the esophagus.”

Mar 2015: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 4632690 “The patient underwent reoperation due to intestinal obstruction after being hospitalized one week before. During the reoperation, the surgeon found the loops of the intestine were very reddened, totally adherent and in some places perforated. The surgeon opined that the lower part of the mesh with the oxidized cellulose appeared as if there was no trace of film and was full of adherences. The mesh was removed with difficultly and a small loop of bowel resection was performed.”

Dec 2014: Proceed Ventral Patch Mesh FDA Adverse Event Report 4364712 “During the procedure, adhesions in the lower abdomen and the prior umbilical hernia repair were visible, with adhesions around the gall bladder. The gall bladder was removed and adhesions were found in the left upper abdomen in the mesh are and in the lower abdomen. The adhesions were removed.”

Aug 2014: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3976573 “Five months following the procedure, the patient experienced an enterocutaneous fistula and bowel perforation which drained fecal matter without exposure of mesh. On [sic], the patient underwent another procedure for the bowel perforation and a surgical washing of cavity was performed. During the procedure, it was observed that the fistula and mesh almost integrated within a short period of time.”

Jun 2014: Proceed Ventral Patch Mesh FDA Adverse Event Report 3877641 “The patient experienced a bowel obstruction. When the patient underwent an exploratory laparoscopic procedure, it was found that the small bowel had adhered to the mesh remnant on the abdominal wall and a small bowel resection with anastomosis was performed.”

May 2014: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3836265 “During the procedure it was noted that there were extensive adhesions. The surgeon performed lysis of the adhesions.”

Close up of Proceed ORC Layer

Jan 2014: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3595709 “The patient then had lower abdominal pain for nearly three years. On [sic], the patient underwent a reoperation. The mesh was completely clotted and was grown into the bowel. The mesh was then completely explanted.”

June 2013: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3193225 “It was reported that she experienced complications; including mesh erosion, dense adhesions, chronic pain, infection, sepsis, kidney dy

sfunction, and she has undergone additional surgeries and revisionary procedures.”

Apr 2013: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 3041004 “The patient experienced an abdominal intestinal fistula. The patient underwent a re-operation on [sic] to have the mesh removed [and] the fistula repaired.”

Mar 2013: Proceed Ventral Patch Mesh FDA Adverse Event Report 3015402 “The patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures.”

Jan 2013: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2931302 “It was reported that after mesh implantation the patient had a small bowel obstruction.”

Proceed Surgical Mesh PolypropyleneDec 2012: Proceed Ventral Patch Mesh FDA Adverse Event Report 2883259 “During the re-operation, the surgeon noted some rare omental adhesions to a failed ventral incisional hernia at the umbilicus, a possible small bowel obstruction, and mesh and peritoneum failure.”

Dec 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2872818 “It was found that the mesh had eroded through the sigmoid colon. The mesh as well as a portion of the colon was surgically removed.”

Jul 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2665604 “It was noted that the mesh had adhered to the bowel.”

Jun 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2599902 “The patient has experienced continued pain and chronic fatigue. The patient was taken to surgery and had adhesions removed.”

May 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2588397 “Ten days following the procedure, the patient experienced an intestinal fistula. An MRI revealed that the center of the mesh was adhered to the intestine.”

May 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2572004 “During the surgery, it was noted that mesh had totally adhered to the intestine and the surgeon was unable to reverse the ileostomy.”

May 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2562349 “During the revision on [sic], the surgeon found many extensive adhesions to the mesh that were not easily removed. There was also a brownish colored substance around a small section of the mesh that may have been due to infection.”

Failed Proceed Hernia MeshMar 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2511837 “Post-operatively on [six], it was noted that the patient had developed an ileus… the surgeon opines that the ileus was caused from an inflammatory response.”

Feb 2012: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2457488 “Approximately one year following implantation the patient was diagnosed with an incarcerated hernia with ingrowths into the mesh and numerous bulges within the mesh providing possible sites for hernia formation. The patient underwent emergency surgery on [sic] due to intestinal obstruction involving incarceration of the small intestine within the mesh. Also, numerous adhesions between the small intestine and the mesh were found.”

Dec 2011: Proceed Ventral Patch FDA Adverse Event Report 2356406 “The patient developed a recurrent hernia and underwent a procedure to repair it on [sic]. During the procedure the old mesh was removed. The mesh appeared to separate from the right side and within this recurrent hernia was some incarcerated omentum. Adhesions were taken down.”

Oct 2011: Proceed Ventral Patch FDA Adverse Event Report 2305028 “The patient was readmitted to a different hospital for emergency surgery for a bowel obstruction. The bowel obstruction occurred at the same site that the mesh was inserted.”

Sept 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2254389 “Twelve months after the procedure, the pt experienced hernia recurrence with symptoms of bulging and pain. The pt underwent reoperation for recurrent hernia on [sic]. During the repair procedure, the patient was found to have large adhesions and adhesions of the bowel with the mesh, which were very complicated to sever.”Torn Proceed Mesh

Jul 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2167288 “Patient presented to a hospital [sic] with complaints of abdominal pain, nausea, vomiting, and abdominal distention. An exploratory laparotomy was performed, which revealed multiple intestinal adhesions. The adhesions were adhered to an inverted mesh. The parietal face of the mesh appeared to be in contact with the intestinal loops. an omentectomy was performed, with release of the intestinal loops adhered to the mesh… The patient continued with intestinal and jejunoileal fistulas and additional surgeries.”

Jul 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2154112 A few years after being implanted with the Proceed hernia mesh, the patient developed watery stools and vomiting. The patient was then diagnosed with peritonitis and perforation of small intestine. The mesh was discovered to be “fully adhered to the loops.” An abundance of pus was found near the bowel, which was densely adhered to the mesh and difficult to separate. It was necessary to resect 15 cm of the small intestine. At the conclusion of the surgery it was “very difficult to close the skin with suture due to previous resection of skin necrosis.” “The patient was reoperated three more times. The last due to a new intestinal perforation caused by occlusion of the mesh in the ileum. A week after the last intervention, the patient experienced a cardiorespiratory arrest and died after cpr was unsuccessful.” The surgeon expressed that “the cause and contributing factors for the mesh adhering to the intestines and abdominal wall was that the orc was degraded too soon not allowing peritoneum formation.” The surgeon determined that “the cause and contributing factors for the patient death was reoperations and intestinal fistula.”

Jul 2011: Proceed Ventral Patch FDA Adverse Event Report 2146761 “During the second procedure, the surgeon noted a small bowel obstruction and adhesions on the mesh.”

Polypropylene Separating From PolypropyleneJun 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2138506 “The patient underwent an emergency exploratory laparotomy, extensive adhesiolysis which lasted for over three hours, a resection three feet of small bowel, small bowel enteroenterostomy on [sic] and the mesh was removed. The incisional hernia remains unrepaired.”

Jun 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2127397 “During the procedure, it was noted that the whole surface of the mesh had grown into the intestines and the mesh was removed.”

Jun 2011: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 2119049 “The patient experienced an intra abdominal perforation and bleeding from a serosa which occurred three to four days post op. While still in the hospital, the patient was returned to surgery and the mesh was removed on [sic]. The patient currently has open fistulas and an open abdomen. The patient’s condition is critical and remains in intensive care.”

Nov 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1910229 “At a later date, the surgeon noted dense adhesions and that the bowel was stuck to the mesh.”

Aug 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1822004 “After going home, the patient complained of pain and wouldn’t eat. The patient was taken back to the hospital where she underwent 8 hours of emergency surgery. The surgical mesh used became entangled which perforated the small bowel in four places. During the surgery, the surgeon stated it was hard to distinguish what was muscle and what was bowel. He “teased” out the mesh and then used compression for the bleeding. As of [sic], the patient was still in the hospital with three fistulas which drained from her belly.”Proceed mesh tearing and delaminating

Jul 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1780313 “About one year after placing mesh, the patient developed a new fistula and adhesions of the material. The surgeon opines that the cellulose was absorbed before the growth of the new tissue. As the result of the new fistula, another surgery was performed to repair the fistula.”

Jun 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1747998 “The patient returned to the hospital with severe abdominal pain and vomiting. On [sic] the patient underwent surgery and was found to have an ileus. Upon looking into abdominal cavity, it was found that the ileum had grown into the mesh. The mesh was removed and re-fixed in place after the intestinal end to end resection was completed.”

May 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1693967 “The patient returned to the hospital with fecal fistula on the tenth post-operative day. On the fourteenth post-operative day, the patient underwent wound exploration which revealed a 3×3 area of pressure necrosis on the colon, another small intestinal perforation away from the first one and two areas of necrosis of the gut. The surgeon removed the mesh and inserted tube drains in the small intestine and colonic lesions… The patient was in the intensive care unit on assisted ventilation due to respiratory distress. The patient expired [DIED] on the twenty second post-operative day due to respiratory complications.”

May 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1692080 “The patient presented several months after the surgery with pain. Upon exploratory laparoscopy, the surgeon visualized adhesions to the mesh and a bowel resection was performed.”

Apr 2010: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1669367 Patient experienced cramping and “underwent an exploratory laparotomy for adhesions.”Proceed Hernia Mesh Ripped

Apr 2010: Proceed Ventral Patch FDA Adverse Event Report 1666639 “The patient returned to the emergency room at a different hospital on [sic] and was found to have a bowel obstruction.”

Nov 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1523679 “Following her discharge, the patient experienced pain, fatigue and fever reaching 102 degrees, and was admitted to another hospital ten days later with abdominal wall cellulitis. The patient underwent an exploratory laparotomy two days later. Following the laparotomy, the patient was diagnosed by the surgeon who performed the laparotomy with widespread panniculitis with multiple subcutaneous abscesses and subcutaneous emphysema as well as a perforated terminal ileum. The surgeon also noted that the tissue was “grossly infected” and that there was “necrotic and foul smelling stool” within the abdomen. The surgeon also found that there were “several loose staples” and that there was a “quarter size hole” in the small bowel… surgical mesh was removed from the patient. The following month, the patient was transferred to another facility for continued management of the infection, where she underwent multiple procedures, including debridement and washout procedure along with fascial closure related to the small bowel injury, infection and repairs. She was discharged sixteen days later.

ORC Partly Attached to PolypropyleneNov 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1523674 “Pt presented to her doctor with abdominal pain and was informed the mesh was “not working as intended” and was the cause of the pain. The following year, the pt underwent surgery to excise the mesh. The surgeon noted dense adhesions of the uterus to the anterior abdominal wall, bladder, and bilateral pelvic sidewalls… The small bowel was reportedly adhered to the ventral hernia mass.”

Oct 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event report 1516683 “Pt experienced adhesions to mesh, resulting in a small bowel obstruction. The pt underwent a surgical procedure and 10 x 15 cm of mesh was removed. The original procedure was two years prior.”

Aug 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1435661 “It was reported that during the surgery, it was found that the previous mesh in the abdomen was adhered to the mesentery as well as the bowel and the bowel was resected about six to eight inches.”

Jul 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1420564 “Adhesions with both bowel and omentum had developed against the mesh. The adhesions were only associated with areas of the mesh and not to any other area of the abdominal wall. The adhesions were against the mesh polypropylene material and not the tacks.”

May 2009: Proceed Ventral Patch FDA Adverse Event Report 1392889 Patient’s bowel became attached to the Oxidized Regenerated Cellulose side of the mesh.”

Apr 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1356351 “Pt presented with “adhesions” one day following a hernia repair with mesh implant. A ct was performed which showed that the mesh was stuck to the bowel and the bowel was swollen, which the surgeon interpreted as a sign of inflammation.”

Mar 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1343854 “The patient complained of significant pain following the procedure. The patient was returned to surgery at which time the reporting surgeon observed a small portion of the bowel adherent to the mesh.”

Feb 2009: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1314085 “The patient developed impaired blood pressure, pain and clinical signs of a paralytic ileus, five days post-operatively. The patient underwent a laparotomy, at which time a paralytic ileus was confirmed. The patient was treated conservatively for the ileus and, the mesh was explanted and replaced.”

Dec 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1273910 “Presented approx one week later with severe bowel adhesions. The pt was returned to surgery; a bowel resction was performed.”

Oct 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1212107 “The pt presented with nausea, vomiting, and pain four days after the initial surgery. The pt was returned to surgery for device explant, at which time, the surgeon observed a fibropurulent peel with a brown gelatinous discharge underneath the mesh, and encasing the small bowel.”

Jun 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1066533 “The pt was returned to surgery eighteen days after the original date, for mesh explant and repair due to “extrusion of the mesh.” Site found to be infected and left to heal by secondary intention. Approx two months after the original date, the pt had a laparotomy at which time the surgeon reports adhesions to the “bowel friendly” mesh.”

Jun 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 1066140 “There was a mucoid substance on the surface of the mesh and the majority of small intestine was adherent to the underside of the mesh. The bowel was freed and the mesh was excised.”

Jan 2008: Proceed Multi-Layer Laminate Mesh FDA Adverse Event Report 977475 “A patient in which proceed mesh had been used to repair a hernia defect presented with a bowel obstruction and was returned to surgery. An examination of the patient during surgery showed an adhesion had formed between the bowel and the layer of ORC. It is assumed that the bowel obstruction was caused by the presence of adhesion.”

Proceed Ventral Hernia PatchProceed Hernia Mesh Lawsuit

Call 1-800-701-3672 to speak to one of our hernia mesh intake specialist. To stay current on the Proceed hernia mesh litigation follow our Proceed Hernia Mesh Lawsuit FaceBook page. For more information on hernia mesh, please visit our hernia mesh lawsuit page.

Content Created By:

C. Brett Vaughn RN, BSN, JD