Mesh Related Clinical Mesh Related Clinical Complications Complications
other than other than Infection and PainInfection and Pain
WHEN THINGHS GO WHEN THINGHS GO BADLY WRONGBADLY WRONG
ICEBERG PROBLEMICEBERG PROBLEM
THE EMERGED THE EMERGED PART IS ONLY PART IS ONLY
ONE TENTH OF ONE TENTH OF THE ENTIRE THE ENTIRE
BLOCKBLOCK
PRELIMINARY REMARKPRELIMINARY REMARK
“ …the technique“ …the techniqueof prosthetic implantationof prosthetic implantation
is far more important is far more important than the type of prosthetic”than the type of prosthetic”
EarleEarle--Mark, Surg Cl N Am 2008Mark, Surg Cl N Am 2008
MAJOR COMPLICATIONS MAJOR COMPLICATIONS AFTER HERNIA REPAIRAFTER HERNIA REPAIR
Br J Surg 2000Br J Surg 2000
MetaMeta--analysis of 34 randomized trials: total analysis of 34 randomized trials: total 6804 pts6804 pts
Complications were rare but more common in Lap Complications were rare but more common in Lap repairrepair
Lap GroupLap Group: : 4.74.7/1000 severe complications /1000 severe complications (visceral/vascular): 2 pts with intestinal obstruction(visceral/vascular): 2 pts with intestinal obstruction
Open groupOpen group: : 1,11,1/1000/1000
INTESTINAL OBSTRUCTIONINTESTINAL OBSTRUCTIONDATA FROM SWEDISH HERNIA REGISTERDATA FROM SWEDISH HERNIA REGISTER
Hernia 2005Hernia 2005In Sweden incidence of hernia repair in patients older than 15 years is In Sweden incidence of hernia repair in patients older than 15 years is 200/100.000 inhabitants.200/100.000 inhabitants.
19921992--2000: 33.275 repairs2000: 33.275 repairs
90 pts (0,02%) developed intestinal obstruction after surgery90 pts (0,02%) developed intestinal obstruction after surgery
Risk factorsRisk factors: female, age >60+, early admission, several admissions: female, age >60+, early admission, several admissionsTAPP showed a slight increase of the risk compared to Lichtenstein and TEPTAPP showed a slight increase of the risk compared to Lichtenstein and TEP
ETIOLOGY OF P.O. BOWEL ETIOLOGY OF P.O. BOWEL OBSTRUCTIONOBSTRUCTION
Not strictly linked to biomaterial, Not strictly linked to biomaterial, but more commonly caused by the but more commonly caused by the approach and its complications, as approach and its complications, as
tears in the peritoneum suture or as tears in the peritoneum suture or as port site hernia in Lap repairsport site hernia in Lap repairs..
PROSTHETIC GUILT LISTPROSTHETIC GUILT LIST
1. WIRE MESH: 1. WIRE MESH: historicalhistorical2. PLUG 2. PLUG 3. PHS 3. PHS 4. FLAT ONLAY MESH4. FLAT ONLAY MESH5. FLAT UNDERLAY LAP MESH5. FLAT UNDERLAY LAP MESH6. KUGEL VENTRAL PATCH6. KUGEL VENTRAL PATCH
WIRE MESH MIGRATIONWIRE MESH MIGRATION1. Ann Chir 2001,126:4751. Ann Chir 2001,126:475Migration into the bowel lumen and obstruction2. South Med J 1998,91:496Migration into the intestinal lumen of wire mesh causing obstruction
30 years after repair.Lady, 50. Incisional hernia repair 1964 with a stainless steel mesh
in the preperitoneal space. She had 1° attack of bowel obstruction 30 years after . At laparotomy fragments of wire were found in many sites of the bowel and also in the lumen. Most were removed with segments of bowel.
The patient died 52 days p.o. for respiratory failure and congestive heart failure, prehesisting
PROSTHETIC GUILT LISTPROSTHETIC GUILT LIST1. WIRE MESH: 1. WIRE MESH: historicalhistorical
2. PLUG 2. PLUG 3. PHS3. PHS4. FLAT ONLAY MESH4. FLAT ONLAY MESH5. FLAT UNDERLAY LAP MESH5. FLAT UNDERLAY LAP MESH6. KUGEL VENTRAL PATCH 6. KUGEL VENTRAL PATCH
THE PLUGTHE PLUGPlug shrinks and the shrunken plug or Plug shrinks and the shrunken plug or meshoma can migrate and/or erode meshoma can migrate and/or erode surrounding tissues (Amid 1999).surrounding tissues (Amid 1999).The meshoma may be responsible forThe meshoma may be responsible for-- visceral injuryvisceral injury-- chronic painchronic pain-- vas obstructionvas obstruction
PLUG MIGRATIONPLUG MIGRATIONIn Literature it seems to be anedoctical, but to In Literature it seems to be anedoctical, but to be honest it is more frequent because many be honest it is more frequent because many cases haven’t been published.cases haven’t been published.May be it was more frequent in early 90’s, May be it was more frequent in early 90’s, when Authors didn’t advise to fix the plug.when Authors didn’t advise to fix the plug.Negro (EHS Berlin 2009) reported 11 cases Negro (EHS Berlin 2009) reported 11 cases found in the Literature of bowel injury by a plug found in the Literature of bowel injury by a plug in the period 1995in the period 1995--2009.2009.
PLUG MIGRATION: reportPLUG MIGRATION: report
11. . Int Surg 1999; 84;57 Male, 45. Plug migration into the scrotum
22. . Am Surg 2004,70:298Am Surg 2004,70:298 Male, 50.Male, 50.PainPain in the left lower quadrant in the left lower quadrant 18 months after18 months after
repair with Perfix Plug : laparoscopic approach. repair with Perfix Plug : laparoscopic approach. Adhesiolisis and plug removal. RecoveredAdhesiolisis and plug removal. Recovered
33. . Am Surg 2007;70:132Am Surg 2007;70:132 Male, 76Small bowel obstruction with volvolous and bowel
erosion by a plug. Resection.
PP Mesh mimicking PP Mesh mimicking an an adnexal malignancyadnexal malignancy
Hernia 2009, 13:221Hernia 2009, 13:221 Female, 79Female, 79
Hernia repair at ‘76 with Perfix plug secured Hernia repair at ‘76 with Perfix plug secured with sutures.with sutures.
3 years later presented with a slowly enlarging 3 years later presented with a slowly enlarging 44--5 cm right5 cm right--sided cystic adnexal mass. sided cystic adnexal mass. Removal. The pathology revealed a cystic Removal. The pathology revealed a cystic foreign body reaction to mesh.foreign body reaction to mesh.
5. Hernia 2005;9:93. Male,67Perforation of the sigmoid
History of bladder cancer treated with cystectomy and Bricker History of bladder cancer treated with cystectomy and Bricker urinary derivation.urinary derivation.2 years previously2 years previously Left Hernia RepairLeft Hernia RepairNo sign of perforation or obstruction. Normal peristalsisNo sign of perforation or obstruction. Normal peristalsisOccasional episodes of Occasional episodes of rectal bleedingrectal bleeding..Suspecting a diverticulitis, a Barium Enema was performed: the Suspecting a diverticulitis, a Barium Enema was performed: the contrast material spread in the left inguinal region.contrast material spread in the left inguinal region.At Colonoscopy an image in the sigmoid was similar to At Colonoscopy an image in the sigmoid was similar to diverticulum or fistuladiverticulum or fistulaCT scan confirmed a large absess in the left inguinal region, CT scan confirmed a large absess in the left inguinal region, containing bariumcontaining bariumSigmoid resection and removal of the plug that had perforated Sigmoid resection and removal of the plug that had perforated the sigmoid. the sigmoid.
6. Surg Today 2010;40:566Male, 79
Acute abdomen 2 years later: bowel perforation by a plug
2 years later Right Inguinal Repair with a plug2 years later Right Inguinal Repair with a plug6 months earlier small bowel resection for ischemia6 months earlier small bowel resection for ischemiaAdmission in Emergency Dept.Admission in Emergency Dept.TC indicated migration of the plug into the pelvic cavityTC indicated migration of the plug into the pelvic cavityLaparotomy: 20 cm of bowel tethered to right pelvic wall.Laparotomy: 20 cm of bowel tethered to right pelvic wall.A plug almost totally protruding through the peritoneum, A plug almost totally protruding through the peritoneum, adherent to the bowel with a small perforation.adherent to the bowel with a small perforation.Direct repair.Direct repair.RecoveryRecovery
PROSTHETIC GUILT LISTPROSTHETIC GUILT LIST1. WIRE MESH: 1. WIRE MESH: historicalhistorical2. PLUG 2. PLUG
3. PHS3. PHS4. FLAT ONLAY MESH4. FLAT ONLAY MESH5. FLAT UNDERLAY LAP MESH5. FLAT UNDERLAY LAP MESH6. KUGEL VENTRAL PATCH 6. KUGEL VENTRAL PATCH
PHSPHS
Hernia 2008;12:437Hernia 2008;12:437 Male, 56Male, 56Bowel obstruction and perforation 18 months after left hernia repair
by contact with the mesh. No previous history of abdominal surgeryBowel resection and anastomosis, recovery.Etiology of patient’s complication : hypotesis1- tear in the peritoneum or placement through the sac2-improper deployement of the deep patch: IT WAS CONICAL3-too deep placement of the underlying patch
PROSTHETIC GUILT LISTPROSTHETIC GUILT LIST1. WIRE MESH: 1. WIRE MESH: historicalhistorical2. PLUG2. PLUG3. PHS3. PHS
4. FLAT UNDERLAY LAP MESH4. FLAT UNDERLAY LAP MESH5. FLAT ONLAY MESH5. FLAT ONLAY MESH6. KUGEL VENTRAL PATCH 6. KUGEL VENTRAL PATCH
TAPPTAPP--TEPTEPLap repairs could be associated with peritoneal defects or Lap repairs could be associated with peritoneal defects or
tears. Non closure of these tears can lead to bowel tears. Non closure of these tears can lead to bowel obstruction for bowel adhesion to the meshobstruction for bowel adhesion to the mesh
1. Aust N Z J Surg 1998,68:751. Aust N Z J Surg 1998,68:75
2. Hernia 2008; 12:5352. Hernia 2008; 12:535..Case report: Case report: Male, 62 Male, 62 TAPP repair of Right Indirect Inguinal Hernia.TAPP repair of Right Indirect Inguinal Hernia.PP (12 x 12 cm) mesh fixed to Cooper Lig. and above with tackers. PP (12 x 12 cm) mesh fixed to Cooper Lig. and above with tackers.
Suture of peritoneum with tackers, superiorly, covering the mesh. Suture of peritoneum with tackers, superiorly, covering the mesh. Readmission after 48 hrsReadmission after 48 hrs for acute abdomen. Laparoscopy: the for acute abdomen. Laparoscopy: the small bowel was herniated through the peritoneal defect. Reduction small bowel was herniated through the peritoneal defect. Reduction of the bowel and suture of the defectof the bowel and suture of the defect
BOWEL OBSTRUCTION BOWEL OBSTRUCTION AFTER INGUINAL LAP AFTER INGUINAL LAP
REPAIRREPAIR1.1. Adhesive diseaseAdhesive disease2.2. Herniation Herniation
a) a) Early Early herniation: through peritoneal defectherniation: through peritoneal defectb) b) LateLate herniation: through trocar siteherniation: through trocar site
Both herniations occur usually within 1Both herniations occur usually within 1°° week p.o.week p.o.Adhesions problems are later, after 3 weeks.Adhesions problems are later, after 3 weeks.
BOWEL BOWEL OBSTRUCTIONOBSTRUCTIONHernia 2005,9:178Hernia 2005,9:178
Occurrence after Occurrence after TAPP 0.5%;TAPP 0.5%; afterafter TEP 0.07%TEP 0.07%
Cumulative 0.28%Cumulative 0.28%
Occurrence after Occurrence after Lichtenstein repair: 0.16%Lichtenstein repair: 0.16%
BOWEL PERFORATION BOWEL PERFORATION AFTER TAPPAFTER TAPP
J Laparoendoscop Adv Surg Tech A 2007;17:669J Laparoendoscop Adv Surg Tech A 2007;17:669--7272
Male, 66. TAPP 1996Male, 66. TAPP 1996Intermittent diarrhea. Benign lesion of the caecum.Intermittent diarrhea. Benign lesion of the caecum.Right emicolectomy.Right emicolectomy.PP mesh had eroded the bowelPP mesh had eroded the bowel
INCISIONAL HERNIAINCISIONAL HERNIAEnteroEntero--cutaneous fistulacutaneous fistula
Hernia 2009,13:323Hernia 2009,13:323Male, 50Male, 50Emergency admission for abdominal pain and fever.Emergency admission for abdominal pain and fever.6 years earlier6 years earlier incisional hernia repair. Recurrence and second incisional hernia repair. Recurrence and second repair the following year with repair the following year with ePTFEePTFE mesh.mesh.On admission the patient was not septicOn admission the patient was not septic. . A fluctuating area was A fluctuating area was incised and drained. A low output biliary fistula developed. CT scan incised and drained. A low output biliary fistula developed. CT scan revealed enterorevealed entero--cutaneaous fistula.cutaneaous fistula.An exploratory laparotomy with bowel resection and asportationAn exploratory laparotomy with bowel resection and asportation
of the mesh was performed.of the mesh was performed.
Major meshMajor mesh--related complications related complications following hernia repair: events following hernia repair: events
reported to the FDAreported to the FDA
Surg Endosc 2005,19:1556Surg Endosc 2005,19:1556
In 253 adverse events reported to FDA from In 253 adverse events reported to FDA from 1996 to 2004 only 13 1996 to 2004 only 13 (5%)(5%) intestinal intestinal complications were involving complications were involving ePTFEePTFE
MESH MIGRATION INTO MESH MIGRATION INTO THE BLADDER THE BLADDER
AFTER TEP AFTER TEP 3 RECENT REPORTS (2006, 2007, 2010)3 RECENT REPORTS (2006, 2007, 2010)
THE SAME COMPLICATION OCCURRED THE SAME COMPLICATION OCCURRED AFTER STOPPA REPAIRAFTER STOPPA REPAIR
“NIHIL NOVI SUB SOLI”“NIHIL NOVI SUB SOLI”LATIN SAYINGLATIN SAYING
ALSO WITH ALSO WITH TAPPTAPP IT CAN IT CAN HAPPENHAPPEN
Case report of migration into bladder Case report of migration into bladder
+ + J Laparoendosc Surg. 1996 Oct;6(5):333J Laparoendosc Surg. 1996 Oct;6(5):333--55+ Urologe A. 2002 Jul;41(4):366+ Urologe A. 2002 Jul;41(4):366--8. 8.
WHY BE AMAZED?WHY BE AMAZED?
LATE REJECTION OF THE LATE REJECTION OF THE MESH AFTER TAPPMESH AFTER TAPP
Surg Endosc 1998,12 (9):1164Surg Endosc 1998,12 (9):1164--5.5.
Retrospective study of 500 TAPP.Retrospective study of 500 TAPP.3 cases of rejection of the mesh at 53 cases of rejection of the mesh at 5--19 months19 monthsThe mesh was removed via a suprapubic midline incisionThe mesh was removed via a suprapubic midline incisionAfter 3 months none of hernia recurred.After 3 months none of hernia recurred.
PROSTHETIC GUILT LISTPROSTHETIC GUILT LIST1. WIRE MESH: 1. WIRE MESH: historicalhistorical2. PLUG2. PLUG3. PHS3. PHS4. FLAT UNDERLAY LAP MESH4. FLAT UNDERLAY LAP MESH
5. 5. FLAT ONLAY MESHFLAT ONLAY MESH6. KUGEL VENTRAL PATCH6. KUGEL VENTRAL PATCH
5. FLAT MESH: inguinal5. FLAT MESH: inguinalHernia 2003;7:161Hernia 2003;7:161 Male, 67Male, 67At 62 repair of Left Inguinal Hernia and at 64 of At 62 repair of Left Inguinal Hernia and at 64 of
right one.right one.Admitted in Emergency for severe abdominal pain. Admitted in Emergency for severe abdominal pain.
Signs of bowel obstruction. Migration of the Signs of bowel obstruction. Migration of the mesh mesh (8x4 cm)(8x4 cm) of right side around the bowel. of right side around the bowel. Recurrence of the right herniaRecurrence of the right hernia
FLAT MESH:FLAT MESH:INCISIONAL HERNIAINCISIONAL HERNIA
Dis Colon Rectum Dis Colon Rectum 1981,1981,24:543:24:543: Fecal fistulaFecal fistula
Hernia 2002,6,144Hernia 2002,6,144:: Fecal fistula Fecal fistula Male, 52Male, 52At 42 xypho-pubic incisional hernia mesh repair. Marlex onlay (?).10 years later appeared a fluctuating painful mass in the left anterior
wall (8 x 5 cm). The patient was septic. Incision of the absess and recovery.
2 weeks later a fecal fistula developed. At the resection of the involved colon and jejunum was found a fistula incorporating a part of the Marlex mesh
A recent opinion target is to A recent opinion target is to address the attention address the attention
of the people of the people againstagainst
SURGICAL MESHSURGICAL MESH
Health Care Nightmare!Health Care Nightmare!Synthetic Surgical Mesh Synthetic Surgical Mesh
ComplicationsComplications
Death by bleedout, death from strangulation of Death by bleedout, death from strangulation of the bowels, perforation of the bladder, male the bowels, perforation of the bladder, male infertility, inability to urinate, hernias, infertility, inability to urinate, hernias, colostomies...just a few of the complications of colostomies...just a few of the complications of the surgical implantation of Synthetic Surgical the surgical implantation of Synthetic Surgical Mesh.Mesh.
Why Truth in Medicine?Why Truth in Medicine?We are patients educating andWe are patients educating and supporting supporting other patients! We are taking action to protect other patients! We are taking action to protect others from being seriously harmed as we have others from being seriously harmed as we have been.been.
Lifelong irreversible complications are caused Lifelong irreversible complications are caused by surgical implantation of Synthetic Surgical by surgical implantation of Synthetic Surgical Mesh for hernias, pelvic floor disorders and Mesh for hernias, pelvic floor disorders and bladder suspension, both male and female.bladder suspension, both male and female.
www.truthinmedicine.us.comwww.truthinmedicine.us.comwww.truthinmedicine.co.ukwww.truthinmedicine.co.uk
“Do not be a Guinea Pig for “Do not be a Guinea Pig for pharmaceutical companies!!”pharmaceutical companies!!”
TRUTH IN MEDICINE TRUTH IN MEDICINE INCORPORATEDINCORPORATED
FIRST ANNUAL CONFERENCEFIRST ANNUAL CONFERENCE
““SURVIVING THE COMPLICATIONS OF SURVIVING THE COMPLICATIONS OF SYNTHETIC SURGICAL MESHSYNTHETIC SURGICAL MESH””
SEPTEMBER 25SEPTEMBER 25--26, 200926, 2009
CONFERENCE SPEAKERS CONFERENCE SPEAKERS “Alternatives to synthetic surgical “Alternatives to synthetic surgical
mesh”mesh”
DEMONSTRATE ON THE STEPS OF DEMONSTRATE ON THE STEPS OF THE U.S. CAPITOL THE U.S. CAPITOL
BUILDING IN WASHINGTON, D.C.!BUILDING IN WASHINGTON, D.C.!LET'S GET THE MESH OUT RALLY!LET'S GET THE MESH OUT RALLY!
OCTOBER 1, 2010OCTOBER 1, 2010
10:00 a.m. to 1:00 p.m.10:00 a.m. to 1:00 p.m.
CONGRESS NEEDS TO KNOW WE ARE CONGRESS NEEDS TO KNOW WE ARE HARMED!HARMED!
WE WILL MAKE THEM AWARE OF THE WE WILL MAKE THEM AWARE OF THE DANGERS OF SYNTHETIC MESH WITH OUR DANGERS OF SYNTHETIC MESH WITH OUR
PRESENCEPRESENCE!!
...and the Sword of the Spirit which is the Word ...and the Sword of the Spirit which is the Word of God.of God.
Ephesians 6:17Ephesians 6:17
PROSTHETIC GUILT LISTPROSTHETIC GUILT LIST1. WIRE MESH: 1. WIRE MESH: historicalhistorical2. PLUG2. PLUG3. PHS3. PHS4. FLAT ONLAY MESH4. FLAT ONLAY MESH5. FLAT UNDERLAY LAP MESH5. FLAT UNDERLAY LAP MESH
6. KUGEL VENTRAL PATCH 6. KUGEL VENTRAL PATCH
Davol first announced a Davol first announced a Kugel Ventral Mesh Kugel Ventral Mesh
recallrecall in 2005 after it was in 2005 after it was discovered that the “memory discovered that the “memory recoil ring”, which opens the recoil ring”, which opens the
patch after it is implanted, patch after it is implanted, can break under the stress of can break under the stress of
placement in the intraplacement in the intra--abdominal space.abdominal space.
Hernia Patch StatisticsHernia Patch Statistics33——Number ofNumber of hernia patch recallshernia patch recalls issued for the Kugel mesh issued for the Kugel mesh patch: December 2005, March 2006 and January 2007.patch: December 2005, March 2006 and January 2007.
66——Different sizes of the Kugel mesh hernia patch have been Different sizes of the Kugel mesh hernia patch have been recalled: extrarecalled: extra--large oval (7.7" large oval (7.7" ×× 9.7"), extra9.7"), extra--large oval (8.7" large oval (8.7" ××10.7"), extra10.7"), extra--large oval (10.8" large oval (10.8" ×× 13.7"), large oval (5.4" 13.7"), large oval (5.4" ×× 7"), 7"), oval (6.3" oval (6.3" ×× 12.3") and large circle (4.5").12.3") and large circle (4.5").
1010——People who issued formal complaints about thePeople who issued formal complaints about the Kugel Kugel mesh hernia patchmesh hernia patch over a threeover a three--month span in the Summer of month span in the Summer of 2005 after experiencing2005 after experiencing hernia patch side effectshernia patch side effects ..
8080——Injuries (not to mention several deaths) as a result of the Injuries (not to mention several deaths) as a result of the Kugel mesh hernia patch, which spurred the Food and Drug Kugel mesh hernia patch, which spurred the Food and Drug Administration and Davol Inc. in January 2007 to issue an Administration and Davol Inc. in January 2007 to issue an updated product recall for the Kugel mesh hernia patch. Many updated product recall for the Kugel mesh hernia patch. Many of these patients have contacted a Kugel patch attorney about of these patients have contacted a Kugel patch attorney about filing afiling a hernia patch lawsuithernia patch lawsuit ..
No data in Medical Literature:No data in Medical Literature:an iceberg without tip!an iceberg without tip!
At least 7 Kugel mesh hernia patch patients have suffered a At least 7 Kugel mesh hernia patch patients have suffered a bowel perforation.bowel perforation.11 Kugel mesh hernia patch patients have experienced 11 Kugel mesh hernia patch patients have experienced breakage of the memorybreakage of the memory--recoil ring, which then migrated recoil ring, which then migrated through the abdominal wall. through the abdominal wall. Several Kugel mesh patch patients have suffered chronic Several Kugel mesh patch patients have suffered chronic enteric fistulas after receiving the patch. enteric fistulas after receiving the patch. One of them died of septic shock and heart attack after an One of them died of septic shock and heart attack after an operation to repair the intestinal fistulas operation to repair the intestinal fistulas
Hernia mesh recall could lead to future complicationsHernia mesh recall could lead to future complications
HERNIA MESH RECALL LAWYERSHERNIA MESH RECALL LAWYERSThe recall lawyers at Saiontz & Kirk, P.A. are investigating The recall lawyers at Saiontz & Kirk, P.A. are investigating
potential lawsuits for individuals who had a defective hernia patch potential lawsuits for individuals who had a defective hernia patch inserted.inserted. Although the manufacturer was aware of problems Although the manufacturer was aware of problems
with their products, they continued to sell defective hernia mesh with their products, they continued to sell defective hernia mesh patches without taking proper precautions to protect patches without taking proper precautions to protect
consumers.consumers.Financial compensationFinancial compensation may be availablemay be available..
WORLDWIDE REGISTRY COMPLICATIONS
SYNTHETIC SURGICAL MESH
Y O U R R E G I S T R A T I O NW I L L P R E V E N T
H A R M T O O T H E R P E O P L E !
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