Hernias are a condition you probably associate with men, but women can suffer from hernias, too.

Updated: 7:48 PM Feb 14, 2012

A common condition for men being overlooked for women
Hernias are a condition you probably associate with men, but women can suffer from hernias, too.
Posted: 3:48 PM Feb 14, 2012
Reporter: Maureen McFadden@wndu.com
Email Address: maureen.mcfadden@wndu.com

Hernias are a condition you probably associate with men, but women can suffer from hernias, too.


They can be painful and debilitating, and while a simple surgery can fix the problem. Sometimes the hardest part for women is getting the right diagnosis.

Author Martine Ehrenclou writes about how patients can take charge of their health care, but recently, Martine had to follow her own advice when she started experiencing severe abdominal pain.

Martine Ehrenclou, suffered from hernias, describes what the pain felt like, "The pain felt like a red hot poker in my lower abdominals."

Martine saw 12 different doctors and spent 10 months in intense pain, still no one could tell her what was wrong. Then she found a doctor who finally gave her an accurate diagnosis.

Ehrenclou describes the moment when she found a doctor that could help her, "She walked in and said this is what you have, and 'I can help you' and I cried!"

http://www.wndu.com/localnews/headlines/A_common_condition_for_men_being_miss_diagnosed_for_women_139310308.html

Barrier agents for adhesion prevention after gynaecological surgery.

Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000475.
Barrier agents for adhesion prevention after gynaecological surgery.
Ahmad G, Duffy JM, Farquhar C, Vail A, Vandekerckhove P, Watson A, Wiseman D.
SourceStepping Hill Hospital, Obstetric & Gynaecology, 30 Badger Road, Altrincham, Cheshire, UK, WA14 5UZ. gaityahmad@hotmail.com

Abstract
BACKGROUND: Pelvic adhesion can form as a result of inflammation, endometriosis or surgical trauma. During pelvic surgery, strategies to reduce pelvic adhesion formation may include placing synthetic barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene or Fibrin sheets between the pelvic structures.

OBJECTIVES: To assess the effect of physical barriers used during pelvic surgery in women of reproductive age on pregnancy rates, pelvic pain, or postoperative adhesion reformation.

SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched September 2007) which is based on regular searches of MEDLINE, EMBASE, CINAHL, PsycINFO and CENTRAL, plus handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. In addition, companies were contacted for unpublished trials.

SELECTION CRITERIA: Any randomised controlled trials (RCTs) comparing the use of physical barriers versus no treatment or other physical barriers in the prevention of adhesions in women undergoing gynaecological surgery.

DATA COLLECTION AND ANALYSIS: Review authors assessed trial eligibility and quality.

MAIN RESULTS: Sixteen RCTs were included. Five trials randomised patients while the remainder randomised pelvic organs. Laparoscopy (six trials) and laparotomy (10 trials) were the primary surgical techniques. Indications for surgery included myomectomy (five trials), ovarian surgery (five trials), pelvic adhesions (four trials), endometriosis (one trial), and mixed (one trial). Eleven trials assessed Interceed versus no treatment, two assessed Interceed versus Gore-Tex, one trial assessed Gore-Tex versus no treatment, and one trial assessed Seprafilm versus no treatment. A single trial assessed Fibrin sheet versus no treatment. No studies reported pregnancy or reduction in pain as outcomes. The use of Interceed was associated with reduced incidence of pelvic adhesion formation, both new formation and reformation following laparoscopic surgery or laparotomy. However, this result should be interpreted with caution. Gore-Tex was more effective than no barrier or Interceed in preventing adhesion formation. There was only limited evidence that Seprafilm was effective in preventing adhesion formation following myomectomy and no evidence to support Fibrin sheet.

AUTHORS' CONCLUSIONS: The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.

Update of
Cochrane Database Syst Rev. 2000;(2):CD000475.
http://www.ncbi.nlm.nih.gov/pubmed/18425865

Conservative Management of Mesh-Site Infection

Conservative Management of Mesh-Site Infection
in Hernia Repair
Brenda Aguilar, MD, Alyssa B. Chapital, MD,
James A. Madura, II, MD, and Kristi L. Harold, MD

JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES


Volume 20, Number 3, 2010

ª Mary Ann Liebert, Inc.

Abstract
Background: Mesh hernioplasty is the preferred surgical procedure for large abdominal wall hernias. Infection
remains one of the most challenging complications of this operation. Salvaging infected prosthetic material after
ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction,
with variable success rates. In this article, we report 3 cases of mesh salvage after laparoscopic
ventral herniorrhapy with a novel use of percutaneous drainage and antibiotic irrigation.
Results: Three patients developed infected seromas after laparoscopic ventral hernia repair. The fascial defect
of the first patient was repaired with a commercially available 20 18 cm polytetrafluoroethylene (PTFE) mesh.
A complex fluid collection developed the following month in the anterior abdominal wall overlying the patient’s
mesh. The cultures grew Staphylococcus aureus. The second patient had a 30 20 cm PTFE mesh placed, which
developed a fluid collection with Enterococcus faecalis and Escherichia coli. The third case underwent repair, using
a another commercially available 22 28 cm PTFE mesh. A fluid collection measuring 20 10 cm in the anterior
abdominal wall developed, growing Staphylococcus lugdunensis. In all 3 cases, a percutaneous drain was placed
within the fluid collection and long-term intravenous (i.v.) access was obtained. I.v. antibiotics were initiated. In
addition, gentamicin (80 mg) with 20mL of saline was infused through the drain 3 times a day. All patients have
remained free of clinical signs of infection following the completion of therapy.
Conclusions: Infected mesh after laparoscopic ventral herniorrhapy without systemic sepsis may be amenable to
nonoperative treatment. A conservative approach that includes percutaneous drainage followed by antibiotic
irrigation is a potential alternative to prosthetic removal in carefully selected patients. Further evaluation of this
technique is warranted to define the most appropriate management strategies for these patients.
Introduction
The placement of prosthetic biomaterials has become a
standard procedure during ventral hernia repair surgery.
Clinical evidence support lower recurrence rates as they
generate ‘‘tension-free’’ closure of hernia defects and provide a
permanent replacement for native fascia that frequently has
been weakened or removed by previous surgery. Reduction
of ventral hernia recurrence by 30%1–3 has been shown.
However, the lower recurrence rates come at the price of
mesh-related complications, including seromas, adhesions,
chronic severe pain, migration, and mesh-related infections.4,5
The exact incidence of mesh infections is difficult to obtain
due to the variable presentation period after surgery. Infections
can arise anywhere from 2 to 39 months6 following repair.
The incidence has been reported from 0.001 to 8%7–14
in the literature. While this appears relatively infrequent,
when compared with other device-related infections, the
clinical significance of this diagnosis portends a complex,9,10
extended course for both the patient and the surgeon.8,12
The rate of mesh infection is influenced considerably by
underlying comorbidity, immunosuppression, incision size,
obesity, history of previous hernia repair or wound infection,
and tobacco use.7–14 Unfortunately, patients with these same
risk factors are also likely to have a recurrent hernia, if the
prosthetic mesh is not utilized in the repair.8
Standard surgical practice has traditionally advocated the
removal of contaminated or exposed prosthetics. Unfortunately,
the removal of the prosthetic materials is often
technically difficult when there is good tissue incorporation
and can increase the risk of subsequent enterocutaneous fistula
formation.15 Achieving closure of the fascial defect after
mesh removal is not usually possible; therefore, a larger
ventral hernia than at the time of original repair may result.
Department of General Surgery, Mayo Clinic Hospital, Phoenix, Arizona.
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
DOI: 10.1089=lap.2009.0274
249
These issues have generated interest in a successful, conservative
treatment algorithm that does not involve mesh removal.
13,14,16,17 In this article, we describe a novel approach to
manage the complex problem of infected prosthetic mesh
following laparoscopic ventral hernia repair (LVHR).
Materials and Methods
This study was conducted by the Department of Surgery at
Mayo Clinic Hospital (Phoenix, AZ). We report 3 cases of
mesh infection after laparoscopic hernia repair with a prosthetic
mesh. The infection was diagnosed by clinical evidence
of pain, redness, induration, fever, and purulent discharge on
aspiration. We attempted to treat these cases with a conservative
approach.
After ultrasonografic confirmation of a fluid collection
surrounding the prosthetic mesh, a computed tomography
(CT)-guided placement of a drain was perform in all cases.
The skin overlying the left abdomen was sterilely prepped,
then draped to infiltrate 1% lidocaine. An 18-gauge needle
was advanced into the fluid collection. Through the needle, an
Amplatz wire was placed in the collection, the tract was
dilated with a 6.8- and 10-Fr fascial dilator, followed by the
placement of a 10-Fr locking loop all-purpose drainage catheter
that was then placed into the fluid collection. Repeat CT
was performed, confirming appropriate placement. A specimen
was sent to the lab for microbiology analysis. The tube
was secured with the skin by using a 2-0 Prolene suture. The
catheter was left to external bulb suction. The patients and
their relatives were instructed to irrigate the catheter with
gentamicin (80 mg) in 20mL of normal saline, leaving the
solution in the cavity for 30 minutes and then returning the
drain to bulb suction. This was performed 3 times per day.
We chose gentamicin as the primary antibiotic for the irrigation
therapy for its properties as a bactericidal agent at low
concentrations and its known activity against Staphylococcus
spp. as well as gram-negative cocci. Local use of gentamicin
provides much higher concentrations at wound sites, so blood
concentrations remain low, thus preventing toxicity. Special
recognition has been given to the use of gentamicin for the
treatment of infected skin cysts and other skin abscesses,
when preceded by incision and drainage to permit adequate
contact between the drug and the infecting bacteria.7
Case 1
A 50-year-old female underwent a robotic bilateral ovarian
cystectomy, at which time she had an abdominal wall mesh
place for an umbilical hernia. This mesh became infected and
was removed. Six months following removal, an LVHR was
performed with a 20 18cm polytetrafluoroethylene (PTFE)
Gore DualMesh (Creative Technologies Worldwide, Flagstaff,
AZ) for a recurrent hernia. One month later, the patient
was found to have erythema over her abdominal wall as well
as an elevated white blood cell count.ACT scan demonstrated
a complex fluid collection in the anterior abdominal wall
overlying the patient’s mesh. Percutaneous drainage of the
abscess was then undertaken, where approximately 100mL of
purulent material was aspirated. A drain was left in place. The
cultures revealed Staphylococcus aureus sensitive to ampicillin
and sulbactam. Drain irrigation with gentamicin (80 mg) in
20mLof normal saline (NS) 3 times a day as well as 1 month of
intravenous (i.v.) antibiotics was initiated. The drain and
central line were then removed. There has been no clinical
evidence of recurrent infection at 18 months of follow-up.
Case 2
A 63-year-old male with end-stage liver disease secondary
to primary sclerosing cholangitis underwent an orthotopic
liver transplant and Roux-en-Y choledochojejunostomy performed
in 2005. He subsequently developed a large ventral
hernia, which was repaired laparoscopically with a 30 20cm
PTFE Gore DualMesh in September 2007. In January 2009, the
patient underwent a routine colonoscopy and developed
Enterococcus faecalis and Escherichia coli bacteremia. An abdominal
CT scan demonstrated a fluid collection posterior to
the abdominal mesh. At that time, an external drain was
placed to treat the infection with gentamicin flushes (80mg in
20mL of NS 3 times a day), as well as i.v. antibiotics through a
peripherally inserted central catheter (PICC line), including
ceftriaxone (2 g once-daily) and ampicillin (2 g 3 times a day).
After 1 month of treatment, there were no clinical signs of
infection. The drain and antibiotics were then discontinued.
He continues to have no sign of infection currently at 11
months of follow-up.
Case 3
A 41-year-old female underwent multiple cesarean sections,
followed by the development of a ventral hernia. This
was repaired 8 times with mesh placement, in most cases. On
one occasion, the mesh had to be removed secondary to infection.
We performed an LVHR with a 22 28 cm PTFE Gore
DualMesh.
The patient presented the following month with generalized
body aches, chills, and fever. An abdominal CT scan was
performed that demonstrated a large fluid collection in the
anterior abdominal wall measuring 20 10 cm. It was drained,
producing 450mL of fluid. A percutaneous drain and a
PICC line were placed. Cultures grew 1þ S. lugdunensis. I.v.
amipicillin and sulbactam as well as gentamicin irrigation
(80mg in 20mL of NS) through the drain 3 times a day was
initiated.
At the end of treatment, a follow-up CT scan performed on
her abdomen and pelvis demonstrated improvement of the
anterior fluid collection previously drained. There remained a
seroma posterior to the mesh that was 9 cm in size without
evidence of abscess features. An attempt to aspirate the seroma
was unsuccessful due to its depth. The patient was
placed on amoxicillin=clavulanate (875 mg) by mouth twicedaily
for an additional 3 weeks of antibiotic therapy. The
anterior drain remained in place during this time and was
removed after it produced less than 10mL of serous fluid
daily. At 13 months of follow-up, she has done well with no
signs of infection.
Discussion
Surgical-site infections continue to be a major source of
morbidity throughout the world, accounting for almost 40–
60%10,18 of all postoperative infectious complications. This
concern, along with the increased costs associated with extended
hospitalization and reparative treatment, justifies
efforts to identify patient populations at risk and optimize
preoperative preparation and perioperative care. In the past
250 AGUILAR ET AL.
few years, the hernia repair with alloplastic prothesis has
become the standard treatment due to lower rates of recurrence,
when compared with simple suture closure. However,
the implantation of synthetic materials are related with
wound-associated complications in up to one third of cases.5
Mesh-related infectious complications occur in up to 13.6%
and usually require recurrent surgical intervention.12 The
more common agents associated with mesh infection are
Staphylococcus species (spp.) (especially S. aureus), Streptococcus
spp. (including group B streptococci), gram-negative
bacteria (mainly Enterobacteriaceae), and anaerobic bacteria
(including Peptostreptococcus spp.).18–21 In a study of meshrelated
infections following ventral herniorrhaphies, 63% of
the microorganisms isolated were methicillin-resistant S. aureus
(MRSA). Rarely, mesh infections are caused by Candida
spp. or Mycobacterium spp.21
Various factors are predictive of prosthetic infections, such
as patient-related illness, including diabetes mellitus, malnutrition,
chronic obstructive pulmonary disease, tobacco
and=or alcohol use, medical therapy with steroids, renal
failure, and morbid obesity.5–10,12,17,18,21 These medical comorbidities
are associated with decreased perfusion of the
skin and subcutaneous (s.c.) tissues as well as immunosuppressive
attributes. Factors directly to the operation, such as
the choice of mesh material and type of surgical procedure,
are still the subject of critical debate. In a meta-analysis of 20
trials (5016 participants) of open versus open nonmesh repair
of groin hernias, it was shown that the rate of postoperative
complications, including infections, was similar in both procedures.
4 A similar clinical trial with 200 adult umbilical
hernia repairs with or without mesh showed no differences in
results between techniques, including infection rate.21 Korenkov
et al.,22 in a clinical, randomized trial of 160 patients
with simple or complex hernias that underwent either suture
repair, autodermal skin graft, or onlay polypropylene mesh
repair, found fewer infectious complications after suture repair
(9%) than after skin graft or mesh repair (18%) for simple
hernias and 23–35% for complex hernias. White et al.23 reported
that the use of a mesh and hernia defect >10 cm were
associated with significantly more wound complications
(44 versus 26%; P<0.05), especially a increased incidence
of seroma (21 versus 7%). They also reported that patients
undergoing mesh repair were more likely to receive antibiotics
(91 versus 71%) and have s.c. drains placed (57 versus
25%), compared to simple primary repair.
The traditional surgical management for infection after
hernia repair with prosthetic materials advocates that all infected
prosthetic materials must be removed, but this leads to
a high risk of hernia recurrence. Innovative studies aim to
provide evidence that a conservative approach may be a
suitable alternative. Carbonell et al.26 studied hernia repairs
by using seven prosthetic mesh biomaterials innoculated with
bacteria in a live animal and concluded that ePTFE was the
least susceptible to infection, and with silver=chlorhexidine
coating, the prosthesis was able to kill all the inoculated
bacteria. Silver-chlorhexidine-impregnated meshes may be
the prosthetics of choice to prevent the occurrence of mesh
infection in LVHR. The literature would support that the
debridement of all purulent material and necrotic tissue is
essential, but it remains debatable whether to remove the
prostheses. Irrigation with antimicrobial solutions has been
attempted in a few trials. Trunzo et al.13 reported 2 cases of
infected seroma after laparoscopic ventral repair: A 20 23 cm
Parietex composite polyester mesh was used in 1 patient,
and a 32 33 cm piece of expanded PTFE was used in the
other. After the infections were diagnosed, the patients were
treated by abscess drainage, parenteral antibiotics, and 4
weeks of gentamicin irrigation (80mg in 30mL of solution)
via a drain 3 times per day. Both patients remained free of
clinical signs of infection at 12 and 16 months, respectively.
Ahmad et al.14 described 13 cases of open ventral hernia repair
with using polypropylene mesh resulting in infection.
They treated their patients with local management, including
incision, drainage, and debridement of the wound, followed
by irrigation with saline=povidone iodine. Eight patients
(62%) required daily dressing changes and five to seven debridements.
Three patients (23%) developed severe sepsis and
complete dehiscence of the wound. These patients averaged
10–12 debridements during recovery. Two patients (15%)
with cellulitis were discharged after 10–12 days with full recovery.
All the patients were followed for 3 months and did
not have recurrence of infection.
Some researchers believe that an individualized approach
is necessary to treat patients with mesh infections, and special
considerations must be taken regarding the type of mesh.27
The use of a multifilament polyester mesh is related to a
higher incidence of infection, small-bowel obstruction, and
enterocutaneous fistula formation than the use of other types
of mesh (e.g., knitted monofilament polypropylene, PTFE, or
woven polypropylene).2,12,19,17 Further, experimental studies
in animals relate the use of microporous mesh to a higher rate
of infections and development of seromas, whereas macroporous
material was shown to be associated with a higher
incidence of adhesive and erosive events.23–25 The ePTFE
mesh has generated conflicting theories as to its ability to be
salvaged in the face of infection. Paton et al.27 concluded that
patients with limited ePTFE mesh infections could be treated
with abscess drainage, antibiotics, and local wound care, but
more extensive infections require mesh removal. Petersen
et al.12 concluded that in their experience with 8 mesh-infected
cases, adequate drainage seemed to be sufficient for polypropylene
or polyester meshes; however, infected ePTFE
patches should be removed early. The researchers explained
that the structural matrix of ePTFE permits fluid retention and
bacterial growth due to inadecuate leucocyte invasion
through the 10-mm pores. Bellon et al.29,30 demonstrated that
S. aureus colonies produce alterations in the structure of
ePTFE. From using electron microscopy, they demonstrated
the deformation of internodal filaments and the creation of
fissures in the ePTFE microstructure, and that alteration of the
biomaterial facilitated the attachment and invasion of bacteria.
Despite these findings, we have had success with the
salvage of ePTFE after laparoscopic ventral hernia repair. In
our experience, infection of ePTFE does not always mandate
removal. Our 3 cases were successfully managed with
drainage, parenteral antibiotics, and gentamicin irrigation
through a drain, with no recurrence of infection.
Conclusions
For patients with an infected mesh in the absence of systemic
sepsis, a conservative approach that includes percutaneous
drainage, followed by antibiotic irrigation, is a potential
alternative to prosthetic removal. Further evaluation of this
MESH-SITE INFECTION 251
technique is warranted to define the most appropriate management
strategies for these patients.
Disclosure Statement
No competing financial interests exist.
References
1. Wassenaar EB, Schoenmaeckers EJ, Raymakers JT, Rakic S.
Recurrences after laparoscopic repair of ventral and incisional
hernia: Lessons learned from 505 repairs. Surg Endosc
2009;23:825–832.
2. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term
complications associated with prosthetic repair of incisional
hernias. Arch Surg 1998;133:378–382.
3. Vrijland WW, Van den Tol MP, Luijendijk RW et al. Randomized,
clinical trial of nonmesh versus mesh repair of
primary inguinal hernia. Br J Surg 2002;89:293–297.
4. Grant AM. Open mesh versus nonmesh repair of groin
hernia: Meta-analysis of randomized trials based on individual
patient data [corrected]. Hernia 2002;6:130–136.
5. Jezupovs A, Mihelsons M. The analysis of infection after
polypropylene mesh repair of abdominal wall hernia. World
J Surg 2006;30:2270–2278.
6. Delikoukos S, Tzovaras G, Liakou P, et al. Late-onset deep
mesh infection after inguinal hernia repair. Hernia 2007;11:
15–17.
7. Falagas ME, Kasiakou SK. Mesh-related infections after
hernia repair surgery. Clin Microb Infect 2005;11:3–8.
8. Kercher KW, Sing RF, Matthews BD, Heniford BT. Successful
salvage of infected PTFE mesh after ventral hernia
repair. Ostom Wound Manag 2002;48:40–45.
9. Bliziotis IA, Kasiakou SK, Kapaskelis AM, Falagas ME.
Mesh-related infection after herniarepair: Case report of an
emergencing type of foreing-body relatedinfection. Infection
2006;34:46–48.
10. Paton BL, Novitsky Y, Zerey M, et al. Management of infections
of polytetrafluoroethylene-based mesh. Surg Infect
2007;8:337–341.
11. Praveen S, Rohaizak M. Local antibiotics are equivalent
to intravenous antibiotics in the prevention of superficial
wound infection in inguinal hernioplasty. Asian J Surg 2009;
32:59–63.
12. Petersen S, Henke G, Freitag M, et al. Deep prosthesis infection
in incisional hernia repair: Predictive factors and
clinical outcome. Eur J Surg 2001;167:453–457.
13. Trunzo JA, Ponsky JL, Jin J, et al. A novel approach for
salvaging infected prosthetic mesh after ventral hernia repair.
Hernia 2009;13:545–549.
14. Ahmad S, Mufti TS, Zafar A, Akbar I. Conservative managment
of mesh-site infection in ventral hernia repair. Ayub
Med Coll Abbottabad 2007;19:75–77.
15. Fawole AS, Chaparala RP, Ambrose NS. Fate of the inguinal
hernia following removal of infected prosthetic mesh. Hernia
2006;10:58–61.
16. Luijendijk RW, Hop WC, Van den Tol MP, et al. A comparison
of suture repair with mesh repair for incisional
hernia. NEJM 2000;343:392–398.
17. Stoppa RE. The treatment of complicated groin and incisional
hernias. World J Surg 1989;13:545–554.
18. Malone DL, Genuit T, Tracy JK, et al. Surgical site infections:
Reanalysis of risk factors. J Surg Res 2002;103:89–95.
19. Demiter S, Gecim IE, Aydinuraz K, et al. Affinity of Staphylococcus
epidermidis to various prosthetic graft materials.
J Surg Res 2001;99:70–74.
20. Cobb WS, Harris JB, Lokey JS, McGill ES, et al. Incisional
herniorrhaphy with intraperitoneal composite mesh: A report
of 95 cases. Am Surg 2003;69:784–787.
21. Arroyo A,Garcia P, Perez F, et al. Randomized, clinical trial
comparing suture and mesh repair of umbilical hernia in
adults. Br J Surg 2001;88:1321–1323.
22. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer
EA, Troidl H. Randomized, clinical trial of suture repair,
polypropylene mesh, or autodermal hernioplasty for incisional
hernia. Br J Surg 2002;89:50–56.
23. White TJ, Santos MC, Thompson JS. Factors affecting wound
complications in repair of ventral hernias. Am Surg 1998;
64:276–280.
24. Amid PK. Classification of biomaterials and their related
complications in abdominal wall hernia surgery. Hernia
1997;1:15–21.
25. Zheng F, Xu L, Verbiest L, et al. Cytokine production following
experimental implantation of xenogenic dermal collagen
and polypropylene grafts in mice. Neurourol Urodyn
2007;26:280–289.
26. Carbonell AM, Matthews BD, Dre´au D, et al. The susceptibility
of prosthetic biomaterials to infection. Surg Endosc
2005;19:430–443.
27. Paton LB, Novitsky YW, Zerey M, Sing RF, et al. Management
of infections of polytetrafluoroethylene-based mesh.
Surg Infect 2007;8:337–341.
28. Bellon JM, Bujan J, Contreras L, et al. Macrophage response
to experimental implantation of polypropylene protheses.
Eur Surg Res 1994;26:46–53.
29. Bleichrodt RP, Simmermacher RK, Van der Lei B,
Schakenraad JM. Expanded polytetrafluoroethylene patch
versus polypropylene mesh for the repair of contaminated
defects of the abdominal wall. Surg Gynecol Obstet 1993;
176:18–24.
30. Bellon JM, Contreras LA, Bujan J. Effect of relaparotomy
through previously integrated polypropylene and polytetrafluoroethylene
experimental implants in the abdominal
wall. J Am Coll Surg 1999;188:466–472.
31. Bellon JM, Jurado F, Carranza A. In vitro interaction of
bacteria with polypropylene=ePTFEprostheses. Biomaterials
2001;22:2021–2024.
Address correspondence to:
Brenda Aguilar, MD
Department of General Surgery
Mayo Clinic Hospital
5777 East Mayo Boulevard
Phoenix, AZ 85054
E-mail: Aguilar.Brenda@mayo.edu

FDA warns mesh used in surgery poses risk

Problems seen in vaginal procedure
By Deborah Kotz and Robert Weisman
Globe Staff / July 14, 2011
Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration.

The agency warned patients and surgeons to consider other options.

The FDA said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh - manufactured by Natick-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies - for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, the agency said, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include pain ful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

Click here to read the rest
http://www.boston.com/lifestyle/health/articles/2011/07/14/fda_warns_mesh_used_in_vaginal_surgery_can_pose_risk

Mesh-related infections after hernia repair surgery

Mesh-related infections after hernia repair surgery
M. E. Falagas1,2, S. K. Kasiakou1Article first published online: 29 NOV 2004

DOI: 10.1111/j.1469-0691.2004.01014.x

Keywords:Hernia repair;infectious complications;mesh-related infection;Staphylococcus aureus;Staphylococcus spp
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Abstract
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open or laparoscopic repair of hernias. The possibility of a mesh-related infection occurring weeks or even years after hernia repair, should be considered in any patient with fever of unknown origin, or symptoms and/or signs of inflammation of the abdominal wall following hernia repair. The reported incidence of mesh-related infection following hernia repair has been 1%–8% in different series, and this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. An approach that combines medical and surgical management is necessary for cases of mesh infection. The antimicrobial treatment regimen chosen initially should include coverage of Staphylococcus spp. and, particularly, Staphylococcus aureus.

Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Introduction
Top of page
Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
Within the last few years, the use of meshes has become standard procedure in hernia repair surgery throughout the world. Implantation of a mesh during the surgical management of this common problem has been found to reduce the rate of recurrence of a hernia. For example, use of a mesh for the repair of incisional hernias has been found in different studies to decrease the recurrence rates by an average of 30%[1–3], while in a randomised clinical trial involving 289 patients in which non-mesh vs. mesh repair of primary inguinal hernia was compared, it was found that recurrence rates were 7% for the non-mesh technique vs. 1% for mesh repair [4]. However, mesh-related complications have become increasingly important. Such complications include seromas, adhesions, chronic severe pain, migration and rejection of the mesh, and mesh-related infections.

The present review focuses on mesh-related infections. Data for the review were obtained from searches of Medline, Current Contents and references from relevant articles. In addition, several articles were identified through searches of the extensive files of the authors. The search terms were ‘mesh’, ‘infection’, ‘open hernia surgery’, ‘laparoscopic hernia repair’, ‘inguinal hernia repair’, ‘infectious complications’, ‘biomaterials’, ‘antibiotic prophylaxis’ and ‘prevention’. All English language papers were carefully reviewed.
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Important advances in research and development by the biomedical materials industry have led to the production of relatively inert and biocompatible surgical meshes. However, it has been noted in clinical practice that surgical meshes can trigger various responses when implanted in the human body, including inflammation (known as foreign body reaction), fibrosis, calcification, thrombosis and infection.

Foreign body reaction refers to a process in which proteins such as albumin and fibrinogen are absorbed initially by the surface of the polymer. Subsequently, the physiochemical properties of each polymer result in the degradation of the absorbed proteins. This process results in the attraction and stimulation of macrophages, which respond by releasing inflammatory substances and growth factors. Other inflammatory cells (T-lymphocytes, polymorphonuclear cells, eosinophils, plasma cells and fibroblasts) are then attracted to the surface of the polymer, leading to the formation of a granuloma. Such granulomas are characterised by locally increased cell turnover, which may continue for periods of several years after the implantation of the mesh. Foreign body reaction also depends on the surface area of the mesh that is in contact with the host tissue [5]. Clinical manifestations of foreign body reaction are seroma, rejection, migration of mesh, adhesions and pain.

Meshes made of non-absorbable polymers have been used most frequently in clinical practice. The main non-absorbable polymers are polyester, polypropylene and expanded polytetrafluoroethylene. However, given the fact that absorbable polymers are associated less frequently with foreign body reactions and adhesion, newer meshes are made of a combination of absorbable and non-absorbable polymers [6,7]. The mechanical and biological properties of meshes are associated with the type of tissue structure (woven or knitted) and the type of fibre used (mono- or multifilament) [8]. The pore size of the mesh also plays a role in the safety and tolerability of surgical meshes [9].
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Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
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Mesh-related infections following surgery occur relatively infrequently compared with other device-related infections. However, they are of considerable clinical importance, not only for the patients and surgeons, but also for other medical specialists. The question of whether the incidence of infectious complications is higher after hernia repair involving the use of a mesh, in comparison with older techniques not involving use of a mesh, remains controversial. The results of a recent trial in which a comparison was made between umbilical hernia repair with or without a mesh in 200 adults showed that the rate of post-operative complications, including infection, was similar following both procedures [10]. A similar result was obtained in a meta-analysis of 20 trials (5016 participants) of open mesh vs. non-mesh repair of groin hernias [11]. In contrast, the results of a randomised trial of 160 patients with simple or complex hernias who underwent suture repair, skin graft or mesh repair showed that the rate of infectious complications was lower following suture repair than following the other two techniques. In addition, mesh implantation led to an increased rate of infections following repair of both simple and complex hernias [12]. A further study showed that the use of mesh during the repair of a ventral hernia or a hernia defect > 10 cm in size was associated significantly with an increased number of wound complications [13].

Incidences of mesh-related infection after hernia repair of up to 8% have been reported (Table 1) [14–18]. The rate of infection is influenced considerably by underlying co-morbidity, and seems to be increased in patients with diabetes, immunosuppression or obesity. Of great interest is whether the type of prosthetic material or the precise technique used for hernia repair can influence the incidence of mesh infection. In most recent published trials, the differences in complication rates following different surgical approaches and the use of different meshes have been compared. However, none of these studies focused specifically on the mesh-related infection rates. Leber et al.[19] conducted a retrospective cohort analysis of 200 patients who underwent open repair of abdominal incisional hernias with prosthetic material, with the aim of determining whether the incidence of long-term complications was influenced by the surgical technique. The authors concluded that the precise surgical approach did not influence the incidence of long-term complications significantly, including mesh infection. Although several authors have suggested that the laparoscopic approach to hernia repair has fewer post-operative complications compared to open repair, there are no clear, specific data regarding mesh-related infection rates [20–22].

Table 1. Incidence of mesh infection after laparoscopic or open hernia repair surgery Reference Study population (n) Technique of hernia repair Incidence of mesh infection
Heniford et al.[14] 407 Laparoscopic ventral and incisional hernia repair 0.98%
Heniford et al.[15] 822 Laparoscopic ventral hernia repair 0.7%
Kirshtein et al.[16] 103 Laparoscopic incisional hernia repair 2%
Petersen et al.[17] 121 Open incisional hernia repair 7%
Cobb et al.[18] 95 Open incisional hernia repair 8%

There is no consensus in the literature as to whether the use of non-absorbable mesh for incisional hernia repair is contraindicated in potentially contaminated surgical settings. Recently published data have indicated that the rate of mesh-related infections is comparable for ‘clean’ surgical procedures and for cases where potentially contaminated surgical procedures, such as appendectomy, cholocystectomy or enterectomy, are performed at the same time as incisional hernia repair [23,24].

The influence of mesh type on the incidence of infection was investigated in a recent study; the results showed that the use of multifilament polyester mesh resulted in a higher incidence of infection, small bowel obstruction and enterocutaneous fistula formation than the use of other types of mesh (knitted monofilament polypropylene, polytetrafluoroethylene or woven polypropylene) [19]. In addition, studies in experimental animals have shown that microporous mesh is associated with higher rates of infection and/or development of seromas, whereas macroporous mesh is associated with a higher incidence of adhesive and erosive events. Microporous mesh has a pore diameter of 10 µm, with the result that bacteria can penetrate the mesh, but polymorphonuclear leukocytes (with a diameter of 75 µm) cannot. This means that the bacteria in the mesh are protected from immunological defence mechanisms [25–27].
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The reported interval between hernia repair and the manifestation of a mesh infection ranges from 2 weeks to 39 months [28]. Patients usually present with symptoms and signs of local acute inflammation (a combination of pain, erythema, tenderness, swelling and increased temperature in the abdominal wall in the area of the mesh). In addition, patients may have systemic manifestations such as fever, malaise, chills or rigors. A mesh-related infection can sometimes manifest with a discharging fistula, or with an intra-abdominal abscess. Rare cases of patients who presented with osteomyelitis following inguinal hernia surgery with implantation of a polypropylene mesh have been reported [29].
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The usual causative organisms associated with cases of mesh infection are Staphylococcus spp., especially Staphylococcus aureus, Streptococcus spp. (including group B streptococci), Gram-negative bacteria (mainly Enterobacteriaceae), and anaerobic bacteria (including Peptostreptococcus spp.) [28]. In a study of mesh-related infections following incisional herniorrhaphy, 63% of the microorganisms isolated were methicillin-resistant S. aureus (MRSA) [18]. Rarely, mesh infections are caused by Candida spp. or Mycobacterium spp. [30,31].

Mesh infections can manifest with chronic, persistent or recurrent symptoms and signs. The infecting agents in some of these reported cases were small-colony variants, usually of S. aureus. The main characteristic of these infections is that they respond poorly to antimicrobial treatment regimens [32].
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The most important point regarding the prevention of mesh-related infections is that foreign body reactions depend on the amount of the prosthesis (mesh) used. For this reason, surgeons should try to minimise the area of mesh that is introduced during the hernia operation, since the inserted foreign material is an ideal medium for bacterial colonisation [33].

In addition, four main approaches to the prevention of mesh infection have been used. First, the wound can be rinsed with an antibiotic-containing solution, starting immediately after the dissection of the hernia sac, and then intermittently until the skin is sutured. It has been shown in an animal model that this approach inhibits the adhesion of bacteria to the surface of the mesh, as well as their growth [34]. Moreover, in a randomised trial of 162 patients who underwent inguinal hernia repair, there were no wound infections following the application of a single dose of cefamandole directly to the wound [35]. However, the effectiveness of lavage with solutions containing antimicrobial agents is controversial, since antibiotics require a defined duration of contact with pathogens, while lavage is usually a more rapid process.

A second approach involves the use of material placed in front of the mesh to slowly deliver an antimicrobial agent locally. In a randomised trial, the use of gentamicin-laced collagen tampons was tested in 301 patients undergoing prosthetic groin hernia repair. The collagen tampons were placed in front of the mesh before the aponeurosis of the external oblique muscle was sutured. This new technique resulted in fewer post-operative infections in comparison with 294 patients undergoing surgical repair for the same hernia without the use of gentamicin-containing collagen tampons [36].

Third, a mesh containing embedded antimicrobial agents can be used. Such a mesh is thought to help prevent bacterial adhesion and colonisation when implanted in wounds, with a subsequent reduced likelihood of post-operative infections.

Finally, traditional intravenous perioperative administration of antimicrobial agents can be used. Although hernia repair operations are classified as clean surgery, the administration of intravenous antibiotics perioperatively has been shown to be beneficial if a prosthetic material (mesh) is involved [37,38].

All of the above-mentioned strategies seem to be beneficial in reducing the incidence of mesh-related infection after hernia repair. However, no definitive recommendation can be made in favour of any particular approach in the absence of comparative outcome data. The current standard preventive strategy for other types of surgery, i.e., the perioperative administration of appropriate intravenous antibiotics, may be used until new data regarding alternative preventive strategies become available. At the present time, additional strategies to prevent mesh-related infections, such as the use of gentamicin-laced collagen tampons with a mesh, are best reserved for patients at high risk of infection, such as diabetic and obese patients.
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A clinician should strongly consider the possibility of a mesh-related infection in any patient who presents with fever of unknown aetiology, symptoms and/or signs of inflammation of the abdominal wall in the area of the mesh, or other less common clinical manifestations of mesh infection, such as an enterocutaneous fistula or abdominal abscess in the area of the mesh.

Imaging techniques, including ultrasound and/or computerised tomography, can be useful for the diagnosis of mesh infection. Such techniques usually reveal an area of inflammation in the subcutaneous fat around the mesh, which has different echogenic or density characteristics, respectively, from that in other conditions, such as seroma. Additionally, the results of these imaging tests can indicate the presence of a fistula or an abscess.

It is important that no attempt should be made to perform a diagnostic paracentesis of mesh-related seromas when there are no symptoms and/or signs of inflammation of the abdominal wall. This is because of the real possibility of introduction of bacteria into the area of seroma during paracentesis, leading to the transformation of an aseptic reaction into an infectious process.

When a mesh-related infection occurs, a combined medical and surgical approach involving intravenous antimicrobial agents and complete surgical removal of the mesh is the preferred management strategy. For a variety of reasons, monotherapy with intravenous antibiotics generally has a poor outcome. The most important of these reasons relates to the fibroblastic response of the organism to the polymer of the implanted mesh, which results in the development of a thick fibrous capsule surrounding the mesh. Consequently, when an infection is established, this capsule restricts the penetration of antimicrobial agents into the infected mesh. In addition, it is well known that Staphylococcus spp., which are the most common causative organisms in mesh infections, produce a biofilm on the prosthesis, with the result that the microorganisms are protected simultaneously from antibiotics and the immune responses of the host organism [39].

Incomplete removal of the mesh should be suspected in any case with persistent or recurrent symptoms and/or signs of mesh infection. However, the results of a recent study suggested that the management of infected mesh might differ according to the type of mesh used. Specifically, it was suggested that infection of polyester or polypropylene mesh might be managed with drainage and antimicrobial agents only, whereas the infected mesh should be surgically removed in cases of infection involving expanded polytetrafluoroethylene mesh [17].
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Clinicians should promptly consider the possibility of mesh infection in any patient who has undergone hernia repair surgery involving a mesh, and who has fever of unknown aetiology or symptoms and/or signs of infection of the abdominal wall. There is no adequate evidence in the literature concerning the specific risk factors for such infections. Whether the surgical technique used for the repair of a hernia or the precise type of implanted mesh influences the rate of development of a mesh-related infection remains to be clarified.

As yet, there are no published reports of comparative trials of different antimicrobial regimens for the management of mesh-related infections. Consequently, no definitive recommendations can be made concerning the preferred medical management strategy. However, given the known facts regarding the microbial aetiology of mesh-related infections, and the pathogenesis and characteristics of infections involving other types of prosthetic material, antimicrobial agents used for the treatment of mesh-related infection should at least include coverage for Staphylococcus spp.

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1Hesselink VJ, Luijendijk RW, De Wilt JH, Heide R, Jeekel J. An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 1993; 176: 228–234.PubMed,ChemPort,Web of Science® Times Cited: 1942Luijendijk RW, Hop WC, Van Den Tol MP et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000; 343: 392–398.DOI: 10.1056/NEJM200008103430603CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 3213Schumpelick V, Conze J, Klinge U. Preperitoneal mesh-plasty in incisional hernia repair. A comparative retrospective study of 272 operated incisional hernias. Der Chirurg 1996; 67: 1028–1035.DOI: 10.1007/s001040050099CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 814Vrijland WW, Van Den Tol MP, Luijendijk RW et al. Randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia. Br J Surg 2002; 89: 293–297.DOI: 10.1046/j.0007-1323.2001.02030.xDirect Link:AbstractPDF(77K)References5Klosterhalfen B, Hermanns B, Rosch R, Junge K. Biological response to mesh. Eur Surg 2003; 35: 16–20.DOI: 10.1046/j.1563-2563.2003.03011.xDirect Link:AbstractFull Article (HTML)PDF(617K)References6Jenkins SD, Klamer TW, Parteka JJ, Condon RE. A comparison of prosthetic materials used to repair abdominal wall defects. Surgery 1983; 94: 392–398.PubMed,ChemPort,Web of Science® Times Cited: 1377Butler CE, Navarro FA, Orgill DP. Reduction of abdominal adhesions using composite collagen–GAG implants for ventral hernia repair. J Biomed Mater Res 2001; 58: 75–80.Direct Link:AbstractFull Article (HTML)PDF(376K)References8Debodinance P, Delporte P, Engrand JB, Boulogne M. Development of better tolerated prosthetic materials: applications in gynecological surgery. J Gynecol Obstet Biol Reprod (Paris) 2002; 31: 527–540.PubMed,ChemPort9Klinge U, Klosterhalfen B, Birkenhauer V, Junge K, Conze J, Schumpelick V. Impact of polymer pore size on the interface scar formation in a rat model. J Surg Res 2002; 103: 208–214.DOI: 10.1006/jsre.2002.6358CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 6410Arroyo A, Garcia P, Perez F, Andreu J, Candela F, Calpena R. Randomized clinical trial comparing suture and mesh repair of umbilical hernia in adults. Br J Surg 2001; 88: 1321–1323.DOI: 10.1046/j.0007-1323.2001.01893.xDirect Link:AbstractPDF(57K)References11Grant AM. Open mesh versus non-mesh repair of groin hernia: meta-analysis of randomised trials based on individual patient data [corrected]. Hernia 2002; 6: 130–136.DOI: 10.1007/s10029-002-0073-1CrossRef,PubMed,ChemPort12Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EA, Troidl H. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002; 89: 50–56.DOI: 10.1046/j.0007-1323.2001.01974.xDirect Link:AbstractPDF(87K)References13White TJ, Santos MC, Thompson JS. Factors affecting wound complications in repair of ventral hernias. Am Surg 1998; 64: 276–280.PubMed,ChemPort,Web of Science® Times Cited: 7614Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic ventral and incisional hernia repair in 407 patients. J Am Coll Surg 2000; 190: 645–650.DOI: 10.1016/S1072-7515(00)00280-5CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 15015Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg 2003; 238: 391–399.PubMed,Web of Science® Times Cited: 18516Kirshtein B, Lantsberg L, Avinoach E, Bayme M, Mizrahi S. Laparoscopic repair of large incisional hernias. Surg Endosc 2002; 16: 1717–1719.DOI: 10.1007/s00464-001-9200-9CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2417Petersen S, Henke G, Freitag M, Faulhaber A, Ludwig K. Deep prosthesis infection in incisional hernia repair: predictive factors and clinical outcome. Eur J Surg 2001; 167: 453–457.DOI: 10.1080/110241501750243815Direct Link:AbstractPDF(66K)18Cobb WS, Harris JB, Lokey JS, McGill ES, Klove KL. Incisional herniorrhaphy with intraperitoneal composite mesh: a report of 95 cases. Am Surg 2003; 69: 784–787.PubMed,Web of Science® Times Cited: 3219Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 1998; 133: 378–382.DOI: 10.1001/archsurg.133.4.378CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 27620McGreevy JM, Goodney PP, Birkmeyer CM, Finlayson SR, Laycock WS, Birkmeyer JD. A prospective study comparing the complication rates between laparoscopic and open ventral hernia repairs. Surg Endosc 2003; 17: 1778–1780.DOI: 10.1007/s00464-002-8851-5CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 4921Carbajo MA, Martin del Olmo JC, Blanco JI et al. Laparoscopic treatment vs open surgery in the solution of major incisional and abdominal wall hernias with mesh. Surg Endosc 1999; 13: 250–252.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 13222Chari R, Chari V, Eisenstat M, Chung R. A case controlled study of laparoscopic incisional hernia repair. Surg Endosc 2000; 14: 117–119.PubMed,ChemPort,Web of Science® Times Cited: 4323Geisler DJ, Reilly JC, Vaughan SG, Glennon EJ, Kondylis PD. Safety and outcome of use of nonabsorbable mesh for repair of fascial defects in the presence of open bowel. Dis Colon Rectum 2003; 46: 1118–1123.CrossRef,PubMed,Web of Science® Times Cited: 2124Birolini C, Utiyama EM, Rodrigues AJ, Birolini D. Elective colonic operation and prosthetic repair of incisional hernia: does contamination contraindicate abdominal wall prosthesis use? J Am Coll Surg 2000; 191: 366–372.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2425Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia 1997; 1: 15–21. CrossRef26Bellon JM, Bujan J, Contreras L, Hernando A, Jurado F. Macrophage response to experimental implantation of polypropylene prostheses. Eur Surg Res 1994; 26: 46–53.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 3727Walker AP, Henderson J, Condon RE. Double-layer prostheses for repair of abdominal wall defects in a rabbit model. J Surg Res 1993; 55: 32–37.DOI: 10.1006/jsre.1993.1104CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2828Taylor SG, O'Dwyer PJ. Chronic groin sepsis following tension-free inguinal hernioplasty. Br J Surg 1999; 86: 562–565.DOI: 10.1046/j.1365-2168.1999.01072.xDirect Link:AbstractPDF(53K)References29Due SS, Billesbolle P, Hansen MB. Osteomyelitis. A rare and serious complication of inguinal hernia surgery. Ugeskr Laeger 2001; 163: 3230–3231.PubMed,ChemPort30Nolla-Salas J, Torres-Rodriguez JM, Grau S et al. Successful treatment with liposomal amphotericin B of an intraabdominal abscess due to Candida norvegensis associated with a Gore-Tex mesh infection. Scand J Infect Dis 2000; 32: 560–562.DOI: 10.1080/003655400458893CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 231Matthews MR, Caruso DM, Tsujimura RB, Smilack JD, Pockaj BA, Malone JM. Ventral hernia synthetic mesh repair infected by Mycobacterium fortuitum. Am Surg 1999; 65: 1035–1037.PubMed,ChemPort,Web of Science® Times Cited: 1232Goring H, Waldner H, Emmerling P, Abele-Horn M. Chronic fistulating wound infection after Lichtenstein repair of inguinal hernia, caused by a small colony variant of Staphylococcus aureus. Der Chirurg 2001; 72: 441–443.DOI: 10.1007/s001040051328CrossRef,ChemPort,Web of Science® Times Cited: 533Deysine M. Pathophysiology, prevention, and management of prosthetic infections in hernia surgery. Surg Clin North Am 1998; 78: 1105–1115.CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 2534Troy MG, Dong QS, Dobrin PB, Hecht D. Do topical antibiotics provide improved prophylaxis against bacterial growth in the presence of polypropylene mesh? Am J Surg 1996; 171: 391–393.DOI: 10.1016/S0002-9610(97)89616-XCrossRef,PubMed,ChemPort,Web of Science® Times Cited: 1835Lazorthes F, Chiotasso P, Massip P, Materre JP, Sarkissian M. Local antibiotic prophylaxis in inguinal hernia repair. Surg Gynecol Obstet 1992; 175: 569–570.PubMed,ChemPort,Web of Science® Times Cited: 3636Musella M, Guido A, Musella S. Collagen tampons as aminoglycoside carriers to reduce postoperative infection rate in prosthetic repair of groin hernias. Eur J Surg 2001; 167: 130–132.DOI: 10.1080/110241501750070592Direct Link:AbstractPDF(139K)37Yerdel MA, Akin EB, Dolalan S et al. Effect of single-dose prophylactic ampicillin and sulbactam on wound infection after tension-free inguinal hernia repair with polypropylene mesh: the randomized, double-blind, prospective trial. Ann Surg 2001; 233: 26–33.DOI: 10.1097/00000658-200101000-00005CrossRef,PubMed,ChemPort,Web of Science® Times Cited: 5238Celdran A, Frieyro O, De La Pinta JC et al. The role of antibiotic prophylaxis on wound infection after mesh hernia repair under local anesthesia on an ambulatory basis. Hernia 2004; 8: 20–22.DOI: 10.1007/s10029-003-0164-7CrossRef,PubMed39Buret A, Ward KH, Olson ME, Costerton JW. An in vivo model to study the pathobiology of infectious biofilms on biomaterial surfaces. J Biomed Mater Res 1991; 25: 865–874.

http://onlinelibrary.wiley.com/doi/10.1111/j.1469-0691.2004.01014.x/full

Liz Taylor Suffered terribly from Adhesions

Elizabeth Taylor Suffered terribly from Adhesions and  had approximently 30 surgeries by the time this article was written in 1973! A hysterectomy, 2 c-sections to boot.
http://news.google.com/newspapers?id=JmUtAAAAIBAJ&sjid=AYkFAAAAIBAJ&pg=2394,3022218&dq=liz+taylor+adhesions&hl=en

and another article;
http://news.google.com/newspapers?id=lVJRAAAAIBAJ&sjid=WzMNAAAAIBAJ&pg=3945,4530201&dq=adhesions&hl=en

AlloDerm® Regenerative Tissue Matrix ~ Mesh alternative for hernia repair

LifeCell Tissue Matrices: new alternatives for soft-tissue repair




There are many reasons patients may need an operation to repair weak or damaged tissue. Hernia surgery, breast reconstruction after mastectomy, revision procedures after breast augmentation surgery, and other diseases and degenerative conditions can all require tissue repair.



To help reduce the risk of potential problems in repairing or replacing weak or damaged tissue, your surgeon may choose to use an alternative: AlloDerm® Regenerative Tissue Matrix or Strattice™ Reconstructive Tissue Matrix from LifeCell. AlloDerm® Tissue Matrix and Strattice™ Tissue Matrix support regeneration (growth of new tissue) and they actually become part of your own body.


Every patient is different and results may vary. Only a physician can determine the best treatment for you. Please ask your doctor to explain the benefits and risks to see if LifeCell products are right for you.
From the manufacturer:

AlloDerm® Regenerative Tissue Matrix provides a strong, intact repair for challenging hernia repair and breast reconstruction postmastectomy procedures. Unlike other acellular human dermis products, AlloDerm® Tissue Matrix is produced through a unique non-damaging process that allows the body to mount its own tissue regeneration process.


Donated human skin tissue supplied by US AATB-compliant tissue banks is aseptically processed using LifeCell’s proprietary technique to remove the epidermis and cells that can lead to tissue rejection and graft failure. The result is an intact acellular matrix of natural biological components that promotes rapid revascularization, white cell migration and cell repopulation.



AlloDerm® Tissue Matrix provides excellent handling properties, exhibits a remarkable versatility to convert into functional tissues that provide structural support (e.g., gingiva and fascia), and is screened and tested according to FDA regulations, AATB standards and appropriate state regulations.



Used in challenging hernia and abdominal wall repair and breast reconstruction postmastectomy procedures, AlloDerm® Tissue Matrix transforms into host tissue for a natural repair and a safe and clinically optimal outcome. Its benefits include:

Abdominal wall reconstruction

Breast reconstruction postmastectomy

LifeCell Corporation Instructions for use:
http://www.lifecell.com/downloads/LC_Alloderm114_IFU_B_T4.pdf

Please review all information with your doctor to see if this is an option for you.

Maude Adverse Event Data on AlloDerm:
MAUDE Adverse Event Report


Results for 'AlloDerm® Regenerative Tissue Matrix' in All of FDA


... LIFECELL CORPORATION ALLODERM REGENERATIVE TISSUE MATRIX MESH, Back to Search Results.

Event Date 04/04/2008. ... Brand Name, ALLODERM REGENERATIVE TISSUE MATRIX. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045000 - 23k - Cached



Enforcement Report for April 16, 2008



... Recall # B-0911-08; d) AlloDerm, Oral Plastic ... B-0912-08; e) Graftjacket Regenerative

Tissue Matrix 5x5cm, .89 ... B-0913-08; f) Repliform Tissue Regeneration Matrix ...

www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120502.htm - 67k - Cached



MedSun Reports



... Manufacturer response for Regenerative Tissue Matrix, AlloDerm

===== LifeCell was notified and will reveiw. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3E%25_%3C%20%0A - 16k - Cached





TPLC - Total Product Life Cycle



... Injury, 1. MDR Distribution by Brand. STRATTICE, 15. ALLODERM, 1. ALLODERM REGENERATIVE

TISSUE MATRIX, 1. ALLODERM TISSUE, 1. LTM, 1. Device Problems. Device emits ...

www.accessdata.fda.gov/.../cfdocs/cftplc/tplc.cfm?id=FTL&min_report_year=2007&long_name=LIFECELL%20CORP. - 20k - Cached



MedSun Reports



... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative

Tissue Matrix. Device manufacturer's name: Medtronic ...

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MedSun Reports



... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative

Tissue Matrix. Device manufacturer's name: Medtronic ...

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Medsun: Newsletter #36, May 2009



... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient

underwent resection of pilocytic astrocytoma in the posterior fossa. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/printer.cfm?id=994 - 19k - Cached



MedSun: Newsletter #36, May 2009



... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient

underwent resection of pilocytic astrocytoma in the posterior fossa. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=36 - 91k - Cached



Enforcement Report for June 18, 2008



... PRODUCT Human Cornea Tissues, Recall # B ... Tissue Matrix, 2x4 cm, .33-76 mm; AlloDerm

GBR; 2x2 cm, .46-86 mm; Graft Jacket, Regenerative Tissue Matrix Ulcer Repair ...

www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120511.htm - 193k - 2009-05-28 - Cached

Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia Repair

Summary of MedSun Reports Describing Adverse Events With Surgical Mesh Products for Hernia Repair
MedSun: Newsletter #36, May 2009

Surgical mesh is a polymeric, biologic or metallic screen intended for implant to reinforce soft tissue or bone where weakness exists. It is typically used in surgery for the repair, reconstruction, or substitution of tissue, commonly in hernia repair surgical procedures.

Over the past 2 years, MedSun has received 29 adverse event reports associated with 30 hernia mesh products in 30 patients. The reports were submitted by 20 hospitals between February 2007 and April 2009. The most frequently reported device problems were:

• Mesh explanted due to recall (6 reports)
• Ring breakage (4 reports)
• Mesh tear (4 reports)
• Defective mesh (3 reports)
• Mesh perforation (3 reports)
• Adhesion issue (2 reports)
• Mesh erosion (2 reports)

None of the reports involved a patient death. Common patient injuries listed below were reported in 15 of these 30 patients. Note: more than one patient injury can be assigned to each report.

• Additional surgical procedure required (18 reports)
• Infection (5 reports)
• Abscess (4 reports)
• Pain/soreness (3 reports)
• Inflammation/swelling (3 reports)

All reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 20 reports involved female patients and a total of 10 reports involved male patients.

MedSun reports contributed to FDA awareness of these device problems. Complications have been reported with a range of hernia mesh manufacturers, a majority of which are associated with the use of Composix Kugel Hernia Patches manufactured by Davol Incorporated, a subsidiary of C.R. Bard. The Bard Composix Kugel Extra Large Oval Patches were first recalled in December 2005. This Class I recall was expanded two times after the original recall notice, first in March 2006 and again on January 24, 2007, which ultimately recalled all product codes and lot numbers belonging to the Bard Composix Kugel Mesh Patches.

In October 2008, the FDA updated its safety information on hernia mesh repair.

Although the vast majority of reports were related to the recalled meshes, MedSun continues to see reports discussing adverse reactions with the recalled mesh, as well as with other mesh products. FDA continues to analyze and evaluate incoming reports about issues with all hernia mesh products.

[Note: The reports have been edited for clarity]

MedSun Surgical Hernia Mesh Adverse Event Reports Received Between February 2007 and April 2009 Device Manufacturer
Device Identifiers
Event Description

Covidien United States Surgical Corporation Parietex Composite (PCO) Model: PCO15 Lot: P1F00935 The patient had a ventral hernia repair. 21 days later, the patient returned for recurrent ventral hernia repair to replace the mesh. The surgeon stated that the mesh was "destructed from suture” and the mesh was stuck to the bowel.
Davol Inc. A subdivision of C.R. Bard, Inc.
Kugel Bard composite mesh
Hernia mesh failed and resulted in infection. Patient has a history of a ventral hernia for which she has suffered chronic infected mesh. She has undergone multiple abdominal wall surgeries since that time.
Davol Inc. A subdivision of C.R. Bard, Inc.
Kugel Composix 10.7x13.7cm
Large piece of Bard Kugel Composix mesh was explanted from the patient. The explanted mesh was part of the recall. Patient experienced chronic hernial infection, located inferior to mesh.
Davol Inc. A subdivision of C.R. Bard, Inc.
Bard Composix mesh
Bard Kugel Composix mesh was explanted from the patient per nationwide recall.
Davol Inc. A subdivision of C.R. Bard, Inc. Bard Composix Kugel Hernia Patch Small Oval
Lot: 43LQD184
Mesh implanted to repair ventral hernia. Patient experienced continued tenderness and bulging to the Right Lower Quadrant (RLQ). Mesh was removed after a few months, with re-repair of ventral hernia and insertion of new mesh.
Unknown Composix Mesh
Patient had mesh implanted many years ago at a different facility to repair ventral hernia. Patient has had hernia reoccurrence despite having mesh implanted. Patient has also experienced a chronic abdominal wound, which was packed.

This patient was seen at our facility with purulent drainage from wound, despite packing. Patient was found to have an exposed and infected mesh. Patient went to the Operating Room for an exploratory laporoscopy where we performed the following: removal of infected mesh, removal of old packing, drainage of marsupialized cavity, and closure with Permacol mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Bard Composix Kugel Mesh Patch
Lot: 43APD292
Cat: 10207
Patient had partial small-bowel obstruction secondary to adhesions that resulted in multiple hospitalizations and required surgery. At the time of surgery, during the dissection of the adhesions to the anterior abdominal wall, the left lateral inferior portion of the prosthesis was found with a fracture to the periphery of the supporting ring. The prosthesis was adherent to loops of small bowel.
Davol Inc. A subdivision of C.R. Bard, Inc. Kugel Hernia Patch
Lot: 43KMD157
Cat: 10105
The patient was brought to the OR for explantation of a MRSA-infected Kugel hernia patch, which had been implanted a few years ago. We excised the abdominal wall mesh and repaired the resultant epigastric defect with a 20 x 10 cm Permacol mesh.
Bard Access Systems Composix Kugel
Lot: 43CND224
Cat: 10202
Recoil ring breakage of Kugel Mesh (used for hernia repair) caused abscess to patient's abdominal wall.
Lifecell Corp Alloderm 6x16cm
Lot: NR: B20904-047
The alloderm product used for hernia repair had ruptured.
Ethicon, Inc. Proceed
Lot: ZLG767
Other: PCDG1
This patient had a hernia repair for three ventral and one umbilical hernia (all three ventral hernias and the umbilical hernia were connected into one large hernia). An approximate 5 X 7 piece of PROCEED mesh was used for this repair. The mesh was placed as an underlay and secured circumferentially with transfascial 0 Prolene sutures. A total of eight sutures were used to secure the PROCEED Mesh. Care was taken to identify the bowel throughout the entire procedure. The physician noted that the patient tolerated the procedure well without complication and was taken to the recovery room in satisfactory condition.

The procedure was done as a same-day-surgery procedure. When at home later that day, the patient developed nausea and vomiting. On the third post-op day, the patient was seen in the Emergency Department with a chief complaint of abdominal pain, nausea/vomiting, and abdominal distention. The patient had not passed any gas or had any bowel movement after the surgery. A CT scan demonstrated that a loop of small bowel incarcerated in the incisional ventral hernia repair. The patient was brought back in for surgery. The physician noted that the etiology of the incarceration was due to the fact that three of the eight transfascial sutures had pulled through the mesh. To remedy the situation, the entire mesh was removed and replaced with a new piece of mesh. The patient tolerated the procedure without complication and was discharged to home five days post-operation.
LifeCell Corporation AlloDerm Regenerative Tissue Matrix
Other: 402025
Patient underwent resection of pilocytic astrocytoma in the posterior fossa. The hospital course was uneventful and the patient was discharged a few days later. The patient returned the next day with fever and pain. The patient was admitted and treated with antibiotics. Cerebrospinal fluid culture revealed an enterobacter aerogenes infection. Nine days later, the patient returned to surgery. There was minimal collection of purulent material in the epidural space; however there was significant collection in the subdural space. The graft to the dura was removed and a new graft from the periosteum was sewn into place.
Tissue Science Laboratories Permacol 15 x 20cm x 1.0mm
Model: REF 101520
Lot: 07B01-9
Patient returned to the Operating Room (OR) for bowel perforation and adhesions. The surgeon dictated in his surgical report that the mesh that had been implanted the previous week had, under pressure, split in the mid-portion. The mesh was removed and none was replaced.
Davol Inc. A subdivision of C.R. Bard, Inc. Kugel Composix
Model:10208
Lot:73COD293
Cat:10208
The patient complained of periumbilical pain and requested that the recalled mesh be removed.
Bard Urological Division Avaulta Solo Synthetic Support System
Lot: CVRK0018
Cat: 486200
Bard Avaulta Solo Posterior Synthetic Support System Mesh tore when being applied. Surgeon was able to complete the procedure with the remainder of the mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel Mesh
Lot: HURB3676
Other:10206
Patient had dehiscence of ventral herniography with surgical mesh. Patient returned to surgery for repair. Operative Note: Patient noted in Recovery Room (RR) to have disruption to the lower part of ventral abdominal hernia repair. Bard composite graft was attached three fourths of the way around his ventral abdominal wall defect. However, distally in the lower part of the incision, the 1-0 Prolene horizontal mattress sutures were disrupted, as were the staples. The Bard composite graft and the staples achieved very poor mesh adherence to the abdominal wall. Surgeon increased the length of the Bard composite graft by sewing another piece of Bard composite graft to the ventral aspect to the largest of the Bard composite graft that was previously implanted.
Davol Inc. A subdivision of C.R. Bard, Inc. None
Mesh removed.
Composix Abdominal mesh
Defective Gortex mesh. Patient had undergone 3 or more incisional hernia repairs with a low transverse abdominal incision, initially made for acute diverticulitis. The patient had a painful bulge in the lower left abdomen and a recurrent hernia on the right lower abdomen, due to failure of the Gortex mesh.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel
Lots: 43GPD434 & 43KOD267
Cat: 10202 Two events involving the same brand (two different lots) of the Kugel hernia mesh. Both lots of the mesh were recalled via a Class I recall in January of this year (2007). The first patient was initially treated for a gunshot wound to the abdomen and developed an incisional hernia, which were repaired with a Kugel patch prior to release of the recall. He recently presented with a recurrent incisional hernia at the 9 and 10 o'clock position. The doctor removed the patch and replaced it with another brand of mesh.

The second patient had a laparoscopic nephrectomy done by a hand-port incisional hernia. The defect was initially repaired with a Kugel mesh device. Approximately a year post-operation, the patient gained 30 pounds and had a reoccurrence of the previous hernia.
Bard Urological Division Pelvicol Acellular Collagen Matrix
Lot: 06B15-1
Other: Reorder No: 482812
Patient with complication (abscess and inflammation) at site of previous surgery where mesh was implanted. Per surgeon, the term "erosion" is what is used in ICD9CM, but is not very accurate. The abscess was cultured, no growth. The mesh was surgically removed 2 months later.
Bard Urological Division Pelvisoft Acelluar Collagen BioMesh
Lot: 06B15-9
Patient with complication (abscess and inflammation) at site of previous surgery where mesh was implanted. The abscess was cultured, no growth. The mesh was surgically removed 5 months later.
Bard Access Systems Bard Composix Kugel Hernia Patch
Lot: 43E0D214
Other: Ref 0010202
Incisional ventral hernia repaired with Bard Mesh, which eventually had to be removed due to defect.
Bard Access Systems Ventralex Hernia Patch
Lot: 43DQD395
Cat: 10302 Patient had a laparoscopic ventral hernia repair. According to the physician, the patient progressed postoperatively as expected, without complication. However, four days later, the patient's condition worsened and the patient had to undergo open surgery where two perforations were noted in the small bowel.
Bard Access Systems Composix Kugel Hernia Patch
Lot: 43EQD414
Cat: 10205 Patient had a laparoscopic ventral hernia repair last year. The patient progressed postoperatively as expected, without complication. However, four days postoperative, the patient's condition worsened and the patient had to undergo open surgery where two perforations were noted in the small bowel.

According to the physician, the Composix Mesh was removed and it was noted that the patch had not retained its oval shape. The patch appeared crumpled on both sides and had creases running along the center of the mesh, indicating that the ring had broken.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel
Model: 10206
Lot: 43APD431 The mesh was placed prior to the manufacturing recall. The patient was brought in for a bowel stricture procedure and, during this surgery, the mesh was identified. Because we were aware that this may have been a recalled mesh product, we called Davol, Inc./C.R. Bard and they confirmed that this was, in fact, a piece of mesh that had been recalled. It was decided that we would remove the mesh, just to be safe.
Bard Access Systems Composix Kugel
Lot: 41ELDP27
Other: REF 0010204 Patient had a bowel obstruction from an incarcerated hernia placed late last year. During that repair the midline incision divided the mesh, which was repaired with nylon. Patient developed a draining wound since that repair.
Ethicon, Inc. Proceed A six month extension was given by the company on outdated mesh. As surgeon was sewing the mesh to the abdomen, the mesh separated. This is not what the mesh is designed to do. The sales representative was notified. The mesh was removed from the patient's abdomen and a different type of (current) mesh was used. All other meshes were pulled from our shelves.

Excerpt from September 2006 Customer Letter:
“Dear Customer,
We are pleased to announce that we have successfully completed stability studies designed to extend the shelf life of PROCEED Surgical Mesh. The results of these studies allow us to expand current expiry dating for an additional six (6) months. This additional data allows for a 12-month shelf-life. An additional 6 months should be added to the date printed on the PROCEED Mesh package for any product currently on the market with an expiration date prior to and including March 2007 (2007 - 3). For example: Current Expiry Date New Expiry Date (October 10, 2006) (April 4, 2007) (February 2, 2007) (August 8, 2007) Any product with an expiry date of April 4, 2007 or LATER reflects the new expiry dating and should be used by the date printed on the package. For example: Current Expiry Date New Expiry Date (April 4, 2007) Date printed on package (Sept 9, 2007) Date printed on package If you have any questions regarding the expiry dating of any PROCEED MESH product, please contact your sales representative.”
Davol Inc. A subdivision of C.R. Bard, Inc. Collamend Implant
Lot: DARA0082
Cat: 1175104 The Sigmoid colon resection was complete and they were suturing the abdomen. The mesh began to spontaneously split as they were suturing. The surgeon did not touch the mesh or cut it in any way. The mesh had to be removed which extended the length of the surgery.
Davol Inc. A subdivision of C.R. Bard, Inc. Composix Kugel Hernia Patch 11.4 cm x 11.4 cm
Lot: 43DOD281
Other: REF 0010204 Patient experienced tenderness and continued bulging at graft placement site to reduce a hernia.



Additional Information:

Class I Recall: Bard Composix Kugel Extra Large Oval Patches. FDA Recall. January 24, 2007.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062944.htm

FDA Safety Information on Hernia Mesh Repair. October 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm#hernia


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MedSun Newsletters are available at www.fda.gov/cdrh/medsun