Showing posts with label mesh related infection. Show all posts
Showing posts with label mesh related infection. Show all posts

Sunday, March 23, 2014

Vaginal mesh for pelvic organ prolapse: Information for healthcare professionals

Vaginal mesh implants used to treat pelvic organ prolapse (POP) include a range of different types of mesh implanted in the pelvic floor area in a number of different ways to support the vaginal wall and/or internal organs. The mesh can be synthetic, ‘biological’ or a combination of the two and it may be absorbable or non-absorbable.

MHRA investigation into vaginal mesh implants

In light of an increasing number of adverse events and patient concerns being reported, the MHRA launched an investigation to better understand the use of these devices and the complications associated with their use.

MHRA workshop

The MHRA held a workshop in March 2012 under the chairmanship of Professor Paul Abrams, which included representatives of the Royal College of Obstetricians and Gynaecologists, the British Association of Urological Surgeons, the British Society of Urogynaecology, NICE, the University of Aberdeen Health Services Research Unit, and representatives of some manufacturers of these devices, to consider how to make this a safer procedure.
The meeting covered:
  • types of vaginal mesh
  • clinical experience, training and outcomes of prolapse surgery
  • complications arising from the use of vaginal mesh
  • NICE/IPAC guidance
  • adverse event reporting
  • responsibilities of involved parties (clinicians, regulators and manufacturers).
Further information on the outcomes of this workshop can be found in the section Responsibilities of the parties involved in the manufacture, regulation and surgical provision of vaginal meshes

MHRA review

In light of an increasing number of adverse events and patient concerns being reported, the MHRA launched an investigation to better understand the use of vaginal tapes/slings and meshes and the complications associated with their use.
Although MHRA have had very few reports of problems with these devices we have noted concerns about their safety that are being expressed by patients and patients’ groups. We do take the problems and issues reported very seriously and share concern for their safety, and those that have experienced unwanted complications from them.
In February 2012, the MHRA commissioned a systematic review of the available literature on the incidence of the most frequently reported adverse events associated with different meshes/tapes/slings. The results can be found on Summaries of the safety/adverse effects of vaginal meshes for prolapse
We continue to actively investigate and gathering evidence on the safety of these vaginal mesh and tape devices to better inform patients, doctors and surgeons about the risks, benefits and uses of these devices.

Adverse events that should be reported

The MHRA is still gathering information on the use and complications associated with these devices and would encourage reporting of adverse events to us.
Adverse events related to these devices that we expect clinicians to report to us include the following:
Pre-procedural
  • mesh appears unsuitable to implant e.g. rough or sharp edges; too hard or brittle; not to specification
  • packaging compromised affecting sterility.

Procedural related
  • tape/mesh tears or disintegrates when implanting or fixing mesh in place
  • bladder perforation.

Post operatively
  • patient has an unexpected severe adverse/allergic tissue reaction to the mesh
  • bladder perforation.

Longer-term patient follow-up
  • evidence of mesh shrinkage, disintegration, hardening, brittleness
  • recurrence of prolapse
  • bladder perforation
  • vaginal perforation
  • recurrence of stress or urge incontinence
  • mesh erosion/extrusion through tissues - especially where further surgery is needed for partial or total mesh removal
  • dyspareunia
  • persistent pelvic/groin pain.

Further information

NHS Choices webpage on treatment for prolapse of the uterus (external link).

NICE guidance

The National Institute for Health and Clinical Excellence (NICE) has produced guidance on the use of mesh for pelvic organ prolapse, which is available on the NICE website, along with summaries of the guidance produced for patients.
For the following procedures NICE guidelines state that current evidence on the efficacy and safety of these procedures is inadequate in quantity and quality. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Infracoccygeal sacropexy using mesh for uterine prolapse repair (IPG280)

Infracoccygeal sacropexy using mesh for vaginal vault prolapse repair (IPG281)

Insertion of mesh uterine suspension sling (including sacrohysteropexy) for uterine prolapse repair(IPG282)

Sacrocolpopexy with hysterectomy using mesh for uterine prolapse repair (IPG284)

For the procedure Sacrocolpopexy using mesh for vaginal vault prolapse repair (IPG283), current evidence on the safety and efficacy of sacrocolpopexy using mesh for vaginal vault prolapse repair appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance and audit.

Saturday, January 14, 2012

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Date Issued: July 13, 2011

Audience:

Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence
Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence
Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence
Medical Specialties: gynecology, urogynecology, urology, general surgery, internal medicine, family practice, emergency medicine

Device:
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.

Background:
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

Purpose:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.1

Summary of Problem and Scope:
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:

Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Recommendations for Health Care Providers:

As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:

Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.
In addition, the FDA also recommends that health care providers:

Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:
Surgical mesh is a permanent implant that may make future surgical repair more challenging.
A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.

Recommendations for Patients:
Before Surgery
Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.

Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.

In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:

Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
After Surgery

Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.

FDA Activities:
The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:

Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.
Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.
Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements2 should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations3.

To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:

Manufacturer's name
Product name (brand name)
Catalog number
Lot number
Size
Date of implant
Date of explant (if mesh was removed)
Details of the adverse event and medical and/or surgical interventions (if required)
Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

-Additional Information

Urogynecologic Surgical Mesh Implants4
Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse (July 2011) (PDF - 243KB)5
Press Release: Surgical placement of mesh to repair pelvic organ prolapse poses risks6
Federal Register Notice: Urogynecologic Surgical Mesh7
Federal Register Notice Ammendment: Urogynecologic Surgical Mesh8

http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm

Tuesday, November 08, 2011

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

ยช 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
ยช 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 1รพ 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

Thursday, September 29, 2011

His and Her Hernias: Pelvic Pain Culprit Tough to Diagnose in Women

His and Her Hernias: Pelvic Pain Culprit Tough to Diagnose in Women
Posted: 9/6/11 04:23 PM ET Follow Women's Health , Cedars Sinai , Dr. Glenn Braunstein , Abdominal Pain , Female Health , Hernias , Hiatal Hernia , Inguinal Hernia , Male Health , Pelvic Pain , Women , Los Angeles News .

Women who complain to their doctor of persistent lower abdominal pain could be suffering from any number of ailments: fibroids, endometriosis, ovarian cysts or complications of past pelvic surgeries. With those many possibilities, there often is another that does not even occur to many doctors: hernias.

Hernias often are considered a problem that primarily afflicts men, and in fact, they are far more prevalent in males -- women account for only about 8 percent of diagnosed hernias in the United States. Furthermore, women often do not display the telltale bulge that indicates a hernia, making this an often elusive diagnosis for women who suffer from these excruciating ailments. Women also may complain first to a gynecologist, who is more likely to consider a "female" issue as the cause for the pain, rather than a hernia.

Hernias can appear in various locations. They occur when layers of the abdominal wall weaken, and then tear or bulge. This allows the inner lining of the abdomen to push through the weak spot, forming a sac. A portion of the intestine or other abdominal tissue may slip through, causing pain and other complications. The most common and noticeable symptom is a protrusion in the groin or abdominal area. This symptom may be so slight in women that it goes unnoticed, or it may not be there at all.

Hernias are classified by location. The most common include incisional, occurring in an area weakened by a surgical procedure; femoral, on the outer groin; umbilical, in the belly button; hiatal, in the upper stomach; pelvic floor; and inguinal, in the inner groin. The inguinal type accounts for 80 percent of all hernias, and most occur in men due to a natural weakness in this area. Occult -- or hidden -- inguinal or femoral hernias can cause tough-to-diagnose pelvic pain in women but also are associated with groin pain in men and athletes.

Women's hernias frequently are tiny and internal, which is why they're so often mistaken for other conditions. Because they are unsuspected, they may go unnoticed on an ultrasound or other diagnostic test. The tears themselves may be invisible even on an MRI until fat or other tissue pushes through them.

What Causes Hernias?

A combination of pressure and an opening or weakness of muscle or tissue is the ultimate cause of all hernias. That weakness may be congenital, it may be the result of a surgery, or it may occur later in life. Lifting heavy objects, straining during bowel movements or urination, fluid in the abdomen, obesity, chronic coughing or sneezing, and pregnancy can all contribute to increased risk of hernias. Age and sex also can indicate risk for hernias, with 90 percent of hernias occurring in older men.

Men's vulnerability to hernias can be traced back to the womb. A male fetus' testicles form in the abdomen, then move along the inguinal canal to the scrotum. That canal closes almost completely after birth, leaving just a small space for the spermatic cord to pass through, but not enough room for the testicles to move back into the abdomen. Sometimes, that canal doesn't close properly, creating a weak spot where a hernia will occur. Women have a similar weakness in the femoral canal, where the femoral artery, vein and nerve pass through.

Prevention techniques for hernia are the same as for most other diseases: maintain a healthy weight, eat high-fiber foods to avoid constipation and straining, and stop smoking. If lifting a heavy weight, be sure to do it properly -- bending from the knees, not the waist -- or avoid heavy lifting altogether.

Recognizing Hernias

Women may identify pain as being in their ovaries, and hernia pain may occur around that area. The pain of an occult hernia, however, will not feel like a cramp. It may be described as a sharp, shooting pain in the vagina, around the hip and the back, into the flank and through the thighs. Women also may complain of pain during bowel movements, when their bladder is full, during intercourse, or during their menstrual period. That pain may worsen with exercise, prolonged standing or sitting, lifting, bending, laughing, coughing, climbing stairs -- basically, anything that increases pressure on the abdomen.

All of these additional pains can lead patients to any number of specialists who might diagnose them with -- in the case of women -- any number of gynecological problems. Many women and men are misdiagnosed with lumbar disc, hip, psychosomatic pain, or a host of other ailments.

Finding hidden hernias in women relies on clinical examination. Even with all the sophisticated tools at physicians' disposal -- ultrasound, MRI, herniography -- examination by an MD who knows what to look for is key. If the patient is lying down, this may conceal what little evidence there is of a hernia, so standing sometimes reveals a subtle bulge. More often, occult hernias cannot be seen or felt. Vaginal examination may reveal telltale tension and tenderness in the pelvic muscles, and reproducing a patient's pain by applying pressure on the internal inguinal area is one method that has been considered effective.

Once hernias are diagnosed and identified, pain can be managed with over the counter or prescription medications until they can be surgically repaired. For some, minimally invasive surgery is an option. Laparoscopic procedures in which the hole is patched with mesh have shown to be effective and to significantly alleviate pain.

For men, inguinal hernias not only have been a historic bane -- the afflicted have included Galileo, Michelangelo, Lord Nelson, Sir Winston Churchill and even Sir Astley Cooper, a pioneer in corrective surgical procedures -- they also long led to an industry of gear and protective, or supposedly rehabilitative, wear and devices. With advances in surgery and technology, the once-extensive ads for trusses and the like largely have disappeared, although an online search will still bring up a number of products and suggestions. In fact, while a truss might be recommended as a short-term support, it will not prevent a hernia from worsening or treat the hernia itself.

For women, chronic pelvic pain can be tough to diagnose -- and even tougher to live with. It means they might not be able to bend down to pick up their child. Sex may be too painful to endure. It can impair their ability to work. Lack of awareness of hernias in women can lead women to multiple doctors and multiple treatments, and endless frustration when they don't work. That's why it's important for patients and doctors alike to be aware of the possible causes, and keep looking until an answer is found.

http://www.huffingtonpost.com/glenn-d-braunstein-md/his-and-her-hernias-pelvi_b_950590.html?view=print&comm_ref=false

Wednesday, September 21, 2011

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

Hernia. 2011 Sep 11. [Epub ahead of print]


Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

Ashar BS, Dang JM, Krause D, Luke MC.

SourceOffice of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 422, Silver Spring, MD, 20850, USA, Binita.Ashar@fda.hhs.gov.



Abstract

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.



PMID:21909977[PubMed - as supplied by publisher]
 
http://www.ncbi.nlm.nih.gov/pubmed/21909977

Thursday, July 14, 2011

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

Friday, July 01, 2011

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.
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Mesh-related non-infectious complications
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
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].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Mesh-related infectious complications
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
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Incidence
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
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 ยตm, with the result that bacteria can penetrate the mesh, but polymorphonuclear leukocytes (with a diameter of 75 ยตm) cannot. This means that the bacteria in the mesh are protected from immunological defence mechanisms [25–27].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Clinical symptoms and signs
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Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
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Diagnosis and treatment
Conclusions
References
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].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
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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].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
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Mesh-related infectious complications
Incidence
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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.
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Diagnosis and treatment
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Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
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].
Jump to…Top of pageAbstractIntroductionMesh-related non-infectious complicationsMesh-related infectious complicationsIncidenceClinical symptoms and signsMicrobiologyPreventionDiagnosis and treatmentConclusionsReferences
Conclusions
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 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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References
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Abstract
Introduction
Mesh-related non-infectious complications
Mesh-related infectious complications
Incidence
Clinical symptoms and signs
Microbiology
Prevention
Diagnosis and treatment
Conclusions
References
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