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Transvaginal Surgical Mesh
Patch Lawsuit, Bowel Perforation Lawsuit, Bladder
Perforation Lawsuit, Failed Pelvic Organ Prolapse Surgery
Lawsuit, Failed Stress Urinary Incontinence Surgery Lawsuit,
and Failed Transvaginal Surgical Mesh Implant Surgery
Lawsuit Information by Transvaginal Surgical Mesh Patch
Lawyer, Bowel Perforation Lawyer, and Failed Pelvic Organ
Prolapse Surgery Lawyer
The
FDA has recently announced that over 1000 women who have
had transvaginal surgical mesh implanted in them for
Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence
(SUI) have suffered health
complications. These transvaginal mesh complications
have included recurrence of prolapse and/or incontinence,
erosion of the mesh through the vagina infection, pain,
urinary problems, vaginal epithelium, bowel perforation,
bladder perforation, and blood vessel perforation.
If you or a
loved one has suffered from a failed Pelvic Organ
Prolapse (POP) surgery or Stress Urinary Incontinence (SUI)
surgery, it is important to seek immediate medical
attention. For information on a
failed Pelvic Organ
Prolapse (POP) surgery lawsuit or Stress Urinary
Incontinence (SUI) surgery lawsuit, please feel free to
contact
Defective Transvaginal Surgical Mesh Lawyer,
Jason Coomer, via
e-mail message or use our
submission form.
Transvaginal Surgical Mesh
Lawyer, Bowel Perforation Lawyer, Bladder Perforation
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Stress Urinary Incontinence Surgery Lawyer, and Failed
Transvaginal Surgical Mesh Implant Surgery Lawyer
Transvaginal surgical mesh has commonly
been used to treat Pelvic Organ Prolapse (POP) and Stress
Urinary Incontinence (SUI). Over the past three years, the
FDA has received over 1,000 reports from nine surgical mesh
manufacturers of complications that were associated with
surgical mesh devices used to repair Pelvic Organ Prolapse
(POP) and Stress Urinary Incontinence (SUI).
The most frequent complications include
erosion through vaginal epithelium, infection, pain, urinary
problems, and recurrence of prolapse and/or incontinence.
There were also reports of bowel, bladder, and blood vessel
perforation during insertion. In some cases, vaginal
scarring and mesh erosion led to a significant decrease in
patient quality of life due to discomfort and pain,
including dyspareunia. Treatment of the various types of
complications include additional surgical procedures (some
of them to remove the mesh), IV therapy, blood transfusions,
and drainage of hematomas or abscesses.
According to information from the U.S.
Food & Drug Administration (FDA), these health complications
have included mesh erosion through the vagina, pain,
infection, bleeding, pain during sexual intercourse, organ
perforation, and urinary problems. In at least three
instances, women are known to have died as a result of
transvaginal mesh complications.
Transvaginal Surgical Mesh
Lawyer, Bowel Perforation Lawyer, Bladder Perforation
Lawyer, Failed Pelvic Organ Prolapse Surgery Lawyer, Failed
Stress Urinary Incontinence Surgery Lawyer, and Failed
Transvaginal Surgical Mesh Implant Surgery Lawyer
The United States Food and Drug
Administration released the below FDA Safety Communication
update on July 13, 2011 regarding
Serious Complications Associated with Transvaginal Placement
of Surgical Mesh for Pelvic Organ Prolapse.
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.
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
requirements should follow the reporting procedures
established by their facilities. Device manufacturers must
comply with the Medical Device Reporting (MDR) regulations.
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
Transvaginal Surgical Mesh
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Surgery
Lawsuits are
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mistakes and medical carelessness as well as defective back
implant products.
If you have
been injured by a defective product, feel free to
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inquiry or
send an e-mail to Texas lawyer Jason Coomer.
He may be able to help you recover your damages.
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For more information on dangerous product liability
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Texas Dangerous Product Liability Lawyer Jason S.
Coomer. Below are some specific types of potential
product liability lawsuits. There are many other
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Austin Texas product liability lawyer, Jason S. Coomer, helps
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Transvaginal Surgical Mesh
Lawyer, Bowel Perforation Lawyer, Bladder Perforation
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Transvaginal Surgical Mesh Implant Surgery Lawyer
If you or a
loved one has suffered from a failed Pelvic Organ
Prolapse (POP) surgery or Stress Urinary Incontinence (SUI)
surgery, it is important to seek immediate medical
attention. For information on a
failed Pelvic Organ
Prolapse (POP) surgery lawsuit or Stress Urinary
Incontinence (SUI) surgery lawsuit, please feel free to
contact
Defective Transvaginal Surgical Mesh Lawyer,
Jason Coomer, via
e-mail message or use our
submission form.
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