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Thursday, July 21, 2011 Share it
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Georgia: Transvaginal Mesh Patch Failure News Tweet this
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Transvaginal Mesh Patch Failure
Get more gadgets for your site
A July 2011 FDA alert warns of serious complications associated with transvaginal
mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary
incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects About Me Blog Archive
caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal ▼ 2011 (135)
Mark
mesh patches are not rare and commonly include serious issues such as: ▼ July (13)
Zamora
Georgia:
Erosion of the vaginal tissue EMAIL: Transvagin
Infection al Mesh
galawyerblog(at)yahoo.co Patch
Bleeding m www.ageorgialawyer.net Failure
Mark is an attorney News
Pain
licensed in GA, with J and J must
Urinary problems such as incontinence offices in Atlanta and pay S.C.
Brunswick, GA. He limits $327
Pain during sexual intercourse (dyspareunia) million
his practice to consumers.
Organ perforation (puncturing) from surgical tools during mesh implantation This blog is intended only Las Vegas:
to serve as one for general Aria
Less frequent problems included Hotel/Casi
observations, passing no Guests
Return of POP along of rumors, news, &
and commentary, not Legionnair
Neuro-muscular problems
advice. I don't make any es...
Vaginal scarring/shrinkage representations about the Seroquel:
accuracy of the Label
Emotional problems
information contained in Change
any page on this site or because of
Heart
FDA Alerts and Research Find Transvaginal Patches Unsafe referred to from this site. If Risks
I don't respond to an
2011 FDA Alert – Serious and painful complications are associated with the email, don't take it Multaq on the
FDA
transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also personally, just can't Watch List
finds the risky surgical mesh treatment of POP to be no more effective than traditional respond to all of them. Again
treatment.
View my complete profile The FDA has
2011 Study Published – The New England Journal of Medicine published research published
its latest
showing an increased risk of complications associated with transvaginal mesh quarterly
implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh Twitter list o...
had a higher risk of defect including:
Drug Safety Lilly Says
7 times the risk of bladder perforation Communication: Alzheimer
Multaq and increased Patients
Nearly twice the risk of urinary incontinence (loss of bladder control) risk of death and Didn’t
serious cardiovascular Improve
3.2 percent of women required follow-up surgery to correct problems adverse events. FDA
2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to http://t.co/U9qSZjD 11 Investigate
minutes ago s Bracco
transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the
total adverse reports to over 3,800. Drug Safety Podcast: Diagnostic
Ongoing review of s&
bisphosphonates & Excess
2010 Study Published – A study featured in the Obstetrics & Gynecology journal had Radia...
potential increased
to be terminated due to the extent of injuries to participants who received the
risk of esophageal Antipsychotic
transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 cancer. s Used for

2. cancer. s Used for
percent experienced erosions, and other complications included two cystotomies http://t.co/vYsQ0Ed 25 Parkinson'
(bladder incision) and one blood transfusion. minutes ago s Despite
Warnin...
Drug Safety
2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh Communication: Spiriva Risks
manufacturers about complications related to the device and its treatment of POP and Ongoing review of for
SUI. bisphosphonates & Cardiovasc
potential increased ular
Over 200 Lawsuits Filed Already
risk of esophageal Problems?
More than 200 women across the United States have filed lawsuits against three of the
cancer. Georgia
makers of transvaginal mesh patches:
http://t.co/OlvinLs about News:
C.R. Bard 2 hours ago Serious
FDA approves blood- Complicati
Johnson & Johnson’s Ethicon ons
thinning drug Brilinta to
Associate
American Medical Systems treat acute coronary
d wit...
syndromes.
Complications have been reported for several other manufacturers of surgical mesh as http://t.co/mYozjuw Ultimate
well including: about 5 hours ago Sports
Spray
Boston Scientific Scimmed Drug Safety Podcast:
Lawsuit
Increased radiation Verdict
Sofradim exposure when using
CardioGen-82 PET FDA:
Caldera scans. CytoSport’
http://t.co/eqEsb1V 2 s Milk
Mentor Corporation Shakes
days ago
Contain no
What Should You Do?
Milk
If you have suffered complications due to the implantation of a transvaginal patch to
treat POP, you are not alone, and you have a right to compensation. By filing a claim ► June (35)
against the surgical mesh manufacturer, you could receive compensation for medical
► May (16)
costs, other financial burdens and the pain and suffering caused by this defective
medical device. You will also send a clear message to the manufacturer that it is ► April (18)
unacceptable to sell medical devices that harm innocent people. ► March (17)
► February (13)
Posted by Mark Zamora at 10:14 AM
► January (23)
Labels: transvaginal mesh failure, Transvaginal Placement of Surgical Mesh
► 2010 (338)
► 2009 (197)
J and J must pay S.C. $327 million ► 2008 (213)
A South Carolina judge has rules that Johnson & Johnson must pay $327 million for ► 2007 (171)
deceptive marketing of its Risperdal antipsychotic medication. ► 2006 (323)
► 2005 (223)
Judge Roger Couch chastised the company's management for allowing "the profit-at-
all-costs mentality to cloud" their approach to marketing the drug. The letter to
doctors, which eventually drew a warning from FDA for false and misleading claims,
was a "clever effort" to "manipulate the message" about Risperdal, Couch ruled (as
quoted by Bloomberg).
Read more: SC judge orders J&J to pay $327M in Risperdal case -
FiercePharmahttp://www.f iercepharma.com/story /sc-judge-orders-jj-pay -327m-risperdal-case/2011-06-06#ixzz1SkxGdart
Posted by Mark Zamora at 9:04 AM
Wednesday, July 20, 2011
Las Vegas: Aria Hotel/Casino Guests &
Legionnaires' Disease
Tests from the Centers for Disease Control and Prevention have determined that six former
guests of the Aria hotel in Las Vegas' City Center have been diagnosed with Legionnaire's
Disease, a form of pneumonia. All of the patrons have recovered, but the disease can
sometimes be fatal. Aria officials are notifying guests who stayed at the hotel from June 21 to
July 4 that they might have been exposed to the bacteria, and if they feel ill to quickly seek
medical attention.

3. According to the Las Vegas Review Journal, "Legionella, the bacterium that causes
Legionnaires' disease, is often found in air-conditioning cooling towers, whirlpool spas,
showers, faucets or other water sources. The bacterium can rapidly reproduce in warm,
stagnant waters." The hotel received inspections that determined the bacteria was present in
the showers and faucets of numerous rooms.
From the A ria site:
A me ssage from ARIA:
In cooperation with the Southern Nevada Health District, ARIA Resort is contacting guests
who may have stayed with us from June 21 to July 4 at a time when water tests detected
elevated levels of Legionella bacteria in several of our guest rooms.
Health officials have recently notified us of a few reported instances of guests who visited
ARIA, were diagnosed with, treated for, and recovered from Legionnaires' disease (a form of
pneumonia caused by Legionella bacteria). In an abundance of caution, we are attempting to
notify guests who may have been exposed to these bacteria during this short period.
ARIA has in place a water treatment program and, once the initial tests were received, we
immediately implemented a comprehensive abatement effort. All subsequent tests have come
back with no detectable levels of active Legionella.
Posted by Mark Zamora at 1:48 PM
Labels: aria legionnaire's
Seroquel: Label Change because of Heart Risks
From the FDA and other sources:
Seroquel is a drug that is widely prescribed. Also known as Quetiapine, it is used to treat
either schizophrenia or bipolar disorder. In those with bipolar it is used for depressive
episodes, acute manic episodes associated with bipolar I disorder, and maintenance treatment
of bipolar I disorder (as adjunct therapy to lithium or divalproex).
Last week, this label change:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of seventeen placebocontrolled trials
(modal duration of 10 weeks) largely in patients taking
atypical antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of death in placebo-treated
patients. Over the course of a typical 10-week controlled trial, the rate of
death in drug-treated patients was about 4.5%, compared to a rate of about
2.6% in the placebo group. Although the causes of death were varied, most
of the deaths appeared to be either cardiovascular (e.g., heart failure,
sudden death) or infectious (e.g., pneumonia) in nature. Observational
studies suggest that, similar to atypical antipsychotic drugs, treatment with
conventional antipsychotic drugs may increase mortality. The extent to
which the findings of increased mortality in observational studies may be
attributed to the antipsychotic drug as opposed to some characteristic(s) of
the patients is not clear. SEROQUEL (quetiapine) is not approved for the
treatment of patients with dementia-related psychosis [see Warnings and
Precautions (5.1)]
Posted by Mark Zamora at 10:56 AM
Tuesday, July 19, 2011

4. Multaq on the FDA Watch List Again
The post below sets out the drugs on the FDA watch list. Making the list again is
Dronedarone or Multaq.
Physicians should not stop prescribing these drugs, nor should patients stop
taking them, according to the FDA.
In the case of dronedarone, reports of several potential signals of risk reported for 2010
were followed by regulatory action.
The AERS watch list for the first quarter of 2010 cited potential signals of
congestive heart failure for the drug. On February 22, 2011, the FDA revised
the warnings and precautions section of dronedarone's label regarding
patients with new or worsening heart failure during treatment to state that
postmarketing cases of such problems have been reported. The label had
originally stated that there were limited data for patients with atrial
fibrillation/atrial flutter who develop worsening heart failure during
dronedarone therapy, but nevertheless advised clinicians to consider
suspending or discontinuing the drug if heart failure commences or
worsens.
In the second quarter, AERS identified potential signals of torsade de
pointes, a rare kind of ventricular tachycardia.
The list for the third quarter of 2010 listed a potential signal for an
interaction with warfarin that increases its anticoagulant effect. On March
21, 2011, the drug interactions section of dronedarone's label was changed
to mention postmarketing cases of higher internal normalized ratio (INR)
clotting times with or without bleeding events in patients taking warfarin.
Physicians were advised to monitor INR in such individuals. The label had
originally stated that in clinical trials, "there was no observed excess risk
for bleeding compared to placebo" when dronedarone was coadministered
with oral anticoagulants to patients with atrial fibrillation/atrial flutter, and
that INR should be monitored according to the warfarin label.
Potential signals of liver failure for dronedarone appeared in the watch list
for the last 3 months of 2010. On February 11, 2011, the FDA changed the
warnings and precautions section of the label to mention postmarketing
cases of hepatocellular liver injury and acute liver failure, and the need to
promptly discontinue dronedarone if such an injury is suspected. Other
parts of the label were revised accordingly.
For more information, please read the source of this post:
http://www.medscape.com/viewarticle/746530
Posted by Mark Zamora at 6:08 AM
Labels: multaq information, multaq lawyer, multaq news
The FDA has published its latest quarterly list of drugs to monitor after having identified
potential signs of serious risks or new safety information. The new watch list covers
the first 3 months of 2011. Here's the list for 2011 so far:
Potential Signals of Serious Risks/New Safety Information Identified by AERS,
January to March 2011
Potential Signal of a
Additional Information (as of
Product Serious Risk/New Safety
May 31, 2011)
Information
Adalimumab
Hepatic dysfunction, hepatic
(Humira, Abbot
failure
Laboratories)
Azathioprine Acute febrile neutrophilic The label's adverse reactions

5. (Imuran, dermatosis (Sweet's section was updated in May to
Prometheus) syndrome) include Sweet's syndrome
Cetuximab
(Erbitux, Eli Lilly Corneal infection, ulcerative
and Bristol-Myers keratitis, skin necrosis
Squibb)
Dabigatran The FDA issued a safety
etexilate mesylate Labeling for proper storage communication on March 29
(Pradaxa, and handling to preserve reminding users and pharmacies
Boehringer potency about the correct handling and
Ingelheim) storage of the drug
Dronedarone HCl
Renal impairment, renal
(Multaq, Sanofi-
failure
Aventis)
Fibrin Sealant Graft failure in
Tisseel VH and Evicel have been
(Tisseel VH, ophthalmological procedures
used off- label in ophthalmological
Baxter Healthcare; and lack of efficacy in
and neurosurgical procedures as
Evicel, Omrix neurosurgical procedures for
tissue adhesives
Pharmaceuticals) repair of dural tears
Immune Globulin
Thromboembolic adverse
Subcutaneous
events have been reported in The product was taken off the
(Human) 6% Liquid
association with numerous market on April 4
(Vivaglobin, CSL
product lots
Behring)
Iron sucrose
injection (Venofer,
Anaphylactic reactions
Luitpold
Pharmaceuticals)
Quinolone products Pseudotumor cerebri
Malathion (Ovide,
Taro Burns and burning
Pharmaceutical sensations
Industries)
Mercaptopurine
Hepatosplenic T-cell
(Purinethol, Teva
lymphoma
Pharmaceuticals)
Prasugrel HCl
Hypersensitivity reactions
(Effient, Eli Lilly)
Rituximab (Rituxan,
Hypogammaglobulinemia
Roche)
Medication errors resulting
Ropinirole HCl
from similarities in product
(Requip,
name and labeling to
GlaxoSmithKline)
risperidone
Posted by Mark Zamora at 6:03 AM
Lilly Says Alzheimer Patients Didn’t Improve
Eli Lilly & Co. said patients with Alzheimer’s disease whose conditions worsened upon
taking the experimental drug semagacestat didn’t improve after dosing was halted.
Lilly stopped development of the pill in August after data showed it harmed patients
instead of helping them.
Even seven months after patients ceased the use of semagacestat, they still had more
trouble with thinking, remembering and mental functioning than those who didn’t
receive the medication, the Indianapolis-based company said today.
Source: http://www.bloomberg.com/news/2011-07-19/li lly-says-alzheimer-patients-on-failed-drug-didn-t-
improve.html?cmpid=yhoo

6. Posted by Mark Zamora at 5:58 AM
Saturday, July 16, 2011
FDA Investigates Bracco Diagnostics & Excess
Radiation in PET Scans
The FDA has warned about the potential for excess radiation exposure in patients
who underwent heart scans involving a radioactive drug called CardioGen-82.
Bracco Diagnostics Inc. is the maker of this drug. It has been is used in some positron
emission tomography, or PET, scans involving the heart in order to diagnose heart
disease. Bracco Diagnostics is part of Bracco SPA, a private firm based in Milan,
Italy. A company spokeswoman said the firm was working with FDA and other
regulatory authorities to investigate the problem.
The agency said it recently became aware of two patients who underwent PET imaging
scans with CardioGen-82 and were later found to have detectable levels of radiation
several months after their PET scans. Both patients were crossing the border to or
from the United States when radiation detectors identified radiation originating from
them.
The FDA said it believes "that the risk of harm from this exposure is minimal, although
any unnecessary exposure to radiation is undesirable." The total number of patients
who might have been exposed to excess radiation is currently unknown, but the FDA
said the investigation into the problem is continuing.
Source here.http://online.wsj.com/article/BT-CO-20110715-714106.html
Posted by Mark Zamora at 9:49 AM
Labels: bracco diagnostics and radiation
Friday, July 15, 2011
Antipsychotics Used for Parkinson's Despite
Warning
From Web MD:
Doctors continue to prescribe antipsychotic drugs to their patients with Parkinson's
disease and psychosis, despite "black box" warnings from the FDA linking them to
increased risk of death among patients with dementia, a study shows. A black box
warning is the strongest drug warning issued by the FDA.
The study is published in the Archives of Neurology.
The black box warning for antipsychotics says the drugs are associated with an
increased risk of death for those with dementia, which is common among people
diagnosed with Parkinson's. Some commonly prescribed antipsychotics also worsen
symptoms of Parkinson's.
http://www.webmd.com/parkinsons-disease/news/20110711/antipsychotics-used-for-
parkinsons-despite-warnings
Posted by Mark Zamora at 4:23 PM
Spiriva Risks for Cardiovascular Problems?

7. This news from several sources, including Pharmalot and the British Medical Journal.
The conclusion is troubling - the "meta-analysis explains safety concerns by
regulatory agencies and indicates a 52% increased risk of mortality associated with
tiotropium mist inhaler in patients with chronic obstructive pulmonary disease.
What is Spiriva? Tiotropium bromide is a long-acting, 24 hour, anticholinergic
bronchodilator used in the management of chronic obstructive pulmonary disease
(COPD). Tiotropium bromide capsules for inhalation are co-promoted by Boehringer-
Ingelheim and Pfizer under the trade name Spiriva. It is also manufactured and
marketed by Cipla under trade name Tiova. Source.
The study is titled, "Mortality associated with tiotropium mist inhaler in patients with
chronic obstructive pulmonary disease: systematic review and meta-analysis of
randomised controlled trials."
Abstract
Objective To systematically review the risk of mortality associated with long term use
of tiotropium delivered using a mist inhaler for symptomatic improvement in chronic
obstructive pulmonary disease.
Data sources Medline, Embase, the pharmaceutical company clinical trials register,
the US Food and Drug Administration website, and ClinicalTrials.gov for randomised
controlled trials from inception to July 2010.
Study selection Trials were selected for inclusion if they were parallel group
randomised controlled trials of tiotropium solution using a mist inhaler (Respimat Soft
Mist Inhaler, Boehringer Ingelheim) versus placebo for chronic obstructive pulmonary
disease; the treatment duration was more than 30 days, and they reported data on
mortality. Relative risks of all cause mortality were estimated using a fixed effect meta-
analysis, and heterogeneity was assessed with the I2 statistic.
Results Five randomised controlled trials were eligible for inclusion. Tiotropium mist
inhaler was associated with a significantly increased risk of mortality (90/3686 v
47/2836; relative risk 1.52, 95% confidence interval, 1.06 to 2.16; P=0.02; I2=0%).
Both 10 g (2.15, 1.03 to 4.51; P=0.04; I2=9%) and 5 g (1.46, 1.01 to 2.10; P=0.04;
I2=0%) doses of tiotropium mist inhaler were associated with an increased risk of
mortality. The overall estimates were not substantially changed by sensitivity analysis
of the fixed effect analysis of the five trials combined using the random effects model
(1.45, 1.02 to 2.07; P=0.04), limiting the analysis to three trials of one year’s duration
each (1.50, 1.05 to 2.15), or the inclusion of additional data on tiotropium mist inhaler
from another investigational drug programme (1.42, 1.01 to 2.00). The number needed
to treat for a year with the 5 g dose to see one additional death was estimated to be
124 (95% confidence interval 52 to 5682) based on the average control event rate from
the long term trials.
Conclusions This meta-analysis explains safety concerns by regulatory agencies and
indicates a 52% increased risk of mortality associated with tiotropium mist inhaler in
patients with chronic obstructive pulmonary disease.
Source:
From the FDA in 2008:
Update 10/07/2008: FDA’s Early Communication About an Ongoing Safety Review
issued on March 18, 2008 stated that Boehringer Ingelheim, the maker of Spiriva
HandiHaler (tiotropium bromide), had conducted a pooled analysis of 29 trials that
suggested a small excess risk of stroke (2 cases per 1000) with tiotropium bromide
over placebo. FDA has now received preliminary data from UPLIFT (Understanding the
Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo
controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with
chronic obstructive pulmonary disease (COPD). The preliminary results of UPLIFT
reported by Boehringer Ingelheim to the FDA showed that there was no increased risk
of stroke with tiotropium bromide (Spiriva HandiHaler) compared to placebo.
Two recent publications1, 2 reported increased risk for mortality and/or cardiovascular
events in patients who received tiotropium or inhaled anticholinergics. Both studies

8. examined cardiovascular outcomes. Singh et al. 1 performed a systematic review and
meta-analysis of 17 clinical trials enrolling 14,783 patients treated with inhaled
anticholinergic drugs used for the treatment of chronic obstructive lung disease. Lee et
al. 2 performed a case-control study of 32,130 patients (320,501 controls) treated with
inhaled medications, including an anticholinergic, for the treatment of chronic
obstructive lung disease.
FDA expects to receive the complete report for UPLIFT in November 2008. Results
from this trial will also help to address some issues raised about tiotropium in the two
recent publications. Due to the amount of data collected in UPLIFT, a complete review
of the results could take several months, at which time FDA will update this
communication with the final results of the UPLIFT analysis, as well as all the available
data regarding tiotropium and stroke risk.
1. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse
cardiovascular events in patients with chronic obstructive pulmonary disease. JAMA
2008; 300 (12): 1439-1450.
2. Lee TA, Pickard S, et al. Risk of Death Associated with Medications for Recently
Diagnosed Chronic Obstructive Pulmonary Disease. Annals of Internal Medicine 2008;
149: 380-39
Posted by Mark Zamora at 7:40 AM
Labels: spiriva lawyers, sprivia dangers
Thursday, July 14, 2011
Georgia News: Serious Complications Associated
with Transvaginal Placement of Surgical Mesh for
Pelvic Organ Prolapse
News on July 13th from the FDA on transvaginal mesh products.What you should
know about the recall:
From 2008 to 2010, the FDA received 2,874 injury reports resulting from
TVM.
Of these reports, three involved patients who died from those complications.
Research estimates 10% of women with TVM implants suffer from erosion
within a year of surgery.
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.

9. 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.

10. 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
Posted by Mark Zamora at 1:13 PM
Labels: Pelvic Organ Prolapse, Transvaginal Placement of Surgical Mesh
Wednesday, July 13, 2011
Ultimate Sports Spray Lawsuit Verdict
A Federal Court Judge in Missouri granted a verdict for St.
Louis Rams linebacker David Vobora in his lawsuit against the
maker of a sports supplement called Ultimate Sports Spray.
Vobora claimed that the product had been made with the NFL-
banned substance methyltestosterone, and that his use of the
product triggered a positive doping test that resulted in
Vobora’s four-game suspension in 2009. Vobora won $5.4
million in the judgment, reflecting lost marketing opportunities
and lost wages (during suspension), as well as damage to his
reputation.
In issuing the ruling the judge said the vcompany—inamed Anti-
Image ia Wikipedia
Steroid Program LLC (aka S.W.A.T.S.), a Key Largo, FL-based company—
intentionally misrepresented the supplement. Vobora reportedly had the product
tested, revealing it contained methyltestosterone but did not list the ingredient on the
label.
While Vobora cleared the two supplements via the NFL Hotline, the league has stated
its policy holds strict liability on each player for what they put in their bodies.
Posted by Mark Zamora at 6:12 AM
Labels: swats inc. methyltestosterone

11. FDA: CytoSport’s Milk Shakes Contain no Milk
Pesky things, words. Why, if it's called a "milk" shake, that is what is in it right?
Wrong.
CytoSport Inc.’s nutritional shakes are misbranded, according to FDA, because their
labels prominently feature the word “MILK," however these products contain no milk.
In an FDA warning letter sent to Michael Pickett, chief executive officer and president
of the company, the agency said the labels for “Chocolate Muscle Milk Protein
Nutrition Shake" (14 fl. oz.), “Vanilla Crème Muscle Milk Light Nutritional Shake" (4-
8.25 oz. servings) and “Chocolate Peanut Caramel Muscle Milk" (5.57 oz.) are in
violation of section 403(a)(1) of the Federal Food, Drug, and Cosmetic Ac [21 U.S.C. §
343(a)(1)].
FDA added the actual statements of identity on the “Protein Nutrition Shake" and
“Nutritional Shake" products are in significantly smaller and less prominent type than
the words “MUSCLE MILK" on these product labels. Further, while the product labels
include the statement "Contains No Milk" on the principal display panel, the ingredient
statements say these products contain milk-derived ingredients, such as calcium and
sodium caseinate, milk protein isolate and whey. The allergen statement printed on
both of these products states, ''This product contains ingredients derived from milk . . .
."
The “Contains No Milk" statement could give consumers the impression that these
products are free of milk-derived ingredients, according to FDA.
The “Chocolate Muscle Milk Protein Nutrition Shake" and “Vanilla Crème Muscle Milk
Light Nutritional Shake" products are also misbranded, according to FDA because
they purport to be milk (by prominently featuring the word “MILK" on the labels), but do
not follow federal regulation of the definition and standard of identity for milk. The
standard of identity for milk (21 CFR 131.110) describes milk as “the lacteal secretion,
practically free from colostrum, obtained by the complete milking of one or more
healthy cows," and it lists the vitamins and other ingredients that may be added.
According to the ingredient list on product labels, CytoSport’s products contain no
milk and contain numerous ingredients not permitted by the standard.
Imagine that.
Posted by Mark Zamora at 6:06 AM
Thursday, June 30, 2011
Best Burn Centers in the US

12. With the news of the NAPA firepot recall, some folks have been asking about burn centers
that seem to be head and shoulders above the rest. Here is a compilation:
Shriners Hospitals for Children have hospitals devoted to burns. They are
in Boston, Cincinnati, and Sacramento CA.
The University of Washington Harborview Medical Center. Harborview has treated over
15,000 since 1974. They treat nearly all the burn victims in Washington. They are also one of
the first to adopt the removal of dead tissue as early as possible to prevent infection.
Harborview Medical Center is located at 325 Ninth Avenue, Seattle, WA. They have a 96%
survival rate with burns over 75% of the body.
Nationwide Children's Hospital, in Columbus, Ohio, at 555 South 18th Street, Suite 6G,
Columbus, Ohio 43205.
Tampa General Hospital Regional Burn Center is one of only four burn centers in Florida. It is
a 13 bed unit with expansion.
In the South, here are specialized burn centers:
Alabama
Children's Hospital of Alabama Medical Center
1600 7th Avenue South
Birmingham, AL 35233
Joseph M. Still Burn Center at Doctors Hospital of Augusta
3651 Wheeler Road
Augusta , GA 30909
www.doctors-hospital.net
Emory University Burn Center
Grady Memorial Hospital
80 Butler Street
Atlanta, GA 30335
Florida:
Orlando Regional Medical Center -- Burn / Tissue Rehab Unit
1414 South Kuhl Ave
Orlando, FL 32806-2134 United States
407 841-5176 begin_of_the_skype_highlighting 407 841-5176 end_of_the_skype_highlighting
Tampa General Hospital -- Tampa Bay Regional Burn Center
PO Box 1289
Tampa, FL 33601 United States
813 251-7617 begin_of_the_skype_highlighting 813 251-7617 end_of_the_skype_highlighting
University of Florida -- Shands Burn Center
1600 SW Archer Road
Gainesvillw, FL 32610 United States
352 395-0200 begin_of_the_skype_highlighting 352 395-0200 end_of_the_skype_highlighting
University of Miami -- Jackson Memorial Burn Center
1800 NW 10th Ave
Miami, FL 33136 United States
Posted by Mark Zamora at 7:36 PM

13. Labels: napa fire gel recall, Napa Home Garden recall
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