Transvaginal mesh lawyer

News, musings and commentary on pharmaceutical law issues, technology, and litigation. Lawyers for consumers and injured

people.(No advice on this blog, though) 404-451- 7781. galawyerblog(at)yahoo.com Find us always at: www.ageorgialawyer.com

A Georgia Lawyer

Thursday, July 21, 2011

Transvaginal Mesh Patch Failure

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

caused by the surgical mesh or during implantation of the patch.

According to the FDA, significant complications resulting from transvaginal

mesh patches are not rare and commonly include serious issues such as:

Erosion of the vaginal tissue

Infection

Bleeding

Pain

Urinary problems such as incontinence

Pain during sexual intercourse (dyspareunia)

Organ perforation (puncturing) from surgical tools during mesh implantation

Less frequent problems included

Return of POP

Neuro-muscular problems

Vaginal scarring/shrinkage

Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the

transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also

finds the risky surgical mesh treatment of POP to be no more effective than traditional

treatment.

2011 Study Published – The New England Journal of Medicine published research

showing an increased risk of complications associated with transvaginal mesh

implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh

had a higher risk of defect including:

7 times the risk of bladder perforation

Nearly twice the risk of urinary incontinence (loss of bladder control)

3.2 percent of women required follow-up surgery to correct problems

2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to

transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the

total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had

to be terminated due to the extent of injuries to participants who received the

transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15

Georgia: Transvaginal Mesh Patch Failure NewsShare this on Facebook

Tweet this

This has been shared 4 times.

Get more gadgets for your si te

Share it

Mark

Zamora

EMAIL:

galawyerblog(at)yahoo.co

m www.ageorgialawyer.net

Mark is an attorney

licensed in GA, with

offices in Atlanta and

Brunswick, GA. He limits

his practice to consumers.

This blog is intended only

to serve as one for general

observations, passing

along of rumors, news,

and commentary, not

advice. I don't make any

representations about the

accuracy of the

information contained in

any page on this site or

referred to from this site. If

I don't respond to an

email, don't take it

personally, just can't

respond to all of them.

View my complete profile

About Me

Drug SafetyCommunication:Multaq and increasedrisk of death andserious cardiovascularadverse events.http://t.co/U9qSZjD 11

minutes ago

Drug Safety Podcast:Ongoing review ofbisphosphonates &potential increasedrisk of esophagealcancer.

Twitter

▼ 2011 (135)

▼ July (13)

Georgia:Transvaginal MeshPatchFailureNews

J and J mustpay S.C.$327million

Las Vegas:AriaHotel/Casino Guests&Legionnaires...

Seroquel:LabelChangebecause ofHeartRisks

Multaq on theFDAWatch ListAgain

The FDA haspublishedits latestquarterlylist o...

Lilly SaysAlzheimerPatientsDidn’tImprove

FDAInvestigates BraccoDiagnostics &ExcessRadia...

Antipsychotics Used for

Blog Archive

Follow Share Report Abuse Next Blog» [email protected] New Post Design Sign Out

percent experienced erosions, and other complications included two cystotomies

(bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh

manufacturers about complications related to the device and its treatment of POP and

SUI.

Over 200 Lawsuits Filed Already

More than 200 women across the United States have filed lawsuits against three of the

makers of transvaginal mesh patches:

C.R. Bard

Johnson & Johnson’s Ethicon

American Medical Systems

Complications have been reported for several other manufacturers of surgical mesh as

well including:

Boston Scientific Scimmed

Sofradim

Caldera

Mentor Corporation

What Should You Do?

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

against the surgical mesh manufacturer, you could receive compensation for medical

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

unacceptable to sell medical devices that harm innocent people.

Posted by Mark Zamora at 10:14 AM

Labels: transvaginal mesh failure, Transvaginal Placement of Surgical Mesh

A South Carolina judge has rules that Johnson & Johnson must pay $327 million for

deceptive marketing of its Risperdal antipsychotic medication.

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


J and J must pay S.C. $327 million

Wednesday, July 20, 2011

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.

Las Vegas: Aria Hotel/Casino Guests &

Legionnaires' Disease

cancer.http://t.co/vYsQ0Ed 25

minutes ago

Drug SafetyCommunication:Ongoing review ofbisphosphonates &potential increasedrisk of esophagealcancer.http://t.co/OlvinLs about

2 hours ago

FDA approves blood-thinning drug Brilinta totreat acute coronarysyndromes.http://t.co/mYozjuw

about 5 hours ago

Drug Safety Podcast:Increased radiationexposure when usingCardioGen-82 PETscans.http://t.co/eqEsb1V 2days ago

s Used forParkinson's DespiteWarnin...

Spiriva RisksforCardiovascularProblems?

GeorgiaNews:SeriousComplicationsAssociated wit...

UltimateSportsSprayLawsuitVerdict

FDA:CytoSport’s MilkShakesContain noMilk

► June (35)

► May (16)

► April (18)

► March (17)

► February (13)

► January (23)

► 2010 (338)

► 2009 (197)

► 2008 (213)

► 2007 (171)

► 2006 (323)

► 2005 (223)

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 Aria site:

A message 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

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)]


Seroquel: Label Change because of Heart Risks

Tuesday, July 19, 2011

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


Labels: multaq information, multaq lawyer, multaq news

Multaq on the FDA Watch List Again

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

Product

Potential Signal of a

Serious Risk/New Safety

Information

Additional Information (as of

May 31, 2011)

Adalimumab

(Humira, Abbot

Laboratories)

Hepatic dysfunction, hepatic

failure

Azathioprine Acute febrile neutrophilic The label's adverse reactions

(Imuran,

Prometheus)

dermatosis (Sweet's

syndrome)

section was updated in May to

include Sweet's syndromeCetuximab

(Erbitux, Eli Lilly

and Bristol-Myers

Squibb)

Corneal infection, ulcerative

keratitis, skin necrosis

Dabigatran

etexilate mesylate

(Pradaxa,

Boehringer

Ingelheim)

Labeling for proper storage

and handling to preserve

potency

The FDA issued a safety

communication on March 29

reminding users and pharmacies

about the correct handling and

storage of the drug

Dronedarone HCl

(Multaq, Sanofi-

Aventis)

Renal impairment, renal

failure

Fibrin Sealant

(Tisseel VH,

Baxter Healthcare;

Evicel, Omrix

Pharmaceuticals)

Graft failure in

ophthalmological procedures

and lack of efficacy in

neurosurgical procedures for

repair of dural tears

Tisseel VH and Evicel have been

used off- label in ophthalmological

and neurosurgical procedures as

tissue adhesives

Immune Globulin

Subcutaneous

(Human) 6% Liquid

(Vivaglobin, CSL

Behring)

Thromboembolic adverse

events have been reported in

association with numerous

product lots

The product was taken off the

market on April 4

Iron sucrose

injection (Venofer,

Luitpold

Pharmaceuticals)

Anaphylactic reactions

Quinolone products Pseudotumor cerebri

Malathion (Ovide,

Taro

Pharmaceutical

Industries)

Burns and burning

sensations

Mercaptopurine

(Purinethol, Teva

Pharmaceuticals)

Hepatosplenic T-cell

lymphoma

Prasugrel HCl

(Effient, Eli Lilly)Hypersensitivity reactions

Rituximab (Rituxan,

Roche)Hypogammaglobulinemia

Ropinirole HCl

(Requip,

GlaxoSmithKline)

Medication errors resulting

from similarities in product

name and labeling to

risperidone


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

Lilly Says Alzheimer Patients Didn’t Improve


Saturday, July 16, 2011

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


Labels: bracco diagnostics and radiation

FDA Investigates Bracco Diagnostics & Excess

Radiation in PET Scans

Friday, July 15, 2011

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


Antipsychotics Used for Parkinson's DespiteWarning

Spiriva Risks for Cardiovascular Problems?

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."

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 µg (2.15, 1.03 to 4.51; P=0.04; I2=9%) and 5 µg (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 µg 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

Abstract

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


Labels: spiriva lawyers, sprivia dangers

Thursday, July 14, 2011

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.

Georgia News: Serious Complications Associated

with Transvaginal Placement of Surgical Mesh for

Pelvic Organ Prolapse

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


Labels: Pelvic Organ Prolapse, Transvaginal Placement of Surgical Mesh

Wednesday, July 13, 2011

Image v ia Wikipedia

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 company—inamed Anti-

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.


Labels: swats inc. methyltestosterone

Ultimate Sports Spray Lawsuit Verdict

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.


FDA: CytoSport’s Milk Shakes Contain no Milk

Thursday, June 30, 2011

Best Burn Centers in the US

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:

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


University of Florida -- Shands Burn Center

1600 SW Archer Road

Gainesvillw, FL 32610 United States


University of Miami -- Jackson Memorial Burn Center

1800 NW 10th Ave

Miami, FL 33136 United States


Alabama

Older PostsHome

Subscribe to: Posts (Atom)

Labels: napa fire gel recall, Napa Home Garden recall

Ethereal template. Powered by Blogger.

Transvaginal mesh lawyer

Technology

Transcript of Transvaginal mesh lawyer