Follow Share Report Abuse Next Blog» firstname.lastname@example.org New Post Design Sign OutA Georgia LawyerNews, musings and commentary on pharmaceutical law issues, technology, and litigation. Lawyers for consumers and injuredpeople.(No advice on this blog, though) 404-451- 7781. galawyerblog(at)yahoo.com Find us always at: www.ageorgialawyer.comThursday, July 21, 2011 Share it Share this on FacebookGeorgia: Transvaginal Mesh Patch Failure News Tweet this This has been shared 4 times.Transvaginal Mesh Patch Failure Get more gadgets for your siteA July 2011 FDA alert warns of serious complications associated with transvaginalmesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinaryincontinence (SUI). The FDA has received more than 3,800 reports of adverse effects About Me Blog Archivecaused by the surgical mesh or during implantation of the patch.According to the FDA, significant complications resulting from transvaginal ▼ 2011 (135) Markmesh 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 AriaLess 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 dont 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 HeartFDA Alerts and Research Find Transvaginal Patches Unsafe referred to from this site. If Risks I dont respond to an2011 FDA Alert – Serious and painful complications are associated with the email, dont take it Multaq on the FDAtransvaginal placement of surgical mesh, and their occurrence is not rare. FDA also personally, just cant Watch Listfinds the risky surgical mesh treatment of POP to be no more effective than traditional respond to all of them. Againtreatment. View my complete profile The FDA has2011 Study Published – The New England Journal of Medicine published research published its latestshowing an increased risk of complications associated with transvaginal mesh quarterlyimplants. 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. FDA2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to http://t.co/U9qSZjD 11 Investigate minutes ago s Braccotransvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings thetotal adverse reports to over 3,800. Drug Safety Podcast: Diagnostic Ongoing review of s& bisphosphonates & Excess2010 Study Published – A study featured in the Obstetrics & Gynecology journal had Radia... potential increasedto be terminated due to the extent of injuries to participants who received the risk of esophageal Antipsychotictransvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 cancer. s Used for
cancer. s Used forpercent 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 Safety2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh Communication: Spiriva Risksmanufacturers about complications related to the device and its treatment of POP and Ongoing review of forSUI. bisphosphonates & Cardiovasc potential increased ularOver 200 Lawsuits Filed Already risk of esophageal Problems?More than 200 women across the United States have filed lawsuits against three of the cancer. Georgiamakers 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 Ultimatewell 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 noWhat Should You Do? MilkIf you have suffered complications due to the implantation of a transvaginal patch totreat 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 defectivemedical 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 companys management for allowing "the profit-at-all-costs mentality to cloud" their approach to marketing the drug. The letter todoctors, which eventually drew a warning from FDA for false and misleading claims,was a "clever effort" to "manipulate the message" about Risperdal, Couch ruled (asquoted 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#ixzz1SkxGdartPosted by Mark Zamora at 9:04 AMWednesday, July 20, 2011Las Vegas: Aria Hotel/Casino Guests &Legionnaires DiseaseTests from the Centers for Disease Control and Prevention have determined that six formerguests of the Aria hotel in Las Vegas City Center have been diagnosed with LegionnairesDisease, a form of pneumonia. All of the patrons have recovered, but the disease cansometimes be fatal. Aria officials are notifying guests who stayed at the hotel from June 21 toJuly 4 that they might have been exposed to the bacteria, and if they feel ill to quickly seekmedical attention.
According to the Las Vegas Review Journal, "Legionella, the bacterium that causesLegionnaires 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 inthe 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 guestswho may have stayed with us from June 21 to July 4 at a time when water tests detectedelevated levels of Legionella bacteria in several of our guest rooms.Health officials have recently notified us of a few reported instances of guests who visitedARIA, were diagnosed with, treated for, and recovered from Legionnaires disease (a form ofpneumonia caused by Legionella bacteria). In an abundance of caution, we are attempting tonotify 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, weimmediately implemented a comprehensive abatement effort. All subsequent tests have comeback with no detectable levels of active Legionella.Posted by Mark Zamora at 1:48 PMLabels: aria legionnairesSeroquel: Label Change because of Heart RisksFrom the FDA and other sources:Seroquel is a drug that is widely prescribed. Also known as Quetiapine, it is used to treateither schizophrenia or bipolar disorder. In those with bipolar it is used for depressiveepisodes, acute manic episodes associated with bipolar I disorder, and maintenance treatmentof bipolar I disorder (as adjunct therapy to lithium or divalproex).Last week, this label change:WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSISElderly patients with dementia-related psychosis treated with antipsychoticdrugs are at an increased risk of death. Analyses of seventeen placebocontrolled trials(modal duration of 10 weeks) largely in patients takingatypical antipsychotic drugs, revealed a risk of death in drug-treatedpatients of between 1.6 to 1.7 times the risk of death in placebo-treatedpatients. Over the course of a typical 10-week controlled trial, the rate ofdeath in drug-treated patients was about 4.5%, compared to a rate of about2.6% in the placebo group. Although the causes of death were varied, mostof the deaths appeared to be either cardiovascular (e.g., heart failure,sudden death) or infectious (e.g., pneumonia) in nature. Observationalstudies suggest that, similar to atypical antipsychotic drugs, treatment withconventional antipsychotic drugs may increase mortality. The extent towhich the findings of increased mortality in observational studies may beattributed to the antipsychotic drug as opposed to some characteristic(s) ofthe patients is not clear. SEROQUEL (quetiapine) is not approved for thetreatment of patients with dementia-related psychosis [see Warnings andPrecautions (5.1)]Posted by Mark Zamora at 10:56 AMTuesday, July 19, 2011
Multaq on the FDA Watch List AgainThe post below sets out the drugs on the FDA watch list. Making the list again isDronedarone or Multaq.Physicians should not stop prescribing these drugs, nor should patients stoptaking them, according to the FDA.In the case of dronedarone, reports of several potential signals of risk reported for 2010were 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 dronedarones 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 dronedarones 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/746530Posted by Mark Zamora at 6:08 AMLabels: multaq information, multaq lawyer, multaq newsThe FDA has published its latest quarterly list of drugs to monitor after having identifiedpotential signs of serious risks or new safety information. The new watch list coversthe first 3 months of 2011. Heres 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 ofProduct Serious Risk/New Safety May 31, 2011) InformationAdalimumab Hepatic dysfunction, hepatic(Humira, Abbot failureLaboratories)Azathioprine Acute febrile neutrophilic The labels adverse reactions
(Imuran, dermatosis (Sweets section was updated in May to Prometheus) syndrome) include Sweets 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) risperidonePosted by Mark Zamora at 6:03 AMLilly Says Alzheimer Patients Didn’t ImproveEli Lilly & Co. said patients with Alzheimer’s disease whose conditions worsened upontaking the experimental drug semagacestat didn’t improve after dosing was halted.Lilly stopped development of the pill in August after data showed it harmed patientsinstead of helping them.Even seven months after patients ceased the use of semagacestat, they still had moretrouble with thinking, remembering and mental functioning than those who didn’treceive 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
Posted by Mark Zamora at 5:58 AMSaturday, July 16, 2011FDA Investigates Bracco Diagnostics & ExcessRadiation in PET ScansThe FDA has warned about the potential for excess radiation exposure in patientswho 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 positronemission tomography, or PET, scans involving the heart in order to diagnose heartdisease. 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 otherregulatory authorities to investigate the problem.The agency said it recently became aware of two patients who underwent PET imagingscans with CardioGen-82 and were later found to have detectable levels of radiationseveral months after their PET scans. Both patients were crossing the border to orfrom the United States when radiation detectors identified radiation originating fromthem.The FDA said it believes "that the risk of harm from this exposure is minimal, althoughany unnecessary exposure to radiation is undesirable." The total number of patientswho might have been exposed to excess radiation is currently unknown, but the FDAsaid the investigation into the problem is continuing.Source here.http://online.wsj.com/article/BT-CO-20110715-714106.htmlPosted by Mark Zamora at 9:49 AMLabels: bracco diagnostics and radiationFriday, July 15, 2011Antipsychotics Used for Parkinsons DespiteWarningFrom Web MD:Doctors continue to prescribe antipsychotic drugs to their patients with Parkinsonsdisease and psychosis, despite "black box" warnings from the FDA linking them toincreased risk of death among patients with dementia, a study shows. A black boxwarning 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 anincreased risk of death for those with dementia, which is common among peoplediagnosed with Parkinsons. Some commonly prescribed antipsychotics also worsensymptoms of Parkinsons.http://www.webmd.com/parkinsons-disease/news/20110711/antipsychotics-used-for-parkinsons-despite-warningsPosted by Mark Zamora at 4:23 PMSpiriva 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 byregulatory agencies and indicates a 52% increased risk of mortality associated withtiotropium mist inhaler in patients with chronic obstructive pulmonary disease.What is Spiriva? Tiotropium bromide is a long-acting, 24 hour, anticholinergicbronchodilator 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 andmarketed by Cipla under trade name Tiova. Source.The study is titled, "Mortality associated with tiotropium mist inhaler in patients withchronic obstructive pulmonary disease: systematic review and meta-analysis ofrandomised controlled trials."AbstractObjective To systematically review the risk of mortality associated with long term useof tiotropium delivered using a mist inhaler for symptomatic improvement in chronicobstructive pulmonary disease.Data sources Medline, Embase, the pharmaceutical company clinical trials register,the US Food and Drug Administration website, and ClinicalTrials.gov for randomisedcontrolled trials from inception to July 2010.Study selection Trials were selected for inclusion if they were parallel grouprandomised controlled trials of tiotropium solution using a mist inhaler (Respimat SoftMist Inhaler, Boehringer Ingelheim) versus placebo for chronic obstructive pulmonarydisease; the treatment duration was more than 30 days, and they reported data onmortality. 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 mistinhaler was associated with a significantly increased risk of mortality (90/3686 v47/2836; 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 ofmortality. The overall estimates were not substantially changed by sensitivity analysisof 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 durationeach (1.50, 1.05 to 2.15), or the inclusion of additional data on tiotropium mist inhalerfrom another investigational drug programme (1.42, 1.01 to 2.00). The number neededto treat for a year with the 5 g dose to see one additional death was estimated to be124 (95% confidence interval 52 to 5682) based on the average control event rate fromthe long term trials.Conclusions This meta-analysis explains safety concerns by regulatory agencies andindicates a 52% increased risk of mortality associated with tiotropium mist inhaler inpatients with chronic obstructive pulmonary disease.Source:From the FDA in 2008:Update 10/07/2008: FDA’s Early Communication About an Ongoing Safety Reviewissued on March 18, 2008 stated that Boehringer Ingelheim, the maker of SpirivaHandiHaler (tiotropium bromide), had conducted a pooled analysis of 29 trials thatsuggested a small excess risk of stroke (2 cases per 1000) with tiotropium bromideover placebo. FDA has now received preliminary data from UPLIFT (Understanding thePotential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebocontrolled clinical trial with Spiriva HandiHaler in approximately 6000 patients withchronic obstructive pulmonary disease (COPD). The preliminary results of UPLIFTreported by Boehringer Ingelheim to the FDA showed that there was no increased riskof stroke with tiotropium bromide (Spiriva HandiHaler) compared to placebo.Two recent publications1, 2 reported increased risk for mortality and/or cardiovascularevents in patients who received tiotropium or inhaled anticholinergics. Both studies
examined cardiovascular outcomes. Singh et al. 1 performed a systematic review andmeta-analysis of 17 clinical trials enrolling 14,783 patients treated with inhaledanticholinergic drugs used for the treatment of chronic obstructive lung disease. Lee etal. 2 performed a case-control study of 32,130 patients (320,501 controls) treated withinhaled medications, including an anticholinergic, for the treatment of chronicobstructive lung disease.FDA expects to receive the complete report for UPLIFT in November 2008. Resultsfrom this trial will also help to address some issues raised about tiotropium in the tworecent publications. Due to the amount of data collected in UPLIFT, a complete reviewof the results could take several months, at which time FDA will update thiscommunication with the final results of the UPLIFT analysis, as well as all the availabledata regarding tiotropium and stroke risk.1. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adversecardiovascular events in patients with chronic obstructive pulmonary disease. JAMA2008; 300 (12): 1439-1450.2. Lee TA, Pickard S, et al. Risk of Death Associated with Medications for RecentlyDiagnosed Chronic Obstructive Pulmonary Disease. Annals of Internal Medicine 2008;149: 380-39Posted by Mark Zamora at 7:40 AMLabels: spiriva lawyers, sprivia dangersThursday, July 14, 2011Georgia News: Serious Complications Associatedwith Transvaginal Placement of Surgical Mesh forPelvic Organ ProlapseNews on July 13th from the FDA on transvaginal mesh products.What you shouldknow 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 ProlapsePelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs inplace become weak or stretched. Thirty to fifty percent of women may experiencePOP in their lifetime with 2 percent developing symptoms. When POP happens, theorgans bulge (prolapse) into the vagina and sometimes prolapse past the vaginalopening. More than one pelvic organ can prolapse at the same time. Organs that canbe 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 IncontinenceStress urinary incontinence (SUI) is a leakage of urine during moments of physicalactivity, such as coughing, sneezing, laughing, or exercise.Purpose:On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional PatientInformation on serious complications associated with surgical mesh placed throughthe vagina (transvaginal placement) to treat POP and SUI.Based on an updated analysis of adverse events reported to the FDA andcomplications described in the scientific literature, the FDA identified surgical mesh fortransvaginal repair of POP as an area of continuing serious concern.
The FDA is issuing this update to inform you that serious complications associatedwith surgical mesh for transvaginal repair of POP are not rare. This is a change fromwhat the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear thattransvaginal POP repair with mesh is more effective than traditional non-mesh repair inall patients with POP and it may expose patients to greater risk. This SafetyCommunication provides updated recommendations for health care providers andpatients and updates the FDA’s activities involving surgical mesh for the transvaginalrepair of POP.The FDA continues to evaluate the effects of using surgical mesh to repair SUI andwill communicate these findings at a later date.For detailed information, please see: Urogynecologic Surgical Mesh: Update on theSafety 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 eventsreported to the FDA for surgical mesh devices used to repair POP and SUI for theprevious 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008through Dec. 31, 2010, the FDA received 2,874 additional reports of complicationsassociated with surgical mesh devices used to repair POP and SUI, with 1,503 reportsassociated with POP repairs and 1,371 associated with SUI repairs. Although it iscommon for adverse event reporting to increase following an FDA safetycommunication, we are concerned that the number of adverse event reports remainshigh.From 2008 – 2010, the most frequent complications reported to the FDA for surgicalmesh devices for POP repair include mesh erosion through the vagina (also calledexposure, extrusion or protrusion), pain, infection, bleeding, pain during sexualintercourse (dyspareunia), organ perforation, and urinary problems. There were alsoreports 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 FDAconducted a systematic review of the published scientific literature from 1996 – 2011to evaluate its safety and effectiveness. The review showed that transvaginal POPrepair with mesh does not improve symptomatic results or quality of life over traditionalnon-mesh repair. The FDA continues to evaluate the literature for SUI surgeries usingsurgical 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 mostcommon and consistently reported mesh-related complication from transvaginal POPsurgeries using mesh. Mesh erosion can require multiple surgeries to repair and canbe debilitating for some women. In some cases, even multiple surgeries will not resolvethe complication.Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POPrepair with mesh that has been reported in the published scientific literature and inadverse event reports to the FDA since the Oct. 20, 2008 FDA Public HealthNotification. Reports in the literature associate mesh contraction with vaginalshortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painfulsexual intercourse or an inability to engage in sexual intercourse. Also, men mayexperience irritation and pain to the penis during sexual intercourse when the mesh isexposed in mesh erosion.The complications associated with the use of surgical mesh for POP repair have notbeen 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 torecommend 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 availablePosted by Mark Zamora at 1:13 PMLabels: Pelvic Organ Prolapse, Transvaginal Placement of Surgical MeshWednesday, July 13, 2011Ultimate Sports Spray Lawsuit VerdictA Federal Court Judge in Missouri granted a verdict for St.Louis Rams linebacker David Vobora in his lawsuit against themaker 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 theproduct triggered a positive doping test that resulted inVobora’s four-game suspension in 2009. Vobora won $5.4million in the judgment, reflecting lost marketing opportunitiesand lost wages (during suspension), as well as damage to hisreputation.In issuing the ruling the judge said the vcompany—inamed Anti- Image ia WikipediaSteroid Program LLC (aka S.W.A.T.S.), a Key Largo, FL-based company—intentionally misrepresented the supplement. Vobora reportedly had the producttested, revealing it contained methyltestosterone but did not list the ingredient on thelabel.While Vobora cleared the two supplements via the NFL Hotline, the league has statedits policy holds strict liability on each player for what they put in their bodies.Posted by Mark Zamora at 6:12 AMLabels: swats inc. methyltestosterone
FDA: CytoSport’s Milk Shakes Contain no MilkPesky things, words. Why, if its called a "milk" shake, that is what is in it right?Wrong.CytoSport Inc.’s nutritional shakes are misbranded, according to FDA, because theirlabels prominently feature the word “MILK," however these products contain no milk.In an FDA warning letter sent to Michael Pickett, chief executive officer and presidentof the company, the agency said the labels for “Chocolate Muscle Milk ProteinNutrition 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 inviolation 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 thanthe words “MUSCLE MILK" on these product labels. Further, while the product labelsinclude the statement "Contains No Milk" on the principal display panel, the ingredientstatements say these products contain milk-derived ingredients, such as calcium andsodium caseinate, milk protein isolate and whey. The allergen statement printed onboth of these products states, This product contains ingredients derived from milk . . .."The “Contains No Milk" statement could give consumers the impression that theseproducts are free of milk-derived ingredients, according to FDA.The “Chocolate Muscle Milk Protein Nutrition Shake" and “Vanilla Crème Muscle MilkLight Nutritional Shake" products are also misbranded, according to FDA becausethey purport to be milk (by prominently featuring the word “MILK" on the labels), but donot follow federal regulation of the definition and standard of identity for milk. Thestandard 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 morehealthy 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 nomilk and contain numerous ingredients not permitted by the standard.Imagine that.Posted by Mark Zamora at 6:06 AMThursday, June 30, 2011Best Burn Centers in the US
With the news of the NAPA firepot recall, some folks have been asking about burn centersthat seem to be head and shoulders above the rest. Here is a compilation:Shriners Hospitals for Children have hospitals devoted to burns. They arein Boston, Cincinnati, and Sacramento CA.The University of Washington Harborview Medical Center. Harborview has treated over15,000 since 1974. They treat nearly all the burn victims in Washington. They are also one ofthe 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 Childrens 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 isa 13 bed unit with expansion.In the South, here are specialized burn centers:AlabamaChildrens Hospital of Alabama Medical Center1600 7th Avenue SouthBirmingham, AL 35233Joseph M. Still Burn Center at Doctors Hospital of Augusta3651 Wheeler RoadAugusta , GA 30909www.doctors-hospital.netEmory University Burn CenterGrady Memorial Hospital80 Butler StreetAtlanta, GA 30335Florida:Orlando Regional Medical Center -- Burn / Tissue Rehab Unit1414 South Kuhl AveOrlando, FL 32806-2134 United States 407 841-5176 begin_of_the_skype_highlighting 407 841-5176 end_of_the_skype_highlightingTampa General Hospital -- Tampa Bay Regional Burn CenterPO Box 1289Tampa, FL 33601 United States 813 251-7617 begin_of_the_skype_highlighting 813 251-7617 end_of_the_skype_highlightingUniversity of Florida -- Shands Burn Center1600 SW Archer RoadGainesvillw, FL 32610 United States 352 395-0200 begin_of_the_skype_highlighting 352 395-0200 end_of_the_skype_highlightingUniversity of Miami -- Jackson Memorial Burn Center1800 NW 10th AveMiami, FL 33136 United StatesPosted by Mark Zamora at 7:36 PM
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