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Transvaginal mesh lawyer 

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Slide 1: Follow Share Report Abuse Next Blog» markzamoralaw@gmail.com New Post Design Sign Out A Georgia 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 Thursday, July 21, 2011 Share it Share this on Facebook Tweet this This has been shared 4 times. Get more gadgets for your site Georgia: Transvaginal Mesh Patch Failure News 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 About Me Blog Archive 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 ▼ 2011 (135) ▼ July (13) Georgia: Transvagin al Mesh Patch Failure News J and J must pay S.C. $327 million Las Vegas: Aria Hotel/Casi no Guests & Legionnair es... Seroquel: Label Change because of Heart Risks Multaq on the FDA Watch List Again The FDA has published its latest quarterly list o... Lilly Says Alzheimer Patients Didn’t Improve FDA Investigate s Bracco Diagnostic s& Excess Radia... Antipsychotic s Used for 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 Twitter Drug Safety Communication: Multaq and increased risk of death and serious cardiovascular adverse events. http://t.co/U9qSZjD 11 minutes ago Drug Safety Podcast: Ongoing review of bisphosphonates & potential increased risk of esophageal cancer.
Slide 2: 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 cancer. http://t.co/vYsQ0Ed 25 minutes ago Drug Safety Communication: Ongoing review of bisphosphonates & potential increased risk of esophageal cancer. http://t.co/OlvinLs about 2 hours ago s Used for Parkinson' s Despite Warnin... Spiriva Risks for Cardiovasc ular Problems? Georgia News: Serious Complicati ons Associate d wit... Ultimate Sports Spray Lawsuit Verdict FDA: CytoSport’ s Milk Shakes Contain no Milk ► June (35) ► May (16) ► April (18) ► March (17) ► February (13) ► January (23) ► 2010 (338) FDA approves bloodthinning drug Brilinta to treat acute coronary syndromes. http://t.co/mYozjuw about 5 hours ago Drug Safety Podcast: Increased radiation exposure when using CardioGen-82 PET scans. http://t.co/eqEsb1V 2 days ago J and J must pay S.C. $327 million 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-atall-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). ► 2009 (197) ► 2008 (213) ► 2007 (171) ► 2006 (323) ► 2005 (223) 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.
Slide 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
Slide 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 Product Adalimumab (Humira, Abbot Laboratories) Azathioprine Potential Signal of a Serious Risk/New Safety Information Hepatic dysfunction, hepatic failure Acute febrile neutrophilic The label's adverse reactions Additional Information (as of May 31, 2011)
Slide 5: (Imuran, Prometheus) Cetuximab (Erbitux, Eli Lilly and Bristol-Myers Squibb) dermatosis (Sweet's syndrome) Corneal infection, ulcerative keratitis, skin necrosis section was updated in May to include Sweet's syndrome Dabigatran etexilate mesylate Labeling for proper storage (Pradaxa, and handling to preserve Boehringer potency Ingelheim) Dronedarone HCl (Multaq, SanofiAventis) Fibrin Sealant (Tisseel VH, Baxter Healthcare; Evicel, Omrix Pharmaceuticals) Immune Globulin Subcutaneous (Human) 6% Liquid (Vivaglobin, CSL Behring) Iron sucrose injection (Venofer, Luitpold Pharmaceuticals) Renal impairment, renal failure Graft failure in ophthalmological procedures and lack of efficacy in neurosurgical procedures for repair of dural tears The FDA issued a safety communication on March 29 reminding users and pharmacies about the correct handling and storage of the drug Tisseel VH and Evicel have been used off- label in ophthalmological and neurosurgical procedures as tissue adhesives Thromboembolic adverse events have been reported in The product was taken off the association with numerous market on April 4 product lots Anaphylactic reactions Quinolone products Pseudotumor cerebri Malathion (Ovide, Taro Pharmaceutical Industries) Mercaptopurine (Purinethol, Teva Pharmaceuticals) Prasugrel HCl (Effient, Eli Lilly) Burns and burning sensations Hepatosplenic T-cell lymphoma Hypersensitivity reactions Rituximab (Rituxan, Hypogammaglobulinemia Roche) Ropinirole HCl (Requip, GlaxoSmithKline) Medication errors resulting from similarities in product name and labeling to 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-timprove.html?cmpid=yhoo
Slide 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-forparkinsons-despite-warnings Posted by Mark Zamora at 4:23 PM Spiriva Risks for Cardiovascular Problems?
Slide 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 BoehringerIngelheim 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 metaanalysis, 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
Slide 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.
Slide 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.
Slide 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 NFLbanned 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. Image ia Wikipedia In issuing the ruling the judge said the vcompany—inamed AntiSteroid 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
Slide 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" (48.25 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
Slide 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 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 University of Florida -- Shands Burn Center 1600 SW Archer Road Gainesvillw, FL 32610 United States 352 395-0200 begin_of_the_skype_highlighting University of Miami -- Jackson Memorial Burn Center 1800 NW 10th Ave Miami, FL 33136 United States end_of_the_skype_highlighting end_of_the_skype_highlighting 352 395-0200 end_of_the_skype_highlighting Posted by Mark Zamora at 7:36 PM
Slide 13: Labels: napa fire gel recall, Napa Home Garden recall Home Older Posts Subscribe to: Posts (Atom) Ethereal template. Powered by Blogger.

   
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