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testkitscredencemedicure · 4 years

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Latest Management Strategies for Hospitalized COVID-19 Patients

The disease spectrum of COVID-19 is very wide. On the one hand are the asymptomatic or mildly symptomatic patients and on the other hand are patients who are fighting for their lives in the intensive care units. A significant number of hospitalized patients undergo severe inflammatory reactions triggered by SARS-CoV-2. Besides supportive therapy, more aggressive treatment strategies are being increasingly used with variable degrees of success.

Blood Purifying Devices

Extracorporeal blood purification (EBP) is a treatment in which blood from a patient is passed through a device (e.g. a membrane or a sorbent) in which a solute (waste products, toxins) and possibly water are also removed. When fluid is also removed, replacement fluid is added. EBP is used primarily in patients with renal failure (Renal Replacement Therapy-RRT). More than twenty years ago, it was seen that RRT could also remove inflammatory mediators from the plasma of septic patients. A survival benefit with hemofiltration was also noted later. Hence, started the use of blood purification as a treatment for human septic shock.

The role of cytokine storm and hyper inflammation, on the severity of COVID-19 patients has been well corroborated in different studies. In an article published in Intensive Care, Ruan et al documented high concentrations of inflammatory biomarkers like C- reactive protein, ferritin and IL-6 in COVID-19 patients who died. They concluded that COVID-19 mortality may be due to virus activated “Cytokine Storm Syndrome” or fulminant myocarditis.

Blood purification devices have now been given permission for use in severe cases of COVID-19 in a number of countries. One brand of blood purifying devices, CytoSorb, was used to treat more than seventy critically ill COVID-19 patients and specifically added to Coronavirus treatment guidelines in Italy and Panama, March 25, 2020. The use of CytoSorb has now begun in seriously ill COVID-19 patients who have cytokine storm and life threatening complications such as Acute Respiratory Distress Syndrome (ARDS), in Italy, China, Germany and France. Preliminary data of the seventy patients tested, shows that there is a marked reduction in Cytokine storm and inflammation, improved lung functions, weaning from mechanical ventilation and a reversal of shock.

CytoSorb is now specifically recommended in the Italy Brescia Renal COVID Task Force Guidelines for treating patients with severe COVID-19 infection and stage 3 renal failure on continuous RRT, published in Italian Society of Nephrology website. Blood purification in COVID-19 infections is also recommended to treat Cytokine Storm by the National Health Commission in China. This technology has been used in thousands of Extra Corporeal Membrane Oxygenation (ECMO) treatments to date, in non COVID-19 patients around the world.

On April 10, 2020, US FDA gave emergency use authorization (EUA) for a pair of Blood Purification Systems to treat adult COVID-19 patients admitted in ICU. The EUA applies to Trumo BCT Inc’s Spectra Optia Apheresis and Marker Therapeutics AG’s Depuro D2000 Adsorption Cartridge. On April 13, 2020 it gave EUA for the CytoSorbent System too.

Mesenchymal Stem Cell Transplantation (MSC)

Umbilical Cord derived Mesenchymal Stem Cells (MSCs) have been used safely and effectively for immune mediated inflammatory diseases such as Graft Versus Host Disease (GVHD) and Systemic Lupus Erythematosus (SLE). MSCs play a positive role in two ways, by immunomodulation and by their ability to differentiate. Immunomodulatory actions are related to secretion of cytokines and because of the direct interactions with immune cells. The immunomodulatory effects are further enhanced by the activation of Toll-Like Receptors (TLR) in MSCs by pathogen associated molecules such as Lipopolysaccharides (LPS) or single stranded RNA from viruses like SARS-CoV-2.

The first step in the pathogenesis of COVID-19 is the entry of SARS-CoV-2 into human cells by attaching to Angiotensin Converting Enzyme-2 (ACE-2) receptors by its spike proteins. A research team from Germany revealed that cellular serine protease TMPRSS2, for SARS-CoV-2 Spike Protein priming, is also important for host cell entry and spread.

ACE2 receptors are present widely on tissues in the body, like type 2 Pneumocytes of lungs, kidney, intestines, capillary endothelium etc. However, the immune cells such as T and B lymphocytes and macrophages, in the bone marrow, lymph nodes, thymus, and the spleen, are all negative for ACE-2 receptors. MSCs are also ACE-2 receptor and TMPRSS2 negative. This makes them immune to SARS-CoV-2. This is the basis of using them in severe COVID-19 infections.

The viral infection causes a total failure of function of lymphocytes and almost the whole immune system. Several studies have reported lymphopenia and high levels of C-reactive protein in COVID-19 patients with severe infections. MSCs play a role by reversing the lymphocyte subsets, mainly through dendritic cells. The interactions of MSCs with the dendritic cells leads to a shift of the immune system from T helper 1 to T helper 2 type of responses.

After entering the human body through the intravenous route, part of the MSCs accumulate in the lung. There, they probably improve the microenvironment, protect alveolar epithelial cells, prevents pulmonary fibrosis and improve lung functions. Due to their immunosuppressive capacity, MSCs significantly decrease the serum levels of pro inflammatory cytokines and chemokines. This leads to decreased attraction of mononuclear/macrophages to the fragile lung, at the same time recruiting more regulatory dendritic cells to the sites of inflammation. They also increase IL-10 and Vascular Endothelial Growth Factor (VEGF), which promotes lung repair.

US FDA has authorized Umbilical cord derived Mesenchymal Stem Cell (MSC) transplant, to prevent life threatening lung inflammation that accompanies severe cases of COVID-19. They have provided authorization for a twenty four patient clinical trial for such patients.

An article related to the use of MSCs in COVID-19 pneumonia, was published by Leng Zikuan, Zhu Ronjia, Hou Wei, et al in the Journal of Aging and Disease, February28, 2020. They studied the effects of MSC transplant on seven COVID-19 patients with pneumonia. A favorable result was reported in all of them.

Use of Convalescent Sera in COVID-19 Patients

Immunity is of two types- active and passive. Active immunity is when the human body mounts an immune reaction in response to an invading microorganism. Passive immunity is when the body is not actively involved in producing immunity. This involves introducing preformed antibodies into the human body through various routes. A classic example of this is the newborn receiving maternal antibodies that protect the newborn till the age of around six months.

Convalescent Sera has been used as early as the twentieth century, to stem the outbreak of viral diseases such as poliomyelitis, measles, mumps and influenza. In the 2009-2010 H1N1 influenza virus pandemic, convalescent sera was used to treat patients with severe H1N1 disease, requiring intensive care. Convalescent serum was also used in the 2013 West African Ebola Virus epidemic. In previous epidemics of Coronaviruses, SARS 1 in 2003 and MERS in 2012, Convalescent Sera was used for patients who were hospitalized.

Recently on April 13, 2020, US FDA issued guidelines to health care providers and investigators on the administration and study of convalescent plasma, collected from individuals who have recovered from COVID-19. COVID-19 convalescent plasma has not yet been approved for use by FDA. It is regulated as an investigational product. Eligibility criteria for the potential patients:

Laboratory confirmed COVID-19.

Severe or immediately life threatening COVID-19, for example:

Informed consent provided by the patient or a health care proxy.

Severe disease is defined as one of the following:

Life threatening disease is defined as one or more of the following:

Shortness of breath (dyspnea)

Respiratory frequency ≥ 30

Blood oxygen saturation ≤ 93%

Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen < 300.

Lung infiltrates > 50% within 24-48 hours.

Respiratory failure.

Septic shock

Multiple organ dysfunction or failure.

So, the research continues, as the pandemic spreads. Scientists, epidemiologists and researchers are working at a fast and furious pace along with the governments of their countries, to expand their knowledge of the disease, its diagnosis and management.

HEALTH DISCLAIMER This blog provides general information and discussions about health and related subjects. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment. The content is for information purpose only and is not a medical advice. Qualified doctors have gathered information from reputable sources; however Credence Medicure Corporation is not responsible for errors or omissions in reporting or explanations. No individual should use the information, resources and tools contained herein to self diagnose or self treat any medical condition. If you or any other person has a medical concern, you should consult with your health care provider or seek other professional medical treatment. Never disregard professional medical advice or delay in seeking it because of something that have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately. The opinions and views expressed on this blog and website have no relation to those of any academic, hospital, health practice or other institution. Credence Medicure Corporation gives no assurance or warranty regarding the accuracy, timeliness or applicability of the content.

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davidslepkow · 5 years

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(via Ethicon’s PROCEED Hernia Mesh lawsuit | FDA Asleep at the Wheel?) ETHICON PROCEED HERNIA MESH LAWSUIT | FDA ASLEEP AT THE WHEEL?Many lawsuits are now pending against Johnson and Johnson and their corporate subsidiary Ethicon, as a result of the allegedly defective PROCEED Ventral Patch. Some surgical mesh attorneys and hernia mesh victims assert that the PROCEED hernia mesh is defective. They also allege that they were not properly warned of the dangers of this proceed mesh medical device. Will there be a Proceed Hernia Repair Surgical Mesh by Ethicon settlement in 2019? Many victims are searching the world wide web for hernia mesh settlements information. Other victims are seeking info about “symptoms of hernia mesh problems.” Despite, numerous recalls and lawsuits, Ethicon Inc. is still currently marketing Proceed hernia mesh. If you need to file a proceed hernia mesh lawsuit then contact a proceed mesh lawsuit law firm.

Ethicon laughably asserts that the Proceed Ventral patch and Proceed hernia mesh, “has demonstrated a recurrence rate of just 0% to 10% in multiple studies.” Ethicon also asserts on its website that Proceed mesh has, “Strong repair with potential for low recurrence.”‘ Ethicon websiteWILL THERE BE A PROCEED STATE COURT CONSOLIDATED LAWSUIT?It looks like there will be a consolidated Ethicon Proceed, Ethicon Proceed Ventral and Prolene Hernia system hernia mesh lawsuit in New Jersey State Court. Notably, this hernia mesh lawsuit will not in all likelihood include Prolene mesh.Proceed lawsuit update 2019: “The New Jersey Supreme Court is considering whether to establish a new consolidation program for all hernia mesh lawsuits filed in the state involving Ethicon Proceed and Prolene products, and whether the cases should be centralized before one judge for coordinated pretrial proceedings. In a notice to the bar (PDF) issued in December, Glenn A. Grant, the Acting Administrative Director of the Courts announced that the court has received an application for the creation of a Multicounty Litigation (MCL) involving all Ethicon Proceed Surgical Mesh, Proceed Ventral and Prolene Hernia Mesh Systems filed in New Jersey Courts.”PROCEED MESHDespite these assertions by Ethicon, many victims have filed proceed mesh lawsuits. If you are looking for a mesh firm to file a Proceed hernia mesh lawsuit, retain one of the best Proceed mesh law firms. Ethicon and Johnson and Johnson have equally disturbing and embarrassing issues related to another allegedly defective hernia mesh medical device they manufacture, Ethicon Physiomesh.This surgical mesh proceed post looks into the complicated issues related to a mesh recall and addresses an important question many victims are wondering: what is proceed mesh made of? Was a proceed mesh brochure ever circulated? How do I find out if the mesh implanted in me was previously subjected to a proceed ventral patch recall? How do I determine the proceed mesh recall lot number? If the proceed mesh implanted in me was not technically subject to the Ethicon proceed mesh recall, can I still file a Proceed mesh lawsuit? What firm is the best Proceed mesh law firm in the United States?WE ARE CURRENTLY REVIEWING FOR POTENTIAL LAWSUITS, THE FOLLOWING TYPES OF MESH MANUFACTURED BY JOHNSON & JOHNSON AND ETHICON INC:PhysiomeshProlene Hernia System (PHS)Prolene 3D PatchUltraproProceed hernia meshPhysiomesh hernia mesh lawsuit settlement 2018Proceed hernia mesh otherwise known as Proceed mesh has a reputation for causing infection and pain as well as bowel obstruction. There have been reported instances of the device disintegrating after implanted in the victims body. “Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).” FDAPROCEED SURGICAL MESH | ETHICON PROCEED MESH LAWSUITProceed hernia mesh settlement 2018Proceed Surgical Mesh was approved by the FDA on 05/25/2006 as a result of the FDA’s controversial 510(k) premarket notification process. The FDA 510k process does not require clinical human trials before a medical device can be marketed by the manufacturer. Johnson and Johnson asserted that Proceed Surgical mesh was substantially similar to a predicate device: PROCEED Trilaminate Surgical Mesh. Johnson and Johnson asserted that “PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.” https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060713.pdfWHO IS ETHICON AND WHAT INVOLVEMENT DO THEY HAVE WITH PROCEED MESH?“Defendant Ethicon, Inc. is a wholly owned subsidiary of Defendant Johnson & Johnson. Defendant Ethicon, Inc. is a corporation incorporated in the State of New Jersey with its principal place of business in Somerville, New Jersey. Ethicon is a medical device company involved in the research, development, testing, manufacture, production, marketing, promotion and/or sale of medical devices including Proceed (hereinafter may be referred to as the “product”). J&J, directly and/or through the actions of Ethicon, Inc., has at all pertinent times been responsible for the research, development, testing, manufacture, production,marketing, promotion, distribution and/or sale of Proceed.” RUBY CAVEECK complaint against Ethicon, IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF PENNSYLVANIA, Case 2:17-cv-01084-JFC Document 1 Filed 08/17/17PROCEED SURGICAL MESH RECALL 2006- 18,270 MEDICAL DEVICES RECALLED (MANY ALREADY SURGICALLY IMPLANTED)On January 04, 2006 a FDA product recall of PROCEED Surgical Mesh occurred. Victims are seeking more information about the Ethicon Proceed recall. Most importantly victims were trying to determine the proceed mesh recall lot numbers. This was a disturbing and unsettling recall of 18,270 medical devices! Many of these defective Proceed medical devices had already been implanted in unwitting victims. According to the FDA, “There is a total of 1,070 consignees that have received recall product divided between hospitals and distributors nationwide. The product has been distributed internationally to the following countries: Argentina, Australia, Austra, Brazil, Canada, Chile Colombia, Czechoslovakian Republic, France, Germany Greece, Guaynabo, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Republic of Yemen, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirate, United Kingdom, Venezuela.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=43417&CREATE_DT=2006-01-26PROCEED MESH RECALL | ETHICON PROCEED MESH RECALLThe FDA listed the Recalling Firm / Manufacturer as “Ethicon, Inc. US Highway 22 West Somerville NJ 08876. It is widely known that Ethicon’s corporate headquarters are in New Jersey to this day. Ethicon’s reason for the Proceed mesh recall was “Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.” FDA recall reportThis proceed mesh recall was unfortunate to say the least. An Ethicon proceed recall is the last thing Johnson and Johnson needed at that time. This hernia mesh recall may have been the impetus for some people to file a proceed mesh lawsuit.This recall was Terminated 3 on September 28, 2006. For information on recalls in general, see also:Voluntary Recalls – 21 CFR 7Mandatory Device Recalls – 21 CFR 810Corrections and Removals – 21 CFR 806Definitions Overview2ND PROCEED RECALL: PROCEED SURGICAL MESH RECALL 2010- VERY LIMITED (87 MESH DEVICES) BUT UNSETTLINGOn October 18, 2010 the FDA issued a class 2 medical device recall of PROCEED Surgical Mesh. To be fair to Ethicon, the class 2 recall was not for all proceed hernia mesh but pertained to: PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618. There were only 87 medical device products recalled by Johnson and Johnson. Date Initiated by Firm: October 18, 2010, Date posted: January 14, 2011. Recall number: Z-0903-2011 FDA Recall event ID: 57021.According to ‘spin’ from Ethicon the reason for the recall was “There is a potential for delamination in one lot of Proceed surgical mesh” The FDA Determined Cause for the Proceed mesh recall was “Nonconforming Material/Component.” Ethicon took the following action as a result of the recall, “Ethicon sent Urgent Voluntary Product Recall letters via Fed Ex on October 18, 2010. The letters described the issue with the affected product and instructed customers not to use it. They are to immediately remove the recalled product from their inventory and return it according to the instructions provided. A reply card is attached and must be filled out and returned to Stericycle whether or not the customer has product in their possession. Separate correspondence has been sent to end customers stating that if they have purchased the recalled product through a distributor, to return the product directly to Stericycle. Replacement product will be provided at no additional charge for all recalled product.” Id. Date Initiated by FirmDate PostedRecall Status1Open3, ClassifiedRecall NumberZ-0903-2011Recall Event ID57021510(K)NumberK060713Despite the fact that the number of recalled Proceed mesh medical devices were a limited amount, the recall is disturbing nonetheless. Such defects in medical devices can cause serious complication, injuries and symptoms on unwitting victims. Such alleged pattern of negligence and carelessness from Ethicon could be used as leverage by top Plaintiff hernia mesh law firms to make a “Proceed hernia mesh settlement 2018” a reality rather than a pipe dream. Proceed mesh victims are desperately seek a surgical mesh settlement and are disappointed there was no global hernia mesh settlement 2017. It is time for Ethicon and Johnson and Johnson to open up their pocketbook and make “hernia mesh settlement 2018” a reality. The purpose of this post and other posts on this blog concerning Ethicon Physiomesh is to provide a Johnson and Johnson Mesh lawsuit update.3RD ETHICON PROCEED RECALL: PROCEED HERNIA MESH RECALL 2014On February 19, 2014 the FDA issued a “Class 2 Device Recall Ethicon Inc.” The class 2 recall pertained to: Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. (Product Code PCDB1 – Lot number – GGG157, Product Code PCDT1 – Lot number – GGG158, Product Code PCDJ1 – Lot number -GGG159) The Manufacturer Reason for Recall: “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination”. Id.Ethicon took the following action as a result of the Proceed mesh recall, “Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or [email protected]. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.” FDAThis is another troubling Proceed mesh misstep by Johnson and Johnson and their corporate subsidiary Ethicon Inc. All of these missteps can only lead to one conclusion, Ethicon must open up their pocketbooks for a global Proceed mesh settlement 2018.ASSORTED PROCEED HERNIA MESH LAWSUITSBelow you will find some descriptions and allegations of various hernia mesh lawsuits against Ethicon as a result of Surgical Proceed mesh.SHELLY K. COPPEDGE V. ETHICONIn 2012 SHELLY K. COPPEDGE filed a lawsuit against ETHICON, INC. This lawsuit was filed on August 2nd, 2012 IN THE UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS MARSHALL DIVISION. Ms Coppedge requested a jury trial seeking her day in Court as a result of the complications she suffered as a result of Proceed hernia mesh. She alleged that “The surgeon herein used Proceed Oval Mesh, manufactured, designed, and marketed by Ethicon, Inc., with Lot No. BHG341, and Catalog No. PCDG1.”Aboutlawsuits reported on the Coppedge lawsuit stating,”A lawsuit has been filed over problems with Ethicon Proceed hernia mesh, alleging that the patch disintegrated inside the body of a Texas woman, leading to infection and other complications.” https://www.aboutlawsuits.com/ethicon-proceed-hernia-mesh-lawsuit-31609/According to the complaint, “Plaintiff Shelly K. Coppedge required subsequent surgeries to try to remedy the complications cause by the mesh, including a disintegration of the mesh and infection of the mesh. Even after the two subsequent surgeries, Plaintiff Shelly K. Coppedge continues to suffer various infirmaries due to complications caused by the Proceed mesh that was designed, marketed, and tested by Defendant Ethicon, Inc.” https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2012-08-02-Ethicon-Proceed-Complaint.pdfMs. Coppedge acting by and through her hernia mesh attorneys and their hernia mesh law firm further went on to allege, “The Proceed Mesh was defective and unreasonably dangerous, and not suitable for implantation in Shelly K. Coppedge, and others similarly situated. The product was not properly tested and was marketed as being reasonably safe for its intended use as an implantable mesh for incisional hernias, among other ailments. This defective product was a producing cause of Plaintiff Shelly K. Coppedge’s injuries and damages.” Id.“Defendant made implied and express warranties to Shelly K. Coppedge, and others similarly situated in the stream of commerce, that the product (Proceed Mesh) was safe, had been tested, and was a better alternative for its intended use as an implantable mesh to treat an incisional hernia than other products. This was not true at the time of the implantation in August of 2009 for which Plaintiff was not warned or instructed, nor were any of the medical professionals in the stream of commerce notified of the problems to which Ethicon, Inc. was fully aware of by August of 2009.” Id.WHAT IS PROCEED MESH MADE OF?“Proceed Hernia Repair Surgical Mesh by Ethicon PROCEED™ Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of an oxidized regenerated cellulose (ORC) fabric, and PROCEED™ Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth, while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.” Medlineproceed mesh brochuresymptoms of hernia mesh problemsproceed mesh priceproceed mesh recall lot numbersANOTHER PROCEED MESH LAWSUITIn a lawsuit complaint filed in IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF PENNSYLVANIA, the victim asserted that “Defendants’ Proceed was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design. As a result of the defective design and/or manufacture of the Proceed, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.” https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2017-8-17-proceed-caveeck-complaint.pdfA DISCOVERY STIPULATION CONCERNING PROCEED MESHRead a discovery/ document production stipulation entered into by Johnson and Johnson and the hernia mesh law firms “Plaintiffs and Defendants Ethicon, Inc. (“Ethicon”) and Johnson & Johnson (“J&J”) (collectively, “Defendants”) have advised the court that they desire to enter into a stipulation concerning the production of hernia mesh documents for the Prolene, Prolene Soft, Ultrapro, Proceed and Vypro hernia mesh products.” https://www.wvsd.uscourts.gov/MDL/ethicon/pdfs/PTO_66.pdfETHICON ASSERTS THE FOLLOWING PROPAGANDA:“A study of PROCEED Mesh demonstrated a low recurrence rate (1.3%) at 1 year382Mesh repairs demonstrated superior to suture repair in multiple open hernia studies383‡Mesh repair has demonstrated a recurrence rate of just 0% to 10% in multiple studies383Conventional suture repair has a recurrence rate of up to 63%383Partially absorbable design is engineered to minimize adhesions381Unique construction of PDS® support ring helps ensure compliance with abdominal wall381Distributes abdominal forces equally across the mesh381Does not buckle when pulled up toward the abdominal wall381Secure placement and stable positioning” http://www.ethicon.com/healthcare-professionals/products/hernia-repair-and-fixation/hernia-mesh-tissue-separating-mesh/proceed-ventral-patchPROCEED MESH ADVERSE EVENT REPORTS:It is troubling that there are a number of FDA adverse event reports related to Proceed hernia mesh. Victims can only hope that the combination of FDA adverse event reports combined with a growing number of proceed Ventral Patch mesh lawsuits will convince Ethicon and Johnson and Johnson to engage in Proceed ventral patch mesh settlements 2018. Johnson and Johnson played hardball concerning mesh settlements 2017. This makes it nearly impossible to determine what the average settlement for proceed mesh 2017 or the average Proceed mesh patch settlements 2018. Many surgical mesh victims are concerned with complications years later that they may not be able to anticipate at this time.BELOW I HAVE SET FORTH VARIOUS FDA ADVERSE EVENT REPORT RELATED TO PROCEED HERNIA MESH:“JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH,SURGICAL, POLYMERICCatalog Number PVPSDevice Problem Migration of device or device componentManufacturer Narrative:To date the device has not been returned. If the device or further details are received at a later date asupplemental medwatch will be sent. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Event Description:It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2010 and mesh wasimplanted. The patient experienced erosion and recurrent hernia. On (b)(6) 2011, the patient underwent removal of encapsulated ventral hernia mesh and scar revision, with midline diastasis plication and placement of strattice xenograph. No additional information was provided.”Report Date10/18/2010JOHNSON & JOHNSON ETHICON PROCEED VENTRAL PATCH HERNIA REPAIR MESHBack to Search ResultsLot Number BG8LCDZ0Device Problems Failure to Adhere or Bond; Product quality issueEvent Date 03/26/2010Event Type InjuryEvent DescriptionInitial surgery repair (b)(6) 2010, status post laparoscopic appendectomy and ventral incisional herniorrhaphy with mesh ar the supraumbilical midlinetrocar site. (b)(6) 2010, recurrent ventral incisional hernia with laparoscopic ventral herniorrhaphy with meshReport Date03/08/2012ETHICON INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERICBack to Search ResultsCatalog Number XCPVPMDevice Problem Other (for use when an appropriate device code cannot be identified)Event Type InjuryEvent DescriptionIt was reported that a patient underwent an umbilical hernia repair procedure on (b)(6) 2011 and mesh was used. The patient developed pain and purulent drainage after the procedure. The patient returned to surgery on (b)(6) 2011, for an incision and drainage of abscess and removal of infected mesh. The mesh was removed and sent to pathology and cultures were done. The culture results showed no growth. The pathology exam of tissue and mesh shows inflammation and necrosis of the tissue and disrupted mesh.Manufacturer Narrative(b)(4). It was reported that a patient underwent an incarcerated umbilical hernia repair procedure on (b)(6) 2011 and mesh was used.Manufacturer NarrativeManufacturer NarrativeDate sent to the fda: (b)(4) 2012. (b)(4) – abscess occurred. No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Report Date03/16/2017JOHNSON & JOHNSON INTERNATIONAL PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERICCatalog Number PVPSDevice Problem Material separationEvent Type InjuryEvent DescriptionIt was was reported that the patient underwent a surgery for incarcerated umbilical hernia in 2016 and mesh was implanted. The patient returned and required the mesh to be removed. During reoperation, it was found that the mesh was disintegrated into multiple small pieces. The mesh was removed from patient. No additional information is available.Manufacturer Narrative(b)(4). Additional surgical intervention. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Maude report #: mw5068099.Report Date12/16/2010ETHICON, INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERICBack to Search Results Catalog Number XCPVPMDevice Problem Other (for use when an appropriate device code cannot be identified)Event Type InjuryManufacturer Narrative(b)(4). Wound drainage occurred. Conclusions: no conclusion can be drawn at this time. Should add’l info be obtained, a supplemental 3500a form will be submitted accordingly.Event DescriptionIt was reported that the pt underwent an open repair of a primary incisional/ventral single defect hernia on (b)(6) 2010, and mesh was placed. At discharge on (b)(6) 2010, no issues were noted. Post-operatively, the pt experienced serous non infected wound drainage. The surgeon evacuated 2cc of serous fluid with a syringe. The wound has now healed well.

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newstfionline · 6 years

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Exporting pain: U.S.-made medical devices cause serious injuries, pain overseas

By Andrew W. Lehren and Emily Siegel, NBC News, Nov. 25, 2018

After years in the military and playing rugby, Wolfgang Neszpor was used to his battered body making noises, but he was stunned when he heard his recently repaired shoulder squeak.

“It was loud. You could really hear it outside my body,” he said.

He went to his doctor, who, when examining him, lifted up his arm.

“I nearly went through the roof,” Neszpor recalled. “I can take a fair bit of pain. But it was a stupid amount of pain.”

Two months earlier, Neszpor, 36, had gotten a new shoulder joint made out of carbon. It was a PyroTITAN, made by Integra LifeSciences, a New Jersey company that ranks among the biggest medical device companies in the world.

Neszpor lives in Australia, where his operation was performed in 2014. He believed the Made in the USA label meant his shoulder would be fixed with state-of-the-art technology.

What he did not know is that even though it was made in the USA, the U.S. Food and Drug Administration had not, and still has not, deemed it good enough for Americans. A clinical trial is underway and the company said it hopes to get approval upon completion. But the agency has permitted its sale overseas since 2012 under an obscure provision in which the PyroTITAN was registered as an “export only” device, requiring far less FDA scrutiny than for devices that are sold domestically.

The PyroTITAN is one of more than a dozen export-only devices with troubled track records identified by NBC News, including U.S.-made implants for losing weight that instead led to emergency surgeries, stents that could cut into arteries they were supposed to save, and heart valves sold in Spain and Italy that, according to the FDA, caused severe infections and may have caused a five-year-old child to die. There may well be more. NBC News found these by analyzing and comparing databases in 10 countries, and a lack of international standards for identifying devices means it is difficult to know how many other troubled devices exist.

For U.S. companies, exporting medical devices is big business, valued last year at more than $41 billion. Currently about 4,600 devices are registered with the FDA as “export only” devices. Several executives for medical device makers said registering the devices is faster, less expensive and has involved less oversight than getting them approved for sale inside the U.S. The troubled devices identified by NBC News have been sold around the world. The destinations range from the Netherlands to Namibia, Chile to Canada, Japan to Germany.

NBC News probed export-only devices as part of a global project organized by the International Consortium of Investigative Journalists, a news organization notable for its work on the Panama Papers, to examine the medical device industry. More than 250 reporters in 36 countries worked on stories that began publishing Sunday.

The FDA says its oversight for these products is limited. “The FDA does not have the authority to take action on export-only devices marketed in other countries simply because they do not meet the agency’s requirements for marketing in the United States,” the agency told NBC News.

The PyroTITAN already had documented problems before it was embedded into Neszpor’s shoulder. The company had alerted the medical community in 2012 that some models could break. After his surgery, more flaws emerged. In 2013, Australian authorities warned that, for some, the PyroTITAN broke in its first year. A 2016 recall cautioned the device needed so much friction to snap into place that it could burn the arm bone when it was implanted. Out of an untold number of implants, at least 19 patients needed to have the PyroTITAN removed. Neszpor is one of them.

“That raises a lot of ethical and moral and health questions,” said Dr. Sidney M. Wolfe, who helped establish Public Citizen, a consumer health advocacy organization, and frequently testifies before Congress on patient safety.

“It sort of also raises the question, ‘Is an American life worth more than a British life or an Australian life?’” he said. “I mean that’s the reason they’re not being approved here, is because you’re protecting an American life. So why would it be okay for another country?”

Nezspor believes his life was diminished by the PyroTITAN shoulder, and it has hurt his family.

“I thought I was really going to get something out of it,” said Nezspor, the father of six children. “You sit here and mull over it. You feel like less of a person because you can’t get involved in your kids’ lives and you can’t do the things that you want to do.”

#exporting medical devices #PyroTITAN #FDA

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learningrendezvous · 6 years

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Science and Society

SYMBIOTIC EARTH: HOW LYNN MARGULIS ROCKED THE BOAT AND STARTED A SCIENTIFIC REVOLUTION

Directed by John Feldman

Explores the life and ideas of Lynn Margulis, a scientific rebel who challenged entrenched theories of evolution to present a new narrative: life evolves through collaboration.

SYMBIOTIC EARTH explores the life and ideas of Lynn Margulis, a brilliant and radical scientist, whose unconventional theories challenged the male-dominated scientific community and are today fundamentally changing how we look at our selves, evolution, and the environment.

As a young scientist in the 1960s, Margulis was ridiculed when she first proposed that symbiosis was a key driver of evolution, but she persisted. Instead of the mechanistic view that life evolved through random genetic mutations and competition, she presented a symbiotic narrative in which bacteria joined together to create the complex cells that formed animals, plants and all other organisms - which together form a multi-dimensional living entity that covers the Earth. Humans are not the pinnacle of life with the right to exploit nature, but part of this complex cognitive system in which each of our actions has repercussions.

Filmmaker John Feldman traveled globally to meet Margulis' cutting-edge colleagues and continually asked: What happens when the truth changes? SYMBIOTIC EARTH examines the worldview that has led to climate change and extreme capitalism and offers a new approach to understanding life that encourages a sustainable and symbiotic lifestyle.

DVD / 2018 / (Grade 8evel: 10 - 12, College, Adults) / 147 minutes

CELLING YOUR SOUL

Directed by Joni Siani

An examination of our love/hate relationships with our digital devices from the first digitally socialized generation, and what we can do about it.

In one short decade, we have totally changed the way we interact with one another. The millennial generation, the first to be socialized in a digital world, is now feeling the unintended consequences.

CELLING YOUR SOUL is a powerful and informative examination of how our young people actually feel about connecting in the digital world and their love/hate relationship with technology. It provides empowering strategies for more fulfilling, balanced, and authentic human interaction within the digital landscape.

The film reveals the effects of "digital socialization" by taking viewers on a personal journey with a group of high school and college students who through a digital cleanse discover the power of authentic human connectivity, and that there is "No App" or piece of technology that can ever replace the benefits of human connection.

DVD / 2017 / (Grades 6-12, College, Adult) / 48 minutes

CRACKING CANCER

Directed by Judith Pyke

A clinical research trial at the Personalized OncoGenomics Program is changing the way scientists think about the future of cancer care.

Six years ago Zuri Scrivens, the mother of a toddler, was very ill with incurable breast cancer that had spread to her liver and lymph nodes. Today Zuri has no signs of cancer, not because of a miraculous new cancer drug, but thanks to a diabetes medication.

CRACKING CANCER follows a group of patients with incurable cancer on a trailblazing journey through a highly experimental clinical trial at the BC Cancer Agency in Vancouver called POG -- Personalized OncoGenomics.

The trial compares patients' normal DNA -- each cell's complete set of instructions -- with that of their tumors, to find the genetic mutations causing their cancer. Zuri's cancer driver was a mutation that caused a very high growth factor. The team plowed through decades of data to isolate which drug in all of medicine, not just cancer, might block that growth factor. They zeroed in on a diabetes medication. Zuri received the drug and standard hormone treatment. Within 5 months, her cancer became undetectable.

POG offers a radical new way of treating cancer, not according to where it originates in the body, but rather as a disease of genetic mutations. Thousands more will join the trial, all hoping for their own salvation, all helping science to crack the cancer code.

DVD / 2017 / (Grades 10-12, College, Adults) / 44 minutes

DANGEROUS IDEA, A: GENETICS, EUGENICS AND THE AMERICAN DREAM

Directed by Stephanie Welch

Examines the history of the US eugenics movement and its recent resurrection, which uses false scientific claims and holds that an all-powerful "gene" determines who is worthy and who is not.

There is a dangerous idea that has threatened the American Dream from the very beginning. It is a strong current of biological determinism which views some groups, races and individuals as inherently superior to others and more deserving of fundamental rights. Despite the founders' assertion that "all are created equal," this idea was used to justify disenfranchising women, blacks and Native Americans from the earliest days of the Republic.

A DANGEROUS IDEA: GENETICS, EUGENICS AND THE AMERICAN DREAM reveals how this dangerous idea gained new traction in the 20th century with an increasing belief in the concept of an all-powerful "gene" that predetermines who is worthy and who is not. The film reveals how this new genetic determinism provided an abhorrent rationale for state sanctioned crimes committed against America's poorest, most vulnerable citizens and for violations of the fundamental civil rights of untold millions.

Featuring interviews with social thinkers including Van Jones and Robert Reich as well as prominent scientists in many fields, A DANGEROUS IDEA is a radical reassessment of the meaning, use and misuse of gene science. Like no other film before it, this documentary brings to light how false scientific claims have rolled back long fought for gains in equality, and how powerful interests are poised once again to use the gene myth to unravel the American Dream.

DVD / 2017 / (Grades 10-12, College, Adult) / 106 minutes

BLUESPACE

Directed by Ian Cheney

Contrasts sci-fi ideas about terraforming Mars with the state of NYC's waterways, and questions the viability of colonizing Mars before making our own planet sustainable.

Could humans live on Mars? Would we want to? Emmy-nominated filmmaker, Ian Cheney, provides insight into our currently unsustainable relationship with our home planet by examining the sci-fi speculation of "terraforming," or making another planet Earth-like, by altering its atmosphere. He calls on a multifaceted brain trust to process this big idea including a desert camp of Mars hopefuls, a bevy of sci-fi writers, Hurricane Sandy survivors, the Gowanus Dredgers Canoe Club, and a who's who of astrobiologists and earth scientists. BLUESPACE makes a strong case for taking better care of our water-rich planet so that future generations won't have to resort to interplanetary colonization.

At times whimsical and funny, serious and poignant and always stimulating, this is a unique exploration of current thinking about the origins and evolution of life and its relationship to water.

DVD includes both the original 73- minute version of the film and a 54- minute classroom version.

DVD / 2016 / (Grades 10 -12, College, Adults) / 73 minutes

FUTURE OF WORK AND DEATH, THE

Directors: Sean Blacknell, Wayne Walsh

In this provocative documentary, worldwide experts in the fields of futurology, anthropology, neuroscience and philosophy consider the impact of technological advances on the two certainties of human life: work and death.

Charting human developments from early man, past the Industrial Revolution, to the digital age and beyond, The Future of Work and Death looks at the astonishing exponential rate at which mankind creates technologies to ease the process of living. As we embark on the next phase of our 'advancement,' with automation and artificial intelligence driving the transformation from man to machine, the film gives a shockingly realistic look into the future of human life.

Featuring a host of knowledgeable but endearingly eccentric experts including author Will Self, futurist Gray Scott, transhumanist Zoltan Istvan, and neuroscientist Rudolph Tanzi, The Future of Work and Death is profoundly insightful, often surprising, and always engaging.

DVD / 2016 / 89 minutes

ANTIBIOTIC HUNTERS, THE

Directed by Bruce Mohun

Scientists are hunting urgently for new antibiotics -- a challenge that is taking them to some remote and unusual places.

Increasing resistance to antibiotics has been called the most pressing global health problem of our time. Medical experts are predicting a post-antibiotic era, in which people will die of infections easily treated just a few years ago -- unless we find more of these miracle drugs.

THE ANTIBIOTIC HUNTERS follows drug researchers as they investigate the slimy green fur of sloths, the saliva of Komodo dragons, the blood of alligators, and the bacteria in British Columbia caves and on the ocean floor off the coast of Panama -- all part of the urgent hunt to find the building blocks of new antibiotics.

DVD / 2015 / (Grades 7-12, College, Adult) / 44 minutes

DEATH BY DESIGN

Directed by Sue Williams

Debunks the notion that electronics is a 'clean' industry by revealing the human and environmental cost of electronic gadgets that are designed to die.

Consumers love - and live on - their smartphones, tablets and laptops. A cascade of new devices pours endlessly into the market, promising even better communication, non-stop entertainment and instant information. The numbers are staggering. By 2020, four billion people will have a personal computer. Five billion will own a mobile phone.

But this revolution has a dark side that the electronics industry doesn't want you to see.

In an investigation that spans the globe, award-winning filmmaker Sue Williams investigates the underbelly of the international electronics industry and reveals how even the tiniest devices have deadly environmental and health costs.

DEATH BY DESIGN tells the stories of young Chinese workers laboring in unsafe conditions, American families living with the tragic consequences of the industry's toxic practices, activists leading the charge to hold brands accountable, and passionate entrepreneurs who are developing more sustainable products and practices to safeguard our planet and our future.

From the intensely secretive electronics factories in China, to the high tech innovation labs of Silicon Valley, DEATH BY DESIGN tells a story of environmental degradation, of health tragedies, and the fast-approaching tipping point between consumerism and sustainability.

DVD / 2015 / (Grades 7-9, College, Adults) / 73 minutes

PLANETARY

Directed by Guy Reid

A provocative and breathtaking wakeup call - a cross continental cinematic journey that explores our cosmic origins and our future as a species.

We are in the midst of a global crisis of perspective. We have forgotten the undeniable truth that every living thing is connected.

PLANETARY is a provocative and breathtaking wakeup call -- a cross continental, cinematic journey. The film takes us from one of the truly extraordinary events of our civilization, space travel, and looks at how this gave us a totally different perspective on the Earth. It is a humbling reminder of the near-incalculable breadth of our impact on the earth, intellectually challenges us to reconsider our relationship with our home and the urgency to shift our perspective -- to remember that we are planetary.

Featuring interviews with thirty renowned experts including astronauts Ron Garan and Mae Jemison, celebrated environmentalist Bill McKibben, National Book Award winner Barry Lopez, National Geographic Explorer Elizabeth Lindsey and Head of the Tibetan Buddhist Kagyu school, the 17th Karmapa, Janine Benyus, Wade Davis, Joanna Macy, PLANETARY takes viewers on a cinematic journey to experience our world like never before.

DVD / 2015 / (Grades 7-12, College, Adults) / 84 minutes

GROUNDSWELL RISING: PROTECTING OUR CHILDREN'S AIR AND WATER

Directed by Renard Cohen

Documents the opposition from both sides of the political spectrum to the ubiquitous practice of fracking for natural gas, and the health and environmental reasons behind it.

GROUNDSWELL RISING gives voice to ordinary folks engaged in a David and Goliath struggle against Big Oil and Gas. We meet parents, scientists, doctors, farmers and individuals across the political spectrum decrying the energy extraction process known as fracking that puts profits over people. This provocative documentary tracks a grassroots movement exposing dangers to clean air, water, and civil rights.

GROUNDSWELL RISING shows how fracking has contaminated drinking water and jeopardized health and quality of life. Homeowners near wells suffer from respiratory ailments and property devaluation. Reina Ripple, of Southwest Pennsylvania Environmental Health Project, chronicles mounting ailments related to fracking. A former industry employee shows skin lesions and edema obtained while working with fracking waste.

Grassroots efforts have achieved bans, moratoriums, and referendums on fracking. Stanford University Professor Mark Jacobson paves the way forward globally with his Solutions Project for 100% renewable energy. Transcending the genre of environmental film, GROUNDSWELL's passionate stories inspire and empower.

DVD / 2014 / (Grades 7-12, College, Adult) / 70 minutes

IRON MINISTRY, THE

By J.P. Sniadecki

Filmed over three years on China's railways, THE IRON MINISTRY traces the vast interiors of a country on the move: flesh and metal, clangs and squeals, light and dark, language and gesture. Scores of rail journeys come together into one, capturing the thrills and anxieties of social and technological transformation. THE IRON MINISTRY immerses audiences in fleeting relationships and uneasy encounters between humans and machines on what will soon be the world's largest railway network.

DVD (Color) / 2014 / 83 minutes

PARTING GIFT, A

Around the world, people donate their bodies to medical science and education. Unlike with organ donation, these donors gift their entire corpse to a medical school, and thus become silent teachers after their death in the hopes that somehow someone learns from their body what they can otherwise not learn from it while they were living.

A Parting Gift follows first-year medical students in the Anatomy Department at Dublin's Trinity College as their education is enriched by direct contact with donor remains. It provides a rare glimpse into the educational process and the emotional process students go through in preparation to learn from the deceased.

DVD / 2014 / 144 minutes

CERN

By Nikolaus Geyrhalter

Multi-award winning director Nikolaus Geyrhalter (HOMO SAPIENS, OUR DAILY BREAD, ELSEWHERE) delivers stunning imagery and fascinating insight into the largest particle physics laboratory in the world. Inside the immense Large Hadron Collider, operated by world-renowned research organization CERN (European Organization for Nuclear Research), the big bang scenario is recreated in search for the smallest particle.

Including interviews with the leading experts who operate and maintain this gigantic Big Bang machine, the film provides fascinating insights into this complex experimental research institution and the quirky geniuses behind the scenes.

For those who do not know a proton from a neutron, CERN provides a chance to learn more about physics from the best and brightest in the field.

Featuring some of the world's leading physicists, including: Beniamino Di Girolamo, Tatuso Kawamoto, Yves Schutz, Pauline Gagnon, and Christophe Grojean.

DVD (Color, Closed Captioned) / 2013 / 75 minutes

DRONES IN MY BACKYARD

Directed by Alan Snitow

How comfortable should Americans be with the growing use of drones by all segments of society?

DRONES IN MY BACKYARD is a funny and scary video mash-up about the coming of aerial drones to the United States.

One day a drone appears in the filmmaker's backyard, hovering over his head. It's the catalyst for an extended meditation and free association on the presence of drones in war-making, the role of drones in surveillance, and the thrill of flying when you put on goggles to see what the drone sees.

Whether it's the Predator, the Argus, or cute little Hummingbirds, drones of all shapes and sizes are flying to a rock and roll beat. We see them following us...and listen to the incessant buzzing of cameras overhead.

DVD / 2013 / (Grades 7-12, College, Adult) / 13 minutes

EXTREME BY DESIGN

Directed by Ralph King Jr. and Michael Schwarz

In a Stanford multidisciplinary, project-based course, student design teams are building a better world...one product at a time.

EXTREME BY DESIGN follows Stanford business, engineering and medical students as they work in teams, using design thinking methods, to develop products and services that serve the needs of the world's poor. One student team works on a breathing device to keep babies alive in Bangladesh. Another seeks a way to store drinking water in Indonesia. The third team project is to design an IV medicine infusion pump.

It's all part of the Design for Extreme Affordability course inspired and launched by the Stanford d.school. The film begins on the first day of the course and ends eight months later as one group of students returns to Asia to test their device amid plans to launch a startup.

At a time of unprecedented global challenges EXTREME BY DESIGN shows the power of human-centered design in creating innovative, effective and sustainable solutions to the complex problems facing us.

DVD / 2013 / (Grades 6-12, College, Adult) / 57 minutes

LIFE APPS: FAVELA FARM (BRAZIL)

Directed by Rodrigo Mac Niven

In Brazil can Pedro build a Life App to help the secret world of urban farms and gardens in Rio's shanty towns?

Pedro is part of a collective of young people in Rio de Janeiro working on new mobile phone technology. Social network apps can serve a dual purpose: They can increase awareness about a cause, and enable users to take action. Social apps help users feel they're making a difference. Pedro goes to Rio and meets Cadu and Dinho, who work on community projects in the Mare and Alemao favelas.

The massive and uncontrolled growth of favelas is a major environmental issue in Rio. In Alemao and Mare alone there are more than 200,000 people, with few proper facilities. Cadu and Dinho are taking Pedro to meet young people from Rio's North Zone, learn about their lives, and research the possibilities for a new "Life App" that can help with green business initiatives in the favela community.