AnatomyDiseasesChemicals and DrugsAnalytical, Diagnostic and Therapeutic Techniques and EquipmentPsychiatry and PsychologyPhenomena and ProcessesAnthropology, Education, Sociology and Social PhenomenaTechnology, Industry, AgricultureHumanitiesInformation ScienceNamed GroupsHealth Care
Surgical MeshHernia, AbdominalPolypropylenesUrinary Incontinence, StressPelvic Organ ProlapseUterine ProlapseSuburethral SlingsPelvic FloorUrinary IncontinenceLawyersHernia, InguinalHerniaEquipment and SuppliesDevice ApprovalShort-Wave TherapyDefibrillators, ImplantableEquipment SafetyPatents as TopicMedical Device LegislationHernia, VentralHernia, DiaphragmaticHerniorrhaphyPolymersAbsorbable ImplantsHydrophobic and Hydrophilic InteractionsSuturesLaryngoplastyPolydioxanoneProfessional CompetenceDental ArticulatorsLasersGift GivingLasers, SemiconductorConflict of InterestInterior Design and FurnishingsFloors and FloorcoveringsTripletsFingersFetal MortalityQuintupletsProstheses and ImplantsSurgical StaplingDental ImplantsDrug ImplantsImplants, ExperimentalBreast ImplantsCounterfeit DrugsFraudThoracic WallThoracoplastyBone ScrewsBiocompatible MaterialsBone and BonesOsseointegrationFracture Fixation, Internal
Surgical Mesh: Any woven or knit material of open texture used in surgery for the repair, reconstruction, or substitution of tissue. The mesh is usually a synthetic fabric made of various polymers. It is occasionally made of metal.Hernia, Abdominal: A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.Polypropylenes: Propylene or propene polymers. Thermoplastics that can be extruded into fibers, films or solid forms. They are used as a copolymer in plastics, especially polyethylene. The fibers are used for fabrics, filters and surgical sutures.Urinary Incontinence, Stress: Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.Pelvic Organ Prolapse: Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.Uterine Prolapse: Downward displacement of the UTERUS. It is classified in various degrees: in the first degree the UTERINE CERVIX is within the vaginal orifice; in the second degree the cervix is outside the orifice; in the third degree the entire uterus is outside the orifice.Suburethral Slings: Support structures, made from natural or synthetic materials, that are implanted below the URETHRA to treat URINARY STRESS INCONTINENCE.Pelvic Floor: Soft tissue formed mainly by the pelvic diaphragm, which is composed of the two levator ani and two coccygeus muscles. The pelvic diaphragm lies just below the pelvic aperture (outlet) and separates the pelvic cavity from the PERINEUM. It extends between the PUBIC BONE anteriorly and the COCCYX posteriorly.Urinary Incontinence: Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE.Lawyers: Persons whose profession is to give legal advice and assistance to clients and represent them in legal matters. (American Heritage Dictionary, 3d ed)Hernia, Inguinal: An abdominal hernia with an external bulge in the GROIN region. It can be classified by the location of herniation. Indirect inguinal hernias occur through the internal inguinal ring. Direct inguinal hernias occur through defects in the ABDOMINAL WALL (transversalis fascia) in Hesselbach's triangle. The former type is commonly seen in children and young adults; the latter in adults.Hernia: Protrusion of tissue, structure, or part of an organ through the bone, muscular tissue, or the membrane by which it is normally contained. Hernia may involve tissues such as the ABDOMINAL WALL or the respiratory DIAPHRAGM. Hernias may be internal, external, congenital, or acquired.Equipment and Supplies: Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.Device Approval: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.Short-Wave Therapy: The use of focused short radio waves to produce local hyperthermia in an injured person or diseased body area.Defibrillators, Implantable: Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes.Equipment Safety: Freedom of equipment from actual or potential hazards.Patents as Topic: Exclusive legal rights or privileges applied to inventions, plants, etc.Medical Device Legislation: Laws and regulations pertaining to devices used in medicine, proposed for enactment, or enacted by a legislative body.Hernia, Ventral: A hernia caused by weakness of the anterior ABDOMINAL WALL due to midline defects, previous incisions, or increased intra-abdominal pressure. Ventral hernias include UMBILICAL HERNIA, incisional, epigastric, and spigelian hernias.Hernia, Diaphragmatic: Protrusion of abdominal structures into the THORAX as a result of congenital or traumatic defects in the respiratory DIAPHRAGM.Herniorrhaphy: Surgical procedures undertaken to repair abnormal openings through which tissue or parts of organs can protrude or are already protruding.Polymers: Compounds formed by the joining of smaller, usually repeating, units linked by covalent bonds. These compounds often form large macromolecules (e.g., BIOPOLYMERS; PLASTICS).Absorbable Implants: Implants constructed of materials designed to be absorbed by the body without producing an immune response. They are usually composed of plastics and are frequently used in orthopedics and orthodontics.Hydrophobic and Hydrophilic Interactions: The thermodynamic interaction between a substance and WATER.Sutures: Materials used in closing a surgical or traumatic wound. (From Dorland, 28th ed)Laryngoplasty: Restoration, reconstruction, or improvement of a defective or damaged LARYNX.Polydioxanone: An absorbable suture material used also as ligating clips, as pins for internal fixation of broken bones, and as ligament reinforcement for surgically managed ligament injuries. Its promising characteristics are elasticity, complete biodegradability, and lack of side effects such as infections.Professional Competence: The capability to perform the duties of one's profession generally, or to perform a particular professional task, with skill of an acceptable quality.Dental Articulators: Mechanical devices that simulate the temporomandibular joints and jaws to which maxillary and mandibular casts are attached. The entire assembly attempts to reproduce the movements of the mandible and the various tooth-to-tooth relationships that accompany those movements.Lasers: An optical source that emits photons in a coherent beam. Light Amplification by Stimulated Emission of Radiation (LASER) is brought about using devices that transform light of varying frequencies into a single intense, nearly nondivergent beam of monochromatic radiation. Lasers operate in the infrared, visible, ultraviolet, or X-ray regions of the spectrum.Gift Giving: The bestowing of tangible or intangible benefits, voluntarily and usually without expectation of anything in return. However, gift giving may be motivated by feelings of ALTRUISM or gratitude, by a sense of obligation, or by the hope of receiving something in return.Lasers, Semiconductor: Lasers with a semiconductor diode as the active medium. Diode lasers transform electric energy to light using the same principle as a light-emitting diode (LED), but with internal reflection capability, thus forming a resonator where a stimulated light can reflect back and forth, allowing only a certain wavelength to be emitted. The emission of a given device is determined by the active compound used (e.g., gallium arsenide crystals doped with aluminum or indium). Typical wavelengths are 810, 1,060 and 1,300 nm. (From UMDNS, 2005)Conflict of Interest: A situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict.Interior Design and Furnishings: The planning of the furnishings and decorations of an architectural interior.Floors and Floorcoverings: The surface of a structure upon which one stands or walks.Triplets: Three individuals derived from three FETUSES that were fertilized at or about the same time, developed in the UTERUS simultaneously, and born to the same mother.Fingers: Four or five slender jointed digits in humans and primates, attached to each HAND.Fetal Mortality: Number of fetal deaths with stated or presumed gestation of 20 weeks or more in a given population. Late fetal mortality is death after of 28 weeks or more.Quintuplets: Five individuals derived from five FETUSES that were fertilized at or about the same time, developed in the UTERUS simultaneously, and born to the same mother.Prostheses and Implants: Artificial substitutes for body parts, and materials inserted into tissue for functional, cosmetic, or therapeutic purposes. Prostheses can be functional, as in the case of artificial arms and legs, or cosmetic, as in the case of an artificial eye. Implants, all surgically inserted or grafted into the body, tend to be used therapeutically. IMPLANTS, EXPERIMENTAL is available for those used experimentally.Surgical Stapling: A technique of closing incisions and wounds, or of joining and connecting tissues, in which staples are used as sutures.Dental Implants: Biocompatible materials placed into (endosseous) or onto (subperiosteal) the jawbone to support a crown, bridge, or artificial tooth, or to stabilize a diseased tooth.Drug Implants: Small containers or pellets of a solid drug implanted in the body to achieve sustained release of the drug.Implants, Experimental: Artificial substitutes for body parts and materials inserted into organisms during experimental studies.Breast Implants: Implants used to reconstruct and/or cosmetically enhance the female breast. They have an outer shell or envelope of silicone elastomer and are filled with either saline or silicone gel. The outer shell may be either smooth or textured.Counterfeit Drugs: Drugs manufactured and sold with the intent to misrepresent its origin, authenticity, chemical composition, and or efficacy. Counterfeit drugs may contain inappropriate quantities of ingredients not listed on the label or package. In order to further deceive the consumer, the packaging, container, or labeling, may be inaccurate, incorrect, or fake.Fraud: Exploitation through misrepresentation of the facts or concealment of the purposes of the exploiter.Thoracic Wall: The outer margins of the thorax containing SKIN, deep FASCIA; THORACIC VERTEBRAE; RIBS; STERNUM; and MUSCLES.Thoracoplasty: Surgical removal of ribs, allowing the chest wall to move inward and collapse a diseased lung. (Dorland, 28th ed)Bone Screws: Specialized devices used in ORTHOPEDIC SURGERY to repair bone fractures.Biocompatible Materials: Synthetic or natural materials, other than DRUGS, that are used to replace or repair any body TISSUES or bodily function.Bone and Bones: A specialized CONNECTIVE TISSUE that is the main constituent of the SKELETON. The principle cellular component of bone is comprised of OSTEOBLASTS; OSTEOCYTES; and OSTEOCLASTS, while FIBRILLAR COLLAGENS and hydroxyapatite crystals form the BONE MATRIX.Osseointegration: The growth action of bone tissue as it assimilates surgically implanted devices or prostheses to be used as either replacement parts (e.g., hip) or as anchors (e.g., endosseous dental implants).Fracture Fixation, Internal: The use of internal devices (metal plates, nails, rods, etc.) to hold the position of a fracture in proper alignment.
AnatomyDiseasesChemicals and DrugsAnalytical, Diagnostic and Therapeutic Techniques and EquipmentPsychiatry and PsychologyPhenomena and ProcessesAnthropology, Education, Sociology and Social PhenomenaTechnology, Industry, AgricultureHumanitiesInformation ScienceNamed GroupsHealth Care
Surgical MeshHernia, AbdominalPolypropylenesUrinary Incontinence, StressPelvic Organ ProlapseUterine ProlapseSuburethral SlingsPelvic FloorUrinary IncontinenceLawyersHernia, InguinalHerniaEquipment and SuppliesDevice ApprovalShort-Wave TherapyDefibrillators, ImplantableEquipment SafetyPatents as TopicMedical Device LegislationHernia, VentralHernia, DiaphragmaticHerniorrhaphyPolymersAbsorbable ImplantsHydrophobic and Hydrophilic InteractionsSuturesLaryngoplastyPolydioxanoneProfessional CompetenceDental ArticulatorsLasersGift GivingLasers, SemiconductorConflict of InterestInterior Design and FurnishingsFloors and FloorcoveringsTripletsFingersFetal MortalityQuintupletsProstheses and ImplantsSurgical StaplingDental ImplantsDrug ImplantsImplants, ExperimentalBreast ImplantsCounterfeit DrugsFraudThoracic WallThoracoplastyBone ScrewsBiocompatible MaterialsBone and BonesOsseointegrationFracture Fixation, Internal
Implant (medicine)Implant (medicine)
... surgical mesh, and penile prosthesis. Medical devices are classified by the US Food and Drug Administration (FDA) under three ... Class I devices include simple devices such as arm slings and hand-held surgical instruments. Class II devices are considered ... Biofunctionalisation Implantable devices List of orthopedic implants Medical device Prosthesis Wong, J.Y.; Bronzino, J.D.; ... The process of implantation of medical devices is subjected to the same complications that other invasive medical procedures ...
Stryker CorporationStryker Corporation
Medical); and reprocessed and remanufactured medical devices as well as other medical device products used in a variety of ... Stryker segregates their reporting into three reportable business segments: Orthopedics, Medical and Surgical (MedSurg), and ... a company developing a flow diversion stent technology to treat brain aneurysms using a mesh design and delivery system, for $ ... neurovascular and spinal devices; as well as other medical device products used in a variety of medical specialties. In the ...
PolyhydroxyalkanoatesPolyhydroxyalkanoates
... surgical mesh, repair patches, slings, cardiovascular patches, orthopedic pins (including bone.lling augmentation material), ... articular cartilage repair devices, nerve guides, tendon repair devices, atrial septal defect repair devices, pericardial ... There are potential applications for PHA produced by micro-organisms within the medical and pharmaceutical industries, ... Fixation and orthopaedic applications have included sutures, suture fasteners, meniscus repair devices, rivets, tacks, staples ...
CellinkCellink
... on developing cellulose based medical implants for applications such as meniscus/cartilage repair as well as surgical meshes. ... Erik Gatenholm, co-founder and CEO of Cellink, started his first biomedical device company known as BC Genesis at age 18 in ...
Implant (medicine)Implant (medicine)
Class I devices include simple devices such as arm slings and hand-held surgical instruments. Class II devices are considered ... International Medical Devices Database - Recalls, Safety Alerts and Field Safety Notices of medical devices - International ... "Three-year results from a preclinical implantation study of a long-term resorbable surgical mesh with time-dependent mechanical ... "Classify Your Medical Device". FDA.gov/MedicalDevices. Food and Drug Administration. 29 July 2014. Retrieved 12 March 2016.. ...
Ethicon Inc.Ethicon Inc.
Perriello, Brad (22 May 2014). "J&J's pipeline includes 30 'major' medical devices and a surgical robot". MassDevice. Retrieved ... This further escalated when, in 2011, the agency received more than 1,000 adverse effect reports from surgical mesh ... Ethicon has manufactured surgical sutures and wound closure devices since 1887. After World War II, Ethicon's market share in ... "Ethicon Gynecare Prolift Mesh - Vaginal Mesh Lawsuit". Girard Gibbs. Retrieved 1 October 2017. "Week Ahead in Health: March 2, ...
Surgical meshSurgical mesh
"Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence". Medical Devices Safety Communications ... Also, most published research reports reference meshes that are currently removed from the medical device market due to ... Experimentation may find differing outcomes for some meshes. The primary function of surgical mesh is to support prolapsed ... Surgical mesh may also be used for pelvic or vaginal wall reconstructions in women and is implemented to add as a growth guide ...
Freddy BoeyFreddy Boey
2 November 2011 First joint venture medical device released by NTU and Insightra Medical Inc. Medical News Today, 18 October ... microfluidic and biomedical devices a coronary stent with drug release capability, a hernia mesh and cardiac peptides for ... such as a surgical tissue retractor which was licensed to Insightra Medical Inc., Irvine, California, and sold in the United ... Boey's research areas are in functional biomaterials for medical devices, nanomaterials and nanostructures for cell ...
List of MeSH codes (J01)List of MeSH codes (J01)
... surgical MeSH J01.637.708.600.700 --- space suits MeSH J01.637.708.700 --- respiratory protective devices MeSH J01.637.708.800 ... maps MeSH J01.897.280.500.480 --- medical illustration MeSH J01.897.280.500.545 --- models, structural MeSH J01.897.280.500. ... lacquer MeSH J01.637.650 --- paper MeSH J01.637.708 --- protective devices MeSH J01.637.708.100 --- air bags MeSH J01.637. ... eye protective devices MeSH J01.637.708.380 --- head protective devices MeSH J01.637.708.500 --- masks MeSH J01.637.708.500.450 ...
Novus ScientificNovus Scientific
Jude Medical, Inc". sjm.com. "Three-year results from a preclinical implantation study of a long-term resorbable surgical mesh ... Jude Medical. The hemostasis division of Radi Medical was responsible for the development of a resorbable polymer seal device ... Matrix Surgical Mesh is a 100 percent resorbable (100% absorbable), synthetic mesh, knitted from two different resorbable ... Novus Scientific was founded in 2008 by the medical device entrepreneur Thomas Engström upon the sale of his previous company ...
Dennis FowlerDennis Fowler
1998 Comparison of Two Composite Meshes using Two Fixation Devices in a Porcine Laparoscopic Ventral Hernia Repair Model. Duffy ... He is a pioneer in the field of endoscopic surgery and has been the first to perform numerous innovative laparoscopic surgical ... Dennis L. Fowler is the Vice President and Medical Director for Perioperative Services at NewYork-Presbyterian Hospital/ ... a device that uses wave frequency (instead of electric current) to divide the tissue and vibration to coagulate blood vessels ( ...
Ulrich SigwartUlrich Sigwart
... spring-like devices made of surgical steel. Sigwart's work made angioplasty predictable which significantly improved the ... He had his medical education in Freiburg (Germany), Basel (Switzerland) and Munster (Germany). After some years in the U.S. ( ... Self expanding mesh stent Andreas Gruentzig had already recognized the problem of abrupt closure and restenosis after ... Following reassuring animal work with self expanding mesh stents in Lausanne Sigwart reported the first human implants of such ...
Uterine prolapseUterine prolapse
This is a mesh-augmented procedure in which the apex of the vagina is attached to the sacrum by a piece of medical mesh ... Surgical options are many and may include a hysterectomy or a uterus-sparing technique such as laparoscopic hysteropexy, ... Bugge, Carol (28 February 2013). "Pessaries (mechanical devices) for pelvic organ prolapse in women". Cochrane Library. doi: ... The evidence does not support use of transvaginal mesh compared to native tissue repair for apical vaginal prolapse. The use of ...
BiomeshBiomesh
Biologic mesh (or biomesh) is a type of surgical mesh made from an organic biomaterial (such as porcine dermis, porcine small ... 2012). "Chapter 6: Prosthetics and fixations devices". Endoscopic Repair of Abdominal Wall Hernias (2nd ed.). Delhi, India: ... New Delhi, India: Jaypee Brothers Medical Publishers. pp. 109-124. ISBN 9789350253021. Retrieved 16 March 2016. Saettele TM, ... The idea of using organic materials for surgical mesh has been around since at least the late 1950s, though researchers soon ...
Sidney YankauerSidney Yankauer
Yankauer devised a suction device for the mouth known as the Yankauer suction tip. The device remains in use in modern medical ... Yankauer helped to design several varieties of wire-mesh anesthesia masks, which were known as the Yankauer mask, the Yankauer- ... PMC 2096187 . Boyd, Carl (January 24, 2013). Echoes from the Operating Room: Vignettes in Surgical History. Trafford Publishing ... A common medical suction device, the Yankauer suction tip, is named for him. Yankauer was born in New York. His parents were ...
LysostaphinLysostaphin
Once a "Staphylococcal" biofilm has formed on an implanted medical device, it is difficult to disrupt due to its antibiotic ... therefore eliminating the need for surgical removal of the infected device. Kokai-Kun JF, Walsh SM, Chanturiya T, Mond JJ (May ... M23.004 Lysostaphin at the US National Library of Medicine Medical Subject Headings (MeSH) EC 3.4.24.75 Molecular and Cellular ... particularly those with implantable devices. Staphylococci cause a significant percentage of device infections, and like many ...
Management of heart failureManagement of heart failure
The STICH trial (Surgical Treatment for IschemiC Heart Failure) will examine the role of medical treatment, coronary artery ... Mesh-like constraint devices such as the Acorn CorCap aim to improve contraction efficacy and prevent further remodeling. ... October 2003). "Global surgical experience with the Acorn cardiac support device". J. Thorac. Cardiovasc. Surg. 126 (4): 983-91 ... has led to the development of alternative surgical approaches to heart failure. These commonly involve surgical left ...
Stress incontinenceStress incontinence
This new device is composed of an 8 cm long laser cut polypropylene mesh and is introduced to the internal obturator muscle ( ... A pessary is a medical device that is inserted into the vagina. The most common kind is ring shaped, and is typically ... Many surgical options have high rates of success. A Cochrane Review of studies found that the less-invasive variants of the ... as patients allege long-term harm and suffering as a result of implanted mesh.[unreliable medical source?] The tension-free ...
MimicsMimics
... has been adopted by biomedical engineers and device manufacturers for R&D purposes in various medical industries: ... Surgical simulation Image import from CT (DICOM) Image segmentation 3D model 3D modeling 3D Slicer Computer representation of ... a design and meshing software for anatomical data. The current version is 20.0, it supports Windows 10, Windows 7, Vista and XP ... Also non-medical industries like materials science use Mimics in image-based R&D. Materialise Mimics is a platform to bridge ...
Atrial septal defectAtrial septal defect
"Device Closure Versus Medical Therapy Alone for Patent Foramen Ovale in Patients With Cryptogenic Stroke". Annals of Internal ... to 0.005-inch Nitinol wire mesh filled with Dacron fabric. Implantation of the device is relatively easy. The prevalence of ... Surgical closure of an ASD involves opening up at least one atrium and closing the defect with a patch under direct ... An example of a percutaneous device is a device which has discs that can expand to a variety of diameters at the end of the ...
Prostatic stentProstatic stent
Although a permanent prostatic stent is not a medical treatment, it falls under the classification of a surgical procedure. ... The braided mesh is designed to expand radially, applying constant gentle pressure to hold open the sections of the urethra ... The prostatic stent is a completely internal device and can be inserted and removed as easily as a Foley catheter. It permits ... Their fixed diameter limits subsequent endoscopic surgical options. They can be placed in less than 15 minutes in a manner ...
CovidienCovidien
... and United States Surgical Corporation (U.S. Surgical), which provided suture and auto suture devices, along with energy-based ... from advanced surgical technologies to general surgical products: Stapling Vessel Sealing Fixation Mesh Hardware Interventional ... Wound Care Incontinence Enteral Feeding Urology Medical Surgical SharpSafety OEM Surgical solutions: Tri-Staple Clearify ... A number of other medical device companies eventually came together with the Kendall Company to form the foundation for ...
Route of administrationRoute of administration
Perivascular medical devices and drug delivery systems: Making the right choices. Biomaterials 128, 56-68 "Vancocin". The ... Textbook of Medical-Surgical Nursing, 9th ed, Philadelphia: Lippincott, 2000. Lavik, E. and R. Langer, Tissue engineering; ... MeSH). ... Proper technique with inhaler devices is necessary to achieve ... perivascular administration (perivascular medical devices and perivascular drug delivery systems are conceived for local ...
MyiasisMyiasis
Although maggot therapy has been used in the US for the past 80 years, it was approved by the FDA as a medical device only in ... Medicinal maggots are placed on the wound and covered with a sterile dressing of gauze and nylon mesh. Too many larvae placed ... and traumatic and post-surgical wounds that are unresponsive to conventional therapies. Maggots were used in medicine before ... Monarch Labs also sells maggots to hospitals and other medical practices, the first US commercial supplier to do so since the ...
Patent ductus arteriosusPatent ductus arteriosus
... a PDA occluder device[citation needed], composed of nitinol mesh, is deployed from the pulmonary artery through the PDA. If ... while symptomatic PDA can be treated with both surgical and non-surgical methods. Surgically, the DA may be closed by ligation ... fa.hms.harvard.edu, Robert E. Gross, Harvard Medical School Office for Faculty Affairs. Patent Ductus Arteriosus (PDA) - ... Devices developed by Franz Freudenthal block the blood vessel with woven structures of nitinol wire. Because prostaglandin E2 ...
Positron emission tomographyPositron emission tomography
PET is both a medical and research tool. It is used heavily in clinical oncology (medical imaging of tumours and the search for ... These are detected when they reach a scintillator in the scanning device, creating a burst of light which is detected by ... Khan, FR; Henderson, JM (2013). "Deep Brain Stimulation Surgical Techniques". In Lozano, AM; Hallet, M (eds.). Brain ... MeSH. D049268. OPS-301 code. 3-74. MedlinePlus. 003827. [edit on Wikidata] ...
AnatomyDiseasesChemicals and DrugsAnalytical, Diagnostic and Therapeutic Techniques and EquipmentPsychiatry and PsychologyPhenomena and ProcessesAnthropology, Education, Sociology and Social PhenomenaTechnology, Industry, AgricultureHumanitiesInformation ScienceNamed GroupsHealth Care
Surgical MeshHernia, AbdominalPolypropylenesUrinary Incontinence, StressPelvic Organ ProlapseUterine ProlapseSuburethral SlingsPelvic FloorUrinary IncontinenceLawyersHernia, InguinalHerniaEquipment and SuppliesDevice ApprovalShort-Wave TherapyDefibrillators, ImplantableEquipment SafetyPatents as TopicMedical Device LegislationHernia, VentralHernia, DiaphragmaticHerniorrhaphyPolymersAbsorbable ImplantsHydrophobic and Hydrophilic InteractionsSuturesLaryngoplastyPolydioxanoneProfessional CompetenceDental ArticulatorsLasersGift GivingLasers, SemiconductorConflict of InterestInterior Design and FurnishingsFloors and FloorcoveringsTripletsFingersFetal MortalityQuintupletsProstheses and ImplantsSurgical StaplingDental ImplantsDrug ImplantsImplants, ExperimentalBreast ImplantsCounterfeit DrugsFraudThoracic WallThoracoplastyBone ScrewsBiocompatible MaterialsBone and BonesOsseointegrationFracture Fixation, Internal
Jacksonville - Dow Corning Breast Implant Lawyer HelplineJacksonville - Dow Corning Breast Implant Lawyer Helpline
Vaginal mesh lawsuit Cook Medical Surgical will be the fifth MDL. Call our new Transvaginal mesh Lawsuit Lawyers help ... Drugs and Devices Harming Women, VaginaL Mesh, Mirena IUD, And Others. Written by lisaspitzer on February 1, 2013. . Posted in ... What Is The Vaginal Mesh Or Bladder Sling?. Prolene mesh is a medical implant used to reinforce weakened or damaged pelvic ... Pelvic mesh lawsuits have become the next big massive run of lawsuits for women injured by these devices. This looks like it ...
breastimplanthelpline.com
Surgical mesh: Defenders shine a light on yet another dangerous medical device | kvue.comSurgical mesh: Defenders shine a light on yet another dangerous medical device | kvue.com
... researchers and medical device companies speak at an FDA hearing about vaginal mesh devices after thousands report problems. ... medical-device-dangers Surgical mesh: Defenders shine a light on yet another dangerous medical device. Women, doctors, ... If you have had experiences with medical device dangers, we encourage you to join the Medical Device Dangers Facebook group. ... an improved medical device registry and legislation to help patients harmed by medical devices seek damages from the device ...
kvue.com
Transvaginal Mesh Injuries: Surgical Mesh Attorney, pelvic organ prolapse (POP), stress urinary incontinence (SUI),...Transvaginal Mesh Injuries: Surgical Mesh Attorney, pelvic organ prolapse (POP), stress urinary incontinence (SUI),...
Issues caused by surgical mesh used tranvaginally include erosion of the mesh through the vagina, mesh contraction or shrinkage ... Are you suffering devestating side-effects after undergoing surgery involving mesh? ... Are you suffering complications as a result surgical mesh? Do you have questions? Concerns? Speak to a medical device attorney ... Mesh also boosts the growth of healthy tissue. Patches, light mesh, light plugs, and surgical grafts are types of mesh used ...
gpwlaw.com
Hernia Surgical Mesh Attorney | Defective Medical Device LawyerHernia Surgical Mesh Attorney | Defective Medical Device Lawyer
If you or a loved one has suffered serious complications and/or additional surgery as a result of a Hernia Surgical Mesh ... Some surgical procedures used to treat hernias employ surgical mesh.. Mesh is made of synthetic materials or animal tissue. It ... Complications from Hernia Surgical Mesh. The use of hernia surgical mesh has led to complications in many patients. Even when ... Have You Experienced Complications from Hernia Surgical Mesh?. Whether youve been diagnosed with surgical mesh complications ...
pbmattorneys.com
50 From Surgical Mesh to DBS - Medical Devices in the 21st Century | Raw Talk Podcast50 From Surgical Mesh to DBS - Medical Devices in the 21st Century | Raw Talk Podcast
50 From Surgical Mesh to DBS - Medical Devices in the 21st Century. ... Medical devices, such as brain-computer interfaces and insulin pumps, have dramatically changed the landscape of the medical ... and controversy surrounding medical devices. We also spoke to two students - George Hanna, a Master of Applied Science and ... who are in the process of designing novel devices to help mobilize people with disabilities and make laparoscopic surgery safer ...
rawtalkpodcast.com
Patent US20050283229 - Coatings for controlling erosion of a substrate of an implantable medical device - Google PatentsPatent US20050283229 - Coatings for controlling erosion of a substrate of an implantable medical device - Google Patents
An implantable medical device, such as a stent, with a coating region for controlling erosion of the substrate region is ... Surgical repair mesh. US4718907 *. 20 Jun 1985. 12 Jan 1988. Atrium Medical Corporation. Vascular prosthesis having fluorinated ... Orbusneich Medical, Inc.. Bioabsorbable medical device with coating. US9220820. 16 Jul 2013. 29 Dec 2015. Atrium Medical ... Atrium Medical Corporation. Coated surgical mesh. US8637111. 6 Sep 2012. 28 Jan 2014. Abbott Cardiovascular Systems Inc.. ...
google.ca
Patent US20020042658 - Hernia repair mesh prosthesis, and method of using same - Google PatentsPatent US20020042658 - Hernia repair mesh prosthesis, and method of using same - Google Patents
The flexible mesh material may be of propylene or other suitable materials, the central portion has an enhanced strength, such ... being a substantially planar member formed of flexible mesh material; the support portions being foldable relative to the ... as being formed of two layers of the mesh material, and the central portion may be stretchable to absorb greater forces imposed ... Mpathy Medical Devices Limited. Surgical implant. US7789821. 8 Aug 2005. 7 Sep 2010. Gyne Ideas Ltd.. Apparatus and method for ...
google.ca
Patente US20050232971 - Biodegradable polymers for use with implantable medical devices - Google PatentesPatente US20050232971 - Biodegradable polymers for use with implantable medical devices - Google Patentes
... hydrophobic polymer containing water-labile bonds such that a device fabricated of the composition or the surface of a device ... Atrium Medical Corporation. Coated surgical mesh. US8591932. 17 Sep 2009. 26 Nov 2013. W. L. Gore & Associates, Inc.. Heparin ... Atrium Medical Corporation. Method of coating a folded medical device. US20060121081 *. 28 Sep 2005. 8 Jun 2006. Atrium Medical ... Atrium Medical Corporation. Method of coating a folded medical device. US8312836. 30 Jul 2008. 20 Nov 2012. Atrium Medical ...
google.es
Patente US7875283 - Biodegradable polymers for use with implantable medical devices - Google PatentesPatente US7875283 - Biodegradable polymers for use with implantable medical devices - Google Patentes
... hydrophobic polymer containing water-labile bonds such that a device fabricated of the composition or the surface of a device ... Surgical repair mesh. US4656083. 11 Mar 1985. 7 Abr 1987. Washington Research Foundation. Plasma gas discharge treatment for ... and coated medical devices. US6093463. 20 Mar 1998. 25 Jul 2000. Intella Interventional Systems, Inc.. Medical devices made ... Coated implantable medical device. US6096525. 26 Nov 1997. 1 Ago 2000. Meadox Medicals, Inc.. Bonding bio-active materials to ...
google.es
Surgical Mesh Maker to Phase Out Defective Medical Device - Massachusetts Injury Lawyer Blog - June 18, 2012Surgical Mesh Maker to Phase Out Defective Medical Device - Massachusetts Injury Lawyer Blog - June 18, 2012
Johnson announces it will no longer be making surgical mesh. - June 18, 2012 ... "Boston medical device recall lawyer", "Boston product liability lawyers", "surgical mesh", "transvaginal surgical mesh", ... Surgical Mesh Maker to Phase Out Defective Medical Device. by Breakstone, White & Gluck ... Gluck are experienced in handling cases involving defective medical devices, including surgical mesh and hip implants. If you ...
massachusettsinjurylawyerblog.com
Protein Expert Witnesses | ForensisGroup ConsultingProtein Expert Witnesses | ForensisGroup Consulting
Complications Following Surgical Mesh Medical Devices. * Can a Party Reimburse Expert Witness Fees for Deposing its Own Expert? ... My expertise includes medical devices, medical implants, surgical implants, surgical devices, biomechanics, biological tissues ... surgical infections, surgical complications, ecmo, ventricular assist devices, transplantation, surgical ethics, pulmonary ... Medical Devices Expert Witness TX 345649. Expertise Description. I have more than 15 years experience in Bio-medical ...
forensisgroup.com
Thrombosis Expert Witnesses | ForensisGroup Expert ConsultingThrombosis Expert Witnesses | ForensisGroup Expert Consulting
Complications Following Surgical Mesh Medical Devices. * Can a Party Reimburse Expert Witness Fees for Deposing its Own Expert? ... surgical infections, surgical complications, ecmo, ventricular assist devices, transplantation, surgical ethics, pulmonary ... Associate director of medical school hematology curriculum at USC Keck school of medicine. Active research in MDS ( ... Currently, I am the Director for two departments, Hematology-Oncology and Pediatrics, for a major medical center in Southern ...
forensisgroup.com
Louisville Personal Injury Attorney | Dangerous Drugs And Medical Devices BlogLouisville Personal Injury Attorney | Dangerous Drugs And Medical Devices Blog
Gain insight into Louisville personal injury claims by reading about Dangerous Drugs And Medical Devices in Brett H. ... Hernia Surgical Mesh Implants. 2017-02-07. Posted By Brett H. Oppenheimer, PLLC ... Dangerous Drugs And Medical Devices Recent Posts in Dangerous Drugs And Medical Devices Category. * Zostavax and Shingles. 2018 ... The Liability of Hospitals and Doctors Printing 3D Medical Devices. 2017-05-31. Posted By Brett H. Oppenheimer, PLLC ...
bluegrassinjury.com
Defenders: Johnson & Johnson pays $117M to settle surgical mesh suit | wfaa.comDefenders: Johnson & Johnson pays $117M to settle surgical mesh suit | wfaa.com
The company agreed to pay Texas and 40 others states to settle allegations that it deceptively marketed transvaginal surgical ... medical-device-dangers Defenders: Johnson & Johnson pays $117M to settle surgical mesh suit. The company agreed to pay Texas ... Surgical mesh: Defenders shine a light on yet another dangerous medical device ... 117 million to resolve allegations that it deceptively marketed transvaginal surgical mesh devices. ...
wfaa.com
medical equipment industry - Express Press Release Distributionmedical equipment industry - Express Press Release Distribution
Surgical Mesh - Medical Devices Pipeline Assessment: Post-Operative Complications Trigger Refurbishments. 2019-03-04 // 0 ... medical equipment industry. Ultrasound Systems- Medical Devices Stage of development, Pipeline Products by Segment 2019. 2019- ... Medical & Surgical Lasers: Companies Bank upon M & A Strategies for Pipeline Enhancement. 2019-03-04 // 0 Comments ... Ablation Equipments - Medical Devices Pipeline Assessment Report Review, Major Players and Product Overview, 2019. 2019-02-25 ...
express-press-release.net
Healthcare Life Sciences - Marketing, Compliance, and Pharmaceutical - Medical Devices - www.hcpro.comHealthcare Life Sciences - Marketing, Compliance, and Pharmaceutical - Medical Devices - www.hcpro.com
... and creative training methods to educate staff members to comply with regulations governing pharmaceutical and medical device ... FDA issues public health watch for transvaginal placement of surgical mesh * Device Regulation Alert: Safety, Compliance and ... Medical Devices Device maker settles allegations it failed to disclose payments to physicians * Device Regulation Alert: Safety ... Former medical device manager pleads guilty to misbranding * Device Regulation Alert: Safety, Compliance and Reimbursement News ...
hcpro.com
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device...Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device...
... from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. ... These include devices such as catheters and surgical mesh. Because of the shutdown of the Sterigenics Willowbrook facility and ... medical device manufacturers and other government agencies-to identify innovative ways to sterilize medical devices that dont ... Certain medical devices need to be sterilized to reduce the risk of those devices causing infections in patients from living ...
fda.gov
Suffering in Silence: Denise Jacobs on Surgical Mesh an unreasonable and substantial risk of illness or injury - Mesh Medical...Suffering in Silence: Denise Jacobs on Surgical Mesh 'an unreasonable and substantial risk of illness or injury' - Mesh Medical...
Im National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 ... This meeting is also about whether mesh should be reclassified from a Class II medical device to a Class III device, thus ... My opinion is that all mesh in the body is a medical device that is capable of causing severe and permanent injury; therefore, ... Medical Devices Safety Communications. THIS IS NOT A LAW FIRM OR MEDICAL WEBSITE. Information that appears here is not intended ...
meshmedicaldevicenewsdesk.com
Self-Fixating ProGrip Mesh Reduces Early Postop Pain in Inguinal Hernia Repairs | MedgadgetSelf-Fixating ProGrip Mesh Reduces Early Postop Pain in Inguinal Hernia Repairs | Medgadget
01mayallday02allday5th Human Factors & User Experience for Medical Device DesignSan Diego, CA, USA ... "NaoTrac" the First Autopilot Surgical Robot for Brain Surgery. Munson Healthcare Selects Naveego Complete Data Accuracy ... Early Bird - Register by Friday, March 8, for the 8th Digital Marketing for Medical Devices West Discounted Rate. Digital ... 24aprallday26allday8th Digital Marketing for Medical Devices WestSan Diego, CA, USA ...
medgadget.com
Surgical mesh - WikipediaSurgical mesh - Wikipedia
"Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence". Medical Devices Safety Communications ... Also, most published research reports reference meshes that are currently removed from the medical device market due to ... Experimentation may find differing outcomes for some meshes. The primary function of surgical mesh is to support prolapsed ... Surgical mesh may also be used for pelvic or vaginal wall reconstructions in women and is implemented to add as a growth guide ...
en.wikipedia.org
Medical Device Safety & Regulation News - Page 2Medical Device Safety & Regulation News - Page 2
The SoomSafety mobile app provides product information and recall notices by the FDA or device manufacturer, giving users some ... FDA Halts Sale of Transvaginal Surgical Mesh Tied to Patient Lawsuits. Medical Device Manufacturing & Supply Chain News April ... New Soom Mobile App Connects Patients with Medical Device Recalls. Medical Device News , Medical Device Safety & Regulation ... Orchestra BioMeds Virtue® SEB Wins FDA Breakthrough Device Designation. Medical Device News June 13, 2019. ...
xtalks.com
Unilene - Surgical Sutures, Polypropylene Mesh, Needles - YouTubeUnilene - Surgical Sutures, Polypropylene Mesh, Needles - YouTube
Polypropylene Mesh and others medical devices. We exporting our products around the world. We are certified in... ... Unilene is a manufacturer of Surgical Sutures, Polypropylene Mesh and others medical devices. We exporting our products around ... Manufacturer & Exporter Of Surgical Sutures Like Absorbable Sutures & Nonabsorbable Sutures - Duration: 9:33. Business Video ... Surgical Sutures , How Its Made - Duration: 3:06. Science Channel 81,907 views ...
youtube.com
Standards, guidelines & publications (medical devices & IVDs) | Therapeutic Goods Administration (TGA)Standards, guidelines & publications (medical devices & IVDs) | Therapeutic Goods Administration (TGA)
All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods ... Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002. ... Reclassification of surgical mesh devices. Guidance to assist sponsors with the reclassification of surgical mesh devices ... Home » Industry » Medical devices & IVDs. Standards, guidelines & publications (medical devices & IVDs). Related information. * ...
tga.gov.au
Federal Register :: Federal Register Documents on Public Inspection for 2017-01-05Federal Register :: Federal Register Documents on Public Inspection for 2017-01-05
Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh. ... Medical Devices:. ...
federalregister.gov
ROFIN Medical - Verdict Medical DevicesROFIN Medical - Verdict Medical Devices
Surgical Innovation Associates secures CE Mark for absorbable mesh. 30 Sep 2020 ... Products in the medical device industry have to meet the highest quality demands. Laser technology as a precise and extremely ... ROFIN to Present its Medical Device Laser Systems at MEDICA 2009. ROFIN will present its laser systems and solutions for a ... The new StarCut Tube Femto is one of the first systems to offer cold laser cutting for medical device manufacturing. Cold ...
medicaldevice-network.com
AnatomyDiseasesChemicals and DrugsAnalytical, Diagnostic and Therapeutic Techniques and EquipmentPsychiatry and PsychologyPhenomena and ProcessesAnthropology, Education, Sociology and Social PhenomenaTechnology, Industry, AgricultureHumanitiesInformation ScienceNamed GroupsHealth Care
Surgical MeshHernia, AbdominalPolypropylenesUrinary Incontinence, StressPelvic Organ ProlapseUterine ProlapseSuburethral SlingsPelvic FloorUrinary IncontinenceLawyersHernia, InguinalHerniaEquipment and SuppliesDevice ApprovalShort-Wave TherapyDefibrillators, ImplantableEquipment SafetyPatents as TopicMedical Device LegislationHernia, VentralHernia, DiaphragmaticHerniorrhaphyPolymersAbsorbable ImplantsHydrophobic and Hydrophilic InteractionsSuturesLaryngoplastyPolydioxanoneProfessional CompetenceDental ArticulatorsLasersGift GivingLasers, SemiconductorConflict of InterestInterior Design and FurnishingsFloors and FloorcoveringsTripletsFingersFetal MortalityQuintupletsProstheses and ImplantsSurgical StaplingDental ImplantsDrug ImplantsImplants, ExperimentalBreast ImplantsCounterfeit DrugsFraudThoracic WallThoracoplastyBone ScrewsBiocompatible MaterialsBone and BonesOsseointegrationFracture Fixation, Internal
HerniasLawsuitsVaginal meshErosionPelvic meshComplications associatedProductsSurgeriesSlingsAtrium C-QurSurgeonsIncisionSuturesBoston ScientificStress urinary incoRecallInjuriesBardRecurrenceAssociated with transvaginal mesh2016Polypropylene meshEthiconLawsuitPatient'sDefective Medical DeviceSynthetic materialsFlexible Composite MeshComplicationInfectionsNovus ScientificLong-Term Resorbable Synthetic MeshManufacturersClinicalCounterfeitHernia mesh attorneyPHYSIOMESHShrinkageJohnsonSurgicallyUrinaryRemove the meshSafety and efficacy
Hernias22
Lawsuits30
Vaginal mesh5
Erosion16
Pelvic mesh4
  • Thousands of women have sued the company, alleging they were injured by the pelvic mesh. (wfaa.com)
  • Johnson & Johnson has agreed to a $117 million multistate settlement over allegations it deceptively marketed its pelvic mesh products, which support women's sagging pelvic organs. (sltrib.com)
  • The pelvic mesh deal requires the company to cease its claims that surgical technique can eliminate any risks, as well as to disclose a list of risks, including loss of sexual function, mesh eroding into the vagina and the possible need for corrective surgery. (sltrib.com)
  • The FDA reported that "it is not clear" that the use of surgical pelvic mesh to repair POP is more effective than traditional procedures that do not use surgical pelvic mesh. (lieffcabraser.com)
Complications associated9
Products81
Surgeries14
Slings4
Atrium C-Qur1
Surgeons10
Incision5
Sutures5
Boston Scientific9
  • On behalf of Boston Scientific and myself as a physician, I want to express my deepest sympathy and my sincere empathy for those women who have been harmed by surgical mesh therapies," said Dr. Ronald Morton Jr., a medical doctor with the urology division at Boston Scientific. (kvue.com)
  • Boston scientific is purposeful and committed to provide medical devices that are safe and effective and supported by clinical evidence supported by physician training and the best possible outcomes," he said, citing studies that show the mesh devices continue to improve. (kvue.com)
  • Last week, a Miami federal court ordered Boston Scientific Corp to pay four women a total of more than $26 million, a judgment for selling faulty transvaginal surgical mesh. (lawmed.com)
  • FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. (mddionline.com)
  • The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. (sanjuanislander.com)
  • Defendants in the first three bellwether trials are American Medical Systems (AMS), Boston Scientific and Ethicon. (lawyersandsettlements.com)
  • Boston Scientific Corporation (NYSE: BSX) today issued the following statement from John Pedersen, Senior Vice President and President of the Company's Urology and Women's Health Division, following the conclusion of a two-day meeting of the U.S. Food and Drug Administration (FDA) Obstetrics & Gynecology Devices Advisory Committee. (news-medical.net)
  • The FDA said Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. (reuters.com)
  • Boston Scientific and Coloplast are the only companies that still sell and distribute meshes for this use, the FDA told Reuters. (reuters.com)
Stress urinary inco12
Recall15
Injuries13
Bard13
Recurrence5
Associated with transvaginal mesh1
20164
Polypropylene mesh1
Ethicon6
Lawsuit8
Patient's8
Defective Medical Device2
Synthetic materials2
Flexible Composite Mesh1
  • Physiomesh Flexible Composite Mesh was removed from the market due to a high rate of failure. (usrecallnews.com)
Complication5
Infections7
Novus Scientific6
Long-Term Resorbable Synthetic Mesh1
  • There are plans to expand this to a multi-centre study involving other hospitals in Singapore and in the U.S. TIGR ® Matrix Surgical Mesh is the World's 1st Long-Term Resorbable Synthetic Mesh, and it received 510(k) clearance from the US Food and Drug Administration (FDA) in February 2010 for use in reinforcement of soft tissues where weakness exists. (mynewsdesk.com)
Manufacturers16
Clinical11
  • Currently, I am the Director for two departments, Hematology-Oncology and Pediatrics, for a major medical center in Southern California, where I am also the Vice Chairman for Clinical Affairs in the Pediatrics Department. (forensisgroup.com)
  • Scientific Federation conferences are covering a broad range of research in the Science, Technology, Medical, Pharma, Clinical and Engineering. (medgadget.com)
  • Lenzer says medical devices are approved with far less scrutiny than drugs, and many high-risk devices go to market without clinical trials. (publicradiotulsa.org)
  • The FDA is considering a proposal to reclassify transvaginal mesh devices used in the repair of POP to Class 3 from their current Class 2 designation, thereby making surgical mesh for POP repair ineligible for the FDA's less-stringent 510(k) approval protocols, and require that such devices be subjected to human clinical trials in order to gain FDA approval for this use. (yourlawyer.com)
  • Dr Björck was the Principle Investigator for the first clinical study of TIGR® Matrix Surgical Mesh . (mynewsdesk.com)
  • At this time, the FDA does not know if the counterfeit surgical mesh meets the authentic product's specifications, including its strength, sterility, or clinical performance. (healthcanal.com)
  • In the ECLIPSE trial, which compared the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system with standard medical care (ie, tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone) for menorrhagia, investigators noted that although both treatment groups had improved scores as measured by the Menorrhagia Multi-Attribute Scale (MMAS), significantly greater improvement occurred in the levonorgestrel intrauterine system group over a 2-year period. (medscape.com)
  • Under what is known as the 510(k) review, the FDA clears about 400 implanted medical devices without clinical testing each year for market that are considered moderate to high risk. (eurekalert.org)
  • Small sample sizes and delays on agreement of protocol may hinder the clinical usefulness of post-approval studies (PASs) on medical devices ordered by the FDA. (eurekalert.org)
  • Post-market surveillance is part of evaluating the safety and effectiveness of medical devices, which typically are approved by the FDA with less clinical data than medications. (eurekalert.org)
  • In any case where such severe adverse events occur, it is of utmost importance for the manufacturer to perform thorough investigations into the cause of the event to determine whether it was a patient-related, product-related, surgical, or clinical issue. (fdli.org)
Counterfeit4
Hernia mesh attorney2
PHYSIOMESH1
  • More serious claims against Physiomesh failure resulted in damage to internal organs or the rupturing the mesh, allowing the intestines to poke through. (gpwlaw.com)
Shrinkage1
Johnson13
  • Johnson & Johnson agreed to pay Texas and 40 other states nearly $117 million to resolve allegations that it deceptively marketed transvaginal surgical mesh devices. (wfaa.com)
  • SEATTLE - Attorney General Bob Ferguson today asked a court to rule that Johnson & Johnson misrepresented, and in some cases failed to disclose entirely, serious risks associated with its surgical mesh devices. (wa.gov)
  • Johnson & Johnson still has not amended some of its instruction packets to warn about other risks associated with its devices, such as the risk of mesh contracture. (wa.gov)
  • The Attorney General filed motions for partial summary judgment in King County Superior Court, asking the court to rule that Johnson & Johnson's omissions and misrepresentations in the devices' instruction packets violated the state Consumer Protection Act. (wa.gov)
  • Johnson & Johnson sold over 12,000 surgical mesh devices in Washington state between 2002 and September 2015. (wa.gov)
  • Outside of the U.S., Johnson & Johnson's devices faced scrutiny as early as 2007. (wa.gov)
  • OLYMPIA - Attorney General Bob Ferguson's today announced that Johnson & Johnson will pay $9.9 million to avoid going to trial for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices. (wa.gov)
  • Washington women experienced pain, suffering, and life-altering complications that Johnson & Johnson knew were associated with its devices, including chronic pain, pain with sexual intercourse, and numerous urinary issues. (wa.gov)
  • In addition to paying $9.9 million, the resolution prohibits Johnson & Johnson from making unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices. (wa.gov)
  • The surgical mesh devices manufactured and sold by Johnson & Johnson and its subsidiaries are implanted through the vagina and used to treat two conditions in women - pelvic organ prolapse, when organs shift from their normal position, and various urinary issues, including incontinence. (wa.gov)
  • Johnson & Johnson knew that some of the most serious risks it failed to include - chronic pain, pain with sexual intercourse and more - were associated with the use of its mesh devices. (wa.gov)
  • One such hernia mesh manufacturer is Johnson & Johnson. (waterskraus.com)
  • I have spent over 25 years in the device industry with industry-leading companies including Johnson & Johnson, Spacelabs Medical, Cyberonics and Northstar Neuroscience. (medgadget.com)
Surgically2
Urinary2
Remove the mesh2
Safety and efficacy2