• vaginal
  • Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the US Food and Drug Administration that warns patients and surgeons to consider other options. (bostonglobe.com)
  • Boston Scientific executives yesterday said they are looking into the issue but would not say whether they plan to continue selling the mesh for vaginal surgery. (bostonglobe.com)
  • As we've reported previously, one such type of surgical mesh, the Mentor ObTape Vaginal Sling , was withdrawn from the market in 2006 because of a high rate of serious complications. (yourlawyer.com)
  • The most frequent included erosion of the mesh erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse or the incontinence. (yourlawyer.com)
  • In some cases, vaginal scarring and mesh erosion led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia. (yourlawyer.com)
  • As a result, between 17 and 18 percent of the women who were implanted with a Mentor ObTape Vaginal Sling suffered from complications, with many forced to undergo a difficult surgical procedure to have the device removed. (yourlawyer.com)
  • Reuters News and the Philadelphia Inquirer are reporting that a New Jersey jury ordered Johnson & Johnson to pay punitive damages of $7.76 million to a former nurse who blames its vaginal mesh implant for years of severe problems despite unsuccessful repair surgeries. (sheller.com)
  • Bloomberg also reports that an FDA "report last year found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for organs that slump, or "prolapse," because of weakened support. (sheller.com)
  • There have been many lawsuits filed in the U.S. over the last several years regarding a type of product known as 'trans-vaginal mesh. (reichandbinstock.com)
  • The mesh sling patch is a product commonly used for the repair of tissue deterioration following pelvic organ prolapse, in the treatment of stress urinary incontinence, or for repair of weakened vaginal wall tissue problems. (prweb.com)
  • On July 26th, 2012, Bloomberg reported a California Jury awarded mesh plaintiff Christine Scott $5.5 million because of injuries caused by Bard's Avaulta Plus vaginal implant (case no. (prweb.com)
  • Surgical mesh may also be used for pelvic or vaginal wall reconstructions in women and is implemented to add as a growth guide for damaged tissue. (wikipedia.org)
  • Mesh surgery can be performed in various areas of the pelvic region, such as cystocele, rectocele, and vaginal vault or uterus. (wikipedia.org)
  • The use of a transvaginal mesh in treating vaginal prolapses is associated with side effects including pain, infection, and organ perforation. (wikipedia.org)
  • The FDA decided to order Ethicon and other transvaginal mesh manufacturers to cease production until extensive testing and research on each of vaginal mesh device was conducted. (wikipedia.org)
  • tissue
  • Mesh-related problems reported to the FDA include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it. (bostonglobe.com)
  • Surgical mesh products are used to reinforce soft tissue where weakness exists. (ohsonline.com)
  • There are now claims, however, that the mesh creates a risk of infection and inflammation in the patients, and that the materials of which it is made is incompatible with long-term contact with human tissue. (reichandbinstock.com)
  • and (4) while transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results. (springer.com)
  • Surgical mesh is implanted to strengthen tissue repair and minimize the rate of recurrence. (wikipedia.org)
  • On the contrary, if the mesh is too stiff, tissue will erode and inflammatory responses will cause post-surgical complications. (wikipedia.org)
  • Additionally, the mesh has enough strength to withstand basic actions and tissue behavior in physiological conditions, particularly during tissue regeneration through the mesh itself. (wikipedia.org)
  • With surgery (for example native tissue repair, biological graft repair, absorbable and non-absorbable mesh repair, colpopexy, colpocleisis). (wikipedia.org)
  • According to the Cochrane Collaboration review (2016) current evidence does not support the use of transvaginal surgical mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity. (wikipedia.org)
  • Having initiated R&D and filed the first patent back in 2004, Novus has developed the world's first long-term resorbable synthetic surgical mesh which was cleared for use by the FDA in February 2010 for use in reinforcement of soft tissue where weakness exists. (wikipedia.org)
  • This key feature contributes to the functional regenerated tissue that ultimately replaces the degraded mesh, as shown in preclinical trials. (wikipedia.org)
  • This allows the body to heal effectively, ideally, forming strong tissue as the mesh is absorbed. (wikipedia.org)
  • The weakened tissue of the abdominal wall is re-incised and a repair is reinforced using a prosthetic mesh. (wikipedia.org)
  • synthetic mesh
  • The very selective mesh user might see the concerns as a possible justification of their caution in "picking their cases" to use synthetic mesh products. (springer.com)
  • For this reason, it is especially advised that these be repaired via a tension free repair method using a synthetic mesh. (wikipedia.org)
  • The development of biologic mesh largely has derived from the need of a biocompatible material that addresses "the problems associated with a permanent synthetic mesh, including chronic inflammation, foreign body reaction, fibrosis, and mesh infection. (wikipedia.org)
  • implants
  • The warning is of particular significance to health care professionals and their patients with surgical mesh implants as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers. (ohsonline.com)
  • As a former ICU nurse I'm experienced with the health complications that can result, and the sensitive nature of some of the side effects resulting from mesh implants. (prweb.com)
  • BC Genesis focused on developing cellulose based medical implants for applications such as meniscus/cartilage repair as well as surgical meshes. (wikipedia.org)
  • infection
  • Typical advantages attributed to biologic meshes include reducing the risk of infection (from using non-biologic surgical meshes) and is absorbed into the resulting scar as part of cellular ingrowth. (wikipedia.org)
  • Such cases include: People with unstable medical conditions Repair using mesh is withheld if a person has an active infection within the groin or within the blood stream Elective repair is delayed in pregnant women until 4 weeks after delivery Additionally, certain medical conditions can prevent people from being candidates for laparoscopic approaches to repair. (wikipedia.org)
  • erosion
  • Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. (bostonglobe.com)
  • woven
  • Surgical mesh is a loosely woven sheet which is used as either a permanent or temporary support for organs and other tissues during surgery. (wikipedia.org)
  • A mesh is similar to a web or a net in that it has many attached or woven strands. (wikipedia.org)
  • A metal mesh may be woven, knitted, welded, expanded, photo-chemically etched or electroformed (screen filter) from steel or other metals. (wikipedia.org)
  • In clothing, mesh is loosely woven or knitted fabric that has a large number of closely spaced holes. (wikipedia.org)
  • Fiberglass mesh is a neatly woven, crisscross pattern of fiberglass thread that can be used to create new products such as door screens, filtration components, and reinforced adhesive tapes. (wikipedia.org)
  • Woven meshes are basic to screen printing. (wikipedia.org)
  • Fence for livestock or poultry (chicken wire or hardware cloth) Humane animal trapping uses woven or welded wire mesh cages (chicken wire or hardware cloth) to trap wild animals like raccoons and skunks in populated areas. (wikipedia.org)
  • Surgery
  • In December 2015, the European Scientific Committee on Emerging and Newly Identified Health Risks ( SCENIHR ) published its scientific opinion on the safety of surgical meshes in urogynecological surgery. (bfarm.de)
  • She had surgery to take the mesh out. (presspublications.com)
  • Sheller P.C. defective medical device attorneys are investigating complications and injuries resulting from the replacement (revision) surgery performed on women who had the defective transvaginal mesh from the manufacturers listed below. (sheller.com)
  • Women may need more surgery because of mesh-related complications. (sheller.com)
  • Those opposed to mesh usage in POP surgery might welcome this communication and may even suggest that the concerns might have been more strongly expressed. (springer.com)
  • Also, most published research reports reference meshes that are currently removed from the medical device market due to complications post-surgery. (wikipedia.org)
  • Hernia surgery is one of the most common current applications of surgical mesh. (wikipedia.org)
  • Pessaries should be offered to women considering surgery as a non-surgical alternative. (wikipedia.org)
  • Surgical suture is a medical device used to hold body tissues together after an injury or surgery. (wikipedia.org)
  • For example, in 1980, research presented at the first ever World Biomaterials Congress detailed the examined use of dermal collagen of sheep to construct biological mesh for reconstructive surgery. (wikipedia.org)
  • In our search for a biological mesh for reconstructive surgery, we investigated sheep dermal collagen. (wikipedia.org)
  • lawsuits
  • Boston Scientific, which has had a string of setbacks stemming from its cardiac devices in recent years, is one of several companies that already face lawsuits over the mesh. (bostonglobe.com)
  • practice
  • Those enthusiastic mesh users might regard the concerns as too strong and a potential impingement on their ability to practice using such prostheses. (springer.com)
  • Meshes are used as drum heads in practice and electronic drum sets. (wikipedia.org)
  • clinical
  • At this time, FDA does not know if the counterfeit surgical mesh meets the authentic product's specifications, including its strength, sterility, or clinical performance. (ohsonline.com)
  • Therefore, it is not immediately apparent whether this represents a significant amount of research on the clinical effectiveness of any particular mesh product or for any specific patient population that would support clinical decision making. (wikipedia.org)
  • Further rigorously designed RCTs are required to clarify comparative clinical effectiveness and safety of the many available biological mesh products for most surgical indications in which their use has been suggested. (wikipedia.org)
  • patients
  • The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. (prweb.com)
  • If the product is defective when it's used in the manner intended by the manufacturer, there's liability," said Tom Girardi, senior partner at the Girardi Keese law firm in Los Angeles, which represents about 75 patients who used Boston Scientific's mesh. (bostonglobe.com)
  • Patients should contact their surgeon if they experience problems that they think may be related to surgical mesh. (ohsonline.com)
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if it is available. (yourlawyer.com)
  • Much controversy surrounds Ethicon's transvaginal meshes used on patients with female genital prolapse. (wikipedia.org)
  • Advances
  • The latissimus dorsi breast reconstruction flap has a number of advantages, but despite the advances in surgical techniques, it has remained vulnerable to skin dehiscence or necrosis at the donor site (on the back). (wikipedia.org)
  • adverse
  • From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. (bostonglobe.com)
  • In the FDA's analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications. (sheller.com)
  • This further escalated when, in 2011, the agency received more than 1,000 adverse effect reports from surgical mesh manufacturers. (wikipedia.org)
  • randomized contro
  • The academic observer will appreciate that the FDA has appeared to conscientiously evaluate the peer-reviewed scientific literature on the safety and effectiveness of surgical mesh for POP, including relevant randomized controlled trials (RCTs), systematic reviews, and selected observational studies. (springer.com)
  • Several surgical indications are addressed by this collection of [randomized controlled trials (RCTs)] with relatively few studies per indication. (wikipedia.org)
  • procedure
  • The agency said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh -- manufactured by Natick-based Boston Scientific Corp., Covidien plc of Mansfield, and several other companies -- for this procedure. (bostonglobe.com)
  • medical
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