Vaginal Mesh Sling Recall Lawsuit Attorney News Archive

First Federal Bard Transvaginal Mesh Lawsuit Scheduled for Trial in February 2013
- Ennis & Ennis
05/04/2012 - On May 1, 2012, U. S. District Judge Joseph R. Goodwin, the presiding judge for all federal transvaginal mesh lawsuits against C.R. Bard Inc., issued an Order scheduling the first bellwether trial in MDL 2187 to begin February 5, 2013.
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Multimillion-dollar lawsuit over vaginal mesh
- CTV
04/18/2012 - A multimillion-dollar lawsuit has been filed by a group of women who say their lives have never been the same since they had a surgical mesh inserted in them to help treat an embarrassing problem. All the women had the mesh inserted to help relieve their urinary incontinence and a problem with sagging pelvic organs. But now, some are saying they are suffering severe complications from the treatment and say they were never fully warned of the risks.
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Vaginal Mesh Device Sold in the US Without FDA Approval
- Ennis & Ennis
04/11/2012 - Bloomberg News reported that Johnson & Johnson marketed the Gynecare Prolift mesh device in March 2005, touting it as an “innovative and effective surgical option” for weakened pelvic muscles. However, the U.S. Food and Drug Administration (FDA) did not clear the Gynecare Prolift mesh until May 2008, after Johnson and Johnson sought approval for a related product.
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CR Investigates: Dangerous medical devices
Most medical implants have never been tested for safety
-Consumer Reports
03/28/2012 - Tens of millions of Americans live with medical devices implanted in their bodies—artificial joints, heart defibrillators, surgical mesh. And it’s a safe bet that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.
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Markey targets Boston Scientific and other vaginal mesh manufacturers in new bill
- Boston Globe
03/23/2012 - When Jaye Nevarez underwent surgery four years ago with a vaginal mesh implant to relieve her urinary incontinence, the mother-of-three from Colorado said she had no idea that the device inserted in her pelvis was very similar to one that had been recalled nearly a decade earlier because of postsurgical complications, including persistent pain and infections.
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J&J Sold Vaginal Mesh Implant Without U.S. Regulatory Approval
- Bloomberg
03/21/2012 - Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them.
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Vaginal Mesh Lawsuits Consolidated and Transferred Before One Judge
Ennis & Ennis, P.A. Reports of Consolidation and Transfer of Transvaginal Mesh Lawsuits to West Virginia District Court
- Ennis & Ennis
02/13/2012 - Ennis & Ennis, P.A. reports that the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an Order to consolidate and transfer three vaginal mesh multidistrict litigations (MDLs) into a single proceeding before Chief Judge Joseph R. Goodwin in the U.S. District Court Southern District of West Virginia.
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House Democrats Call for Safety Hearings on Lap Bands and Transvaginal Mesh:
Ennis & Ennis, P.A. Supports the House Democrat’s Position in Questioning Whether FDA Medical Device Approval Process Protects the Public
- Ennis & Ennis
02/02/2012 - House Democrats from the Energy and Commerce Committee, led by Representative Henry Waxman of California, urged Republicans to hold hearings to examine Lap-Band weight loss devices and transvaginal mesh devices, which have developed serious defects after being implanted.
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Government takes closer look at surgical mesh
- KPRC
01/30/2012 - A medical product implanted into to tens of thousands of women is now facing closer scrutiny by the federal government. The product is called surgical mesh and has been widely used to treat a condition called Pelvic Organ Prolapse. This condition arises when organs in the pelvis begin to shift or sag, causing incontinence, pain and intimacy problems. The U.S. Food and Drug Administration estimates 50 percent of women suffer from this problem, and mesh has been used to treat POP in tens of thousands of women.
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House Democrats Urge GOP Leadership To Hold Hearings on Unsafe Medical Devices
- Bloomberg
01/25/2012 - A group of Democratic members of the House Energy and Commerce Committee sent a letter to Republican committee leaders Jan. 20, urging them to hold hearings to examine medical devices that have developed serious defects after being implanted in patients.
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House Democrats Seek Hearing on J&J Mesh, Allergan Lap-Band
- Bloomberg
01/21/2012 - House Democrats called for congressional hearings on a gastric band made by Allergan Inc. and transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients. U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers.
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FDA orders new mesh implant studies
- Modern Medicine
01/14/2012 - Increased reports of complications have prompted the US Food and Drug Administration (FDA) to order new postmarket surveillance (522) studies of surgical mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.
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FDA Requires Transvaginal Mesh Makers to Study Risks:
Ennis & Ennis, P.A. explains the FDA’s Order to manufacturers of transvaginal mesh devices requiring safety studies to be conducted on the devices used to treat pelvic organ prolapse and stress urinary incontinence.
- Ennis & Ennis
01/09/2012 - On January 3, 2012, the U.S. Food and Drug Administration (FDA) mandated postmarket surveillance studies be performed by manufacturers of urogynecologic surgical mesh devices. The FDA issued 88 postmarket study orders to 33 manufacturers of transvaginal mesh for pelvic organ prolapse (POP) and 11 postmarket study orders to seven manufacturers of mesh mini-slings for stress urinary incontinence (SUI). “These are studies that should have been conducted before the devices were approved by the FDA,” commented attorney Holly Ennis of Ennis & Ennis, P.A.
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Health warning: Women's pelvic mesh linked to infection
- Digital Journal
01/06/2012 - The FDA has issued a warning, on Jan 5, about post-surgical health risks for women who receive a type of surgical mesh, in relation to pelvic problems. The meshes are produced by many leading medical device manufacturers. The U.S. Food and Drug Administration (FDA) have instructed medical device manufacturers to examine safety complications in relation to a type of surgical mesh which is widely used to repair women's pelvic problems.
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FDA probes JNJ, Bard and others on transvaginal mesh risks
- Mass Device
01/06/2012 - As public pressure mounts over the potential harm caused by transvaginal mesh implants the FDA ordered device makers, including Johnson & Johnson and C.R. Bard , to take another look at complication rates associated with their devices.
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J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says
- Bloomberg
01/05/2012 - Johnson & Johnson and C.R. Bard Inc. must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women. The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
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FDA Orders Studies for J&J Vaginal Mesh Implants
- Bloomberg
01/04/2012 - U.S. regulators ordered Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) to study rates of organ damage, infection and painful sex linked to vaginal mesh implants, reacting to doctors and patients who say the devices have harmed women.
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"Vaginal Mesh Surgery Poses Greater Risks than Benefits", Warns FDA
- Brunei FM!
01/04/2012 - Adult women all over the world are familiar with vaginal mesh implantation for the repair of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Originally, it was considered as the best treatment for these conditions. But recently, vaginal mesh lawsuits have multiplied all over the United States after complaints of deadly complications brought by the implantation of vaginal mesh started to appear and increase at a fast pace.
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Vaginal Mesh Lawsuits Scheduled For Trial
- Ennis & Ennis
01/03/2012 - The first Ethicon Gynecare vaginal mesh lawsuits are scheduled to go to trial before a jury in New Jersey state court in November of 2012.. Judge Carol E. Higbee is overseeing the litigation where more than 350 lawsuits over Ethicon Gynecare transvaginal mesh have been centralized for pretrial proceedings.
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Updated Guidance for Use of Vaginal Mesh for POP
- OBGYN.net
12/26/2011 - In further response to the Safety Communication issued by the FDA in July 2011 regarding the use of vaginal mesh, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) jointly state that the use of vaginal placement of synthetic mesh for the treatment of pelvic organ prolapse (POP) should be reserved for high-risk women for whom the benefits may outweigh the risks.
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Medical Devices Need Tracking After FDA Clearance, Senators Say
- Bloomberg
12/15/2011 - Medical implants that have sparked thousands of patient lawsuits, from Johnson & Johnson (JNJ)’s artificial hips to vaginal meshes made by Boston Scientific Corp., would face new tracking requirements under a bill introduced by three U.S. senators. Under the legislation, the Food and Drug Administration could order companies to conduct safety studies of devices even after they’re approved and could grant conditional approvals pending the result of ongoing trials. That would raise the bar for products approved through the so-called 510(k) system, which now requires companies only to show their devices are similar to those already on the market.
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ObGyn and Urogynecologic Societies Issue Joint Opinion on Transvaginal Mesh
- Ennis & Ennis
12/092011 - On November 21, 2011, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) issued a Joint Committee Opinion opining that due to the concerns about the safety and efficacy of the use of transvaginal mesh to treat pelvic organ prolapse (POP), it should be reserved for high-risk women for whom the benefit may justify the risk.
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More than 100 women are suing companies and the FDA is under fire, too.
- Sexis Health
10/27/2011 - Johnson & Johnson and the Food and Drug Administration are finding themselves under a bit of scrutiny for pushing a product through approval that perhaps shouldn't have made the cut. It's called Gynecare TVT and it's a vaginal mesh used in treating incontinence and prolapsed pelvic organ issues. And it's allegedly causing serious issues for some women.
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FDA panel recommends more stringent classification of vaginal mesh
- AAJ
10/20/2011 - Surgical mesh used to treat vaginal pelvic organ prolapse (POP) should be reclassified as a high-risk medical device because its risks may outweigh its benefits, the FDA Obstetrics and Gynecology Devices Panel recently recommended at a hearing on the devices.
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Mesh lawsuits pile up for C.R. Bard
- Mass Device
09/30/2011 - Dozens of patients with lawsuits against C.R. Bard Inc. asked to join a multi-district federal case against the company for allegedly selling defective and dangerous products – its Avaulta transvaginal mesh.
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Plaintiffs with C.R. Bard Mesh Device Claims May be Added to Avaulta MDL
- Ennislaw
09/20/2011 - Twenty-nine plaintiffs with claims arising from the implantation of a C.R. Bard pelvic mesh device have requested that the Judicial Panel on the Multidistrict Litigation (MDL) expand the scope of the Bard Avaulta MDL to include their cases.
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Notify FDA of Adverse Events with Medications and Medical Devices
- Ennislaw
09/19/2011 - In a world of endless technology, there are so many unused informational resources for patients. According to Ennis & Ennis, P.A. one of the single most helpful resources for patients is the U.S. Food and Drug Administration (FDA) website. In addition to having the ability to research data on drugs and medical devices, the FDA website also allows a consumer to easily report adverse events experienced with FDA-regulated drugs, medical devices, nutritional products and cosmetics.
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Ennis & Ennis, P.A. Explains the Purpose of the Upcoming FDA Advisory Meeting for Transvaginal Mesh
- Ennislaw
08/17/2011 - With a significant increase in the amount of complaints associated with the surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP), the US Food and Drug Administration (FDA) will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee on September 8-9, 2011. Ennis and Ennis, P.A. reports that the purpose of the meeting is to consider regulatory changes that may improve the understanding and effectiveness of the devices. Some of the regulatory changes being considered include:
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New warning on surgical mesh as pelvic support
- Union Tribune
08/17/2011 - The Food and Drug Administration recently updated a safety warning about serious health complications associated with the use of surgical mesh to treat pelvic organ prolapse, or POP, a condition in which the muscles and ligaments supporting a woman’s pelvic organs weaken, allowing organs like the bladder to slip out of place.
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It was a simple implant to cure an embarrassing problem... The incontinence operation that's ruining women's lives
- Mail Online
08/15/2011 - Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems following childbirth.
As a result the NHS is now facing a crisis on a par with the compensation claims for leaking silicone breast implants in the Nineties.
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FDA’s Recommendations to Women Considering Pelvic Organ Prolapse Surgery
- Ennislaw
08/11/2011 - Last month the U.S. Food and Drug Administration (FDA) updated a Safety Communication, warning of the dangers associated with the surgical placement of mesh through the vagina to repair pelvic organ prolapse (POP). According to Ennis & Ennis, P.A., this update follows a recent significant increase in the number of adverse events reported to the FDA. For women who are considering surgery for pelvic organ prolapse, it is important to know that within this updated Safety Communication, the FDA makes the following recommendations:
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Brevard women sue over mesh devices
- Florida Today
08/09/2011 - As the U.S. Food and Drug Administration considers stricter regulations for approving medical devices, whatever the federal agency decides comes too late for several local women. Damaged, they say, by mesh devices implanted to treat a common pelvic floor disorder, all of them tell similar stories about doctors' assurances the devices might help.
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FDA’s Transvaginal Mesh Device Recommendations to Health Care Providers
- Ennislaw
08/08/2011 - On July 13, the U.S. Food and Drug Administration (FDA) updated an advisory on vaginal mesh implants reporting that there is little evidence that the implants improve pelvic organ prolapse and that patients are exposed to a number of risks and complications, which are not rare. According to Ennis & Ennis, P.A., the FDA then issued a Safety Communication, which provided an Overview, a Summary of Adverse Event Reports, a Review of their Literature, a Summary of their Key Findings and Recommendations with regards to these transvaginal mesh devices.
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FDA Issues Post Operative Recommendations for Women with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
- Ennislaw
08/04/2011 - On July 13, the U.S. Food and Drug Administration (FDA) updated an advisory on vaginal mesh implants reporting that there is little evidence that the implants improve pelvic organ prolapse and that patients are exposed to a number of risks and complications, which are not rare. According to Ennis & Ennis, P.A., the FDA then issued a Safety Communication, which provided an Overview, a Summary of Adverse Event Reports, a Review of their Literature, a Summary of their Key Findings and Recommendations with regards to these transvaginal mesh devices.
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Vaginal Mesh: New FDA Warnings
- WebMD
08/01/11 - As a healthcare provider one really knows that a serious concern has arisen when it makes the evening news. But in my book, nothing tops the alarm bells that go off when a medical product suddenly appears on the TV screen at my gym followed by the phone number of an out of state legal firm soliciting for clients. This just happened when I was on the cross trainer last week so it seemed important to share the most accurate information I could find about the newest FDA warnings for vaginal mesh.
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Mesh Pelvic Surgery Runs Afoul of FDA
- Third Age
07/29/2011 - Mesh pelvic surgery, used in women to hold up sagging internal organs, isn't necessarily more effective than other options, says the FDA. In addition, complications are common, with the most frequent complication being the protrusion of the mesh through the vaginal wall.
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Risky pelvic mesh highlights worries about FDA process
Untested medical devices found to erode patients' insides
- MSNBC
07/26/2011 - Janet Holt figured she simply had an infection “down there.”
But instead of a prescription, her doctor told her she’d need a procedure. Her bladder had slipped out of place, creating an uncomfortable condition known as pelvic organ prolapse, which affects many women as they age.
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Mesh used in pelvic surgeries under scrutiny
- Chicago Tribune
07/26/2011 - The pain began almost immediately after Cheryl Sorrels had pelvic surgery to correct a bulging bladder three years ago. There was also a lot more bleeding than she expected. Sorrels chalked that up to a difficult recovery. It wasn't until the 58-year-old began a new relationship that she realized she had a bigger problem: When she and her partner were intimate, a piece of thin, porous material stuck in her vagina made them both very uncomfortable.
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Doctors concerned over FDA mesh warnings
- Post-Gazzette
07/26/2011 - The FDA earlier this month renewed safety warnings on the use of mesh through the vagina to repair pelvic organ prolapse, saying the procedure could pose greater risks than other remedies for the condition that strikes thousands of older women every year.
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FDA Issues Safety Communication Update On Serious Complications Associated With Transvaginal Placement Of Surgical Mesh For Pelvic Organ Prolapse.
- Ennislaw
07/20/2011 - The L.A. Times reported on July 13, 2011 the FDA released an updated advisory on serious complications associated with Transvaginal placement of surgical mesh for pelvic organ prolapse. The FDA has scheduled a meeting for a panel of outside experts for recommendations on how to proceed on September 8-9, 2011.
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Pelvic Mesh for Incontinence May Carry Added Risk for Women: FDA
- HealthFinder
07/18/2011 - A mesh device used to support the pelvic organs and help ease incontinence in women appears to carry more risks than previously thought, the U.S. Food and Drug Administration announced Wednesday. In an "updated safety communication warning," the FDA said that surgical placement of the mesh through the vagina to fix a condition known as pelvic organ prolapse may lead to greater risks than other surgical methods, while not providing any greater clinical benefit.
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FDA Warning; Pelvic Mesh used in Abdominal surgery poses risk
- Salient News
07/16/2011 - The Food and Drug Administration is warning doctors and patients that using a mesh product in vaginal repair surgery can lead to serious complications. Dr. William Maisel, the FDA’s deputy director and chief scientist in the device division, said there are “clear risks” associated with the mesh. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications.
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FDA warns mesh used in surgery poses risk
- Boston Globe
07/14/2011 - 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 Food and Drug Administration.
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FDA: Repairing Pelvic Organ Prolapse With Mesh Risky
- WebMD
07/14/2011 - The risks of placing mesh through the vagina to repair pelvic organ prolapse may outweigh its benefits, according to the FDA. Risks include mesh protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from tools used in the mesh placement, and urinary problems. Additional surgeries and/or hospitalization may be needed to treat the complications or remove the mesh.
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FDA Warns: 'Serious Complications' Arise From Vaginal Mesh Implant
- TIME
07/14/2011 - Surgical mesh implants used to treat weakening in the pelvic region, a particularly common problem after childbirth, may actually do more harm than good, the Food and Drug Administration (FDA) reports Wednesday.
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FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
- FDA
07/14/2011 - The FDA has released a safety communication on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse to health care providers involved in surgical mesh repair procedures as well as patients considering to receive a surgical mesh implant to repair organ prolapse and/or stress urinary incontinence.
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FDA reevaluating vaginal mesh implants
- LA Times
07/13/2011 - Following a spike in reported complications, the Food and Drug Administration released an updated advisory Wednesday about a surgical mesh implanted in women to strengthen vaginal tissue that can become weakened, especially after childbirth. In its report, the FDA says a review of industry literature and the adverse event reports has shown little evidence that the device, which is implanted vaginally or abdominally, improves pelvic organ prolapse, where a woman's uterus, bladder, or rectum can slip out of place. The review found that vaginal implantation exposes patients to a number of serious risks.
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Judge Allows Plantiff To Amend Complaint In Surgical Mesh Device Case
- HarrisMartin
05/24/2011 - A California federal judge has ordered the plaintiffs in a transvaginal surgical mesh device case to amend their complaint to state where each plaintiff underwent her respective procedure and to explain whether the claims are based on one defective device or on multiple mesh devices that share a common defect.
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If you or a loved one have suffered or been injured from a defective transvaginal mesh sling you may be entitled to compensation. Contact the vaginal mesh sling attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding your transvaginal mesh sling injury a possible class action lawsuit, or any other type of vaginal mesh litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page.

Bard Avaulta Transvaginal Mesh Implant Lawsuit Information::

Gynecare Prolift Pelvic Floor Repair System Lawsuit Information::