Three multidistrict litigations (MDL) were consolidated after the U.S. Judicial Panel on Multidistrict Litigations (JPML) found that the lawsuits and side effects were similar even though they involved three separate surgical mesh manufacturers, AMS, Boston Scientific, and Ethicon.

The JPML stated that “Centralization therefore will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary,” as well as limit any potential overlap that occurs when you have more than one defendant and product.  This means that since the issues in the separate cases are similar, consolidating (or putting them in the same trial/court) them will avoid duplicating legal procedures when these procedures can be taken in just one event. Instead of going thru three separate trials, there will just be one trial but covering all the issues in the three cases.

The three MDLs ordered for consolidation are:

American Medical Systems, Inc. Pelvic Repair System Products Liability Litigation; Boston Scientific Corp. Pelvic Repair System Products Liability Litigation; and Ethicon, Inc., Pelvic Repair System Products Liability Litigation — MDL No. 2325, MDL No. 2326, and MDL No. 2327, respectively.

The cases involved different designs of transvaginal mesh and pelvic mesh implants. However, the JPML says that despite the difference in the designs, the plaintiffs in each case alleged similar injuries due similar defects that allegedly plague each of the different devices.

Transvaginal mesh complications and injuries have been subject of FDA Safety Warnings as well as Congressional hearings in the last year. Women who have filed vaginal mesh lawsuits claim similar injuries including pelvic pain, mesh erosion, infection, painful intercourse, perforation of the bowel or bladder and the need for corrective surgery.

Read more about transvaginal mesh side effects at http://vaginalmesh.legalview.com/.

CR Bard, a leading trans vaginal mesh manufacturer, has been named in a lawsuit alleging that the surgical mesh is responsible for serious complications.

Mary Ann McCloskey received a vaginal mesh implant made by CR Bard in November 2006. However, the mesh eroded into her vaginal lining, resulting in pain and internal bleeding.

Although she has undergone multiple surgeries to correct the issue, the mesh has grown into her tissue, which makes it difficult to remove. McCloskey  has been unable to live a normal life. Her husband agrees.

She and her husband are seeking a judgement of $100,000 plus costs.

Women who have experienced the painful side effects of vaginal mesh, including mesh erosion or mesh shrinkage, should contact a vaginal mesh lawyer to discuss their legal rights. LegalView provides free case consultations. For more information, visit http://vaginalmesh.legalview.com/.

Lora Gunn, a North Carolina resident, filed a transvaginal mesh case against mesh manufacturer Endo Pharmaceuticals together with its predecessor American Medical Systems (AMS) in January 2012. Claiming that she suffered from mesh erosion, where the mesh eroded into surrounding organs, Gunn is seeking general, punitive, and exemplary damages, plus compensation for medical and hospital expenses, loss of income, and diminished earning capacity.

Even with what would seem to be a David versus Goliath bout, Gunn boldly asserts her right to be compensated from a problematic vaginal mesh surgery. Gunn claims to have exhausted additional medical options, and faces the possibility of life long injuries.

Under the FDA 510 (k) approval system, AMS’s vaginal mesh device was listed as a predecessor of another device manufactured by Endo Pharmaceuticals. When Endo sought approval for its vaginal mesh product from the FDA, it only needed to show that its device was “substantially equivalent” to its predecessor to be granted clearance to market its device.

As early as 2004, the World Health Organization has issued warnings that “mesh systems have an unacceptably high complication rate.” WHO further discouraged continued use of these devices until further studies have been conducted. In 2011, the FDA have also issued warnings against the safety and efficiency of transvaginal mesh.  Gunn’s cause of action against the two companies is that despite warnings about the safety risks of mesh devices, they were still sold in the public.

Women who have gone under a similar surgical procedure are encouraged to follow the steps of Gunn, if not for compensation, at least to bring attention to the matter to encourage women to seek other options for a pelvic organ prolapse.

Women are encouraged to consult with a vaginal mesh lawyer to learn more about their legal rights. Read more about vaginal mesh complications at http://vaginalmesh.legalview.com/.

Transvaginal mesh products and devices are a major concern for the medical community and lawyers alike.

HarrisMartin Publishing held the first vaginal mesh conference in Savannah Ga. in January 2012. Discussions about the history, function and potential vaginal mesh side effects were many of the highlights of the convention attended by 200 participants.

Reports of transvaginal mesh complications and injuries have risen in numbers such that even the legal and medical communities are now feeling the magnitude of the issue. Recently, House Democrats have called for hearing on reported transvaginal mesh injuries from products of particular manufacturers. In fact, they also called for an immediate reconsideration of Section 510(k) of the Food, Drug and Cosmetic Act, apparently as a response to the growing number of transvaginal mesh-related injuries. When health and life is at stake, everybody must participate.

LegalView, a leading online legal resource, connects women who have been injured from vaginal mesh to personal injury lawyers. Vigilance must be exerted in finding out how health care providers are tackling this issue, how the government is finding ways to minimize, if not eradicate, any risk to any patient, and how to help the many women who are suffering from vaginal mesh complications.

After seeking a hearing on the safety of transvaginal mesh, House Democrats are now advancing their campaign for safe and effective medical devices by calling the overhauling of the Food and Drug Administration’s Pre-Market Notification (PMN) Clearance or simply 510(k) Approval System, and thus introducing HR 3847 – a legislation that will allow the FDA to block clearance of devices whose predicates were previously identified with safety issues.

Under Section 510 (k) of the Food, Drug and Cosmetic Act, clearance to medical devices can be granted even without human testing for as long as they are “substantially equivalent” to past devices previously cleared. These ‘past devices’ are called predicates.

Democratic legislators, led by Rep. Edward Markey, D-Mass, are zeroing in at current vaginal mesh products and other medical devices whose predicates were withdrawn from market due to safety issues and defects. Citing injuries from transvaginal implants produced by leading manufacturers, Democrats want the FDA to update the present 510(k) System so that devices with defective predicates are not allowed to be sold without the manufacturers proving first that the new devices do not suffer the defects of its predicates. Democrats basically want that present transvaginal mesh and other medical devices “do not mimic the mistakes made by other products.”

History should not repeat itself. LegalView supports all efforts to make these medical devices safer and more effective. For those suffering from transvaginal mesh injuries, information is available at LegalView on transvaginal mesh devices as well as legal assistance.

The FDA has issued an FDA Safety Communications, dated July 13, 2011, regarding vaginal mesh complications which are serious and may even be permanent. The attention not only of patients who are considering or may already have availed of prolapse surgery was called, as well as the health care providers who implant the vaginal mesh device.

As early as 2008, the FDA already communicated the possible health complications caused by surgical mesh in curing Pelvic organ prolapse (POP) and Stress urinary incontinence (SUI). POP occurs when the tissues that hold the pelvic organs in place become weak or stretched, while SUI is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

The FDA’s literature review found out that, among others, mesh erosion and mesh contraction can be identified as complications arising from transvaginal mesh surgery.

Mesh erosion is identified to be the most common and most reported mesh-related complication, while mesh contraction (or shrinkage of the device) is considered as a “previous unidentified risk.”

Mesh contraction may lead to “vaginal shortening, vaginal tightening, and vaginal pain.” And both mesh erosion and mesh contraction may affect a patient’s ability to engage in sexual intercourse. Also, the FDA report mentions that the complication may also affect the patient’s male partner as men may experience penal irritation during intercourse when a mesh is exposed or has shrunk.

Patients who are experiencing these symptoms must immediately consult their health care provider and a transvaginal mesh lawyer who can assist them in filing a report on transvaginal mesh complications. Learn more about transvaginal mesh complications from LegalView.

The Food and Drug Administration has advised patient to weigh the risks and benefits of using transvaginal mesh devices. LegalView, a leading online legal resource, strives to provide information and free case consultations to women and their families who have been effected by vaginal mesh.

Transvaginal mesh is a surgical mesh used to treat pelvic organ prolapse and incontinence in women. TVM was created due to excellent surgical outcomes using other mesh products. Some of its precedents are surgical success in treating abdonimal wall hernia (around 1950s),  abdominal repair of pelvic organ prolapse (POP) (since 1970s), and urinary stress incontinence (since late 1990s). In hopes that the same device will aid in POP repair, transvaginal mesh was introduced in the field as an alternative to treating prolapsed organs.

Before the advent of transvaginal mesh, traditional non-mesh repair was common to treat prolapsed cases. Absorbable suture materials are used in this procedure. Here, the torn or damaged connective tissue is joined back together by the absorbable suture materials, thus, creating scars to hold them back together. However, the success of the remedy depends fully on the quality of the individual’s own scar tissue formation.

This uncertainty and inconsistency pushed surgeons and researchers to look for other treatment options, including vaginal mesh, where the mesh is inserted through the vaginal to help support the prolapsed organ.

However, many women have reported complications with vaginal mesh, including pain, mesh erosion and mesh shrinkage, all of which impact their quality of life. Because of this, transvaginal mesh is not as successful of a treatment option as hoped.

In fact, this medical marvel has caught Congress’s attention – Congress has requested vaginal mesh hearings to look into the safety of this device.

The still unknown benefits and disadvantages of transvaginal mesh bring about the need for a health care provider’s complete disclosure on this procedure to a patient. If you have experienced vaginal mesh side effects, it will be wise to consult a transvaginal mesh lawyer for possible legal action.

Modern medical devices are fruits of an increasing knowledge and technology in the field of medicine, specifically in pharmacology and surgery. One of these modern medical devices is a vaginal mesh. A medical device surgically implanted, vaginal mesh is intended to correct prolapse or the falling down or slipping of a body part from its usual position or relations. These innovations are intended to bring about cure and better health to those suffering from these physical anomalies.

However, the Food and Drug Administration (FDA) has issued warnings about the side effects that these devices can bring about. The magnitude of this concern has reached Congress such that House Democrats have already called for congressional hearings regarding vaginal mesh devices manufactured by some companies saying “the devices are hazardous to patients.”

Vaginal mesh was thought to be an emerging medical cure. But the fact that the FDA has ordered manufacturers to conduct studies to look into reports of internal injuries caused by these vaginal mesh devices reflects the other side of this supposed medical marvel.

Patients who have undergone surgeries using vaginal mesh have to take legal action and help the authorities in determining the safety of these devices. Congress is making a move. Those who are affected and are potentially vulnerable to these supposed vaginal mesh health hazards should consult their physicians, even if they have not experienced any symptoms.

Women who are currently experiencing symptoms such as vaginal pain, infections, pelvic organ prolapse re-occurrence, or vaginal mesh erosion should immediately consult their physicians for medical attention. Legal action might also be inevitable for those who suffer from vaginal mesh-connected side effects. For additional information about vaginal mesh or to get a free legal consultation, visit http://vaginalmesh.legalview.com.

Let’s hope that Congress acts immediately to review the safety of vaginal mesh and other medical devices. It is hoped that the faster they do this, the safer it is for patients.

According to a recent article by Businessweek, The U.S. Food and Drug Administration wrote a letter to 33 vaginal mesh manufacturers, including Bard and Johnson & Johnson, requiring that the companies study the potential vaginal mesh complications and rates of organ damage. The agency requested three year trials on safety and effectiveness.

Vaginal mesh was originally approved by 501 (k) approval process, where a medical device may be FDA approved if it is similar to other products currently on the market. However in some cases, the original device used to approve newer medical devices was recalled or voluntarily pulled from the market.

Both Johnson & Johnson and Bard have been named in several vaginal mesh lawsuits nationwide, which allege severe complications from the medical device, ranging from mesh erosion, mesh shrinkage, painful sex, severe pain and other complications.

Additional information about vaginal mesh complications can be found at www.legalview.com.

In light of the recent U.S. Food and Drug Administration warnings about vaginal mesh and potential problems associated with other medical devices, the approval process has come under scrutiny.

Currently, the FDA 501 (k) approval process clears newly developed or manufactured medical devices with little testing, as long as the device is similar to another medical device already on the market, known as predicate devices. Bloomberg reports that the 501 (k) process clears close to 90 percent of all medical device applications.

However, if the predicate device is ever recalled or pulled from market due to safety concerns, the similar products given approval through the 501 (k) process are still available. The predicate device for several vaginal mesh products, Boston Scientific’s ProteGen mesh was pulled less than a year after it was approved. ProteGen mesh was used as a predicate device for Johnson & Johnson’s Gynecare TVT, which in turn was used as a predicate device for other vaginal mesh 501(k) approval applications.

These medical devices are still available on the market, even though the original device has been shown to be unsafe for consumers.

As advocates for consumer safety, LegalView urges the revamp of an outdated approval process to better serve the consumers the FDA aims to protect.

For more information about vaginal mesh lawsuits or other medical devices that have been approved via the 501(k) process with the predicate later recalled, please visit LegalView.com.