Dallas Fort Worth Injury Lawyer Blog

As a Texas medical doctor and Transvaginal Mesh Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted Transvaginal Mesh medical device.

According to the Public Citizen watchdog group, the surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects.

Public Citizen, said that mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence. The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.

Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this July update to inform that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP. Read the FDA PDF Report here.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

The literature review revealed that:

Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
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.

Public Citizen, estimates that 67,500 women had the non-absorbable mesh implanted last year. According to the Food and Drug Administration, in a safety warning July 13, the agency received 1,503 reports of complications associated with the material from January 2008 to December 2010 when used to repair pelvic organ prolapse.

“Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately,” Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement.

The material is made by at least nine manufacturers, according to the FDA.

Public Citizen wants the FDA to require manufacturers to recall non-absorbable surgical mesh devices and future versions to be subject to more stringent approval requirements.

As a Texas medical doctor and YAZ, Yasmin and Ocella Personal Injury attorney, I am providing this litigation update, information and commentary.

Judge Herndon overseeing the federal Yaz and Yasmin MDL, has rejected the consolidation of multiple cases during the early bellwether trials. The Court plans for “meaningful” settlement negotiations after the initial trials are held. These mini trials will help decide how juries will to respond to similar evidence and testimony like other cases in the litigation.

There are more than 6,350 lawsuits that have been centralized in the U.S. District Court for the Southern District of Illinois. All of the cases allege that Bayer failed to adequately warn about the risk of serious and potentially life-threatening side effects of Yaz and Yasmin birth control, such as a stroke, pulmonary embolism, deep vein thrombosis or gallbladder disease.

In October 2010, the Court issued an order for a handful of cases to be prepared for three early trials, known as bellwether cases. The first trial, which is scheduled to begin in 2012, will involve a pulmonary embolism injury claim. The second trial will involve a gallbladder injury and the third trial will involve a venous thromboembolism (VTE), a deep vein thrombosis (DVT).

In August 19, 2011, the Court issued an order for the Gallbladder (“GB”) trial setting, that the Parties shall exchange their GB trial-pool selections on September 7, 2011. For the Venous Thromboembolism (“VTE”) trial setting, the Parties shall exchange their VTE trialpool selections on December 2, 2011.

Each side shall select four GB cases and four VTE cases. Each side shall exercise any veto (maximum of one, minimum of zero) on September 9, 2011, for the GB cases. Each side shall exercise any veto (maximum of one, minimum of zero) on December 6, 2011, for the VTE cases.

On September 14, 2011, after the exercise of any vetoes over the parties’ GB trial-pool selections, the parties shall submit the names of the remaining GB cases to the Court without indicating which party picked which case. Also on September 14, 2011, each party shall provide to the Court and to the other party a factual summary concerning each GB case submitted to the Court for trial selection, so that the Court receives two submissions on each case.

On December 12, 2011, after the exercise of any vetoes over the parties’ VTE trialpool
selections, the parties shall submit the names of the remaining VTE cases to the Court without indicating which party picked which case. Also on December 12, 2011, each party shall provide to the Court and to the other party a factual summary concerning each VTE case submitted to the Court for trial selection, so that the Court receives two submissions on each case.

Plaintiffs’ attorneys requested Judge Herndon to consolidate several cases for the 2nd and 3rd trials. They argued that trying cases one plaintiff at a time would “commit this litigation to a lifespan of eternity.” Plaintiffs states that there has been no movement by Bayer towards a Yaz settlement agreement, and suggested that effeciences would be served by trying several cases at a time after the 1st bellwether trial.

On August 18, Judge Herndon rejected this request and indicated that the 2nd and 3rd bellwether trials will proceed and shall be individual plaintiffs.

“The Court has no intention of presiding over anything into eternity, let alone this litigation, and the Court is presently working on a process that will engage the parties in settlement discussions following the bellwether trials in a meaningful way,” Judge Herndon wrote.

Yaz and Yasmin are birth control pills that contain a newer type of progestin, known as drospirenone, which has been linked to an increased risk of blood clots and other injuries. The Yaz and Yasmin litigation also involves cases filed over a newer version of the birth control pills, sold as Beyaz, as well as generic equivalents, such as Ocella and Gianvi.

Although the first trials are approaching, the number of lawsuits is expected to continue to grow as Yaz and Yasmin lawyers review and file additional cases in the coming months and years for women who have experienced health problems from the birth control pills. Early estimates suggested that more than 25,000 women may eventually file a Yaz birth control suit.

As a Texas medical doctor and DePuy Hip Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted DePuy ASR and DePuy Pinnacle Metal on Metal Hip prosthesis.

The Food and Drug Administration has received many complaints recently about failed hip replacements. The FDA has received more than 5,000 reports since January concerning metal-on-metal hips. The majority of complaints involve patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years. Metal-on-metal hip replacement systems are a widely used type of artificial hip, which are designed to last about 15 years. However, complaints suggest that thousands of people are experiencing early failure of the hip implants within a few years of surgery, often leading to additional surgery to replace the hip.

The complaints confirm that all-metal replacement hips are becoming the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007.

Some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear. This is known as metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.

Hip replacement is one of the most common procedures in the United States and all-metal implants accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the artificial hip devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints. Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. The F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients.

In August 2010, a DePuy ASR hip recall was issued for more than 90,000 of the metal hip implants, after it was discovered that a higher-than-expected number were failing within a few years of surgery. Similar problems have been reported in connection with other metal-on-metal hip implants sold by other companies.

In February 2011, the FDA launched a new website in February 2011, which was designed to provide information about the risks associated with metal-on-metal hip replacements.

The FDA has now asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.

As problems and questions grow, some surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available.

For many patients, it is too late. The number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the DePuy A.S.R. and the Zimmer Durom cup probably reflects a surge of lawsuits filed against their makers.

According the recent New York Times review, there were 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.

It is impossible to say how many adverse reports about all-metal hips have been submitted. The Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.

Many individuals throughout the United States have already filed metal-on-metal hip replacement lawsuits over problems allegedly caused by metallosis or metal poisoning. All DePuy ASR hip lawsuits have been consolidated in federal court as part of an MDL, or multidistrict litigation, in Northern District of Ohio. Lawsuits over DePuy Pinnacle hip metal-on-metal implant replacements, which is another has been consolidated in the Northern District of Texas in Dallas.

Continue reading " Risks of DePuy Metallosis Following a Metal On Metal Hip " »

As a Texas Medical Doctor and Dallas dangerous dog attorney, I am writing this update to inform the public about recent dog attacks.

A Washington jury found Pierce County partly responsible for injuries suffered by a woman mauled by a pit bull. The jury awarded $2.2 million to the woman who was attacked by a neighbor's dog who entered her house through an open door.

The jury determined the owners of the dog were 52 percent responsible. Pierce County received 42 percent of the liability because animal control officials took no action after getting a dozen complaints from the neighborhood. The injured woman, was assigned 1 percent of the blame. She suffered injuries while trying to pull the pit bull off her two Jack Russell terriers.
Read full story here.

Around the Web
A 9 tear old girl is recovering after a savage mauling by a neighbor's pit bull and may have suffered permanent nerve damage. Sabrina Carrasco of Sacramento, was attacked after the pit bull got out of the fenced yard where it was kept.
Read full story here.

A 75 year old San Diego woman faced the possible amputation of a second limb after she was attacked by a pair of pit bulls.The woman was jumped by the two dogs in the backyard.

Surgeons at Scripps Mercy Hospital had to remove her badly mauled leg and tried to save her equally mangled arm, but the injuries to the woman's arm were so severe that it might have to be amputated as well. Read full story here.

A 74-year-old Florida man died after two next-door dogs ripped off one of his arms, nearly detached his other arm and severely disfigured his face, police said. Read more here.

A 4-year-old boy died after being bitten in the throat by one of his father's dogs, New York City police said. Read more here.

Four pit bull mix dogs fatally mauled a New Mexico woman while she was on a Sunday afternoon walk, police said. Read full story here.

A pet Rottweiler forced its way into a Houston home and killed its owners' baby daughter. The attack occurred while Alva Vaughn was washing another of her nine dogs in the bathroom. The 3 months old baby, was in a swing in the living room. When Vaughn heard a dog barking, she found the child on the floor with her head and hands mangled. Read the full story here.

Folks need to bear in mind that certain breeds of dogs are dangerous and no amount of love and attention can fix the wild nature. Most if not all people would consider a lion or a tiger impossible to tame and those big cats are too dangerous to be a pet in a neighborhood. Likewise some dog breeds are just bred for their viciousness and attacking qualities. These dogs are too dangerous to be pets.

Read more about dog bites here from the CDC.

As a DePuy Pinnacle Hip Replacement attorney and Texas Medical doctor I am providing this important update, regarding the first MDL hearing held in my home town of Dallas, Texas.

Attorneys from throughout the United States who represent DePuy Pinnacle hip replacement plaintiffs, met today in the U.S. District Court for the Northern District of Texas. This hearing was held in Dallas, and was the first status conference with the judge presiding over the recently formed multi-district litigation (MDL). The meeting between the plaintiff and defense attorneys was quite cordial and the hearing with Judge Kinkeade, lasted over 2 hours. This was an informal, esssentially a meet and greet type of hearing, much different from other types of contentious hearings.

It was interesting to stand at the back of the courtroom and observe the proceedings, the court room was jam packed, standing room only.

The meeting of the attorneys representing DePuy and various plaintiffs with Judge Kinkeade, addressed the format and structure of the pretrial proceedings and the composition of a committee of plaintiffs’ attorneys, who will serve in leadership positions and perform coordinated actions of the lawsuits consolidated in the MDL.

In May 2011, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all DePuy Pinnacle lawsuits filed in federal district courts throughout the United States will be consolidated for pretrial proceedings before U.S. District Judge Kinkeade.

According to a Master Case List released by the court on July 20, there are already 213 cases consolidated in the MDL. As DePuy Pinnacle hip replacement lawyers continue to investigate and file new cases, the federal MDL will continue to grow.

All of the suits have similar allegations that the DePuy Pinnacle Acetabular Cup System was defectively designed or manufactured, and that inadequate warnings were provided about the risk of early complications or problems, which have been developing within a few years of the surgery. In some cases, the DePuy Pinnacle hip problems may result in the need for additional surgery to replace or revise the hip replacement.

Many of the petitions also allege that DePuy, a subsidiary of Johnson & Johnson, has been aware of the problems with their metal-on-metal hip implants for some time and that a DePuy Pinnacle hip recall should have been issued several years ago.

DePuy filed a brief last week regarding the selection of the plaintiffs’ leadership positions. DePuy claimed that several DePuy Pinnacle lawyers representing plaintiffs in the federal MDL proceedings are continuing to file cases in state courts, naming local defendants such as physicians and sales representatives to avoid removal to federal court. DePuy argued that those attorneys should not be appointed to leadership positions, because such conduct impedes the progress of the litigation and undermines the goals of the MDL proceeding.

Johnson & Johnson and DePuy also face thousands of lawsuits over the recalled DePuy ASR hip replacement system, because of a higher-than-expected failure rate. The DePuy ASR hip was approved as a substantial equivalent design to the DePuy Pinnacle metal-on-metal hip, and faces the similar allegations regarding design problems with the two devices.

In October, the American Academy of Orthopaedic Surgeons (AAOS) issued a warning about potential problems with metal on-metal hip replacements, indicating that patients and the medical community should be aware that pain months after hip replacement surgery may be a sign of metal-on-metal hip cobalt toxicity. In addition, the FDA launched a new website in February to provide information about the risks associated with metal-on-metal hip replacements.

As a Texas medical doctor and Actos Bladder Cancer Attorney I am providing this information and commentary.

The maker of the world's best-selling diabetes drug is facing many lawsuits as adverse medical research shows that taking the pill for more than a year raises the risk of bladder cancer.

In June, Takeda Pharmaceuticals Co. Ltd. halted sales of Actos, in Germany and France after pressure from government health regulators. Actos (pioglitazone) is a medication manufactured and sold by Takeda Pharmaceuticals for treatment of Type 2 diabetes. The drug is part of the same class of medications as Avandia (rosiglitazone), which has been linked to an increased risk of heart problems. As a result of concerns about Avandia side effects, sales of Actos have grown substantially in recent years.

The U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research. The FDA has approved updated label information for pioglitazone (Actos) and medications that contain it, following its warning in June about bladder cancer risk with the drug.

The FDA new labeling, released Friday, warns that use of pioglitazone for more than a year may increase the risk of bladder cancer, a finding based on an interim analysis of an epidemiological study.

Other medications that will carry the warning include pioglitazone/metformin (Actoplus Met), pioglitazone/metformin extended release (Actoplus Met XR), and pioglitazone/glimepiride (Duetact).

The updated label recommends against use of pioglitazone in patients with active bladder cancer and urges cautious use in those with a history of bladder cancer.

It also urges patients to contact their healthcare provider if they experience any potential symptoms of bladder cancer, including blood in their urine, urinary urgency, or pain on urination.

Actos, despite other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to greatly increase risk of heart attacks. Avandia's use was banned in the Eurpoean Union and sharply restricted here.

Recently lawsuits were filed in courts across the country. They allege Actos triggered bladder cancer, in some cases deadly, in patients who took the pills daily for years.

The claims allege that when a manufacturer distributes a drug, they owe it to the public to ensure that their product is safe for use and it appears that Takeda Pharmaceuticals failed to fulfill that fundamental duty.

The FDA analyzed data from the first five years of a 10-year Actos safety study Takeda begun in 2002 and concluded this June that risk of bladder cancer was 40 percent higher for patients taking Actos for at least a year.

As a Texas medical doctor and Transvaginal Mesh Attorney I am providing this information and commentary.

Read previous Transvaginal Mesh side effect blog here.
A number of lawsuits over Bard Avaulta mesh and other transvaginal products manufactured by C.R. Bard have been filed throughout the United States. The general allegations in these claims are that women experienced painful complications after receiving the vaginal mesh products for repair of pelvic organ prolapse (POP) and other gynecological and urological medical conditions.

Most recently, more than 100 people have filed a Bard Avaulta vaginal mesh lawsuit. At least 84 of the cases are filed in the federal court system, where they have been consolidated for as part of an MDL, or multidistrict litigation, before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia. Another 37 cases have been filed in New Jersey state court, where the litigation has been centralized before Judge Higbee in Atantic County.

According to a case management order issued in the Bard Avaulta MDL, the next step of the litigation involves the selection of a pool of potential bellwether cases. In the order, Judge Goodwin indicated that the discovery process is not anticipated to begin before October.

Other products manufactured and sold by C.R. Bard have been included in the MDL and New Jersey state court litigation, including the Align, Pelvicol, Pelvilace, PelviSoft, Pelvitex, uretex and Ugytex mesh systems.

All of the complaints involve allegations that the transvaginal mesh products were defectively designed and that C.R. Bard failed to adequately research the risks associated with the mesh or warn about the risk of possible complications that can result in pain and disfigurement.

Bard vaginal slings have been associated with erosion of the mesh into the vagina, infection, recurrence of prolapse, urinary problems and painful sexual intercourse, among others complications. Awareness about the potential risk or transvaginal mesh problems has increased in recent weeks, following a warning issued by the FDA last month.

In July 2011, the FDA issued a statement indicating that they have been unable to find any evidence that Bard Avaulta mesh and other transvaginal mesh systems for repair of pelvic organ prolapse provide any significant benefits over other available means of treatment. More than 1,500 reports of complications with vaginal mesh products, such as the Bard Avaulta Mesh and other similar systems, have been received by the FDA over the past three years

As a Texas medical doctor and Fracking water contamination attorney, I want to pose this rhetorical question; What happens when the foxes are guarding the hen house? Consider that as you savor your morning coffee, which may be contaminated with benzene, from a contaminated water aquifer.

Oil and gas industry as well as government regulators have maintained for many decades that a drilling technique known as hydraulic fracturing, or fracking, that is used for natural gas wells has never contaminated underground drinking water. The fracking process, involves water and toxic chemicals being injected at high pressure into the ground to break up rocks and release the gas trapped there. This process according to industry officials, occurs thousands of feet below drinking-water aquifers and because of that distance, the drilling chemicals allegedly pose no risk.

According to ExxonMobil at a Congressional hearing on drilling...“There have been over a million wells hydraulically fractured ...and there is not one, not one, reported case of a freshwater aquifer having ever been contaminated from hydraulic fracturing...”

But there is in fact a documented case, and the E.P.A. report suggests there may be more. Researchers, were unable to investigate many suspected cases because their details were sealed from the public when energy companies settled lawsuits with landowners. E.P.A. says this practice continues to prevent them from fully assessing the risks of certain types of gas drilling.

The American Petroleum Institute, dismissed the assertion that sealed settlements have hidden problems with gas drilling, and according to their data, they have found that drinking water contamination from fracking is highly improbable.

The documented E.P.A. case, and the report was published in 1987, and the contamination was discovered in 1984. The report concluded that hydraulic fracturing fluids or gel used by the Kaiser Exploration and Mining Company contaminated a well roughly 600 feet away on the property of James Parsons in Jackson County, W.Va., referring to it as “Mr. Parson’s water well.”

“When fracturing the Kaiser gas well on Mr. James Parson’s property, fractures were created allowing migration of fracture fluid from the gas well to Mr. Parson’s water well,” according to the agency’s summary of the case. “This fracture fluid, along with natural gas was present in Mr. Parson’s water, rendering it unusable.”

In their report, E.P.A. officials also wrote that Mr. Parsons’ case was highlighted as an “illustrative” example of the hazards created by this type of drilling, and that legal settlements and nondisclosure agreements prevented access to scientific documentation of other incidents. “This is typical practice, for instance, in Texas,” the report stated. “In some cases, the records of well-publicized damage incidents are almost entirely unavailable for review.”

Industry officials emphasize that all forms of drilling involve some degree of risk. The question, they say, is what represents an acceptable level. Once chemicals contaminate underground drinking-water sources, they are very difficult to remove, according to federal and industry studies.

A 2004 study by the E.P.A. agency concluded that hydraulic fracturing of one kind of natural gas well — coal-bed methane wells — posed “little or no threat” to underground drinking water supplies. The study was later criticized by some within the agency as being unscientific and unduly influenced by industry.

Instances of gas bubbling from fracked sites into nearby water wells have been extensively documented. The industry has also acknowledged that fracking liquids can end up in aquifers because of failures in the casing of wells, spills that occur above ground or through other factors.

Both types of contamination can render the water unusable. However, contamination from fracking fluids is widely considered more worrisome because the fluids can contain carcinogens like benzene.

The risk of abandoned wells serving as conduits for contamination is one that the E.P.A. is currently researching as part of its national study on fracking. Many states lack complete records with the number or location of these abandoned wells and they lack the resources to ensure that abandoned and active wells are inspected regularly.

A 1999 report by the Department of Energy said there were about 2.5 million abandoned oil and natural gas wells in the United States at the time.

Short answer, carbon based energy is not the answer, in this current heat wave that most of the country is withering under, think of the amount of solar energy that can be harvested?

Studies have shown that a solar array set up, in Nevada can supply all of the energy needs of the USA, for the next century.

Continue reading " Fracking Water Contamination " »

As a Texas medical doctor and Transvaginal Mesh Attorney I am providing this information and commentary.

11.6% of women who undergo surgery with transvaginal placement of Ethicon Gynecare Prolift Mesh for repair of pelvic organ prolapse (POP) have to undergo additional operations due to post operative complications.

This complication rate was found as a result of a new study, published by the American Journal of Obstetrics and Gynecology. Most of the re-operations were due to urinary incontinence that occurred after the mesh was implanted, with other problems including transvaginal mesh complications and prolapse recurrence.

Researchers reviewed the outcomes for 524 patients who received the Ethicon Gynecare Prolift vaginal mesh over a 4 year period. At a follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. Over 50% of those reoperations were due to urinary incontinence, More than 25% due to mesh-related complications and more than 25% due to recurring prolapse. The researchers found that the number of mesh-related complications and POP decreased when experienced medical teams implanted the mesh.

The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems was first introduced in September 2005, and Gynecare Prolift+M variations were introduced in May 2008. The vaginal mesh or bladder sling is designed reinforce weakened or damaged tissue on the pelvic floor that hold organs in place, such as the bladder, the uterus and the rectum.

Recently, the FDA issued a warning about the risk of problems with Ethicon Gynecare vaginal mesh and other similar products used for pelvic organ prolapse. The agency declared that transvaginal surgical mesh for pelvic organ prolapse does not provide any benefit over other means of treatment, and has been associated with hundreds of reports of serious problems.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh problems after pelvic organ prolapse repair surgery, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infection, pelvic pain, urinary problems, vaginal scarring among other complications.

A number of Gynecare Prolift mesh lawsuits have been filed against Ethicon, Inc., which is a subsidiary of Johnson & Johnson. At least 400 complaints have been filed in New Jersey state court over the Prolift mesh and other similar vaginal bladder sling products made by Ethicon, such as Gynemesh, Prolene Mesh and TVT slings.

In addition to Ethicon vaginal mesh products, problems have also been associated with slings sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies. Transvaginal mesh lawyers are also reviewing potential claims against manufacturers of these products for women who experienced problems with surgical mesh for pelvic organ prolapse repair.

Continue reading " Ethicon Gynecare Prolift Mesh Linked to 11.6% Reoperation Rate " »