Are Vaginal Mesh Implants the Cure or the Problem?

Comments Off

A recent article in the Houston Chronicle asks an important question: Do transvaginal mesh implants worsen the condition of women who suffer from pelvic organ prolapse instead of providing a cure? The Chronicle reports that 3.3 million women in the United States suffer from pelvic organ prolapse and stress urinary incontinence and 350,000 of those patients undergo surgery to rid themselves of pelvic pressure and lower back pain caused by those conditions.

However, what many women are finding out is that the cure for the problems associated with pelvic organ prolapse seems worse than the condition itself. This is true particularly if the surgery involves a transvaginal mesh implant. These implants are made of nonabsorbent material and are intended to provide better support for the pelvic area compared to stitching or grafts.

However, women who expected a cure did not get it. The mesh implants caused significant problems including erosion leading to chronic pain, painful intercourse and even nerve injuries. The mesh, in many women, was popping out through the vaginal walls cutting through the surrounding tissue and causing excruciating pain.

Understanding the Risks of Surgery

In 2008, the U.S. Food and Drug Administration (FDA) alerted consumers about vaginal mesh implants and the complications involved. In 2011, the alert was updated stating that complications were more common than initially thought. Doctors are now telling women that mesh implant surgery for prolapse is often not the only or best option. Prolapse is not life threatening, but a quality-of-life issue. Women who are seeking treatment should look into all options. They should equip themselves with the most information so they can make a decision regarding their course of treatment.

Liability Issues

Women who are experiencing the serious side effects of vaginal mesh implants have filed thousands of lawsuits. One woman who was recently awarded $3.3 million in compensatory damages and $7.8 million in punitive damages testified during the jury trial that the Ethicon mesh was marketed to her as safe and effective.

Anyone who has suffered the adverse effects of these vaginal mesh implants would be well advised to contact an experienced product liability attorney who is currently handling these cases. Please remember that you have legal rights and the right to file a claim seeking damages for your significant monetary and other losses.

First Legal Trial Against Ethicon Sets Stage For Subsequent Legal Actions

Comments Off

Johnson & Johnson and its subsidiary, Ethicon, are facing their first legal trial in a consolidated proceeding in Atlantic County in New Jersey. The proceeding is one of the 1,800 lawsuits that Johnson & Johnson and Ethicon currently face due to the failure to disclose some of the dangerous risks in the label of its transvaginal mesh product, Prolift.

Prolift was introduced to the market in 2005 after it received the approval of the U.S. Food and Drug Administration through the fast-track approval system. The transvaginal mesh was claimed to be similar to Gynecare so that it could bypass the additional testing required for the approval to market the drug.

However, it was not until March 2012 that the FDA released a communication confirming that the Prolift was initially marketed without any clearance or approval, that tests should have been done to determine its readiness for the market, and that it had been illegally marketed to the consumers, risking their health and well-being.

Prolift is used for the treatment of women who have pelvic organ prolapse (POP) and/or stress urinary incontinence. Pelvic organ prolapse is a condition wherein the pelvic organ drops and presses against the vaginal wall. The mesh product works by keeping the organs in place. The problem arises when the mesh product disintegrates or contracts.

Some women complain about pain especially during sexual intercourse. There are other complications that are potentially linked to the use of Prolift, which is why lawsuits have been filed alleging the lack of proper safeguards on the part of Johnson & Johnson and Ethicon to ensure patient safety.

If you want to have your Prolift case evaluated, you may contact our Prolift lawyers at our toll-free number, 1-800-992-6878.

d’Oliveira & Associates 2540 Pawtucket Ave, East Providence, RI 02914 (401) 431-1990

Federal Prosecutors Investigating Recalled Defective Hip Implants

Comments Off

Federal prosecutors are probing Johnson & Johnson’s practices when it came to marketing a line of hip replacements recalled in 2010 because of the high rate of revision surgeries. According to a news report in The Associated Press, the hip replacement recalls were a part of more than 30 product recalls by the health care giant just in the last three years.

defective hip implant

The U.S. Attorney’s Office in Massachusetts and the Civil Division of the U.S. Justice Department last August sent Johnson & Johnson an “informal request” for information about its ASR hip replacements, the company reported in a regulatory filing.

The government has apparently asked for additional documents from the company and its subsidiaries, DePuy, which is one of the world’s largest manufacturers of joint replacements and other orthopedic surgical products. DePuy recalled two artificial joint systems — the ASR Hip Resurfacing System and the ASR XL Acetabular System — in August 2010 because of unexpectedly high rates of failure.

In those cases, the implants came loose or tiny pieces of metal from the defective hip implant had disintegrated into the patient’s body causing immune problems. Several studies including Johnson & Johnson’s own internal study corroborated the fact that these hip implants were susceptible to early failure.

Series of Medical Device Recalls

In 2007, the company paid $84.7 million in government fines as part of a sweeping investigation by the Justice Department into alleged kickbacks where J & J and four other top manufacturers of hip and knee replacement devices were accused of paying surgeons to get them to use their products exclusively between 2002 and 2006.

J & J’s spate of recalls has continued into recent weeks. Last week, the company issued a recall on its “Adept” brand of all-metal hip implants due to high failure rates. On February 22, it recalled its LPS Diaphyseal Sleeve, a knee replacement device, because of the possibility that patients to suffer fractures, loss of mobility, loss of limb, infection or even death.

Justice and Compensation for Victims

The results of the federal probe are still unknown. But, it would be interesting to see how Johnson & Johnson marketed its products. Did the marketing continue even after the company knew that its products were defective and were likely to fail earlier than expected? I hope that is a question federal officials ask.

Victims of these dangerous and defective devices face serious consequences including loss of mobility, loss of income and loss of livelihood. In addition, they are saddled with medical expenses such as cost of surgery, hospitalization and rehabilitation. Anyone who has been injured as a result of a hip or knee implant device would be well advised to contact an experienced product liability lawyer who will fight for their rights and ensure that justice is served.

Plaintiff in Vaginal Mesh Case Testifies that She Cannot Work, Enjoy Sex or Even Sit Down

Comments Off

As a personal injury law firm that is representing many women who have been severely injured as a result of defectively designed and manufactured transvaginal mesh implants, we completely understand what Linda Gross had to endure. Gross, 47, testified in her case against Ethicon in New Jersey, the first out of thousands of vaginal mesh cases against different manufacturers that has gone to trial.

According to news report, Gross told a jury that as a result of a Prolift Gynecare vaginal mesh implant she received in 2006, she cannot work, enjoy sex with her husband or even sit down for more than 20 minutes at a time. There are days, she says, when she cannot even get out of bed. Like many of the victims we encounter, Gross has undergone several surgeries to remove the vaginal mesh to relieve her chronic pain.

Serious Side Effects

What I find interesting about her testimony is the reason she decided to get the implant. Gross said she was impressed by Prolift because of the marketing brochure put out by the company, Ethicon. The brochure claimed that the surgery was minimally invasive, specially designed and “clinically proven.” It also advertised the procedure as low-risk stating that complications are “rare.”

Well, now we know that’s not true. Even the U.S. Food and Drug Administration (FDA) has issued warnings about these products stating that they are known to have cause serious, painful complications in thousands of women. The product is support to alleviate symptoms of pelvic organ prolapse and stress urinary incontinence. But, on the contrary, it causes severe complications including mesh erosion, nerve damage, infections, pain, vaginal scarring and urinary problems.

Holding Negligent Manufacturers Liable

It is appalling that the manufacturers of these products not only failed to warn consumers about the serious complications that could arise from using these products, but marketed the mesh devices with the promise of relief and minimal symptoms. I certainly hope that these women are able to get justice and fair compensation for their losses. I also hope that these manufacturers are held accountable for their negligence and callous disregard for the health and safety of those who buy their products.

Transvaginal Mesh Lawsuits on the Rise: What to Know

Comments Off

An alarming trend has been on the rise as of late, and it’s the increase in dangerous, harmful consequences of transvaginal mesh surgical procedures. As a result, there has been an increase in the number of vaginal mesh lawsuits and claims, and it’s important you arm yourself with the correct information and knowledge before it’s too late.

First, it’s important to know a little bit more about this procedure and what it is used for. Transvaginal mesh is surgically implanted in a woman’s body in order to repair weakened or damaged tissue. It is most commonly used for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a permanent implant potentially made from several different types of materials.

Unfortunately, vaginal mesh implants have increasingly become an item which produces alarming and dangerous results. Either the risks of these implants and the procedure were unknown or were not fully understood, were not disclosed to patients, or the implants themselves being made and utilized are faulty. Either way, it’s a serious issue and it’s only becoming more common, which is why it’s important to know what you’re facing. More

New Yaz Lawsuit filed by California Woman

No Comments

A new Yaz lawsuit has been filed by a California woman who is claiming that Yaz led to her developing kidney stones. This is the first of this type of lawsuit for the birth control product. Most of current cases are related to blood clot issues and some to Gallbladder problems. Like the claims currently on file, any claims linking Yaz with kidney stones will have to  be supported by scientific and medical evidence.

What is unknown is whether the woman from California will be adding her case to the existing Yaz Multi District claim in Illinois.

It’s possible that other cases could crop up, too.  A medication that can cause blood clots could lead to other types of medical issues. Some happen quickly, as in the case of pulmonary embolisms, strokes or DVT’s, but other problems can take much longer to develop.

Current possible side effects include:

  1. Pancreatitis
  2. Stroke
  3. Blood clots in the legs
  4. Heart attack
  5. Gall bladder disease
  6. Blood clots in the lungs

Yasmin and Yaz are both birth control pills manufactured by Bayer that contain drospirenone, an ingredient thought to increase the risk of blood clots. In less than 10 years, they have risen to one of the top options for birth control and are the third best selling drug for Bayer.

Bayer continues to sell the product while also paying out on the lawsuits that have been filed as well as reserving funds for future lawsuits.

California Yaz Attorneys

The California Yaz attorneys at Bisnar | Chase have been helping defective medication victims for decades. Their reputation as one of the country’s foremost drug recall law firms has been solidified with their multimillion dollar settlements and verdicts as well as their commitment to superior client representation.

If you or a family member believe you were injured by Yaz or Yasmin please call  (800) 561-4887 to arrange for a free legal consultation.



Another Mississippi Transvaginal Mesh Lawsuit is Filed

No Comments

Mississippi Transvaginal Mesh lawyers will have their hands full as yet another case of a victim claiming to be injured by this medical device has been filed.

The new lawsuit alleges that the woman’s injuries were caused by three transvaginal mesh products and suffered from these products: American Medical Systems’ Elevate Anterior and Apical System with Intepro Lite, Elevate Apical and Posterior System with Intepro Lite and Johnson & Johnson’s Gynecare TVT System.

According to the complaint, she was implanted with the devices in 2009 to correct her pelvic organ prolapse and stress urinary incontinence. Transvaginal mesh products are used to treat POP and SUI by providing additional support to the walls of the pelvis. More

FDA Panel Sees More Cons than Pros with Metal Hip Implants

No Comments

The U.S. Food and Drug Administration’s 18-member panel, which met recently to discuss the effectiveness of metal-on-metal hip implants, arrived at the conclusion that there are few reasons to continue using these defective medical devices. According to a news report in The Associated Press, there is a growing body of evidence, which suggests that the devices can break down early and expose patients to dangerous metallic particles. The metal-on-metal hip implants, which are being scrutinized by the FDA following numerous consumer complaints about the failing implants, were originally marketed as a longer lasting alternative to older ceramic and plastic models.


J & J Sold Vaginal Mesh Implants Without FDA Approval

No Comments

Johnson & Johnson continued to sell vaginal mesh implants for nine months after federal safety regulators told the company to stop marketing the device. According to a Bloomberg report, the U.S. Food and Drug Administration (FDA), which had received numerous consumer complaints about adverse effects, told the health-care products maker in a letter dated August 24, 2007 to stop selling Gynecare Prolift until the agency decided if the device was “substantially equivalent” to other products on the market. In its letter, FDA officials cited the potentially high risk for organ perforation when surgeons insert the mesh vaginally to shore up weakened pelvic tissues.

The letter prohibited J & J from marketing the device until they provided adequate information and got FDA approval. Selling the device would be a violation of federal law, the letter stated. The FDA cleared the device in May 2008. But, in the interim, J & J continued to market and sell the products.

Life-Changing Side Effects

Now, the company faces more than 1,400 vaginal mesh lawsuits from women who allege a variety of painful side effects including organ perforation, pain, scarring and even nerve damage. Nearly 300,000 in the United States were implanted with these mesh devices in 2010. J & J had started selling Prolift in 2005 without filing a new application after determining on its own that the device was substantially similar to Gynemesh, which was already cleared by FDA. However, FDA officials disagreed with J & J’s interpretation and required that the company file a new application.

Lack of Studies and Testing

This information comes to light even as the U.S. Senate is looking at making changes to the FDA’s device review system, which allows medical devices to be sold without human testing if there are other “substantially similar” products already in the market. Transvaginal mesh implants are among several medical devices that have found their way into the market and into people’s bodies without safety studies or testing. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. and other manufacturers to study organ damage and complications related to these defective products. The agency received 123 complaints about Prolift from 2005 to May 15, 2008, when the device was cleared.

Justice for Victims

It is absolutely outrageous that this industry giant thought that it could get away with violating federal law. Thanks to the lawsuits that have been filed by thousands of women, these facts are now coming to light. The FDA letter was recently unsealed in court at the request of plaintiffs’ attorneys. This also seriously questions the FDA’s ability to enforce the law. One expert quoted in the Bloomberg news report compares the FDA to “a sheriff packing a water pistol.”

These mesh implant products have left thousands of women all over the country with life-changing and irreversible side effects. This account highlights yet another instance of how the safety and health of consumers are compromised by reckless manufacturers who are unwilling to put consumer safety above profits. If you have been affected by these defective products are looking for more information about pursuing your legal rights, please click here.


Texas Vaginal Mesh Attorneys

No Comments

As victims of the defective vaginal mesh and bladder sling products continue to come forward, vaginal mesh attorneys in Texas are working hard to accommodate the significant number of victims. The defective mesh attorneys at Bisnar | Chase have been working around the clock to assist victims across the nation, providing free consultations and lawsuit information as product defect lawsuits gain traction in the courtroom. Women pursuing compensation for their failed devices are hopeful that bladder sling manufactures, as well as mesh production companies, will be held responsible for producing hazardous products and will be ordered to pay millions.

John Bisnar and Brian Chase, head partners of the Bisnar | Chase mesh and bladder sling law firm, are confident that women who have suffered injuries caused by these products’ defects will receive compensation for their injuries. More

Older Entries Newer Entries