Yaz & Yasmin Manufacturer Failed to Warn about Blood Clot Risk

The suits allege that Bayer failed to adequately warn about the drugs’ potentially fatal side effects including the risk of blood clots, pulmonary embolism, and gallbladder disease. Once settlement amounts have been determined, RD Legal Funding, LLC, a leading provider of litigation funding solutions, will provide legal settlement funding to both plaintiffs and their attorneys.

Yaz became the U.S.’s top-selling birth control pill thanks in part to multi-million dollar ad campaigns promoting the drug to women under 35 as the birth control pill that also combatted premenstrual depression and acne. Bayer’s contraceptives generated $1.58 billion in sales in 2010.

However, a study of 1.3 million Danish women published in October 2011 in the British Medical Journal reported that women taking Yaz or Yasmin had double the risk of blood clots, compared with women taking the older contraceptives.

Bayer responded that the study and others showing elevated risks of stroke with blood clots in the legs and lungs had methodological problems. A Bayer-funded study concluded that cardiovascular risks in women taking Bayer products were acceptable and comparable to other birth control pills. But Bayer’s annual report, released in February 2012, implied that the company had settled at least 70 Yaz and Yasmin related cases.

On April 10th, 2012, the FDA ordered Bayer and other contraceptive manufacturers to amend the blood-clot warnings on their labels. For pills such as Yaz and Yasmin that contain drospirenone, warning labels must state that researchers have found they may triple the risk for blood clots. The most recent news indicates that Bayer has agreed to pay $142 million to settle 651 Yaz and Yasmin related lawsuits.

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If you or someone you love has taken Yaz, and suffered because of it, you may be entitled to financial compensation. Call 1-800-732-3070 for a free consultation to learn about your legal options.

Bayer, based in Leverkusen, Germany, has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused sometimes- fatal clots that can lead to heart attacks and strokes, the company said today in its Stockholders’ Newsletter for the first quarter. The company said it paid $142 million in the settlements, for an average of about $218,000 a case.

“This company wants to avoid the possibility of a large jury award in these clot cases,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview. “Settlements provide predictability when it comes to the cost of resolving these cases.” Bayer’s update comes less than two weeks after Richard Vosser, a JPMorgan Chase & Co. analyst, said the drugmaker may have to pay more than 2 billion euros ($2.65 billion) to resolve all the cases over the contraceptives. Bloomberg News reported April 13 that Bayer agreed to pay about $110 million to settle the first 500 U.S. suits over Yasmin, according to people familiar with the accords. On April 10th, the U.S. Food and Drug Administration ordered Bayer and other contraceptive makers to strengthen blood-clot warnings on their products.

Triple Risk of Blood Clots

Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots. The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line, according to the FDA report. Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health. Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betaseron, a multiple sclerosis medication. “Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records,” the company said in the report.

11,900 Yaz / Yasmin Lawsuits

Fewer than half of the cases brought over the contraceptives so far include those injuries, Bayer said. As of April 18th, Bayer faced 11,900 lawsuits over Yaz and Yasmin in the U.S. involving about 14,000 plaintiffs. Bayer officials said they weren’t admitting wrongdoing in any of the settlements.

Yaz / Yasmin Gallbladder Cases

Michael Burg, one of the leaders of a group of plaintiffs’ lawyers that is overseeing the progress of Yasmin cases consolidated before a federal judge in Illinois, said Bayer is pressing ahead with settlement talks about blood clot cases. The drug maker is rejecting women’s claims that the contraceptives damaged their gallbladders or caused them to suffer from gallstones, Burg, who is based in Colorado, said in a telephone interview. “At this point, t they’ve said they don’t anticipate settling any of the gallbladder cases,” he said.

Lawyers suing the drug maker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Plaintiffs’ lawyers contend in court filings that Bayer officials marketed the contraceptives for unapproved uses and misled women about the drugs’ risks.

Yaz / Yasmin Trials on Hold

The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings. Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk. At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December order. The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users. “I don’t anticipate seeing any trials this year,” Burg said today. The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).

The most frequently reported complication is vaginal mesh erosion. This complication is very painful because the mesh causes splitting of the skin, which increases the risk of infection. Pelvic organ prolapse can also return, which was, in many cases, what the mesh was meant to repair in the first place.

Vaginal Mesh Erosion

It was in 2009 when a clinical trial was conducted on Transvaginal Mesh that had to be abruptly stopped. Before the trial was even finished, 15% of the women had experienced vaginal mesh erosion within three months of the trial starting. As for risk factors that these women shared that led to the erosion, there were no common factors except for the fact they had received the mesh, but so had the remaining 85%. Ultimately, 15% is too high of a risk to take because most complications in clinical trials do not typically occur in more than 1% to 2% of the trial participants. If they do, the product usually does not reach the market. In this case, the mesh had already been on the market.

In 2011, the FDA issued a public notice to physicians that from January 2009 to December of 2010, 2,875 injuries had been reported in addition to those reported between 2005 and 2009. These reports involved nine manufacturers.

FDA Recommendations For Women

The FDA issued a set of recommendations for women after having Transvaginal Mesh implanted. Those recommendations say:

• Patients should maintain their schedule of routine checkups so that complications can be caught before they come very severe
• Patients should notify their doctor if symptoms of complications come about, such as vaginal bleeding, groin pain, pelvic pain, painful sex, or incontinence
• Patients should always let physicians know that they have the mesh
• Patients should address their concerns with their doctor and ask any necessary questions
• Patients should ask if mesh was used in their prolapsed pelvic organ surgery if unsure of what the surgery entailed

If you are a recipient of Transvaginal Mesh and you are experiencing complications, you will need to contact your doctor immediately. Bleeding and dangerous infection can occur, so it is best to have any pain addressed as soon as possible.

Transvaginal Mesh Lawsuits

Because of the complications associated with Transvaginal Mesh, lawsuits have and are being filed against the manufacturers for compensation relating to the damages. The complications can cause lifelong consequences and a compromised quality of life. Women that have undergone the surgery have done so to improve their quality of life, but what is happening is the post surgery problems are worse than those before the surgery and sometimes result in several surgeries to correct. To learn of your rights and options, call to schedule your free case evaluation at 1-800-732-3070.

As a result of these complications, women have sought out attorneys to file Transvaginal Mesh lawsuits on their behalf. The complications that can result do compromise quality of life because the complications can be worse than the initial symptoms of organ prolapse or the issue that led to the surgery in the first place. In both 2008 and 2009, the FDA issued warnings about these complications.

Complications

One of the most common complications that have occurred with Transvaginal Mesh is the erosion of the mesh. This can lead to excruciating pain and incontinence, as well as a number of other issues. Those issues include:

· Infections

· Severe pain

· Pelvic organ prolapse reoccurs

· Stress urinary incontinence returns

· Erosion of vaginal epithelium

Unfortunately, these complications are not rare. As of 2008, the FDA stated that these complications were rare. Since then, their stance has changed due to the facts and figures. Out of 2,874 new reports of complications between January 2008 and December 2010, 1,503 of them were related to pelvic organ prolapse repair and 1,371 of them were for stress urinary incontinence.

The result of these complications is a compromised quality of life. The surgery was done in the first place to improve quality of life. While it may have worked well for a while, it ultimately failed.

Transvaginal Mesh Design

As it stands, the design of the surgical mesh is what has been blamed for the complications that women have experienced. The same was said of the ObTape Vaginal Sling that was removed from the market in 2006. Women were reporting impaired healing, urinary tract erosion, and a variety of other complications.

It is the revelation that the ObTape blocked the surrounding tissue from getting the oxygen and nutrients that it needed that led to its removal from the market. Now it is believed that Transvaginal Mesh behaves in the same way. Some of the complications are exactly the same as what had occurred with the ObTape.

Can You File A Lawsuit?

One of the questions that women who have experienced Transvaginal Mesh side effects have asked is whether or not they can file a Transvaginal Mesh lawsuit. The answer is “yes” if you or a loved one has experienced complications related to the mesh. To find out if you can file a lawsuit, call 1-800-732-3070 or fill out the contact form on this page to schedule a free case evaluation.

It has been said that it is believed the design of Transvaginal Mesh is to blame for the complications that thousands of women have experienced. Since 2005, approximately 4,000 women have reported complications with more women most likely coming forward as they learn more about the surgical mesh failure and the symptoms associated with that failure.

FDA Warning To Surgeons

In 2008, the FDA issued a warning to surgeons that Transvaginal Mesh was related to a number of complications after surgery that included bleeding, inflammation, the reoccurrence of pelvic organ prolapse or incontinence, and even infection. With that warning also came a recommendation that surgeons receive special training to avoid any further complications. This additional warning was because there had been reports of even the most experienced surgeons perforating blood vessels and organs. Physicians were warned to:

• Be prepared for complications related to the mesh, such as infection and erosion of the mesh.

• There are complications related to the tool used in the surgery. These complications include perforation of the bladder, bowels, and blood vessels.

• Patients should be informed that the implantation of the mesh is permanent. If complications would come about, additional surgeries may be needed to correct the complication.

• Patients should be aware of all complications because those complications can severely affect their quality of life. Issues such as pain during intercourse, narrowing of the vaginal wall, and scarring can occur.

• If available, physicians should provide patients with a copy of the patient labeling from the manufacturer of the mesh.

Skilled surgeons have had mishaps with the tools used to implant Transvaginal Mesh, which is why the FDA has warned them to be diligent. However, diligence does not always prevent the complications that can occur.

Transvaginal Mesh Lawsuits Increasing

The number of Transvaginal Mesh lawsuits is growing because it is estimated that there were 250,000 procedures completed since the introduction of the product on the market. With thousands of claims already being made, it is suspected that there will be thousands more. Women are coming forward all of the time. Companies such as American Medical Systems, a manufacturer of Transvaginal Mesh, have already had lawsuits filed against them. They are just one of the companies. Other lawsuits have been combined into class action lawsuits, such as the multidistrict lawsuit in West Virginia against C.R. Bard Avaulta Transvaginal Mesh. The allegations state a flaw in the design of the mesh is the cause of the complications.

Seeking Legal Help

If you or a loved one has experienced pain, discomfort, or debilitating complications that are often associated with Transvaginal Mesh, you may be entitled to compensation. By calling 1-800-732-3070 for your free case evaluation, you will learn what your legal rights are and what options are available to you.

These problems are leading to transvaginal mesh lawsuits because of how they compromise quality of life. While the FDA issued their first warning in 2008 with another in 2009, their warning stated that more than 1,000 women had experienced problems with the mesh between 2005 and 2007. A total of nine manufacturers were involved. Those manufacturers were Johnson & Johnson, American Medical Systems, Caldera, Boston Scientific, Mentor, Gynecare, Ethicon, Sofradim, and C.R. Bard, Inc.

Transvaginal Mesh Injury

According to the FDA, the complications that have come about after some women have received Transvaginal Mesh include:

• The mesh eroding through the vagina
• Infection
• Pain
• Bleeding
• Organ perforation
• Pain during sex
• Urinary problems

There have been at least three cases in which women died from Transvaginal Mesh complications. Further complications include bowl and bladder perforation during the surgery.

As of July 2011, the FDA stated that over 2,800 new reports of Transvaginal Mesh complications had been recorded. These procedures had taken place between January 2008 and December 2010. Studies showed that approximately 10% of the women had experienced mesh erosion within a year of having the surgery. For over half of those who experienced erosion, they had to have an additional surgery to remove the mesh. If the complication was severe enough, multiple surgeries were required.

In the end, the FDA stated that they were not clear on whether the repair of pelvic organ prolapse with Transvaginal Mesh was better than non-mesh procedures. As a matter of fact, the agency stated that the mesh procedure may expose the patients to a higher risk of complications.

Surgeon Error

Even if the mesh is not defective, surgeon error can cause complications. These complications can include perforation of organs, blood vessels, or the vaginal wall with the surgical tools used in the procedure. When the FDA alerted physicians of Transvaginal Mesh complications in 2008, they also recommended that those surgeons performing surgeries to implant Transvaginal Mesh to undergo specialized training.

Transvaginal Mesh Side Effects

If you or a loved one has suffered from the complications that can be caused by receiving Transvaginal Mesh, you may be able to receive compensation from the mesh manufacturer. Our Transvaginal Mesh injury attorneys are offering each woman suspecting she is experiencing complications after surgery, a free case evaluation. We urge you to contact us at 1-800-732-3070 or fill out the contact form on this page so that we can help you protect your legal rights.

Out of all of the complications, infection has a two ways in which it occurs. The first is when the tools used to perform the surgery perforate blood vessels, the bowel, bladder, or other organs. The second is when the mesh doesn’t allow the proper nutrients to get to a certain area, resulting in an infection forming.

Who Is At Risk?

The FDA doesn’t know who is at an increased risk of Transvaginal Mesh infections. However, the following are suspected to contribute to the risk of infection:

• The overall health of the patient
• The mesh material
• The size and shape of the mesh
• The surgical technique used to implant the mesh
• Hormonal factors
• If the patient has had a hysterectomy

In the end, the treatment of infection associated with Transvaginal Mesh involves the possible removal of the mesh, blood transfusions, IV therapy, and the treatment of hematomas or abscesses.

Transvaginal Mesh Infection Reporting

If you have been diagnosed with an infection from Transvaginal Mesh, then you will need to report the infection. The FDA has what is called the MedWatch Adverse Event Reporting Program that is designed just for individuals to report the adverse effects of drugs. This helps the FDA keep a record of what drugs are presenting a problem and prompts them to issue warnings to physicians. If you are not comfortable with reporting on your own, a Transvaginal mesh injury lawyer can help you report your infection to the FDA.

Your attorney can also help you in your journey to obtain compensation for the problems that the infection caused you. Chances are, if you are dealing with or you have already dealt with an infection caused by surgical mesh, you have had to undergo a number of painful medical procedures. As it stands, a number of surgical mesh manufacturers have had lawsuits filed against them because their products caused infection or other severe complications.

Winning Compensation For Transvaginal Mesh Infections

If you or a loved one has experienced surgical mesh-related infections, then you have suffered a great deal of pain. The quality of your life has been compromised and, while it is impossible to ever get back what you have lost, you can hold the manufacturer financially responsible. To find out how, call 1-800-732-3070 and schedule your free case evaluation.

]]> http://usdrugrecall.com/drugs/transvaginal-mesh-infections/feed/ 0 http://usdrugrecall.com/drugs/fda-warned-transvaginal-mesh-complications/ http://usdrugrecall.com/drugs/fda-warned-transvaginal-mesh-complications/#comments Tue, 23 Aug 2011 15:26:26 +0000 admin http://www.usdrugrecall.com/?p=1197 Within three years, a total of 9 Transvaginal Mesh manufacturers submitted over 1,000 reports of complications associated with the mesh. These complications included infection, erosion through the vagina, pain, urinary issues, and the recurrence of pelvic organ prolapse or incontinence. Perforations of the bowl, bladder, and blood vessels had also been reported. The individuals that had experienced these complications experienced a decreased quality of life.

It is believed that the number of women experiencing complications from Transvaginal Mesh is much higher than what has been reported to the FDA. This is because there may be a lot of women that are not aware that the symptoms they are experiencing is the failure of the mesh. Then there are those that are experiencing failure of the mesh and they do not know who to contact.

FDA Transvaginal Mesh Warning

Most women will contact their doctor about their symptoms. When it is determined that the symptoms are the result of failed Transvaginal Mesh, the treatment is usually painful because additional surgery to remove the mesh and repair the affected areas is usually required. Other treatments that may be required include:

• Blood transfusion
• Intravenous therapy
• Hematoma or abscess drainage

The failure of the mesh and the pain associated with the aforementioned treatments can be devastating to a patient. That is why some women are turning to their attorneys to file lawsuits against the manufacturers for the pain and suffering they have had to endure. It is believed that the mesh was poorly designed. If the mesh does not allow the tissue around it to receive the oxygen and the nutrients it needs, healing can be slowed. This slowed healing can lead to the injuries defined by the FDA.

Transvaginal Mesh Side Effects

The FDA has not found any specific risk factors for the mesh failing. Specific health problems, hormonal imbalances, or demographic factors have been identified. This is why it is believed that it is the mesh design that is leading to its failure. It has been shown that Transvaginal Mesh did not undergo the clinical trials it should have in order to identify complications.

So far, it has been revealed that women of different ages and health statuses are experiencing the same problems with Transvaginal Mesh. They undergo the procedure to improve their quality of life to find that as little as 12 months later the problems that were corrected are now returning.

Contact A Transvaginal Mesh Lawyuer

If you or a loved one has been the recipient of Transvaginal Mesh and you are experiencing complications that include incontinence, pressure or a feeling of fullness in the lower abdomen, vaginal pain, or vaginal pain during intercourse, you do need to speak with a Transvaginal Mesh attorney at 1-800-732-3070 for a free case evaluation so that you can find out what your legal rights are and how to exercise them. You have the right to seek compensation and for the problems you are experiencing to be addressed properly. That way you can be closer to getting your life back.

In recent years, many of the procedures that are performed to correct POP have involved the implantation of surgical mesh to support the dropped organs. Such meshes involve those manufactured by C.R. Bard Inc., such as the Avaulta Solo, Avaulta Biosynthetic, and Avaulta Plus. Unfortunately, relief is not what some women have experienced. Instead, they have experienced pain.

Transvaginal Mesh Side Effects

Female patients that have experienced painful complications after receiving Transvaginal Mesh have triggered extensive investigations into the product. The findings revealed that the mesh was not researched properly, tested extensively, investigated thoroughly, or even manufactured properly. As a result, the following Transvaginal Mesh complications have been experienced:

• Pain during sexual intercourse
• Fecal and urinary leakage not present prior to the surgery
• Anal or rectal anatomy change
• Pelvic organ prolapse returns
• Infection, scarring, bleeding, and inflammation
• Reduced width or length of the vagina

If you or a loved one received Transvaginal Mesh and you are experiencing any of the above complications, then you should contact the gynecologist or urologist who performed the surgery. You should also contact a Transvaginal Mesh injury attorney to discuss any legal action that you may be able to take.

Questions To Ask Your Doctor

When you inquire with the doctor that performed the surgery, you will want to ask them to tell you about the Transvaginal Mesh product that was used in your surgery. There are a total of nine manufacturers with a number of them named in lawsuits. You will want to share the information you receive from the physician with your lawyer. You will need to know the make, manufacturer, lot number, model number, expiration date, and any other relevant information. You can also request a copy of the product implant sticker from the hospital’s medical records department. That sticker proves what product was implanted.

You will then need to ask the doctor about treatment options for your specific set of complications. Treatment may require you to be referred to a specialist and sometimes the treatment can be quite extensive. Sometimes the damage can be so severe that a pelvic reconstruction surgeon may be required.

Contact a Transvaginal Mesh Lawyer

The complications that can arise from surgical mesh can be life altering. The problems that result from the mesh can result in a quality of life that is more compromised than it was before the mesh was implanted. If you believe or a doctor has confirmed that what you or a loved one is experiencing or has experienced is related to surgical mesh complications, call 1-800-732-3070 to schedule a free case evaluation and learn about what your legal options and rights are for your particular case.

Transvaginal Mesh was created to correct pelvic organ prolapse, a condition in which the pelvic organs drop out of place. The pressure placed on the bladder because of the dropping of the bladder or other organs can lead to embarrassing incontinence issues. The organs that can drop are the small intestine, bladder, rectum, and uterus. The organs drop because the muscles that hold them in place have been weakened by childbirth or from surgery, such as a hysterectomy.

Approximately 40% of women over the age of 50 are experiencing some sort of organ prolapse. The symptoms include reduced bladder control. This means that a person may urinate when they laugh, cough, or sneeze. Women with prolapse may also experience vaginal pain during intercourse. However, one of the most common symptoms is fullness or pressure in the lower abdomen.

The solution for organ prolapse has been surgery and the implantation of Transvaginal Mesh has been the primary surgery for a number of years. The mesh is implanted via the vagina, but some women have experienced complications with the following Transvaginal Mesh products

• Bard Avaulta Solo
• Avaulta Biosynthetic Systems
• Avaulta Plus

Reports citing complications with these products prompted the FDA to issue warnings to physicians regarding possible complications in 2008 and 2009. This has prompted a number of Transvaginal Mesh lawsuits to be filed with monetary rewards being sought and free corrective surgery to be performed on women with faulty mesh products

Pelvic Organ Prolapse

Most of the time more than one organ drops when pelvic organ prolapse has occurred. The name for the exact prolapse condition depends upon the organ involved. For instance, Cystocele is the most common and involves the bladder, Rectocele is when the rectum shifts out of place, Enterocele involves the small intestine causing vaginal prolapse, and vaginal vault prolapse involves the top of the vagina falling into the lower vagina after a woman has had a hysterectomy.

Doctors will instruct women with organ prolapse to not lift, to avoid caffeine because it is a diuretic, and to engage in exercises that will strengthen the pelvic floor muscles. This can help avoid surgery. In the case of Transvaginal Mesh, the product has only lasted so long before causing problems more severe than the ones that led to the surgery in the first place

Issues With Transvaginal Mesh

Complications with Transvaginal Mesh that have been reported include pain, swelling, scarring, recurrence of prolapse, and urinary problems that include incontinence. Overall quality of life has been compromised due to painful sexual intercourse and vaginal scarring. The mesh has actually contracted or eroded in some women.

Transvaginal Mesh Lawsuits

Transvaginal Mesh attorneys have been contacted by women whose quality of life has been compromised by defective mesh. They have experienced various types of organ prolapse that has led to a reduced quality of life. Some have had to have the mesh repaired at their own expense, while others cannot afford such a cost. If you are experiencing any of the aforementioned symptoms after receiving Transvaginal Mesh, you may be entitled to compensation. Call us today at 1-800-732-3070 or fill out our short contact form for your free case evaluation and learn of your options.