FREE CASE EVALUATION: 1-800-632-1404

Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.  Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured.  For a free case evaluation, call 1-800-632-1404.

Side Effects

The U.S. Food and Drug Administration has remarked that there is little evidence to support the claim that transvaginal mesh (TVM) improves pelvic organ prolapse, and doctors should notify patients of the potential risks and long-term side effects of prolapse surgery using vaginal mesh.

Over the past decade, thousands of women have complained of painful side effects associated with the use of transvaginal mesh products, including by Bard and Johnson & Johnson. Transvaginal mesh side effects include:

• Mesh erosion or protrusion of the mesh into soft tissues
• Pain, including during sexual intercourse
• Increased risk of infection in mesh area
• Mesh contraction resulting in vaginal shrinkage
• Organ perforation
• Incontinence
• Bleeding from mesh site
• Damage to nearby organs, which may be permanent

The Problem

In 2008, the FDA first released concerns about the safety of transvaginal placement of mesh. From 2008 to 2010, the FDA received three to five times as many adverse reports associated with mesh used for pelvic organ prolapse repair than what agency received from 2005 to 2007 (nearly 1,000 reports of adverse events were received from 2005-2007).

Many of these patients complain because of erosion or contraction of the mesh material (which has been described as being of a similar material as Rubbermaid storage containers).  The erosion leads to bleeding, severe pelvic pain, painful (or impossible) sexual performance and a recurrence of urinary problems.

In July 2011, the Food and Drug Administration (FDA) issued an update related to what it called ‘serious complications’ related to the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  It is now known that complications linked to transvaginal placement of surgical mesh in SUI and POP patients are not rare and can require multiple surgeries to correct problems related to the use of surgical mesh. In fact, the FDA now says that additional surgeries may actually not be able to repair damage caused by implantation of the mesh.

In other words, the side effects of the mesh placement may be permanent.  These complications from transvaginal placement of surgical mesh include:

• Erosion of the implanted mesh
• Infection and/or bleeding
• Pain, including pain during sexual intercourse
• Problems with organs near the implantation site

Helping You

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.

If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible.

CALL: 1-800-632-1404

FILL OUT THIS FORM BEFORE FOR FREE HELP:

FREE CASE EVALUATION: 1-800-632-1404

Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.  Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured.  For a free case evaluation, call 1-800-632-1404.

Pushing for a Recall

As an attorney who is representing women across the country and in Canada, I was intrigued by a series of articles on the push for a recall of these devices.  Summaries of these articles are:

Bloomberg News (8/26, Edney) reported that “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,” according to Public Citizen, which said that the “products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence.” Public Citizen “estimates that 67,500 women” had the products “implanted last year,” and “the Food and Drug Administration received 1,503 reports of complications…from January 2008 to December 2010.”

The Minneapolis Star Tribune (8/26, Moore) reported that “FDA spokeswoman Karen Riley said the agency will ‘carefully review’ Public Citizen’s request,” and “will hold an advisory committee meeting in September.”  I recently posted a blog on the FDA meeting, which can be viewed by CLICKING HERE.

The AP reported on August 26 that the “FDA announced last month that complications with mesh are higher than previously estimated,” while “Public Citizen said mesh offers no benefit over traditional surgery with stitches.”

The Newark Star-Ledger also on August 26 explained that “nearly 300,000 women in the US had surgery to correct pelvic organ prolapse,” last year. It further pointed out that under “FDA’s controversial 510(k) program,” the material was not “required to be studied in patients” before being used. In response to complaints, last month, William Maisel, deputy director of the FDA’s Center for Devices and Radiological Health, issued a statement saying, “There are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse,” adding, “The FDA…is asking surgeons to carefully consider all other treatment options.”

Helping You

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.

If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible.

CALL: 1-800-632-1404

FILL OUT THIS FORM BEFORE FOR FREE HELP:

FREE CASE EVALUATION: 1-800-632-1404

Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.  Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured.  For a free case evaluation, call 1-800-632-1404.

FDA Sets Meeting

The US Food and Drug Administration (FDA) will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee on September 8-9, 2011. It is our opinion that he purpose of the meeting is to consider regulatory changes that may improve the understanding and effectiveness of transvaginal mesh devices. Some of the regulatory changes being considered include:

• A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices.
• Clinical studies to address the risks and benefits of mesh used to treat POP and SUI.
• Expanded post-market monitoring of device performance.

Currently the mesh used for transvaginal POP repair is classified under Class II, which allows the devices to be cleared for market under the FDA’s 510(k) approval process.  This means that as long as the device is “substantially equivalent” to existing products, they will be approved.  A change from class II to class III would require a significant increase in testing before a device is allowed to be sold, and would furthermore require a supplement be filed with the FDA any time a change is made to the device that may effect safety or effectiveness of the device.

As one example of why this is important, our firm is also representing children and adults who received the Advanced Bionics HiRes90k cochlear implant device.  It is alleged that Advanced Bionics did not tell the FDA when it changed a critical component in the device, and further did not even test the device as changed under actual or simulated use conditions. The end result? A component that is failing more than 33% of the time, a figure unheard of in the medical device industry.

 

CALL: 1-800-632-1404

FILL OUT THIS FORM BEFORE FOR FREE HELP:

FREE CASE EVALUATION: 1-800-632-1404

Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.  Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured.  For a free case evaluation, call 1-800-632-1404.

The Background

There are two reasons the TVM device is usually implanted in women: stress urinary incontinence and pelvis organ prolapse (POP).

Pelvic organ prolapse is when one or more of the pelvic organs including the uterus, small bowell, vagina, bladder, or rectum, fall down or slip out place.  20-30% of women suffer from some degree of prolapse, according to estimates from Brigham & Women’s Hospital. Approximately 300,000 women undergo surgery each year for pelvic organ prolapse in the United States, according to the American Urogynecological Society.

Pelvic organ prolapse is most often linked to strain during childbirth.  Women may also get pelvic organ prolapse if they have surgery to remove the uterus, or a hysterectomy.  Removing the uterus can sometimes leave other organs in the pelvis with less support.  Pelvic organ prolapse can be made worse by anything that puts pressure on your belly, such as being overweight, coughing, constipation, or tumors.  Older women are also more likely to have pelvic organ prolapse.

Stress urinary incontinence is predominantly due to insufficient strength of the pelvic floor muscles.  It results in the loss of a small amount of urine associated with coughing, laughing, sneezing, exercising or other movements that put pressure on the intra-abdominal cavity. In women, physical changes resulting from pregnancy, childbirth, and menopause often contribute to stress incontinence. Stress incontinence can worsen during the week before the menstrual period.

One of treatments for both pelvic organ prolapse and stress urinary incontinence is the placement of a vaginal sling, including the Tension-free Transvaginal Tape (TVT), the transvaginal mesh (TVM), and the mini-sling.

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.

If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible.

CALL: 1-800-632-1404

FILL OUT THIS FORM BEFORE FOR FREE HELP:

FREE CASE EVALUATION: 1-800-632-1404

If you are reading this page, you are likely suffering from pain after a prior surgery implanting a transvaginal mesh device / TVT / TVM system and sling.You may have been diagnosed with stress urinary incontinence or pelvic organ prolapse. Whatever the reason, you are likely in pain today, and we believe we can help you. If you would like to speak to a TVT lawyer, TVM lawyer or transvaginal mesh lawyer, please call us today for a free case evaluation.

An Alabama woman has filed a product liability lawsuit against American Medical Systems (AMS) and Boston Scientific, saying that she suffered injuries due to problems with vaginal mesh sold by the companies for treatment of pelvic organ prolapse and stress urinary incontinence.  The complaint was filed in the U.S. District Court for the Northern District of Alabama, as a result of complications suffered by a patient after she was implanted with an AMS Elevate Anterior and Apical mesh system, as well as a Boston Scientific Pinnacle Posterior Pelvic Floor Repair Kit and Solyx SIS System.

The plaintiff alleges that the transvaginal mesh products were defective and caused her to suffer severe and permanent physical injuries.

According to allegations raised in the complaint, the AMS and Boston Scientific vaginal mesh products are not inert and react adversely to human tissue. The lawsuit also claims the materials harbor infections, can migrate from the location of implantation, and abrades tissues inside the patient’s body. All of these things can adversely affect patient health, the lawsuit states.

Last  month, the FDA issued a warning about the risk of transvaginal mesh problems. The agency indicated that there appears to be no significant benefit in using the vaginal mesh products over other available means of treating pelvic organ prolapse.

Transvaginal Mesh Lawyer Ed Wallis is offering free nationwide confidential consultations to all women who have a transvaginal mesh implant by calling toll free 1-800-632-1404.

YOU SHOULD SEEK IMMEDIATE MEDICAL ATTENTION IF YOU BELIEVE YOU ARE SUFFERING ANY COMPLICATION. The most common complications reported after Transvaginal Mesh Implant are: erosion, pain, infection, urinary problems, bleeding and organ perforation.

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon, Gynecare, and Johnson & Johnson.

CALL: 1-800-632-1404

FILL OUT THIS FORM BEFORE FOR FREE HELP: