Trials of Vaginal Mesh MDL in West Virginia Scheduled for 2014

Posted on Wednesday, September 11, 2013 by Vaginalmesherosion

The litigation of the vaginal mesh lawsuits consolidated into multidistrict litigation (MDL) in West Virginia seemed to be proceeding quite satisfactorily. After encountering some obstacles with the declaration of a mistrial, things are back on track with a new jury chosen in the first MDL trial against Bard. Judge Joseph Goodwin, the presiding judge of the US District Court for the Southern District of West Virginia, has already set aside dates for the hearing of the other MDL involving other vaginal mesh manufacturers.

After the completion of the bellwether cases involving the vaginal mesh lawsuits filed against C.R. Bard, the hearings of the claims against Boston Scientific and Ethicon, Inc. will follow next. The first bellwether case against Ethicon, a subsidiary of Johnson & Johnson, has been slated for trial on August of next year.

Judge Joseph Goodwin on August 29, 2013 issued a court order scheduling the trial dates of the bellwether cases for Boston Scientific. This will represent the first four lawsuits of the 5,938 vaginal mesh lawsuits filed in federal courts. 

This order would have been released earlier if not for the issues relating to the choices of the bellwether cases. Judge Goodwin expressed dissatisfaction on the choices of both parties to represent as bellwether cases as submitted on August 1, 2013.

In a pretrial order, the presiding judge said he was not satisfied with the selections made by both parties. There were multi-product picks from the plaintiffs while the defendants chose cases with potential statute of limitations issues. The choices made by the plaintiffs were not representative of the class since there were complications such as Alzheimer’s disease, vaginal obliteration, participation in drug studies, and infertility issues.

After laying down the guidelines for choosing the bellwether cases, an order was issued by the court on August 29, 2013 naming the four plaintiffs and lining up the dates for the hearing of these cases. The first trial will be heard on February 11, 2013 followed by a June 17 date and a September 9 trial if necessary.

Chosen by Judge Goodwin were the claims of Carol Lynn Fawcett, Roseanne Sanchez, Carolyn F. Smothers, and Katherine L. Hall. Specific Boston Scientific products involved in these cases are the Pinnacle and Obtryx vaginal mesh implants.

Still to be scheduled are the lawsuits lodged against Coloplast and Cook Medical. The lawsuits against American Medical Systems may have to be rescheduled in view of the settlement offered by the company to a single law firm handled by a Houston-based lawyer who had filed lawsuits in both state and federal courts.

Reference:

  • meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices

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For Mental, Physical Pain, Woman Files Vaginal Mesh Lawsuit vs. American Medical Systems in Florida

Posted on Friday, March 8, 2013 by Vaginalmesherosion


A Florida woman who suffered permanent injuries as a result of using the Monarc Subfascial Hammock for her pelvic organ prolapse (POP) is the latest complainant in the highly publicized vaginal mesh lawsuits. She has claimed that the device have caused significant mental and physical pain and suffering.

In her lawsuit against American Medical Systems, the woman is seeking compensatory and exemplary damages for her injuries, pain, suffering, and economic loss. The husband, who is also a co-plaintiff in the case, is also claiming damages for loss of consortium in being deprived of the comfort, enjoyment, and services of his wife as a result of her injuries.

She alleges that the company made false representations by claiming that its product was safe and effective when, in fact, the company knew or should have known that the Monarc Subfascial Hammock was not safe as evidenced by numerous reports of severe complications such as infection, mesh erosion, migrations and perforation of organs.

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Transvaginal Mesh Lawsuit Update: New Study Discusses Trends in Use of Vaginal Mesh to Treat Pelvic Organ Prolapse, Rottenstein Law Group Reports

Posted on Friday, December 14, 2012 by Vaginalmesherosion

(Attorney advertising. Prior results do not guarantee a similar outcome.) As transvaginal mesh lawsuits are growing in number in state and federal courts, a recently-published study indicates transvaginal mesh surgeries at one point represented a majority of all prolapse procedures, the Rottenstein Law Group reports.

New York, NY (PRWEB) December 10, 2012

The study indicates that between 2005 and 2010 the use of vaginal mesh products comprised about 75 percent of all prolapse procedures, according to the Nov. 19, 2012, edition of the American Journal of Obstetrics and Gynecology. Researchers observed more than 78 million “person-years,” identifying 60,152 mesh prolapse procedures. Vaginal mesh surgeries were considerably more common than alternative pelvic organ prolapse procedures at all ages, according to the AJOG study.

“Though the study reflects the increased use of transvaginal mesh procedures during that specific time period, the increase of state and federal scrutiny could indicate a sea change in attitudes toward transvaginal mesh as a solution to pelvic organ prolapse,” said Rochelle Rottenstein, principal of the Rottenstein Law Group, which is currently evaluating cases related to serious transvaginal mesh side effects, including infection, vaginal bleeding, splitting of the vaginal tissue and harm to the vaginal wall. “I encourage anyone who thinks they might have been injured to contact the Rottenstein Law Group today.”

Read full story on PRWeb.com: Transvaginal Mesh Lawsuit Update: New Study Discusses Trends in Use of Vaginal Mesh to Treat Pelvic Organ Prolapse, Rottenstein Law Group Reports

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Younger Women, Not too Concerned about Incontinence

Posted on Thursday, May 17, 2012 by Vaginalmesherosion

Vaginal Mesh Implant
Women searching for the best treatment against incontinence symptoms or bladder weakness probably already have an idea about surgical devices such as the four types of surgical mesh, medical industry publications report. These are predominantly used as implantable substructures intended to lift the sinking bladder or pelvic floor.


Since bladder control problems are seen mostly in the elderly, most women in their 20s do not often concern themselves about pelvic floor health. Even women who regularly attend yoga classes or Pilates sessions often only regard pelvic exercises as part of their weight-loss and flexibility program. One may also reap these benefits from pelvic exercises. However, most importantly, these types of exercise routines are useful in building stronger and more functional pelvic muscles. Women in their younger years do not often realize how valuable it is to prepare their pelvic muscles for future stresses like vaginal delivery, bone degradation, hormonal inconstancies, hysterectomies, and many more. Oftentimes, women only start noticing the need to strengthen their pelvic musculature after they have delivered their first baby.


For the first few days after a vaginal birth, women may find it hard to tell if they are having leaks, especially if the pain brought by possible vaginal tears or episiotomy are severe enough to cloud the patient’s mind. Moreover, because vaginal bleeding is still active until the fourth day postpartum, it may mask the presence of leak episodes.


Based on a study conducted by clinical researchers in Australia, more than 80 percent of women participants (who have never been pregnant) were seen to have signs of incontinence, and 10 percent of them were later diagnosed with it. Experts consider it to be primarily caused by hereditary factors, erroneous voiding habits, innate tissue problems, or the presence of underlying diseases.


Incontinence often sends out subtle warnings during a woman’s younger years. Unexpected leaks due to excitement or fear often suggest weak bladder control. Other possible incontinence flags include frequent trips to the bathroom, sudden urge to void again even when one had just done so, nocturia (waking up more than two times at night because of a full bladder), and even the feeling of wanting to urinate when the abdomen is slightly pressed.


Lately, as was revealed in a study, health organizations and medical experts worldwide are expecting the rise of urinary tract problems in over 50 percent of people aged 20 years and above by the year 2018. Women turning to modern and untried medical implants may further increase and add up to the already rising vaginal mesh proceedings. Click here for more information about pelvic floor health.


References:

fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
nursingtimes.net/home/clinical-specialisms/continence/half-of-adults-to-suffer-urinary-tract-symptoms-by-2018/5035678.article
abc.net.au/health/thepulse/stories/2011/11/17/3367126.htm

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Transvaginal Mesh, a Common Type of Surgical Mesh

Posted on Wednesday, February 8, 2012 by Vaginalmesherosion

Surgical mesh is a woven fabric used for chest wall reconstruction, strengthening tissues, provide support for internal organs, and to treat surgical or traumatic wounds. The fabric is usually made of polypropylene or some other polymer, although a titanium mesh has been used in some back surgeries. There are however, several types of surgical mesh where it has been reported that erosion is the most reported surgical side effect of those devices.



Pelvic Organ Prolapse
A common type of surgical mesh is called transvaginal mesh. One of the common uses of transvaginal mesh is for the treatment of pelvic organ prolapse (POP). This condition occurs when one of the pelvic organs; the bladder, uterus, bowel or rectum, drops from its normal position and begins to push against the vaginal wall. This can happen when the muscles and connective tissues which hold the organs in place have become weakened. If it is deemed that surgery is necessary, a transvaginal mesh is sometimes inserted through an incision in the vaginal wall to provide additional support for the affected organ.


According to the Food and Drug Administration (FDA), there are potential difficulties adversely affecting the health of the many patients caused by transvaginal mesh. These difficulties can include errors that occur during surgery, and effects on estrogen levels.

On August 1, 2010, a study whose researchers reported that a clinical study of transvaginal mesh unit had to stop because of the difficulties that many women were having during the trial. Sixty-five women were to deploy the surgical transvaginal mesh. Of the 65 women, 15 percent are exposed to more complex, more serious corrosion to the protrusion of the mask and the breakdown of tissues.

Vaginal mesh erosion and related vaginal scarring can potentially lead to discomfort and pain. Some patients need additional surgery to remove the mesh, there has also been reports of even several surgeries being required to remove all of the mesh. Injuries to adjacent organs, such as the bowel, bladder, and blood vessels have also been reported to FDA. These injuries have lead many women to file for a vaginal mesh lawsuit. The FDA urges women to discuss with their physician the pros and cons of using mesh for their particular stress incontinence problem.



References:


http://urology.about.com/b/2009/11/06/fda-dear-doctor-letter-serious-complications-of-transvaginal-mesh-for-fallen-bladder-stress-urinary-incontinence.htm


http://www.providence-health-plan.com/transvaginal-mesh/

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Vaginal Mesh Erosion and Ways to Prevent It

Posted on Tuesday, December 27, 2011 by Vaginalmesherosion

The U.S. Food and Drug Administration proclaimed the risks of Implantation of Trans-vaginal Mesh (TVM) in October 2008. It was in October 2008 that the U.S. Food and Drug Administration shared to the public the harm associated with Trans-vaginal Mesh (TVM) implantation.  Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are two conditions that can be treated with TVM implantation.  After an increasing number of incidences about complications brought about by this procedure, the FDA declared safety information about the serious risks of TVM implantation.

The most frequently reported complication is mesh erosion, also called mesh extrusion, protrusion or exposure.  This occurs when the vaginal mesh is exposed through the vaginal skin.  Vaginoscopy, a diagnostic procedure that utilizes an endoscope to view the vaginal canal, is used by physicians to examine and determine the presence of mesh erosion.

Usually, this is caused either by an incision that is not healed completely after the procedure or a low quality surgical mesh material that is implanted.  As studies revealed, women who have low levels of estrogen in their bodies have a high risk in developing this complication.
Some conditions that could induce this complication are history of smoking, past hysterectomy procedures, old age, and mismatch of surgical mesh to the size of the vaginal wall.

There are initial symptoms that signal this complication.  Most frequently, patients experience tightening in the vagina, and most commonly this is associated with dyspareunia and pain while sitting in the same position for a long time. As most commonly recorded, these signs start to appear at least 1 month after the TVM implantation.  Bleeding and foul-smelling vaginal discharges are signs that could be more harmful because these can cause infection.

Treatments vary according to the degree of exposure.  For exposures with 1cm size, these are considered simple erosions and doesn’t require the total removal of the vaginal mesh. Surgeons normally cut off the exposed part of the vaginal mesh and letting the incision site repair on its own. On the other hand, if mesh erosion occurs during healing after the surgery, physicians usually start treating with antibiotics and vaginal estrogen cream. |But if mesh erosion happens some time after while the surgical wound is healing, doctors usually prescribe antibiotic and vaginal estrogen cream treatment. |However, when mesh erosions develop while the tissues of the surgical wound are still in the recovery stage, doctors then use antibiotic and vaginal estrogen cream  as medical care.} But if the exposed mesh is not repaired after two weeks of antibiotic and estrogen cream, the doctor will opt for surgical excision of the mesh.

For an extensive exposure, i.e. when the entire mesh is exposed, the entire vaginal mesh should be removed.   Physicians would then be inclined to recommend a new procedure to treat POP and SUI.

Careful management is needed in mesh erosions since these complications recurs most of the time. Majority of the patients who have experienced mesh erosions went through a number of corrective mesh repairs that are painful and debilitating.  However, this complication can be prevented from recurring.  Patients should carefully watch their activities during recovery period and visit their doctors monthly to check any sign or symptoms of possible mesh erosion after TVM implantation.

References:
http://blogs.webmd.com/womens-health/2011/08/vaginal-mesh-new-fda-warnings.html
http://www.icsoffice.org/Abstracts/Publish/105/000870.pdf
http://www.empowher.com/sexual-well-being/content/vaginal-mesh-erosion-part-2?page=0,2

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