June 2012 Mesh News: FDA Didn’t Approve Vaginal Mesh Products?

It's being reported that  vidence has surfaced that indicates that device manufacturer Johnson & Johnson did not have Food and Drug Administration approval for the transvaginal mesh product they were selling for three years.

men have already been wounded by vaginal mesh devices that have caused serious complications for them. According to a report by Bloomberg.com, the device manufacturer began selling the Gynecare Prolift vaginal mesh device in March of 2005, which was 3 years  before the device was approved by theFDA. Between the time it was released on the market until it was approved, the FDA received 123 reports of complications associated with the Gynecare Prolift device.




Vaginal mesh devices are ways of treating stress urinary incontinence and pelvic organ prolapse, which are both conditions dealing with the weakening of pelvic organs. Complications associated with the devices, however, can cause even further problems, including recurrence of the original problems, urinary tract infections, and mesh erosion. Hundreds of women—more than 550—have filed lawsuits after suffering from transvaginal mesh complications. They are hoping to gain compensation that would help cover medical bills they have incurred due to their side effects.

The Food and Drug Administration reported a fivefold increase in complications associated with vaginal mesh devices, including deaths and malfunctions, in July of 2011. This decision resulted in an advisory panel for the organization recommending that such devices should be reclassified as “high risk” devices that are in need of human testing before it can be determined whether or not they are safe.
FDA process questioned.

Read more here:  http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

Boston Scientific Mesh Litigation Centralized by the JPML (Feb. 7, 2012)

Here is the Transfer Order:


TRANSFER ORDER

Before the Panel: Before the Panel are three dockets involving allegations of defects in
various models of pelvic surgical mesh products manufactured by three groups of manufacturers.

Plaintiffs in almost twenty actions before the Panel have moved pursuant to 28 U.S.C. § 1407, to
centralize all MDL No. 2325, MDL No. 2326, and MDL No. 2327 actions in the Southern District
of West Virginia.  In MDL No. 2325, defendant AMS has moved to centralize the MDL No. 2325
actionsin the District ofMinnesota or, alternatively, if the Panel deems centralization of three MDLs
to be  appropriate, suggests the  Southern  District of West Virginia  as transferee  district. This
litigation currently consists of approximately150 actions spread across the country, as listed on the
attached schedules. The Panel has been notified of numerous additional potentially related actions.



On the basis of the papers filed and hearing session held we find that the actions contained in
eachMDLinvolve common questions offact, and that centralization of each ofMDL No. 2325, 2326
and 2327 in the Southern District of West Virginia will serve the convenience of the parties and
witnesses and promote the just and efficient conduct of this litigation.
IT IS THEREFORE ORDERED that the motionsfor centralization ofMDL No. 2325,MDL
No. 2326, and MDL No. 2327 in the Southern District of West Virginia are granted.

Find it here: http://www.jpml.uscourts.gov/Panel_Orders/MDL-2326-Initial_Transfer.pdf

Transvaginal Mesh Lawsuit Update (February 1, 2012)

Image via Wikipedia

Last week the JPML heard arguments regarding centralizing litigation involving mesh implants. 

The Court heard argument on motions filed on behalf of women who claim to have suffered injuries after being implanted with vaginal mesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The plaintiffs are asking for the JPML to create separate multidistrict litigation (MDL) cases against three different transvaginal mesh manufacturers: American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326) and Ethicon, Inc. (MDL No. 2327).

By pulling together lawsuits that have been filed in federal district courts across the country for pretrial proceedings, the MDLs would make the litigation more efficient, conserve judicial resources and avoid the risk of inconsistent rulings, the plaintiffs argue.

The plaintiffs also are requesting that the cases be transferred to the U.S. District Court for the Southern District of West Virginia and that they be supervised by Chief Judge Joseph R. Goodwin, who currently is overseeing the MDL against another transvaginal mesh manufacturer, C.R. Bard, Inc. (In re Avaulta Pelvic Support Systems Product Liability Litigation, MDL No. 2187)

I expect a decision by 2/15/12. 

August 2, 2011 Transvaginal Mesh News: Ethicon Gynecare Study

News on the mesh failures continues. 

The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems were first brought to market in the fall  of 2005 and Gynecare Prolift+M variations were introduced in  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, the rectum the top of the vagina or the bowel.

A conducted by European researchers suggested that most of the reoperations 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 between January 2005 and January 2009. At a median follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. About 6.9% of those reoperations were due to urinary incontinence, 3.6% due to mesh-related complications and 3% due to recurring prolapse, which the mesh is designed to treat. 

http://www.ajog.org/article/PIIS0002937811009574/fulltext

July 27/11 News: FDA: Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

Last week I  wrote about the recent FDA report regarding TVM failures. Here is the information that has been available in 2008:



Dear Healthcare Practitioner:
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Recommendations

Physicians should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Georgia: Transvaginal Mesh Patch Failure News

Transvaginal Mesh Patch Failure

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:

• Erosion of the vaginal tissue
• Infection
• Bleeding
• Pain
• Urinary problems such as incontinence
• Pain during sexual intercourse (dyspareunia)
• Organ perforation (puncturing) from surgical tools during mesh implantation

Less frequent problems included

• Return of POP
• Neuro-muscular problems
• Vaginal scarring/shrinkage
• Emotional problems

FDA Alerts and Research Find Transvaginal Patches Unsafe

2011 FDA Alert – Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. FDA also finds the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect including:

• 7 times the risk of bladder perforation
• Nearly twice the risk of urinary incontinence (loss of bladder control)
• 3.2 percent of women required follow-up surgery to correct problems

2008 to 2010 – FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study Published – A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008 – FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.
Over 200 Lawsuits Filed Already
More than 200 women across the United States have filed lawsuits against three of the makers of transvaginal mesh patches:

• C.R. Bard
• Johnson & Johnson’s Ethicon
• American Medical Systems

Complications have been reported for several other manufacturers of surgical mesh as well including:

• Boston Scientific Scimmed
• Sofradim
• Caldera
• Mentor Corporation

What Should You Do?
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, you are not alone, and you have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, other financial burdens and the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.

Georgia News: Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

News on July 13th from the FDA on transvaginal mesh products.What you should know about the recall: 

• From 2008 to 2010, the FDA received 2,874 injury reports resulting from TVM.
• Of these reports, three involved patients who died from those complications.
• Research estimates 10% of women with TVM implants suffer from erosion within a year of surgery.

Background:

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.

Purpose:

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 update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, 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.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

Summary of Problem and Scope:

In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

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.

In particular, 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.

The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Recommendations for Health Care Providers:

As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:

• Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
• Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available