Articles tagged: Mesh Erosion

On June 4 of this year, Johnson & Johnson subsidiary Ethicon, Inc. chose to recall four of its vaginal mesh devices from the medical technology market place. As part of this recall action, Ethicon has asked for the US Food and Drug Administration to cease in “commercializing” these four pelvic mesh device systems. Also, Ethicon, Inc. has asked the FDA for one hundred and twenty days to stop this commercialization. In this time frame, the company seeks to notify the doctors and consumers who will be affected by this voluntary mesh device recall. Following these actions, the four devices will no longer be offered around the world. The four Ethicon Mesh Device products affected by this recall will be:

  • Gynecare TVT Secur System
  • Gynecare Prolift+M Pelvic Repair System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift Pelvic Floor System

Ethicon Mesh Device Recall Lawsuit

Presently, Ethicon has found itself to be the target of a large number of both federal and state lawsuit claims. At this time, depositions are being performed and information is being collected that will be used in both state and federal recall lawsuits. Although the recall of these mesh devices was initiated by Johnson & Johnson’s Ethicon, many doctors as well as the victims of mesh injuries are seeking to have an official recall of surgical mesh used transvaginally. Since 2005, there have been nearly 4,000 adverse event reports sent to the US Food and Drug Administration regarding mesh complications and injuries, some of which were in relation to Ethicon devices.

Ethicon Mesh Device Complications

The following complications have been reported by patients treated with Ethicon surgical mesh devices used in the treatment of pelvic organ prolapse:

  • Vaginal shrinkage/scarring
  • Bleeding
  • Infection
  • Vaginal Discharge
  • Mesh Erosion **most common and frequently reported mesh injury**
  • Neuromuscular difficulties
  • Emotional Problems
  • Urinary Complications
  • Recurrence of prolapse/incontinence
  • Organ/Blood Vessel Perforation

Treatment of these various Ethicon mesh device complications may require any combination of the following measures: additional surgeries, blood transfusions, drainage of hematomas/abscesses, IV therapy, and hospitalization.

File an Ethicon Mesh Lawsuit – Recall Device Attorney

Have you been injured by an Ethicon mesh implant device or another brand of transvaginal mesh product? If so, contact the Willis Law Firm today. We are currently interviewing and reviewing the cases of mesh injury victims nationwide. Our firm may be able to help you recover financial damages for all of the physical, emotional, and financial suffering that you have endured. Help us hold the large companies responsible for the harm that their products inflict upon innocent victims. Call for your consultation today.

Ethicon Prolene Mesh Recall

Ethicon, Inc. was founded in 1949 as a subsidiary of parent company Johnson & Johnson as a way to offer a larger selection of products, including medical devices such as surgical sutures. Within the Ethicon, Inc. division, the Gynecare Company was formed in order to offer a wide variety of Women’s Health products, including an array of vaginal mesh implants used in the treatment of pelvic organ prolapse. Unfortunately, many of these mesh products including Ethicon Prolene mesh have become the subject of lawsuit cases. In 2011, the FDA warned the public that injuries from vaginal mesh were not rare, as they had previously stated. Although there was no official FDA Ethicon Prolene Mesh Recall, the company ceased in their marketing and offering of the device by their own decision following numerous injury and complication reports.

Ethicon Prolene Mesh Complications

A woman from Kentucky recently filed a lawsuit against Johnson & Johnson’s Ethicon stating that three of their products used to treat her pelvic organ prolapse and stress urinary incontinence resulted in serious physical harm and disfigurement. The products used in her treatment included: Gynecare Prolift Posterior Pelvic Floor Repair System, Ethicon Prolene Mesh, as well as the Gynecare TVT Obturator system. Although these products were intended to be a permanent surgical solution for POP and SUI, instead they cause her harm and pain. This story is not uncommon, and many patients treated with Ethicon mesh have reported the following complications:

  • Pain
  • Erosion of the device through vaginal walls
  • Vaginal Scarring
  • Shrinkage/Contraction of the Mesh Implant
  • Neuromuscular Problems
  • Emotional Difficulties
  • Urinary Problems
  • Recurrence of Stress Urinary Incontinence/Pelvic Organ Prolapse

Many of these mesh related injuries require prompt medical attention. In the event of Prolene mesh erosion, a revision surgery will be performed in an attempt to recall the implant from the body. Sometimes, multiple revision surgeries will be necessary in order to fully remove the device. Unfortunately, some patients are never able to return to the quality of life they enjoyed prior to their mesh injuries.

File a Mesh Recall Lawsuit: Consult with an Attorney

If you or a loved one has been injured by a vaginal mesh implant with an Ethicon or other brand of device, contact the Willis Law Firm today. Although located in Houston, TX, our firm is currently evaluation hundreds of mesh related claims nationwide. If you have been injured by mesh, contact our firm for a free and confidential Ethicon mesh recall lawsuit evaluation. We may be able to help you recover a substantial amount of financial compensation for your injuries. Don’t delay; let us help you today.

Pelvic Mesh Erosion

Pelvic mesh erosion was recently named the number one most frequently occurring and reported complication of vaginal mesh surgery by the US Food and Drug Administration. This painful and often debilitating condition also goes by the names:

  • Pelvic Mesh Exposure, because the device is exposed through the vaginal wall
  • Pelvic Mesh Protrusion, because the mesh protrudes through the vaginal wall and sometimes outside of the body entirely
  • Pelvic Mesh Extrusion, because the mesh is forcibly thrust outside of its intended position

No matter what you call it, pelvic mesh erosion is an extremely uncomfortable complication of mesh surgery. It is also highly challenging and difficult to treat. Many women who experience pelvic mesh erosion file lawsuit claims against the company that designed, manufactured, and marketed the device in question.

Pelvic Mesh Erosion Revision Surgery

In the event of pelvic mesh erosion, a doctor may attempt to conduct a revision surgery in order to remove all or a part of the vaginal mesh implant. Although sometimes they can be successful, a mesh erosion revision surgery is still another serious and invasive surgical procedure with its own set of risks and potential complications. In some cases, even multiple revision surgeries will not be able to fully retrieve the pelvic mesh from the patient’s body. This is because the mesh may break apart into multiple smaller pieces, making it impossible to fully remove.

Pelvic Mesh Erosion Lawsuit

Mesh erosion/extrusion/exposure/protrusion is frequently cited as the catalyst for a pelvic mesh lawsuit. Not only is erosion the most common complication of transvaginal mesh procedures, it is also one of the most serious. A woman experiencing pelvic mesh erosion will likely find herself in a world of chronic pain, unable to work, and sometimes even to sleep. Additionally, the husbands of pelvic mesh erosion victims often file lawsuit claims as well due to an inability to have sexual intercourse, also called “loss of consortium.”

Suffering From Pelvic Mesh Erosion? Speak to an Attorney

If you or a loved one is suffering from pelvic mesh erosion or other serious complications, contact the Willis Law Firm. We are currently reviewing potential pelvic mesh lawsuit cases nationwide. We know that it can be uncomfortable to discuss these sensitive Women’s Health Issues, so we have female consultants available to discuss your prospective case. All mesh claims are handled on a contingency fee basis; if you do not receive any financial damages, you do not have to pay legal/attorney fees.

FDA Mesh Recall List

The FDA has declared surgical mesh used in the treatment for pelvic organ prolapse and stress urinary incontinence as an area of ongoing concern. In July of 2011, the US Food and Drug Administration also stated that the serious risks and complications following mesh surgery for POP are not rare, a change from their previous 2008 safety warning. In September of last year, the Obstetric-Gynecology Devices Panel of the Medical Device Advisory Committee met in order to further discuss both the effectiveness and the safety of using urogynecologic mesh devices. The panel also sought to choose a position on the marketing and use of these devices in the future. Although there has not been an FDA recall of mesh products, they were reclassified as Class III devices in January of 2012.

FDA Mesh Recommendation List

Recall that vaginal mesh is a permanent implant that can result in making future procedures more difficult or challenging.

Consider other treatment options because usually pelvic organ prolapse and stress urinary incontinence can be treated successfully without the use of vaginal mesh.

  • Other treatments for SUI and POP do not have the same risks and complications.
  • There are both other surgical and non-surgical treatments for SUI and POP.

Only elect to have mesh implanted after carefully studying all of the serious complications and potential risks associated with the transvaginal placement of surgical mesh.

Ask your physician the following mesh related questions before surgery:

  • Will mesh be used in this procedure?
  • Why are you choosing to use mesh rather than a non-mesh treatment option?
  • What other alternatives are there for my treatment, both surgical and non-surgical?
  • Will the mesh implant used in my treatment be felt by my sexual partner during intercourse?

Mesh Complications: Is a Recall in Sight?

Several companies, including Johnson & Johnson’s Ethicon, have chosen to voluntarily recall some of their mesh products. However, to date, there has been no FDA recall of transvaginal mesh devices. However, many victims of mesh injuries and the attorneys that represent them are trying to have the FDA mandate a mesh implant recall for all of these potentially harmful devices.

Consult with a Mesh Recall Attorney

If you or a loved one has been harmed by POP or SUI surgery using transvaginal mesh, contact the Willis Law Firm today. You may be legally entitled to financial compensation, and we may be able to help you secure that settlement. All mesh clients are represented on a fee contingency basis. We are now reviewing mesh recall cases nationwide.

AMS Vaginal Mesh Lawsuit

Lawsuit claims have been filed against American Medical Systems, AMS, in response to injuries sustained by patients treated with its vaginal mesh products for pelvic organ prolapse and stress urinary incontinence. In both of these conditions pelvic tissues are reinforced by a vaginal mesh implant in an attempt to permanently cease troublesome symptoms, like involuntary urine leakage and/or pressure on the vaginal walls. Although AMS Vaginal mesh is proposed as a minimally invasive and permanent surgical solution, it is still to be regarded as a serious surgery that carries with it serious risks and complications. In fact, the US Food and Drug Administration have stated that vaginal mesh treatment for pelvic organ prolapse introduces new risks and side effects that are not present in older non-mesh forms of treatment. Presently, AMS offers the following vaginal mesh products for POP and SUI:

  • AMS MiniArc Single Incision Sling
  • AMS Elevate Prolapse Repair System
  • AMS MiniArc Precise Single-Incision Sling
  • AMS Apogee Vaginal Vault Prolapse Repair System
  • AMS Monarc Subfascial Hammock
  • AMS Elevate Anterior Prolapse Repair System
  • AMS SPARC Sling System
  • AMS In-Fast Ultra Transvaginal Sling
  • AMS BioArc SP Sling System
  • AMS Perigee System
  • AMS BioArc TO Subfascial Hammock

AMS Vaginal Mesh Erosion

The erosion of a mesh implant through the vaginal wall is the most commonly occurring mesh injury according to the US Food and Drug Administration. They came to this conclusion following a review of mesh-related literature collected between the years of 1996-2011, a fifteen year period. The FDA also concluded that mesh erosion and other complications are not linked to any particular brand of mesh, meaning that AMS (American Medical Systems) mesh products, many of which were listed above, have these risks of complications. Shockingly, the victims of AMS vaginal mesh erosion will often have to undergo more than one revision surgery in an attempt to remove the implant from the pelvic region. Unfortunately, in a large number of cases, this complication can never be fully resolved. Mesh victims often report excruciating pain, vaginal discharge, and bleeding as symptoms of mesh erosion, which is also called exposure, protrusion, and extrusion.

Contact an AMS Vaginal Mesh Lawyer: File a Lawsuit

If you have sustained injuries due to pelvic organ prolapse or stress urinary incontinence treatment with AMS vaginal mesh, you may want to consider filing a lawsuit claim. Contact the Willis Law Firm today in order to have a free case review in order to properly assess your legal options. At present, we are reviewing vaginal mesh cases nationwide. All AMS lawsuit clients are represented on a contingency fee basis; if we don’t recover for you, you are not responsible for paying legal or attorney fees.

Ethicon Mesh Litigation

At this time there is both federal and state level litigation proceeding against Johnson & Johnson’s Ethicon division in regards to several of their vaginal mesh products. At the federal level there is Mesh multi-district litigation against Ethicon, Inc. Multidistrict litigation is a legal term that refers to a process used for the expedition of complicated lawsuits, in this case product liability cases against Johnson & Johnson subsidiary Ethicon, Inc. MDL consolidates a large number of cases for all pretrial proceedings and the discovery process. If at this time they are not resolved or settled, then the case is sent back to its original court. Presently in the state level Ethicon Mesh Litigation that is taking place in New Jersey, depositions are being conducted of many of the top ranking executives of Ethicon including, Alex Gorsky, the CEO of Johnson & Johnson.

Ethicon Mesh Litigation Depositions

The depositions of the Ethicon and Johnson & Johnson executives that are currently being conducted will be used in both the federal level multi-district Ethicon Mesh Litigation as well as the state action of New Jersey. The hope is that these depositions will explain the motives behind the company’s continuing to market vaginal mesh products following all of the information from the FDA regarding the risks of serious complications that come with vaginal mesh. At present, hundreds of lawsuits have been filed against Ethicon citing their mesh products as being responsible for serious injuries and harm caused to patients. Mesh litigation is also being pursued against:

  • American Medical Systems
  • C. R. Bard
  • Boston Scientific

Mesh Complications

The FDA has been very clear in outlining the serious complications and dangers that can occur from using Ethicon Mesh or any other transvaginal mesh implant, including:

  • Vaginal Mesh Erosion (also called protrusion, extrusion, exposure)
  • Bleeding
  • Vaginal Discharge
  • Pain (worsened during sexual activity)
  • Emotional and neuromuscular problems
  • Mesh contraction (often resulting in vaginal shrinkage/scarring)
  • Organ Perforation (of bladder, colon, rectum, vaginal apex, etc)
  • Urinary problems and recurrence of vaginal prolapse

Vaginal Mesh Lawyer: Ethicon Litigation Consultation

If you have been injured by Ethicon mesh or any other brand of vaginal mesh implant, contact the Willis Law Firm today. With over 25 years of dedicated legal service, we are ready to help you exercise your legal rights. You may be entitled to financial compensation for your injuries, and we can help you recover that money. Our firm is currently reviewing mesh litigation cases nationwide; all Ethicon lawsuits are taken on a contingency fee basis.

Around three hundred thousand women have surgery for pelvic organ prolapse each year, and of these, about seventy thousand are performed using vaginal mesh implants. Pelvic organ prolapse happens when tissues in the pelvic region weaken and an organ sinks from its original spot and begins to push against the vaginal walls; this typically takes place following childbirth or surgery. Although between thirty and fifty percent of women will experience POP within their lifetime, only about 2% will exhibit symptoms. For the women who do become symptomatic, a vaginal mesh surgery may be performed in order to strengthen weakened tissue and restore organs to their appropriate locations. Ethicon, a subsidiary of Johnson and Johnson, offers a large number of vaginal mesh products used to treat both pelvic organ prolapse as well as stress urinary incontinence. The Gynecare division of Ethicon was established on order to provide these Women’s health mesh solutions.

What Mesh Products does Johnson and Johnson Ethicon Offer?

There are a large number of vaginal mesh products offered by Johnson and Johnson’s Ethicon division. The Ethicon Gynecare products include:

  • Ethicon Gynecare TVT Exact Continence System
  • Ethicon Gynecare TVT RetroPubic System
  • Ethicon Gynecare TVT Abbrevo Continence System
  • Ethicon Gynecare TVT Obuturator System
  • Ethicon Artisyn Y-Shaped Mesh
  • Ethicon Gynecare Gynemesh
  • Ethicon Gynecare Prosima Pelvic Mesh
  • Ethicon Gynecare Prolift Pelvic Mesh

Recent statements made by the US Food and Drug Administration say that surgery for pelvic organ prolapse with a vaginal mesh implant introduces additional complications that are not present in non-mesh treatments for POP. In addition to these complications being classified as “not rare,” the FDA has also stated that mesh surgery does not present any additional benefits as far as recovery or restoration of quality of life.

Johnson and Johnson Ethicon Mesh Complications

According to the FDA, mesh complications are serious risk presented by all brands and models of transvaginal mesh products. According to the FDA, the most common mesh complaints include bleeding, infection, organ perforation, urinary problems, and the erosion of the mesh through the vaginal wall. Additionally, there have also been incidents reported to the FDA through their MedWatch Safety Reporting program of emotional problems, vaginal shrinkage, neuromuscular problems, recurrence of pelvic organ prolapse, and vaginal scarring. Mesh injury lawsuits have been filed against Johnson and Johnson Ethicon as well as Boston Scientific, American Medical Systems, and C. R. Bard.

Free Johnson and Johnson Ethicon Mesh Injury Consultation

If you have experienced severe complications following treatment with Johnson and Johnson Ethicon Mesh or another mesh product, call the Willis Law Firm today. You may have a legal claim against the company that manufactured your mesh device, and we may be able to help you recover substantial monetary compensation. Don’t delay; call us today and let us help you get the settlement you deserve.

**All Johnson and Johnson Ethicon mesh lawsuits are filed on a contingency fee basis.**

J&J Ethicon Mesh Lawsuit

The Ethicon division was created by J&J in order to expand the horizon of products offered to include medical devices. The Gynecare division of Ethicon, Inc. was established in order to specialize in the creation and marketing of women’s health devices, including vaginal mesh implants. However, in recent years these Ethicon mesh products have become the target of hundreds of personal injury and product liability lawsuit claims. In fact, nearly three hundred lawsuits are pending against J&J’s Ethicon division alleging that the mesh implants are responsible for a large number of complications and injuries. One 65 year-old New York woman says that here Johnson & Johnson mesh has left her unable to work, have sexual intercourse with her husband, or even sleep through the night. She believes the regulations failed to protect her and that adequate testing was not required prior to the device being used in her treatment.

FDA J&J Ethicon Mesh Warning

The United States Food and Drug Administration has issued several warnings of escalating severity regarding vaginal mesh products, including those offered by J&J’s Ethicon. Earlier this year the FDA reclassified vaginal mesh as a Class III device, meaning that it carries with it the highest degree of risk. The FDA has also identified the following Ethicon Mesh complications:

Vaginal Mesh Erosion: occurs when the mesh implant protrudes through vaginal wall. Very painful and often requires more than one revision surgery in order to treat. Sometimes vaginal mesh exposure is never able to be fully treated and is permanently detrimental to the patient’s quality of life.

Vaginal Pain: vaginal pain following surgery with a J&J Ethicon Mesh product can be an indication of several different mesh complications. In addition to mesh erosion, severe pain may indicate mesh contraction or mesh shrinkage, which can result in serious vaginal scarring and disfiguration. Sometimes this pain is also accompanied by vaginal discharge or bleeding.

Organ Perforation: also a serious complication associated with J&J Ethicon mesh. The following organs may be perforated by vaginal mesh implants: vaginal apex, bowel, colon, rectum, urethra, and blood vessels.

Additional Ethicon Mesh complications include reports of urinary problems, emotional problems, neuromuscular issues, and reoccurrence of pelvic organ prolapse. These various side effects and complications have been cited in a large number of Ethicon Mesh Lawsuit claims.

File a J&J Ethicon Mesh Lawsuit: Speak with a Lawyer

If you have or a loved one have experienced any of the previously mentioned mesh complications following treatment with a J&J Ethicon Mesh product, call the Willis Law Firm today. We may be able to help you secure financial compensation for your injuries. At present we are reviewing cases nationwide; all mesh clients are represented on a fee contingent basis. If we don’t recover for you, you don’t have to pay.

Transvag Mesh

“The Next Medical Device Controversy: Vaginal Mesh,” an article on the website of Bloomberg Businessweek Magazine provided valuable insight into the product liability issues surrounding these transvag mesh devices and the controversy surrounding. A growing number of lawsuits against the manufacturers of these mesh products allege that the companies did not perform adequate testing in order to assess the risks associated with their products. The victims of transvaginal mesh complications often experience the following painful and sometimes debilitating complications:

  • Constant Vaginal Pain (often making it difficult to sleep as well as complete daily activities)
  • Inability to have sexual intercourse with partner
  • Erosion of the Device through vaginal walls
  • Urinary Problems

FDA Transvag Mesh Warnings

In July of 2011, the FDA noted that women who are treated for pelvic organ prolapse and/or stress urinary incontinence with transvaginal mesh implants demonstrate a five-fold increased risk of serious complications. This was in contradiction to a 2008 warning, in which the agency said that complication risks were rare. Recently an advisory committee for the FDA decided to reclassify trans vag mesh as a high risk device, called Category III. These types of products require more extensive testing prior to being placed on the market.

Trans Vag Mesh Lawsuits

At the publication time of the article, there were nearly three hundred pending lawsuits against Johnson & Johnson in regards to their transvaginal mesh implants. In addition to this J&J litigation, there were also a number of other lawsuits filed against other mesh manufacturers including: Boston Scientific, American Medical Systems, and C. R. Bard. Personal injury attorneys expect the number of transvag mesh lawsuit claims to rise as the issue receives additional media attention and publicity. Pelvic organ prolapse surgery is a fairly common procedure, and in about ¼ of these procedures trans vag mesh implants are used. Although media attention regarding mesh complications has slowed the use of implants, a large number of women may still come forward with mesh injuries.

File a Transvag Mesh Lawsuit: Free Attorney Consultation

If you or a loved one has been injured as the result of pelvic organ prolapse or stress urinary incontinence surgery with a transvaginal mesh implant, you may have a viable lawsuit claim. Contact the Willis Law Firm today for your free and confidential mesh lawsuit evaluation. We are now accepting new transvaginal mesh clients in all fifty states, and we never bill mesh victims any legal or attorney fees unless we recover in their favor. Don’t delay; call us today and let us help you protect your legal rights.

Ethicon, Inc. is a division of Johnson & Johnson that was founded in 1949 as a way to increase the scope of products offered by the company. Within Ethicon, Inc., the Gynecare Division was created in order to offer a large variety of Women’s Health devices, including several vaginal mesh products. Vaginal mesh is a type of surgical mesh implant that can be composed of either biologic or synthetic materials. Typically these Ethicon mesh products are used as a permanent surgical solution to pelvic organ prolapse or stress urinary incontinence.

After the release of several FDA warnings questioning both the safety and effectiveness of vaginal mesh products, hundreds of lawsuits have been filed against the creators and marketers of these devices, including Johnson & Johnson’s Ethicon division. Additionally, mesh lawsuits have been filed against American Medical Systems (AMS), C. R. Bard, and Boston Scientific.

Types of Ethicon Mesh Devices

Johnson & Johnson’s Ethicon division offers a variety of different vaginal mesh and bladder sling products to treat stress urinary incontinence and pelvic organ prolapse. Several of these products have been the subject of lawsuit claims as well as multi-district litigation regarding their serious complications. The following are all Ethicon Women’s Health products:

  • Ethicon Gynecare TVT Abbrevo Continence System
  • Ethicon Gynecare Gynemesh
  • Ethicon Gynecare TVT Secure System
  • Gynecare TVT Retropubic System Tension-Free Support for Incontinence
  • Gynecare TVT Exact Continence System
  • Gynecare Prolift Pelvic Mesh
  • Ethicon Gynecare Prolene Mesh
  • Gynecare TVT Obturator System Tension-Free Support for Incontinence
  • Gynecare TVT Family of Products
  • Ethicon Gynecare Prosima Pelvic Mesh

File an Ethicon Mesh Lawsuit: Speak with an Attorney

The victims of vaginal mesh injuries are often embarrassed and do not know how to best protect their legal rights and the interests of their families. If you have been injured following surgery with an Ethicon Mesh product, it is important to remember that the problem is with the mesh implant and not with you.

At the Willis Law Firm, we have compassionate and qualified female consultants ready to speak with you in complete confidence regarding your mesh injuries. You may be entitled to financial compensation for your Ethicon injuries, medical expenses, as well as time lost in wages. If you have been injured by vaginal mesh surgery, call the Willis Law Firm today. We are currently accepting new mesh lawsuit clients nationwide; as always, injury victims are represented on a contingency fee basis. If we do not recover for you, you are not responsible for legal fees and expenses. You have nothing to lose; call us today and let us help.