Vaginal mesh devices are one of the modern innovations introduced as an alternative surgical treatment for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). However, in the FDA Health and Safety Alert concerning transvaginal mesh devices, it mentioned that patients have reported experiencing mesh erosion.

What is mesh erosion?

POP and SUI have been treated by stitching the muscle tissues in the vaginal wall together. The vaginal wall is naturally sturdy, able to support the other organs located around the abdomen. But due to child birth or surgery, the pelvic muscles surrounding the abdomen weaken and are unable to provide support.

Vaginal mesh was designed as an additional surgical treatment option – a mesh device is implanted to provide support for the organs and allow the tissue to grow into the device. Theoretically, the tissues should heal first and not let the mesh device move in the process. Problems arise when the mesh device erodes even before the tissues heal.

Vaginal mesh erosion can be experienced few weeks after surgery. One cause may be due to incorrect placement or a defective mesh device. Also, because the vagina is not a sterile surgical environment, infections during the healing period can cause the mesh to erode. Patients are usually given 5 weeks or more to wait for the tissues to heal. Some patients may lose track of this period and engage in sexual intercourse within this time which can also cause the vaginal mesh to erode.

Some patients reported having foul-odored discharges a few weeks after surgery. This may be a sign of infection, or mesh erosion, or both. Some patients reported feeling pain or discomfort, urinary problems, or recurrence of prolapse and incontinence. These are signs of vaginal mesh erosion.

Mesh erosion would require one or more surgeries to correct it; either to remove a part of the eroded material, or to remove the entire device.

It is very important that the physician or the surgeon was able to explain thoroughly the possibility of a mesh erosion to the patient. This is a very serious complication as this will lead to more health risk and more surgeries for the patient.

Women put their hopes in what pharmaceutical manufacturers of mesh devices promise. You will know that this promise is not kept when you are experiencing the symptoms of mesh erosion. LegalView offers free consultation to guide women on how to deal with a vaginal mesh erosion claim.

Vaginal mesh shrinkage (or contraction) is one known cause of complications and injuries reported by women who underwent vaginal mesh surgery. These medical innovation known as a vaginal mesh device started to be used for Pelvic Organ Prolapse (POP) and hernia. Ideally, the device is supposed to support the vaginal wall, which in turn supports the organs surrounding the organ. This should prevent the other organs from moving from their natural position. Vaginal mesh shrinkage, or contraction in a more clinical term, is exactly what it is — shrinking of the device.

It is not so difficult to imagine what effect shrinking will lead to, especially when it is used as a support. Imagine a post in your house, shrinking. Naturally, the weight it carries will have to eventually collapse. This is vaginal mesh shrinkage.

In a journal published by the The American College of Obstetricians and Gynecologist in 2010, it showed that vaginal mesh shrinkage is a known complication of vaginal mesh surgeries. But this is not the most frightening thing about it. The journal said in its discussion that the origin “of this phenomenon is still unknown.”

Here are some theories explaining how vaginal mesh shrinkage may occur:

Some researchers say that the shrinkage  may be a physical consequence of the inflammatory response to the mesh, that is, the body’s inflammation pushes the foreign material causing it to shrink.  Others theories that it may be a result of inadequate tissue in-growth into the mesh. Whatever the reason is, the journal concludes that shrinkage becomes very high when the material is introduced into a biological tissue. Using imaging techniques such as ultrasonography or magnetic resonance imaging, the researchers saw that the dimensions of the graft were assessed after the surgery, and compared with the original mesh device before the surgery.

Again, these are just theories.

In a study presented at the 34th Annual Scientific Meeting of the International Urogynecological Association,  it was shown that long-term changes in mesh volume found mean contraction of 30 percent, 65 percent, 85 percent from its original size. This was seen after follow-up durations of 3, 6, and 8 years, respectively. The study thus showed that the shrinkage is progressive and there is a linear evolution of the contraction rate with time, raising the worrying possibility that mesh contraction syndrome will be more frequent. This is but just an observation, and as discussed, there is really no definite explanation yet about shrinkage in vaginal mesh devices.

Common signs associated with shrinkage is pain and discomfort and dyspareunia (painful sexual intercourse). The study also showed that surgical intervention is necessary to avoid further complications caused by vaginal mesh shrinkage.

Had patients knew this, would they have proceeded with their transvaginal mesh surgery? Or would have the physician encouraged these women had they known this? None can tell definitely. But the fact remains the manufacturers of these mesh devices are obliged to have known all of these findings before they introduced these devices into the market.

If you feel you are experiencing vaginal mesh shrinkage, consult a physician immediately. Also, LegalView can give you legal advice, free of charge, to let you know your rights as a patient.

Read more about transvaginal mesh injuries at LegalView.

Controversies about vaginal mesh surgery and the effects of vaginal mesh devices are rising. So, lawsuits may be inevitable for many.

As technology develops and new treatments emerge, liability in the medical field has become more complex as well. That’s where our laws come in. In medical treatments,  the Informed Consent Law has been enacted. This is the law which requires that physicians disclose to their patients information that is critical in order for the patient to decide whether or not she should accept the proposed treatment.

The physician must verify that the patient understands all the facts, future consequences, and all potential risks of a surgery or treatment to be performed.

In order to arrive at informed consent, the patient concerned must possess the following:

1. The ability to understand the information, and
2. Comprehension of the relevant facts about the situation.

Under the Informed Consent Law, this must be reduced into writing. Before surgery, the patient is given a sheet, the Informed Consent Form, which contains detailed information about the procedure and potential risks. The patient must signify in this sheet that she was informed of all the necessary details she need to give her consent and that she has understood everything she was told.

With this, patients can choose whether or not to proceed.

Many women who have undergone a vaginal mesh surgery also signed paperwork prior to their surgery. However, due to a rising number of complaints, many feel that the risks were not adequately explained.

We not ask:

How complete is the information presented to you? Were you told that many women have reported complications they are experiencing because of their transvaginal mesh surgery? Were you informed about the FDA Health and Safety Alert on vaginal mesh complications?

LegalView offers free legal consultation to assist patients who feel they are not well-informed about the surgery they went through. Read more about transvaginal mesh injuries at LegalView.

Patients who are suffering from serious complications such as vaginal mesh erosion, neuromuscular problems, vaginal scarring, and many other complications are not just facing medical complications and health problems; these women might very well be facing getting lost inside a legal labyrinth with the many difficult legal questions that they will have to face.

An example of this is a transvaginal mesh lawsuit filed against a vaginal mesh manufacturer, American Medical Systems (AMS), which was acquired by another company, Endo Pharmaceuticals in 2011. In recent lawsuit named both companies as responsible parties for mesh complications. Lawyers for Endo Pharmaceuticals raised the issue that they were fraudulently included in the vaginal mesh case.

The question of who is responsible will be difficult especially to someone who wants nothing more than better health.

Also, some may wonder whether a vaginal mesh lawsuit is a class action lawsuit or not. LegalView provides an article explaining that it is NOT a class action lawsuit.

These are questions that cannot be left to just anyone. Livelihood, health, and family resources are at stake at every step of the way for patients of transvaginal mesh complications. For this reason, it is difficult for patients to try and represent themselves or determine their legal rights.

LegalView extends help to women who are suffering vaginal mesh complications, including mesh erosion, shrinkage and pain. Free legal consultation is provided to those who are trapped in this legal labyrinth.

Read more about vaginal mesh complications and injuries at LegalView.

In July 2011, the FDA issued a Safety Communication reporting 2,874 cases of complications caused by transvaginal mesh surgical devices. The report quoted 1,503 cases involving pelvic organ prolapse (POP) repairs and 1,371 cases involving stress urinary incontinence (SUI) repairs. But that was back in July 2011.

In 2012, it seems that the number will keep on rising.

Transvaginal mesh lawsuits have been filed since the start of this year against different manufacturers of vaginal mesh products.

These following companies may ring a bell:

1. American Medical Systems (a unit of Endo Pharmaceuticals
2. Boston Scientific
3. Caldera Medical
4. CR Bard
5. Endo Pharmaceuticals
6. Island Biosurgical
7. Johnson & Johnson subsidiary Ethicon
8. Mentor Corporation
9. Tyco Covidien (Dublin-based)

Four stand out in this group: Johnson & Johnson, C.R. Bard, American Medical Systems, and Boston Scientific.

Johnson and Johnson, Inc. and Ethicon, Inc. were sued for their Ethicon line of products, including the Gynecare Prolift Pelvic Floor System, the Gynecare TVT System, the Gynecare TVT Obturator System, the Gynecare TVT Secure System, the Gynecare Prolift Anterior, Posterior, and/or Total Pelvic Floor System,and the Gynecare Prolift + M Pelvic Floor Repair System. The main claim against them in this case is the negligent design and the lack of information regarding the effects of pelvic slings, thereby causing injuries such as tissue damage, painful sexual intercourse, erosion, among others.

C.R. Bard, manufacturer of Avaulta Plus-BioSynthetic Support System, Avaulta Solo-Synthetic Support System, Faslata-Allograft, Pelvicol-Tissue, PelviSoft-Biomesh, Pelvitex-Polypropylene Mesh, is also facing lawsuits even at the start of the year. The claim in the lawsuit is complications leading to injuries, additional operations, among others.

American Medical Systems, manufacturer of Elevate, including the Apogee, MiniArc, Monarc, Perigee, and SPARC, is also facing a lawsuit. The claim against the company is the sale of defective products leading to serious injuries.

Boston Scientific, maker of the Posterior Pelvic Floor Repair Kit, is also facing a case. The plaintiff in that case claims complications, including infection, tissue damage, and an adverse reaction to the mesh device.

Caldera Medical, producer of the Caldera Desara pelvic mesh sling, was sued early this year for a product that caused severe injury and failure to disclose the risk of the surgical procedure.

Mentor Corporation, manufacturer of the ObTape Vaginal Sling, has been previously sued for alleged hidden erosion risk in 2010.

The other companies such as Endo Pharmaceuticals, Island Biosurgical, Tyco Covidien, have also been sued as subsidiaries of the four bigger companies.

The issue on the safety and efficiency of transvaginal mesh devices is heating up. Let’s hope that these companies act on the reports and the complaints against their products even before the number of the injured patients rise.

Information about transvaginal mesh complications and transvaginal mesh lawsuits are available. Read about them at LegalView.com.

Drivers may soon have to forego of the perks of high-technology; at least while behind the wheels — driving.

U.S. Transportation Secretary Ray LaHood is putting the pedal to the metal in intensifying his campaign against distracted driving. In a recent announcement, Secretary LaHood made clear the intention of the government to broaden the Federal Guideline in road safety to the extent of disabling built-in distractions while driving. Top of the list includes texting, talking on the phone, surfing the net, or simply punching in coordinates in the GPS. To pursue this, the Secretary called on the car manufacturers to include in their car products means to temporarily disable electronic devices while the car is being driven.

Secretary LaHood’s campaign particularly focused on driving distractions because of the high accident rates caused by driver errors. Distracted driving accounts for most of these errors. Car crash is one of the most common reasons for serious injuries like traumatic brain injuries. Drivers using hand-held gadgets are four times in risk than those who do not. Quoting federal statistics, it was reported that 5,474 people died and an estimated 448,000 were injured in crashes in which distracted driving played a role.

And that was just in 2009.

Now that niftier gadgets and devices have been made available to the market, this proposal now seems to be very appropriate. Ours is a century where technology is practically a part of life. The noble intent of Secretary LaHood to reduce, if not completely eliminate, car accidents related to distractions while driving is a right path taken. After all, it’s not just the life of the driver who is being thought of, but those surrounding him as well.

The recommendation will still go through a 60-day period for public comment. Car manufacturers and automobile associations have expressed cooperation in the safety campaign, as they also try to show how safety and need for techonology during emergencies can be balanced. Car manufacturers have been developing less distracting devices in their products such as GPS devices which allows operation only when the car is stopped.

Read more about car accidents and car crash-related injuries at LegalView.

Law suits are part of our society. The parties to a litigation may just be between two persons. In some, the plaintiff is just one person against two or more defendants, while in some, it could be the other way around: two or more plaintiffs and just one defendant. However, as society evolved, litigation nowadays can be between a person and a corporation. In the eyes of the law, a corporation can be a “person.”

As in the case of transvaginal mesh lawsuits, a patient, who is the plaintiff, can actually sue a vaginal mesh device manufacturer. There will also be a situation where the lawsuit is between two or more patients as against one manufacturer, or one patient against two or more manufacturers.

In these situations, two kinds of lawsuits may arise:

first, a multidistrict litigation, OR second, a class action lawsuit.

A multidistrict litigation is NOT the same as a class action lawsuit.

A multidistrict litigation (MDL) is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. Each of the different cases are instituted by an individual or with a co-plaintiff. The different federal cases of a similar type will then be consolidated. The one who decides whether or not cases should be consolidated is the Judicial Panel on Multidistrict Litigation (JPML). The main consideration in consolidating is the similarity among the different cases. While the main purpose is to expedite the hearing of the cases, to avoid conflicting decisions about such case, and to lessen the expenses of the litigants.

For example: three transvaginal mesh lawsuits were filed by three different complainants in three different places in the U.S. It may be that they are suing the same transvaginal mesh manufacturer, or that they are against three different manufacturers. Because of the similarity of the issues involved, that is, claims for transvaginal mesh injuries, the JPML may order the consolidation of the three transvaginal mesh lawsuits.

A class action lawsuit, on the other hand, is a kind of law suit which is filed on behalf of a group of people who have been in some way injured by the actions of a company. The lawsuit is filed not in an individual capacity. Because of this, a person who joins a class action lawsuit must waive his/her right to sue the company as an individual. In most cases, not all members in a class action lawsuit are given equal compensation. Lawyers in a class action lawsuit are expected to have a heavier work load since he would have to work with a group. To compensate for this, a class action lawsuit attorney usually demands a higher pay for his services.

For example: a gas company in a community distributes in the market products with hazardous ingredients such that it caused sickness in that community, the persons living in that community may file for a class action lawsuit against the gas company for the injuries caused by the product.

At LegalView, we give free legal consultation for persons who are perplexed and confused by the legal system. Women who are experiencing transvaginal mesh complications are invited for free consultation so that they are informed of their rights and the best remedies to take to help them in their situation.

Read more about transvaginal mesh injuries at LegalView.com.

Technology is developing at an incredible rate – so much that we may soon have internet cafes on wheels. The necessity to stay connected has been one consideration that many car owners are considering in choosing a new car. A recent survey published by Deloitte, a consulting company, revealed that 75 percent of consumers ages 19-31 want touch-screen technology in their cars. These next-generation vehicles are getting faster not just in terms of travel time, but also in internet connectivity.

Because of this hype for connectivity, car manufacturers are now pressured to make their cars armed heavier, technologically, than their competitors. Innovations in the digital industry must naturally make their way inside cars, if car manufacturers want to stay on the race.

The German manufacturer of Mercedes-Benz Daimler AG, is working on technology that will enable drivers to read information on the windshield by simply waving their hand. Ford has a car system that converts smartphones into routers, giving passengers Internet access.

The car manufacturers, however, will inevitably have a head-on collision with the National Highway Traffic Safety Administration. Fast as they may be, technology will still have to be tempered by federal guidelines. This may sound as a stifling of innovations to those whose lives are now deeply intertwined with technology. But U.S. Transportation Secretary Ray LaHood is not pulling over.

To him, distracted driving is still considered “a dangerous epidemic” which needs immediate medication. Many states in the U.S. limit the use of cell phones while driving in attempt to lower the distracted driving rate among drivers.

Just recently, Secretary LaHood released a new federal guidelines calling for car manufacturers to disable built-in distractions in their products. Suddenly these car manufacturers are placed in a crossroad. The call of market for technologically armed vehicles and the call of Secretary LaHood seem to be a stumbling block to each other’s way.

This is where the 60-day period for public comment comes into play. The car manufacturers’ intention to provide what the market demands for is totally understandable. But life and safety make more logic over the need for technology. Billions of dollars are spent into developing safer engines, better tires, more responsive airbags, sturdier seat belts, and other safety features. These innovations are only of better use in reducing injuries during an actual car accident. In what seems to be a self-contradiction, equal amount of money is being spent by the car manufacturers to make fancier built-in gadgets for text messaging, net surfing, and the like, all contributing factors in distracted driving accidents.

During the 60-day period, let’s hope that it becomes clear to everyone the difference between luxury and necessity.

The U.S. Food and Drug Administration, pharmaceutical companies, and device manufacturers are striking a deal to double the fees collected by the FDA. The increased amount, which currently stands at $287 million, will be used to expedite reviews of medical devices and ultimately create a faster approval process.

The FDA claims that it needs more employees in order to review medical devices faster, including “seasoned” doctors to head the review departments. The proposed fee hike will add 208 employees over the next five years to expedite the approval process. From 2005 – 2009, more than 18,000 applications were submitted for review under the FDA’s 501 (k) approval process, according to an October 2011 report issued by the FDA’s Center for Devices and Radiological Health (CDRH).

Presently, approval for these devices is regulated under the 510 (k) system of the Food, Drug, and Cosmetic Act. Devices are approved under this system if the manufacturer can show that the product is “substantially similar” to another device previously approved. Transvaginal surgical mesh and other medical devices were approved under this system.

Under the 510 (k) system, an applicant must cite one a previously approved product, called the predicate, that is similar to its product. The FDA may require more than one predicate prior to approval – some extreme cases have required as many as five predicates, before the applicant’s product is approved for market.

The FDA has been under pressure for its lengthy approval processes. An increased budget will definitely affect the time for which the agency must review the applicant’s product.

Manufacturers claim that a faster review will mean more time to correct anything that the FDA may find wrong in its product, as well as making the produce available faster, which will increase the manufacturer’s profits and yield a faster return on investment.

However, many questions arise:

• Will faster reviews ensure safer products?
• Particularly, will transvaginal mesh complications be avoided by faster reviews?
• Will faster reviews under the 510 (k) system change the fact that there are loopholes in the system itself?

We have yet to know.

The agreement between the FDA and the manufacturers will still need the approval of Congress, which has until September 2012 (the expiration of the five-year term of the original user fee agreement) to make a decision. Congress is caught in the middle of two considerations: make products available to the U.S. population before these products are made available in other countries, or, the dangers of approving potentially dangerous medical devices without proper review.

Read more about the complications caused by transvaginal mesh devices and other medical devices at LegalView.com.

Three multidistrict litigations (MDL) were consolidated after the U.S. Judicial Panel on Multidistrict Litigations (JPML) found that the lawsuits and side effects were similar even though they involved three separate surgical mesh manufacturers, AMS, Boston Scientific, and Ethicon.

The JPML stated that “Centralization therefore will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary,” as well as limit any potential overlap that occurs when you have more than one defendant and product.  This means that since the issues in the separate cases are similar, consolidating (or putting them in the same trial/court) them will avoid duplicating legal procedures when these procedures can be taken in just one event. Instead of going through three separate trials, there will just be one trial but covering all the issues in the three cases.

The three MDLs ordered for consolidation are:

American Medical Systems, Inc. Pelvic Repair System Products Liability Litigation; Boston Scientific Corp. Pelvic Repair System Products Liability Litigation; and Ethicon, Inc., Pelvic Repair System Products Liability Litigation — MDL No. 2325, MDL No. 2326, and MDL No. 2327, respectively.

The cases involved different designs of transvaginal mesh and pelvic mesh implants. However, the JPML says that despite the difference in the designs, the plaintiffs in each case alleged similar injuries due similar defects that allegedly plague each of the different devices.

Transvaginal mesh complications and injuries have been subject of FDA Safety Warnings as well as Congressional hearings in the last year. Women who have filed vaginal mesh lawsuits claim similar injuries including pelvic pain, mesh erosion, infection, painful intercourse, perforation of the bowel or bladder and the need for corrective surgery.

Read more about transvaginal mesh side effects at http://vaginalmesh.legalview.com/.