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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Congress Involved with TVMs

Representative Edward Markey (D-MA) has proposed a new legislation to deal with the 510(k) loophole in the FDA’s approval process. The 501(k) process is much easier and cheaper than a Premarket Approval. The 501(k) process generally does not require clinical research.

Medical device regulation, which is controlled by the Medical Device Amendments of 1976, differs markedly from that of drugs and biologics. Devices on the market prior to the 1976 law are allowed to remain on the market until FDA promulgates regulations requiring market applications. New devices, regardless of how risky, that are substantially the same as those already on the market prior to the 1976 law can be marketed after the submission of a premarket notification, commonly referred to as a 510(k) after the applicable section of the FDA law. If FDA determines that the device is substantially equivalent to a pre-existing device, the manufacturer can market the device without further regulatory review. New devices that are not substantially the same as a pre-1976 device must undergo more extensive FDA review and approval prior to marketing.

The 510(k) premarket notification process is still often the means by which new medical devices are approved for the market. Most device manufacturers do not complain about this situation since the 510(k) notification process takes much less time to prepare, requires much less information, gets processed very quickly, and has a low rejection rate.

Under the proposed new bill called the SOUND Act – Safety of Untested and New Devices, the FDA can ask for documentation from the manufacturers to show that the new device has addressed and fixed all potential problems if the device is based on a prior device that had safety issues. While asking for support, Representative Markey cited the complications caused by transavaginal mesh which received approval under the 510(k) process.  The complications caused by the transvaginal mesh have acted as a catalyst for this new legislation. The mesh was approved by the FDA under the 510(k) process. The approval was based on the use of the mesh in other parts of the body. Women who have used tranvaginal mesh have developed serious complications including infections, urinary problems and numerous post surgical complications.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Congress Involved with TVMs

Our firm represents women who received Transvaginal Mesh (TVM) devices and Transvaginal Tape (TVT) devices in both the United States and Canada. We are privileged to help so many women, and wanted to advise our clients and the public on recent activity in the news concerning TVM and TVT devices.

The Boston Globe (3/23, Kotz) reports that at a Thursday morning press conference, Rep. Edward Markey (D-MA) introduced a bill, “the Safety of Untested and New Devices (SOUND) Act, [that] would enable the FDA to require manufacturers of devices based on older devices that have safety issues to provide documentation demonstrating that the new product’s design has fixed potential problems. In an interview following the briefing, Markey said he hoped the legislation would be added to a larger medical device bill that Congress is set to vote on at the end of May.” At the briefing, where he appeared with a Colorado woman who is suing Johnson & Johnson/Ethicon over the Gynecare TVT vaginal mesh implant she received, which had been automatically approved by the FDA based on its similarity to another product of the market, later recalled, Markey claimed that “a loophole in our current law… actually requires the FDA to approve certain kinds of medical devices even if they have reason to believe [the devices] may harm or even kill patients.”

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Unnecessary Surgery

One end result of a TVM or TVT device is surgery to remove eroded mesh materials from the human body, and such a surgery in our opinion is completely and totally unnecessary.

The number of laparoscopic hysterectomy is rising; however, there still are technical problems and disadvantages in the procedure that need further research. In laparoscopic surgical procedures, the surgeon loses direct contact with the surgical site. His vision is restricted. Instead of seeing the entire surgical field including adjacent organs, he can see only the point of surgery, and his view depends on the angle of the camera. The surgeon does not have the tactile feedback of open surgery due to the length of the shaft of the surgical instruments. In addition, the freedom of movement of the video camera and the long-shafted instruments is limited because they are fixed in the abdominal wall. This forces the surgeon into uncomfortable and unnatural body postures affecting the outcome of the operation.

Positions especially when they are static, lead to cramps, muscle pain and rapid fatigue. This can possibly result in an adverse event. Several factors inherent in laparoscopic surgery result in postures that are far from the ideal.

When performing laparoscopic procedures, factors inherent to that type of surgery constrain not only the surgeons’ posture but also their view of the surgical site. Those factors can contribute to error and subsequent adverse outcomes.

The surgical instruments are limited because they can be moved only in certain directions: they can be inserted and removed; moved at an angle about the fulcrum, the point of support at the entry port; rotated about a longitudinal axis as in turning the instrument inside the body cavity; and made to open and close. These limitations restrict the surgeons’ movement of the instruments and frequently force awkward postures of the arms and shoulders, hence can influence the execution of the surgical procedure.

Typically, one thinks of surgical instruments as reusable; however, reusable instruments can be difficult to clean and reassemble after cleaning. Lack of standardization of instruments from different manufacturers sometimes creates difficulties during the operation. Loose working parts on the ends of the instruments such as laparoscopic graspers, an instrument with end-effectors that are expected to grasp tissue, can be ineffective. The surgeon may not be able to identify that problem until the instrument is removed from the abdominal cavity and visually examined, when the loose working parts become obvious.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Unnecessary Surgery

One end result of a TVM or TVT device is surgery to remove eroded mesh materials from the human body, and such a surgery in our opinion is completely and totally unnecessary.

Every patient who has surgery requires some kind of anesthesia. There are three types of anesthesia: local, regional, and general. For local anesthesia, drugs that block nerve conduction (local anesthetics) are injected immediately around the site of surgery before and during the surgical procedure. Local anesthesia is often provided by surgeons without anesthetists present, but when patients have diseases that need to be monitored, when they may require carefully managed sedation, or when a more extensive operation might ensue necessitating general anesthesia, an anesthetist is asked to conduct monitored anesthesia care and is present throughout the case.

Problems can arise from a variety of sources. Underlying diseases can become manifest during an operation independent of the stresses of surgery and anesthesia. These stresses will interact with underlying conditions, making acute exacerbations even more likely. The surgery itself often causes additional specific problems, including the surgeons compressing vital organs or lacerating significant arteries or veins. Other difficulties may be triggered when equipment fails (although these failures are rarely the sole cause of the problem), or when the anesthetist or surgeon makes an overt error. Several strategies are used to prevent problems from occurring. Precase evaluation of the patient and checking the anesthesia equipment disclose immediate hazards. Appropriate planning will make the likelihood of error on the part of the anesthetist or surgeon less likely, but human fallibility cannot be entirely eliminated.

During the surgery, the patient’s ventilation must be mechanically controlled. Failure to do so will result in asphyxia, cardiac arrest, and death. Throughout the operation, the anesthetist is engaged in a large number of tasks. These include (but are not limited to):

• Monitoring the patient and the life-support equipment by direct and electronic observation.
• Adjusting the anesthetic level and administering other medications as needed.
• Recording vital signs and other parameters at least every 5 min.
• Responding to changes in the patient’s condition and taking emergency actions if needed. Evaluating blood loss and urine output.
• Administering IV fluids and, when needed, blood.
• Adjusting the position of the OR table as needed by the surgeons.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Unnecessary Surgery

Is unnecessary surgery a fact? If surgeons know beforehand that an operation is unnecessary, there can be only one reason to go ahead and perform it anyway: money. Although the surgical profession is not riddled with avaricious opportunists who are beyond control, there are some in the medical profession who reject the idea that any unnecessary surgery exists.

“Unnecessary surgery” is surgery performed without any expectation of improving either the quality of a patient’s life or the length of that life. Even with the best intentions, it may turn out that a given operation fails to produce the expected results. While, in one sense, this operation has proved to be “unnecessary,” it is only unnecessary in hindsight.

Since surgery is not an exact science, such judgments will occasionally turn out to have been in error. As it is usually used, however, the phrase “unnecessary surgery” implies that surgeons know that certain operative procedures are not necessary but perform them anyway, thus subjecting patients to unnecessary risk and expense. There are dishonest and unethical people in all businesses and professions. Hysterectomy or removal of the uterus is a common example of unnecessary surgery. The necessity for hysterectomy has declined with the use of alternative therapies.

Although not everyone will need to have their tonsils out, uterus removed, or blood vessels repaired, some people will need these operations for certain specific reasons. This is where surgical judgment comes in. Surgeons are well aware that the indications for certain operations change with new information, and those who remain current with the new information in their specialty are more aware of this than others. You can easily appreciate how important it is for your surgeon to remain up to date. It is estimated that the surgical information base completely turns over every six years. As a result, if your proposed surgeon does not participate in continuing medical education programs — by attending professional meetings or reading surgical journals or making rounds at a teaching hospital — you may be placing yourself in the hands of someone whose knowledge and skills have become obsolete.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

United States Judicial Panel on Multidistrict Litigation Sends Cases to Southern District of West Virginia in MDL 2325, MDL 2326 and MDL 2327

Against the wishes of attorneys for medical device manufacturers, the United States Judicial Panel on Multidistrict Litigation has ordered (Feb. 7, 2012) that In re: American Medical Systems, In re: Boston Scientific Corp., and In re: Ethicon, Inc. will be sent to the United States District Court for the Southern District of West Virginia. This is a result that will be beneficial for all recipients of a TVM transvaginal mesh or TVT transvaginal tape device.

As noted by the Panel:

The central dispute among the parties is where each MDL should proceed. Most plaintiffs argue in favor of three MDLs proceeding in one district; namely, the Southern District of West Virginia. Defendants prefer centralization of each litigation in separate districts. We are persuaded that the Southern District of West Virginia is the most appropriate transferee forum for each of these MDLs. Chief Judge Joseph R. Goodwin of that district is currently presiding over MDL No. 2187, which involves claims of defects in similar pelvic surgical mesh products, and is uniquely situated to preside over the similar claims in these three MDLs. The pelvic surgical mesh products at issue in MDL Nos. 2325, 2326, and 2327 are used to treat similar conditions as those at issue in MDL No. 2187, and they have allegedly resulted in similar injuries. Almost all responding plaintiffs support centralization in this district, and defendants AMS and Boston Scientific concede that the Southern District of West Virginia is an appropriate transferee district. Finally, a number of these actions are brought by plaintiffs who were implanted with multiple products made by multiple manufacturers. Centralization of the three MDLs in one court will allow for coordination of any overlapping issues of fact in such multi-product, multi-defendant actions.

Based on this Order, women who have been injured by the manufacturers of transvaginal mesh will be likely able to experience justice sooner than had the Panel split the cases to multiple districts, or not allowed consolidation under MDL principles at all.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Bill Would Allow FDA to Block Medical Devices Associated with Recalls: Includes Transvaginal Mesh

Several news outlets are reporting that the a congressional bill proposed by the Democratic Party would allow the FDA to block medical devices associated with a recall, closing the 510(k) loophole currently at issue.

Bloomberg News (2/3, Nussbaum) reports, “US regulators should be able to block medical devices based on past products with safety issues, said House Democrats, citing injuries from transvaginal implants like those made by Johnson & Johnson and C.R. Bard Inc.” Legislation “introduced this week would close a loophole that lets devices win approval even when they’re similar to a product already pulled from the market.” The piece explains, “Vaginal implants spurred a Food and Drug Administration alert last year amid patient complaints of pain and internal injuries. The devices were cleared by the agency’s 510(k) system, which allowed them to be sold without human testing once the FDA rules they are similar to existing products.”

CQ (2/3, Subscription Publication) reports that “the measure (HR 3847) was introduced by Democratic Reps. Edward J. Markey of Massachusetts, Henry A. Waxman of California, Jan Schakowsky of Illinois and Rosa DeLauro of Connecticut.” Lawmakers say that “at the heart of the legislation…is a provision that would ensure that the FDA does not clear a new device using the 510(K) process if it is based on an earlier product that had been pulled from the market ‘for causing serious harm to patients.'”

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

House of Representatives Looking for Hearings and Issue Letter

Bloomberg News reports that

House Democrats called for congressional hearings on transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients. U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers. The inquiry is critical as Congress considers an overhaul of Food and Drug Administration rules for medical devices, the Democratic lawmakers said today in a statement. The FDA ordered New Brunswick, New Jersey-based J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants earlier this month, citing reports of internal injuries.

The Democratic Committee Leaders issued a letter stating:

We are writing to renew our October 12, 2011, request for hearings to examine medical devices that have developed serious defects after being implanted in patients and to propose the Committee seek documents related to the “Lap-Band” weight loss device and urogynecologic surgical mesh.  The Committee has failed to schedule the hearing we requested in our October 12 letter, and we remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation.  We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act.

The “Lap-Band” Gastric Band

            The “Lap-Band” is a type of gastric band device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach.  When the device is effective, patients feel full more quickly and thus are more likely to eat less and lose weight.  FDA approved the “Lap-Band” device for obese patients, but has indicated that the device can pose serious risks including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.[1]  In addition, the FDA has said the device is not a “quick fix” for patients struggling with obesity but instead requires “major, long-term changes” to eating habits.[2]

A study published this week in the Archives of Surgery raised questions about the effectiveness of gastric banding, finding that after six years, nearly 50% of patients had either not lost weight or had needed the device to be removed and that over 40% of patients experienced long-term complications.[3]  The study echoed research published in the journal’s March 2011 edition, which found that 40% of patients who received “Lap-Band” surgery had serious complications and concluded that the surgery had “relatively poor long-term outcomes.”[4]  Similarly, a study in the Journal of the American Medical Associationreported that 48% of test group members experienced “adverse events” as a result of the procedure and that nearly 30% required “revisional procedures” to enlarge the stomach above the band.[5]  A study in the Journal of Obesity found high complication and reoperation rates for gastric banding, with 30% requiring an additional operation and 12% requiring the removal of the device altogether.[6]

Even in the face of these serious medical complications, Allergan, the manufacturer of the Lap-Band, is seeking to expand the use of the device in children and young adults.  Allergan is currently seeking FDA approval to market the device to children as young as 14, despite concerns among some physicians that the procedure is too drastic or “extreme” for a young person’s developing body.[7]  The New York Times recently reported that the lure of a seemingly “easy way out” of losing weight may push young people to undergo “Lap-Band” surgery without adequately considering the risks and the dramatic lifestyle changes that are necessary.[8]

The adverse public health consequences associated with use of this device are exacerbated by aggressive marketing and by the lack of a national registry of implanted medical devices, like those that exist in Europe, which would enable public health authorities to obtain more accurate data on the rates of adverse events and device failures.

The tragic results of aggressive marketing by several Lap-Band surgical centers are particularly evident in recent events in Southern California.  In December 2011, FDA issued warning letters to a marketing firm called 1-800-GET-THIN, LLC, and eight surgical centers in California that aggressively market the Lap-Band without adequately informing consumers of the risks associated with the device. [9]  According to a series of reports in the Los Angeles Times, the use of lap-bands by these surgical centers appears to have been associated with significant harm to the health of a number of Southern California patients, including the deaths of five patients since 2009.[10]

Despite these serious risks, 1-800-GET-THIN and the related surgical centers have marketed the device with ubiquitous roadside billboards, advertising inserts, and radio and television ads that “display the smiling faces of thin people and catchy phrases about the benefits” of the surgery.[11]  The ads include phrases such as “DIETS FAIL!  The Lap-Band Works!” and “Let Your New Life Begin.”[12]

The advertisements either do not mention the risk information, qualifying age and weight requirements for the procedure, and the need for meaningful life style change or they present limited information in lettering the FDA called “so small as to render the information illegible.”[13]  One FDA official said he was “astonished” by the number of billboards advertising the procedure and noted that the ads target “a very vulnerable patient population.”[14]

Although Allergan has criticized the advertising campaign and issued voluntary advertising guidelines for the “Lap-Band” in February 2011, these voluntary guidelines have not been effective.  It is unclear what, if any, direct action Allergan took to prevent 1-800-GET-THIN or the related surgical centers from advertising the “Lap-Band” in a false and misleading way.[15]

Urogynecologic Surgical Mesh

            Urogynecologic surgical mesh implants are permanently implanted in the vaginal wall of patients suffering from conditions such as pelvic organ prolapse and urinary incontinence in order to repair weakened or damaged tissue.[16]  These mesh devices were permitted on the market under the 510(k) clearance process, meaning that the devices had to demonstrate that they were “substantially equivalent” to one or more devices already on the market.  Although clinical data can be required under this clearance process, many submissions are cleared without such data.  FDA did not require original clinical studies before clearing urogynecologic surgical mesh through the 510(k) process.[17]

Beginning in October 2008, FDA began to respond to rising reports of complications associated with the surgical mesh by issuing a Public Health Notification calling the transvaginal placement of the mesh “an area of continuing concern.”[18]  In the three years before the notification, over 1,000 adverse events related to the mesh had been reported to FDA.[19]   Over the next three years, the number of reported complications rose to more than 2,800, driving FDA to issue an update on the “serious complications” associated with the device in July 2011.[20]

In 2010 alone, nearly 300,000 synthetic vaginal meshes were implanted in American women.[21]  The most common complication associated with the device is erosion through the vagina, which can be potentially debilitating for some women and require multiple surgeries to correct. [22]  Even with multiple surgeries, some women are never able to recover from the damage.[23]

After years of reports of serious complications associated with use of the device and amid a rising chorus of academic and clinical concern, FDA just last week announced that it was considering reclassifying vaginally implanted surgical mesh as a high risk Class III medical device. [24] The agency ordered 33 manufacturers of the device to conduct postmarket safety studies of the device.[25]

It is unclear when the manufacturers of this device became aware of the serious health risks associated with the device.  It is also unclear if the manufacturers and the FDA have taken appropriate steps to protect patients.

Conclusion

            We believe the Committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh.  We also believe we should hold hearings on the brain stents and metal-on-metal hip implants mentioned in our October 12 letter.

We further ask that the Committee seek documents relevant to both the Lap-Band and intravaginal mesh devices.  In the case of the Lap-Band, we urge you to request documents from Allergan, 1-800-GET-THIN, LLC, and the eight surgical centers named in the FDA’s warning letters to learn the degree to which these entities cooperated in the marketing of the Lap-Band, what steps were taken to minimize the risks the aggressive marketing campaign posed to patients and children in particular, and to obtain additional information regarding their knowledge of and response to device failures and adverse events.  In the case of the intravaginal mesh, we ask that the Committee seek documents from the manufacturers of surgical mesh to ascertain when they first learned of the safety issues associated with certain uses of the device and what, if any, actions they took to limit risks for patients.

As the Committee approaches reauthorization of the Medical Device User Fee Act, we need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.  It is also vital that we understand whether device manufacturers and the FDA are taking appropriate steps to keep hazardous devices from the market and to protect patients from marketed devices that are later discovered to be dangerous.

The Committee’s reauthorization of the Medical Device User Fee Act is an important opportunity to improve the efficiency of the FDA’s review process while at the same time strengthening assurances of safety and efficacy.  Obtaining information about devices like the Lap-Band and intravaginal mesh will be critical to informing members of the Committee on an issue that has thus far been absent from the Committee’s record.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

Johnson & Johnson: One of the Worst in 2011

Website 24/7 Wall Street listed its Ten Most Hated Companies in 2011, and on the list was Ethicon’s Johnson & Johnson. As many of you reading this will know, claims have been filed as a result of Ethicon’s transvaginal mesh POP device. The precise quote from the website is:

Johnson & Johnson (NYSE: JNJ) has experienced a series of product recalls and problems that began with Motrin and Tylenol for children. According to AP, these recalls were among “more than two dozen that J&J has issued since September 2009, for products ranging from adult and children’s nonprescription Tylenol, Motrin, Benadryl and other medicines to prescription drugs for HIV and seizures, defective hip implants that caused severe pain and contact lenses that irritated the eyes.” The parents of a two-year-old who was treated with one of the tainted batches of Children’s Tylenol recently sued the company for the wrongful death of their child. In March 2011, the FDA took over three Tylenol plants owned by Johnson & Johnson. The recalls are beginning to hurt the company. Third-quarter 2011 sales of over-the-counter drugs fell 24% from the previous year. According to Bloomberg, company executives attributed the significant loss of market share to quality issues that kept products off shelves. The long series of problems has ruined what was once a sterling reputation. Since the disclosures mounted two years ago, Johnson & Johnson shares are flat while the DJIA is up 17%, over the past year.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

FDA Issues Mandate

The FDA issued a mandate this week requiring the manufacturers of transvaginal mesh (TVM) products, including American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson, to study the risks and complications of device usage. As a service to the public at large, these are four separate news sources reporting on this pandemic that is affecting thousands of women.

Increased reports of complications have prompted the US Food and Drug Administration (FDA) to order new postmarket surveillance (522) studies of surgical mesh implants used to treat pelvic organ prolapse and stress urinary incontinence. The FDA is also considering reclassifying urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse from Class II to Class III, a higher-risk category that would require clinical trials before approval.

Under the new FDA order, manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for prolapse and single-incision mini-sling devices for stress incontinence. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices.

The FDA said it continues to assess the safety and effectiveness of urogynecologic surgical mesh devices through the following additional actions:

1. Review and analysis of published literature, Medical Device Reports submitted to the agency, and post-approval study reports
2. Epidemiologic research on safety and effectiveness of surgical mesh
3. Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events
4. Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.

The following is required

• – 88 orders for postmarket surveillance studies were issued to 33 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse (POP);
• – 11 orders for postmarket surveillance studies were issued to seven manufacturers of single-incision mini-slings for stress urinary incontinence (SUI); and
• – All manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh for POP and single-incision mini-slings for SUI devices.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

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. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.