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House of Representatives Calls for Hearings on Vaginal Mesh Implants

admin — Mon, 06 Feb 2012 21:14:21 +0000

On January 20, 2012, Representative Henry Waxman of California led House Democrats from the Energy and Commerce Committee in writing a letter to several chairmen, requesting that the Committee hold hearings to review the safety of medical devices implanted into patients. In support of their petition, the congressmen cited problems associated with medical devices, such as transvaginal mesh implants, which have caused serious injuries to patients. According to Rep. Waxman, these harms demonstrate the need for regulatory reform. Some of the vaginal mesh implants that have been the subject of ongoing lawsuits include the Gynecare Prolift, Gynecare TVT, Bard Avaulta, American Medical Systems Perigee, Apogeeand Elevate, and Boston Scientific Obtryx and Pinnacle.

Claims In Pelvic Mesh Litigation Point To Flawed FDA Approval Process

In stressing the need for regulatory reform, Rep. Waxman examined transvaginal mesh implants. According to Rep. Waxman, complications and adverse side effects associated with transvaginal mesh provide a clear illustration as to why regulatory reform is warranted. As discussed in great detail in the letter, transvaginal mesh implants received market clearance from the U.S. Food and Drug Administration (“FDA”) through the expedited 510(k) process. By utilizing this process, manufacturers of these devices did not have to conduct clinical testing in order to receive approval or demonstrate their safety. Since transvaginal mesh was introduced into the market, the FDA has received thousands of adverse event reports, and issued a series of alerts to warn consumers of dangerous complications associated with vaginal mesh. In fact, the FDA is still conducting an ongoing safety review. The FDA estimates that 300,000 women were implanted with vaginal mesh in 2010.

If you or a loved one has already had a vaginal mesh product manufactured by Gynecare, Ethicon, Johnson & Johnson, C.R. Bard, American Medical Systems or Boston Scientific and have had mesh complications such as mesh erosion, contact a vaginal mesh lawyer today for a free consultation.

Public Citizen Calls for Ban on Use of Vaginal Mesh for POP Repair

admin — Fri, 26 Aug 2011 14:06:50 +0000

On August 25, 2011 Public Citizen, a consumer advocacy group representing more than 225,000 members and supporters nationwide, petitioned the Food and Drug Administration (FDA), pursuant to the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 360f and 360h, and 21 C.F.R. §§ 10.30, 810, and 895, to immediately:

(1) ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP) — which were used in an estimated 67,500 surgical procedures in the U.S. in 2010* — because these devices (a) offer no clinically significant benefits in comparison to surgical repairs for POP performed without placement of surgical mesh; and (b) have high rates of serious complications, many of which require additional surgical intervention and some of which are not amenable to surgical correction and result in permanent life-altering harm, therefore presenting “an unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device under the device law, 21 U.S.C. § 360f and 21 C.F.R. § 895.21(a);

(2) order all manufacturers of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to recall these products; and

(3) require that any non-absorbable surgical mesh product specifically designed and labeled for transvaginal repair of POP that is proposed for marketing in the future be classified as a class III device and be approved for marketing only under a pre-market approval application (PMA) that includes data from well-designed, prospective clinical trials that provide a reasonable assurance that the surgical mesh product is safe and effective.

Public citizen and the doctors supporting its petition to ban bladder sling mesh have focused their petition on seven different surgical mesh products that are marketed specifically for use on POP repair. These vaginal mesh products are the following:

Gynecare Prolift Total, Anterior, and Posterior Pelvic Floor Repair Systems (Ethicon, Inc. — a Johnson & Johnson subsidiary)
Gynecare Prolift +M Total, Anterior, and Posterior Pelvic Floor Repair Systems (Ethicon, Inc.)
Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.)
AMS Elevate Anterior and Apical Prolapse Repair System (American Medical Systems, Inc., Minnetonka, MN)
Pinnacle Pelvic Floor Repair Kits (Boston Scientific Corp., Marlborough, MA)
Avaulta Support System (C.R. Bard, Inc., Covington, GA)
Polyform Synthetic Mesh (Proxy Biomedical, Ltd., Galway, Ireland)

Public Citizen’s petition was supported by two doctors who specialize in urogynecological surgery, Daniel S. Elliott, M.D. of the Department of Urology at the Mayo Clinic and L. Lewis Wall, M.D. of Washington University. Public citizen and many doctors believe that commercial interests related to surgical mesh kits for POP repair have taken precedence over patient safety and welfare. In a commentary criticizing the commercial pressures that have led to the proliferation in the use of commercial surgical mesh kits for POP repair, as well as to recent revisions to the American College of Obstetricians and Gynecologists (ACOG) Practice Bulletins on POP that resulted in a downplaying of the experimental nature of these commercial products, Dr. Wall noted the following:

“[Trocar]-and-mesh” device kits for the surgical correction of prolapsed female genitalia are now the rage. New variations on this theme arrive in the medical marketplace with stunning frequency. There is now virtually no cavity in the pelvis that cannot have an artificial mesh threaded through it with the use of a strong right arm and a long enough spike. Whether or not this surgical intervention is good for patients and not just good for surgeons’ pocketbooks and the balance sheets of surgical device manufacturers is as yet unknown because appropriately powered clinical trials with adequate follow-up have not yet been performed, but it is clear that powerful commercial interests are attempting to reshape the field of pelvic surgery for their financial benefit. Operations tied to specific commercial products are being carried out and promoted by groups who stand to benefit directly from their utilization, irrespective of whether or not the operation in question is in the patient’s best interests. This sad reality raises significant ethical questions for pelvic surgeons, for professional associations such as [ACOG], and for governmental regulators. We contend that these issues are not being adequately addressed…

There are clear differences between what is legal and what is ethical with regard to the use of surgical devices such as the ever-expanding number of [trocar]-and-mesh kits now marketed for the treatment of incontinence and prolapse. Unlike drugs—which must be shown by clinical trials to be both safe and effective prior to their release—current regulations in the USA do not require medical devices such as the mesh kits for incontinence surgery and prolapse repair to meet this burden of proof [1]. If the Food and Drug Administration decides that a device is “equivalent” to something that has already been cleared for release, it is allowed to enter the market. Independent clinical trials are not currently required. Thus, permission to allow a new device to enter the market is largely a political decision; but legal permission to market a device is not the same as using it in an ethical manner…

[ACOG] should throw its considerable weight behind efforts to bring the legal requirements for marketing new devices in line with our profession’s ethical obligations to our patients. New medical or surgical devices should not be allowed into the American or any other world market until there is definitive evidence of the devices’ safety and efficacy on the basis of properly designed, properly powered clinical trials. Rather than changing policy to accommodate enhanced reimbursement for ethically questionable practices, ACOG should push for more stringent regulatory control of the medical device industry.

Based on the review of all available peer-reviewed scientific literature and the FDA’s analysis of reports submitted to the MAUDE database, the Public Citizen says the following conclusions can be drawn about the use of transvaginal mesh bladder sling products:

Synthetic surgical mesh placed during transvaginal repair of POP commonly causes many serious adverse events.
Patients who undergo transvaginal POP repair with surgical mesh are subject to many mesh-related complications that do not occur in patients who undergo POP repair without mesh.
The most common complication caused by surgical mesh used in transvaginal POP repair is mesh erosion. This adverse event occurs in approximately 10% of women undergoing transvaginal POP repair with surgical mesh.
More than half of the women who develop mesh erosions from non-absorbable, synthetic mesh require surgical excision. Some women require two or more additional surgeries.
Some adverse events, such as mesh contraction, can be life-altering for some women. Some complications such as pain and dyspareunia may continue despite mesh removal.
New-onset stress urinary incontinence (SUI) has been reported to occur more frequently following transvaginal POP repair with mesh than repair without mesh.

Public Citizen therefore concludes that implantation of vaginal mesh products are not currently “ethically justified” and requests (1) that all current bladder sling mesh products in use be recalled, (2) that the FDA ban the use of these products, and (3) that any future products be subject to the full pre-market approval process including appropriate clinical trials.

Public Citizen FDA Petition (.pdf)

Letter from Daniel S. Elliott, M.D. of the Department of Urology at the Mayo Clinic (.pdf)

Letter from L. Lewis Wall, M.D. of Washington University (.pdf)

13 Questions FDA Says Patients Should Ask Their Vaginal Mesh Surgeons

admin — Fri, 19 Aug 2011 21:23:46 +0000

On July 13, 2011 the FDA released a Safety Communication regarding the usage of synthetic mesh materials for the repair of pelvic organ prolapse. While the FDA has neither taken the vaginal mesh off the market nor called for a recall, they did state that a variety of complications have been reported by patients and surgeons alike, and wish to make this fact known to surgeons and patients alike. Some of thos complications include mesh erosion, dyspareunia and infections.

If you are considering vaginal mesh or bladder sling surgery, the FDA recommends that you ask the following questions from your surgeon prior to the surgery:

Are you planning to use transvaginal mesh in my surgery?

Why do you think I am a good candidate for surgical mesh?

Why is surgical mesh being chosen for my repair?

What are the alternatives to transvaginal surgical mesh repair for pelvic organ prolapse (POP), including non-surgical options?

What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?

Will my partner be able to feel the vaginal mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?

If bladder sling mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?

What can I expect to feel after bladder sling surgery and for how long?

Which specific side effects should I report to you after the vaginal mesh surgery?

What if the mesh surgery doesn’t correct my problem?

If I develop a complication, will you treat it or will I be referred to a specialist experienced with vaginal mesh complications?

If I have a complication related to the bladder mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?

If a tranbsvaginal mesh is to be used, is there patient information that comes with the product, and can I have a copy?

If you or a loved one has already had a vaginal mesh product manufactured by Gynecare, Ethicon, Johnson & Johnson, C.R. Bard, American Medical Systems or Boston Scientific and have had mesh complciations such as mesh erosion, contact a vaginal mesh lawyer today for a free consultation.

Vaginal Mesh Lawyer

admin — Fri, 15 Jul 2011 16:10:32 +0000

FDA Warns Doctors & Patients About Dangers of Vaginal Mesh

On July 13, 2011, the Food and Drug Administration (FDA) issued an urgent public notice advising patients and their healthcare providers to consider alternatives to transvaginal mesh. The advisory also noted that the FDA will be meeting to discuss a potential ban on the mesh. The FDA was prompted to issue this warning after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.

Transvaginal Mesh is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), conditions that may occur after childbirth and pregnancy. In 2010, more than 75,000 women had vaginal mesh surgery to repair POP.

Recent research shows that at least ten percent of women who have received vaginal mesh implants suffer from mesh erosion within 12 months of surgery and more than half of these patients require additional surgery to remove the mesh following complications such a dyspareunia.

Mr. Mendelsohn and the lawyers at Mazie Slater Katz & Freeman, LLC (“MSKF”) represent dozens of clients allegedly harmed by transvaginal mesh and bladder sling products in filed cases against numerous large corporations as including but not limited to C.R. Bard, Inc., Ethicon, Gynecare, Johnson & Johnson, Boston Scientific and American Medical Systems (AMS). In fact, MSKF attorneys have been named liaison counsel (lead counsel) in the cases against Ethicon, Gynecare and Johnson & Johnson and we are actively ltiigating against other manufacturers as well.

If you have been injured as a result of a transvaginal mesh or TVT implant, contact vaginal mesh lawyer today for a free consultation.

Here are some of the Transvaginal Mesh and Bladder Sling cases we handle:

If you have been injured as a result of a transvaginal mesh, TVT implant, or bladder sling mesh
contact vaginal mesh lawyer today for a free consultation.

FDA Warns Patients & Doctors about Transvaginal Mesh

admin — Fri, 15 Jul 2011 14:41:01 +0000

Mr. Mendelsohn and the lawyers at Mazie Slater Katz & Freeman, LLC (“MSKF”) represent dozens of clients allegedly harmed by transvaginal mesh and bladder sling products in filed cases against numerous large corporations as including C.R. Bard, Inc., Ethicon, Gynecare, Johnson & Johnson, Boston Scientific and American Medical Systems (AMS). In fact, MSKF attorneys have been named liaison counsel (lead counsel) in the cases against Ethicon, Gynecare and Johnson & Johnson and we are actively ltiigating against other manufacturers as well.

If you have been injured as a result of a transvaginal mesh or TVT implant, contact vaginal mesh lawyer today for a free consultation.

$80 Million VW & Audi Settlement

admin — Fri, 04 Mar 2011 22:48:55 +0000

CLASS ACTION SETTLEMENT WITH VW/AUDI

We have been litigating what has now been preliminarily certified as a class action lawsuit against Volkswagen and Audi as a result of damage caused by water infiltration in the interiors of numerous Volkswagen and Audi vehicles, model years 1997 to 2009. Due to the defects, water enters the vehicles and causes damage to vehicle components and the interior.

As a result of the lawsuit, VW and Audi implemented “Service Actions” in 2007 and 2008, providing vehicle modifications and repairs, as well as reimbursement for expenses resulting from the drainage problems. These Service Actions provide relief for certain Volkswagen Passat vehicles and certain Audi A4 and A6 vehicles.

In addition, pursuant to a settlement reached and preliminarily approved, relief has been obtained in the form of: (1) implementation of a Service Action for the benefit of owners and lessees of certain Golf/GTI, Jetta, Jetta Wagon and New Beetle vehicles to modify their sunroof drain systems, (2) reimbursements to owners and lessees of certain Volkswagen and Audi vehicles, and (3) enhanced maintenance recommendations to customers and dealers in order
to prevent clogging of sunroof and plenum drain systems.
To learn more about the settlement, the relief obtained, and your rights, you can go to the following website: www.WaterIngressSettlement.com

DePuy ASR Hip & Zimmer Durom Hip

admin — Fri, 04 Mar 2011 21:30:04 +0000

DePuy Hip Recall Lawyers

The DePuy Hip Recall of the DePuy ASR Hip Replacement was announced August 26, 2010 by DePuy Orthopaedics, Inc. Mr. Mendelsohn and the Depuy Hip Recall Lawyers at the Mazie Slater Katz & Freeman, LLC are available to answer any additional questions patients may have about their rights.

The DePuy ASR hip replacements subject to the Depuy Hip recall are both the ASR XL Acetabular System and the ASR Hip Resurfacing System. These DePuy ASR hips have been implanted since 2005 in the United States and since 2001 internationally.

Depuy ASR Hip Revision Surgery

Depuy ASR recall patients may require a painful revision surgery to remove and replace the defective hip implant. DePuy estimates approximately 10,000 patients may need revision surgery, however we believe that this underestimates the number hip revision surgeries that will be necessary.

The DePuy ASR revisions are necessary because the device is defectively designed and manufactured so that high levels of metal ions are released from the Depuy ASR hip. This metal ion release damages tissue, causes pseudotumours, and results in osteolysis requiring hip revision surgery to remove and replace the device. This may happen shortly after the DePuy ASR hip replacement is implanted into the patient or it may take years to occur.

DePuy Hip Revision Patient Profile

The Adverse Event Reports involving the DePuy ASR submitted to the FDA by surgeons performing DePuy hip revision surgeries mention instances of “loosening, pseudotumour and metallosis” / (sic) metalosis. Surgeons have noted upon revision that the DePuy ASR hip cup was “loose and easy to revise”, that the “the cup popped right out” and that “there was no evidence of any bony ingrowth.” This is in spite of the surgeon’s prerevision observation that “The patient was revised to address complaint of extreme pain when weight bearing. X-rays looked good, and cup was in position.”

DePuy Hip Recall Liability Management Program

DePuy is paying surgeons to assist them in getting patients to sign documents for DePuy that allows DePuy to keep the explanted hip implant and to do “testing” on it. The explanted device is a valuable piece of evidence and a patient may not be able to prove a product defect case without the explanted hip device. Patients should be wary of this and not jeopordize their current and future legal rights by signing any documents for DePuy without obtaining independent legal advice. Patients may not realize what they are doing and think they are “just doing what the doctor asked” when they sign the documents. Please realize that your health care insurer is obligated to pay for your revision surgery and testing and it is not necessary for you to sign any documents for DePuy in order to get your revision or testing done. Contact a DePuy Hip Lawyer before you sign any documents for Depuy!

Monetary Damages and Compensation for DePuy ASR Victims

Depuy ASR hip replacement patients may be eligible for compensation due to the injuries they have suffered as a result of being implanted with the defective DePuy ASR hip replacement. Past and future pain, suffering, medical bills, lost earnings, and disfigurement are among the damages that the patients may be entitled to recover. Mr. Mendelsohn and his firm handles cases on a contingent fee basis. The client is never at risk of paying any money out of pocket. If there is no recovery, there is no fee.

Depuy Hip Recall Attorneys

Mr. Mendelsoh and his firm has represented patients against the manufacturers of defective products from almost every state. In addition, we are well-versed in the litigation tactics and J&J organization as we have pursued cases involving other defective products that they have manufactured.

Depuy Hip Recall Lawsuits

Mr. Mendelsohn and his firm is filing individual Depuy Hip Recall lawsuits on behalf of DePuy ASR patients nationwide.

Doctors Not Sued in Depuy Hip Recall Lawsuits

Mr. Mendelsohn and his firmwill not file a lawsuit against any doctor or hospital in the DePuy ASR litigation. We will seek recovery against the manufacturer and distributor of the device.

Time Limitations Will Bar Late Claims

Depuy ASR lawsuits must be filed for patients before the legal deadline or the patient’s rights to compensation will be lost.

Free Initial Claim Evaluation and Depuy Hip Recall Information Packet

Contact Mr. Mendelsohn today by completing the contact form to receive a free no obligation claim evaluation by a lawyer experienced in handling defective product cases. We handle cases nationwide. Contact a Defective Hip Implant Lawyer us today.

Honda Civic Premature Tire & Brake Wear

admin — Fri, 04 Mar 2011 21:27:51 +0000

HONDA CIVIC CONTROL ARM DEFECT LAWYERS

Mr. Mendelsohn and Mazie Slater Katz & Freeman, LLC have filed a proposed class action lawsuit against Honda relating to reported defects in Honda Civic vehicles.

Due to the reported defects with the rear control arms, these vehicles are subject to uneven tire wear, premature tire wear, tire feathering and tire cupping. Our investigation reveals that Honda typically denies warranty coverage for repairs caused by the defects.

If you have owned or leased a Honda Civic that has premature tire wear and you are interested in learning more about how we can help, please provide the following information:

*(denotes required field)

First Name: *

Last Name: *

E-Mail Address: *

Subject: *

Message: *

Phone Number

Address

City

State

Zip

Vehicle Model *

Vehicle Year *

Mileage When Problem Occurred *

Are you willing to send us your failed compenent(s) for our evaluation?

Disclaimer: Transmission and receipt of information contained on this web site does not create an attorney-client relationship between the user and Mr. Mendelsohn or Mazie Slater Katz & Freeman, LLC. Only an express written agreement between the user and Mazie Slater Katz & Freeman, LLC can create an attorney-client relationship with Mazie Slater Katz & Freeman, LLC. This web site constitutes an ADVERTISEMENT. Before making your choice of attorney, you should give this matter careful thought. The selection of an attorney is an important decision. If you believe this web site is inaccurate or misleading, you may report same to the committee on Attorney Advertising, Hughes Justice complex, CN 037, Trenton, New Jersey 08625.