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ethicon feb 18
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J&J Drops Plaintiff Solicitation Discovery Bid In Mesh MDL
Feb 17, 2015 | Law360
By Sindhu Sundar
Johnson & Johnson has withdrawn its discovery motion to pursue its allegations that the plaintiffs' attorneys in transvaginal mesh multidistrict litigation had engaged in illegal plaintiff solicitation and filed lawsuits without legitimate claims. -
Ethicon Vaginal Mesh Settlements Rumored To Be Reached
Feb 17, 2015 | Top Class Actions
By Amanda Antell
According to different sources, Johnson & Johnson has reached at least four different settlements in separate vaginal mesh lawsuits, which named their subsidiary Ethicon as the primary defendant. Reportedly, one of the settled cases recently went to trial in January 2015. -
Evidence Concerning Polypropylene Used in Pinnacle TVM Device May Be Presented at Trial, Judge Rules
Feb 17, 2015 | Harris Martin Publishing
Plaintiffs in a transvaginal mesh case may present evidence concerning the Marlex polypropylene used by Boston Scientific Corp. in its Pinnacle Pelvic Floor Repair Kit, a West Virginia federal judge has ruled, explaining that the methods by which BSC acquired polypropylene resin is relevant to the claims. -
What You Need to Know About Transvaginal Mesh
Feb 17, 2015 | Health 24
By Chandré-Morgan Roberths
Vaginal mesh is a synthetic plastic material called polypropylene. Transvaginal mesh refers to the process in which this plastic is implanted through the vagina. Although this procedure is becoming more common, it is also regarded as dangerous to some women. -
Report Recommending Power Morcellator Devices to Docs Reveals Conflict of Interest
Feb 17, 2015 | Fierce Medical Devices
By Emily Wasserman
Amid mounting backlash over the use of power morcellator devices in women undergoing certain gynecological procedures, new evidence shows that a report issued last year by a professional association of surgeons recommending the tool to physicians may have been biased. -
New Mesh Technique May Avoid Unwanted Fixation in Inguinal Hernias
Feb 17, 2015 | General Surgery News
By Christina Frangou
Spanish surgeons have proposed a new technique for using self-gripping mesh in inguinal hernia repair that may reduce problems of accidental fixation to undesired structures during surgery. In a report published online in Hernia, J.L. Porrero, MD, and colleagues at the Universitario Santa Cristina in Madrid...
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J&J Drops Plaintiff Solicitation Discovery Bid In Mesh MDL
Feb 17, 2015 | Law360
By Sindhu Sundar
Johnson & Johnson has withdrawn its discovery motion to pursue its allegations that the plaintiffs' attorneys in transvaginal mesh multidistrict litigation had engaged in illegal plaintiff solicitation and filed lawsuits without legitimate claims.
U.S. District Judge Joseph Goodwin on Feb. 11 granted J&J's motion to withdraw its discovery motion related to its claims of plaintiff solicitation, though it did not disclose its reasons for the move. An attorney for J&J could not immediately be reached for comment late Tuesday.
An attorney for the plaintiffs said Tuesday that an independent sampling review did not unearth any fraudulent suits in the MDL over vaginal mesh devices manufactured by J&J unit Ethicon Inc.
"The plaintiffs' leadership is pleased that Ethicon has decided to withdraw its motion," Bryan Aylstock of Aylstock Witkin Kreis & Overholtz PLLC said in a statement Tuesday. "Moreover, the plaintiffs' leadership has always stood ready to work with Ethicon to investigate and put an end to any wrongful conduct, and the parties have pledged to work together to investigate and attempt to put an end to any wrongful solicitation of clients."
J&J filed a motion in January pushing plaintiffs in the litigation to offer sooner proof of their injuries, while the plaintiffs argued that J&J had not shown even one fraudulent complaint among the nearly 24,000 cases in MDL, according to court documents.
J&J and Ethicon claimed in their motion that certain "unscrupulous" call centers have somehow obtained the private medical information of certain women and repeatedly harass them to join the litigation for $30,000 to $40,000 settlements, even if they had never had the surgery.
In one such alleged call with a woman who had never had surgery with the mesh — though she'd had an unrelated surgery — a caller suggested that she lie to qualify for the money even after she told them she'd never had mesh implanted, saying, "That's OK, wouldn't you like $30,000?"
But the plaintiffs' attorneys argued that J&J had not shown a link between such call centers and plaintiffs' attorneys, and that the device maker was leveling the claims against them as a stalling tactic, according to court filings.
Ethicon and J&J are represented by David B. Thomas of Thomas Combs & Spann PLLC and Christy D. Jones of Butler Snow PLLC.
Plaintiffs are represented by The Potts Law Firm, Blasingame Burch Garrard Ashley PC, Motley Rice LLC, Beasley Allen Crow Methvin Portis & Miles PC and Aylstock Witkin Kreis & Overholtz PLLC, among others.
The MDL is In re: Ethicon Inc. Pelvic Repair Systems Product Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia. -
Ethicon Vaginal Mesh Settlements Rumored To Be Reached
Feb 17, 2015 | Top Class Actions
By Amanda Antell
According to different sources, Johnson & Johnson has reached at least four different settlements in separate vaginal mesh lawsuits, which named their subsidiary Ethicon as the primary defendant. Reportedly, one of the settled cases recently went to trial in January 2015. This case along with the other three vaginal mesh lawsuits may be the first settlements reached out of the thousands of vaginal mesh lawsuits filed against J&J, its subsidiary, and various medical device manufacturers.
As of now, no details on the Ethicon vaginal mesh settlements have been released. However, some news reports have indicated that the settlements were reached in state court claims, including one settlement for a wrongful death lawsuit, which alleged the decedent plaintiff died as a direct result of vaginal mesh complications. These vaginal mesh settlement agreements were decided upon just days before a status conference was slated to take place before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, regarding the thousands of vaginal mesh lawsuits awaiting trial in federal and state courts across the nation.
In preparation for the status conference, the defendants had been ordered to bring their legal representatives to make decisions related to the lawsuits, which included the possibility for settlements. There are currently several different vaginal mesh multidistrict litigations (MDLs) taking place throughout the United States, each of which are centralized before Judge Goodwin. This includes at least 22,721 Ethicon vaginal mesh lawsuits according to the latest case list from the U.S. Judicial Panel on Multidistrict Litigation (JPML).
Judge Goodwin scheduled the status conference to take place between Feb. 5 and 6, 2015, with each of the defendants being ordered to appear once again with legal representatives in order to make settlement decisions. Recently, several vaginal mesh bellwether trials have been held before Judge Goodwin and resulted in multimillion dollar damage rewards to the plaintiffs, with only a few manufacturers reaching settlement agreements.
If the vaginal mesh manufacturing companies, including Ethicon, are not able to reach settlement agreements with their respective plaintiffs during these status conferences, then hundreds of lawsuits will be refiled into their original district court, and will be scheduled for their own individual trials. These individual vaginal mesh lawsuit trials would be expected to span several years. In fact, the size of the vaginal mesh litigation makes legal experts worry that it would take decades to try each case individually in the event that settlements are not reached.
Each of the vaginal mesh lawsuits involve similar allegations made by women who used the vaginal sling or mesh products and sustained certain personal injuries. The injuries women reported in the vaginal mesh lawsuits include: infection, erosion, mesh tearing, organ tearing, and even death. The plaintiffs argue that the manufacturing companies failed to protect them against their products’ design defects by failing to warn them against the severe vaginal mesh side effects they experienced. Overview of Vaginal Mesh Complications
Vaginal mesh was originally developed for hernia repair during the 1950s, but were later redesigned to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women during the 1970s. It was a simple process, involving surgeons cutting a piece of surgical mesh and molding it into the correct shape and size. The device was then implanted in a woman’s body during surgery. After the first surgery proved to be successful, other medical device manufacturing companies started developing their own variations, eventually establishing the vaginal mesh product market.
Initially, women with POP and SUI were thrilled at the creation of vaginal mesh because they now had a discreet way of treating their bodily conditions. Unfortunately, major design defects were soon discovered, as women across the country reported suffering debilitating vaginal mesh complications. In 2011, approximately 4,000 vaginal mesh injury reports were submitted to the U.S. Food and Drug Administration (FDA), going as far back as five years. In the same year, the FDA made a public warning addressing the severe complications that could occur from using vaginal mesh, stating they were not rare as previously believed.
The complications of vaginal mesh can be devastating to the patients because the side effects are often so painful they interfere with everyday life. For example, mesh erosion often leads to pain during intercourse and the possibility for infection. Oftentimes, women opt to remove the vaginal mesh to prevent further complications, but often still suffer from lasting pain.
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Evidence Concerning Polypropylene Used in Pinnacle TVM Device May Be Presented at Trial, Judge Rules
Feb 17, 2015 | Harris Martin Publishing
Plaintiffs in a transvaginal mesh case may present evidence concerning the Marlex polypropylene used by Boston Scientific Corp. in its Pinnacle Pelvic Floor Repair Kit, a West Virginia federal judge has ruled, explaining that the methods by which BSC acquired polypropylene resin is relevant to the claims.
In a Feb. 12 order, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia also denied as premature BSC’s motion to exclude evidence of its procurement of polypropylene resin from a Chinese distributor, explaining that such evidence is potentially relevant to the ...
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What You Need to Know About Transvaginal Mesh
Feb 17, 2015 | Health 24
By Chandré-Morgan Roberths
Vaginal mesh is a synthetic plastic material called polypropylene. Transvaginal mesh refers to the process in which this plastic is implanted through the vagina. Although this procedure is becoming more common, it is also regarded as dangerous to some women.
Fixing pelvic organ prolapse
This surgical mesh is aimed at fixing pelvic organ prolapse (POP) and stress urinary incontinence (SUI) – conditions usually associated with childbirth, hysterectomy or menopause – permanently, according to Drugwatch.
Pelvic prolapse occurs when the pelvic floor collapses causing a section of the vaginal canal to protrude through the opening of the vagina.
In this procedure, doctors can surgically insert the mesh vaginally or abdominally, but placing the mesh through the vagina is quicker and less invasive.
The use of synthetic mesh has increased in vaginal surgery over the past few years due to more cases of women reportedly suffering from POP.
However, there are grave concerns about the safety and efficiency of transvaginally placed mesh.
Permanent life-altering consequences
Based on the current limited data available, although many patients that undergo vaginal repairs heal without problems, there is seemingly a group of patients who experience permanent life-altering consequences, according to The American Congress of Obstetricians and Gynaecologists (ACOG).
These consequences often include chronic pain and dyspareunia from the use of vaginal mesh.
Pelvic pain, groin pain, and dyspareunia is common with pelvic reconstructive surgery whether the patient has a vaginal mesh implant or not.
However, a side effect that's unique to transvaginal mesh is erosion, which seems to be the most prevalent consequence and may sometimes present complications several years after the initial procedure.
There are increasing claims of vaginal pain associated with changes that occur with mesh surgery and the product itself. One example of these is the 24, 000 lawsuits which manufacturer Johnson & Johnson is facing over its vaginal-mesh implants, recently reported in The Daily Record.
With all the negative publicity that transvaginal mesh surgery is getting, and the ever increasing demand for the restorative procedure it brings confusion.
Who are the best patients for transvaginally placed mesh?
Very little data exists as to who are the best patients for this procedure but it should be reserved for high-risk individuals in whom the benefit of mesh placement far outweighs the risks, such as individuals with recurrent prolapse.
The approach to repairing POP should ultimately take the patient’s medical and surgical history, severity of prolapse, and preference after education regarding the benefits and risks of the (surgical and nonsurgical) alternatives into consideration.
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Report Recommending Power Morcellator Devices to Docs Reveals Conflict of Interest
Feb 17, 2015 | Fierce Medical Devices
By Emily Wasserman
Amid mounting backlash over the use of power morcellator devices in women undergoing certain gynecological procedures, new evidence shows that a report issued last year by a professional association of surgeons recommending the tool to physicians may have been biased.
As The Wall Street Journal reports, the AAGL--formerly known as the American Association of Gynecologic Laparoscopists--said in a May 2014 report that power morcellation "remains safe when performed by experienced, high-volume surgeons." But an AAGL executive officer, New York-based surgeon Arnold Advincula, joined the final discussions of the report even though he had received consulting fees from a morcellator maker, violating the association's conflict-of-interest policies, Ceana Nezhat, the association's president at the time, said in a May 7 email.
"Given the importance of COI surrounding this topic, and the potential press involvement in dissecting COIs of our board members in relation to morcellation, I am shocked the organization would allow their own policies to be 'flexible,'" Nezhat said in the email, as quoted by the WSJ.
The AAGL started beefing up its conflict-of-interest policies in 2013, adopting a rule that forbid executive committee members from doing paid work for drug or device companies. But Advincula and other incumbents on the committee were exempted from the rule under a grandfather clause that Advincula lobbied for himself.
Advincula, chief of gynecological surgery at Columbia Medical Center, received at least $50,000 for speaking and other services in the last 12 months from Blue Endo, a morcellator seller. He said through an AAGL spokeswoman that his consulting relates to sharing clinical expertise and collaborating with scientists and engineers. Lenexa, KS-based Blue Endo did not comment to the WSJ.
The AAGL today maintains that power morcellation with "appropriate informed consent should remain available to appropriately screened, low-risk women," the WSJ reports.
Meanwhile, the FDA and industry is responding to public outcry over the devices. In July, Johnson & Johnson ($JNJ) pulled its related product from the global market, months after suspending sales for the device. In November, the FDA updated its safety guidance for the devices, recommending against using laparoscopic power morcellator tools in the "majority" of women undergoing a hysterectomy or the removal of uterine fibroids.
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New Mesh Technique May Avoid Unwanted Fixation in Inguinal Hernias
Feb 17, 2015 | General Surgery News
By Christina Frangou
Spanish surgeons have proposed a new technique for using self-gripping mesh in inguinal hernia repair that may reduce problems of accidental fixation to undesired structures during surgery.
In a report published online in Hernia, J.L. Porrero, MD, and colleagues at the Universitario Santa Cristina in Madrid described a technique in which they fold the upper third of the mesh over the center third, hiding the microgrips that make the mesh sticky [Dec. 6, 2014. Epub ahead of print].
“This means that only the lower third of the mesh has the microgrips exposed, so it can be easily fixed to the pubic bone and inguinal ligament without undesired fixation to other structures,” they reported.
Self-gripping meshes were developed to prevent need for additional fixation during inguinal hernia repairs, thereby reducing postoperative pain without need for mesh migration. Three-month results from a randomized controlled, multicenter, international clinical trial that compared a sutureless self-gripping mesh to lightweight polypropylene mesh in a traditional Lichtenstein repair showed that surgery duration, early postoperative pain and infection rates were significantly reduced with the self-gripping polyester (Hernia 2012;16:287-294). Longer-term results from that trial have not been reported.
A more recent meta-analysis found that self-gripping mesh was associated with a shorter operating time but no substantial improvement in pain (chronic or acute) or other complications (Ann Surg 2014;259:1080-1085).
Some surgeons have noted that self-gripping mesh can be difficult to maneuver because it can adhere to undesired structures during positioning.
To avoid this problem, Dr. Porrero and colleagues make a small split between the lower and medium third of the mesh to mark the intended split for the spermatic cord. Using this mark, the upper third of the mesh is folded over the medium third, hiding the microgrips for all but the lower part of the mesh. This way, the mesh can be fixed to the pubic bone and inguinal ligament without sticking to undesired structures. Once the lower third of the mesh is in place, the split for the spermatic cord is completed and the upper portion of the mesh is passed below the spermatic cord. Finally, the mesh is unfolded to expose the microgrips, and the medium and upper thirds of the mesh are descended to the final position.
Senior author Oscar Cano-Valderrama, MD, a general and digestive surgeon at the Universitario Santa Cristina, said his team has used the technique in 15 patients to date and that it is an applicable approach for any patient undergoing inguinal hernia repair with a self-gripping mesh.
He said he expects patients to experience less pain with this type of mesh because no sutures are used to fix the mesh. “Nevertheless, long-term results after the use of self-gripping mesh repair are lacking and we need them before this kind of mesh is broadly used.”
Brian Jacob, MD, a hernia surgeon at the Laparoscopic Surgical Center of New York in New York City, who has studied self-gripping mesh use during laparoscopic total extraperitoneal inguinal hernia repair, said he has not had problems with the mesh sticking to unintended structures. Surgeons can use self-gripping mesh “in the creative and individualized manner” they want and patients should experience less pain because of the reduced need for fixation, he said.
“Patients have a fast recovery and we don’t have to worry as much about mesh migration, and we’re putting in less permanent fixation material. Still, only time will tell if there’s a true benefit in reduction of chronic pain and recurrence rates.”
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