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The Johnson & Johnson verdict
Feb 26, 2016 | Pulse Headlines
By Daleska Pedriquez
...For J&J, the thousands of talc cases may not be their biggest concern as the company is facing many other lawsuits over its larger set of products. The most worrier cases for its legal team are the ones related to the pelvic mesh devices made by Ethicon unit. There are more than 44,000 claims from women who say they were harmed by their product and are presenting their case to court. -
$72 million verdict announced against J&J, 1,200 similar talc-cancer cases pending
Feb 26, 2016 | NH Voice
By Emma Tiller
...To cite an example, the company is being targeted of more than 44,000 cases from women who say they have been affected by pelvic mesh devices made by its Ethicon unit. The next J&J talc trial has been set for April in St. Louis and additional trial dates have been set for later the year. -
Mesh Survivor on the FDA’s Oversight of Chinese Boston Scientific Mesh Controversy
Feb 29, 2016 | Mesh Medical Device News Deski
By Jane Akre
I am a mesh victim. I follow your site regularly and receive your newsletter. Like many victims, I hesitate to reply due to litigation, and wish to remain anonymous. However, I felt compelled to forward my opinion on the BSC (Boston Scientific) litigation hold. -
FDA panel recommends approval of Endo's mesh fecal incontinence device
Feb 26, 2016 | Fierce Medical Devices
By Varun Saxena
...Endo wrote in its executive summary of the PMA application that "the Topas system's unique anatomical placement does not require transvaginal incision, or any incision or modifications to the pelvic floor muscle, and thus has a different safety profile than transvaginal mesh devices that are implanted in a different anatomical location to treat different disease states." -
FDA backs Endo’s Topas mesh to treat fecal incontinence
Feb 26, 2016 | Mass Device
By Fink Densford
...In January the FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review. -
FDA Panel Backs Implant for Female Fecal Incontinence
Feb 26, 2016 | MedPage Today
By Shannon Firth
...In its presentations, the sponsor sought to distinguish the TOPAS system from transvaginal mesh devices, which have been associated with severe pelvic pain and organ perforation. The transvaginal mesh devices were also entrenched in countless lawsuits and a complex scam involving unscrupulous health plans who profited from their removal. -
FDA Advisers Back Mesh for Fecal Incontinence
Feb 26, 2016 | Medscape Medical News
By Alicia Ault
...The specter of ongoing safety and litigation issues involving transvaginal mesh hung over the committee's discussion of TOPAS. -
FDA Panel: Urogynecological Mesh Tools Need Higher Risk Level
Feb 26, 2016 | Medscape Medical News
By Alicia Ault
...Instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling, according to US Food and Drug Administration (FDA) advisers. -
Urinary Incontinence Risk Rises Slightly After Vaginal Birth, Study Finds
Feb 26, 2016 | HealthDay
By Robert Preidt
Women who give birth vaginally are slightly more likely to develop urinary incontinence afterward compared to women who have cesarean sections, according to Finnish researchers. -
Welcome to Mesh Medical Device News Desk, aka Mesh News Desk
Feb 28, 2016 | Mesh Medical Device News Desk
By Jane Akre
If you are new to the mesh mess you have come to the right place. There are about 100,000 lawsuits currently filed in the U.S. to address the injuries that come from pelvic mesh.
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Feb 26, 2016 | Pulse Headlines
By Daleska Pedriquez
The recent $72 million verdict againstJohnson & Johnson (NYSE: JNJ) for the alleged links between his talc-based powder and ovarian cancer does not mean a win for the others 1,200 similar cases pending.
The thousands of cases, which are mainly in Missouri and New Jersey, have their similarities but many facts from each one are different. They will have to convince different juries whether in fact the well-known product was the main cause of the plaintiff’s cancer.
Even in cases with similar evidence and expert testimonies, the jury can reach a different conclusion than the jury which granted the $72 million to the family of an Alabama woman who died from ovarian cancer.
There was an attention-grabbing case that resulted in a positive verdict for the plaintiffs in Missouri, but there was also another one in that did not end so positively.
While the survivors of Jacqueline Fox were awarded the incredible high amount by a St. Louis jury on Monday, jurors in a federal court action in South Dakota reached a different verdict in 2013. They found that J&J had been negligent, but they declined to award damages to plaintiff Deane Berg, as reported by Reuters.
Both cases had alleged that their ovarian cancer was caused by their decades-long use of the J&J’s talc-powder products for feminine hygiene. They also presented scientific evidence to back their claim.
One significant difference was that unlike Fox, who passed away several month before the trial had even started, Berg had the luck of being in remission at the time of the trial, according to court documents.
Besides that fact, others differences from the courts to the juries could have vary from the cases. Some stated courts have been considered more plaintiff-friendly than federal courts, where Berg presented her case. Federal courts have also strict rules for the admission of evidence and expert testimony, said lawyers involved in the litigation.Talc cases are not the biggest concern
For J&J, the thousands of talc cases may not be their biggest concern as the company is facing many other lawsuits over its larger set of products.
The most worrier cases for its legal team are the ones related to the pelvic mesh devices made by Ethicon unit. There are more than 44,000 claims from women who say they were harmed by their product and are presenting their case to court.
Besides that, there are 8,000 more cases against J&J’s DePuy subsidiary regarding Pinnacle metal-on-metal hip system. Although thousands of this cases have been settled, the poorly designed hips are still being the subject of new lawsuits.
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$72 million verdict announced against J&J, 1,200 similar talc-cancer cases pending
Feb 26, 2016 | NH Voice
By Emma Tiller
A recent case in a St. Louis court alleging link between Johnson& Johnson Baby Powder and ovarian cancer has garnered media attention and has resulted in additional calls to lawyers from would-be plaintiffs. Jacqueline Fox died of ovarian cancer and it was alleged that the reason behind the cancer was the talc powder, manufactured and sold by J&J. The company has repeatedly claimed that the talcum powder sold by it is safe.
Survivors of Jacqueline Fox have been awarded $72 million by a St. Louis jury Monday. Around 1,200 similar cases are pending, primarily in Missouri and New Jersey state courts, but the facts are different in each case.
There are some cases with similar evidence, but expert testimony, juries in mass personal-injury litigation can have different conclusions. The Fox lawsuit was selected by plaintiff’s lawyers to be the first trail in Missouri.
It has been said that the litigation went largely under the public’s radar until jurors returned the award for the family of Fox. Fox died in October at the age of 62. She died before her trial even started. According to the plaintiffs, Fox used J&J Baby Powder and Shower to Shower Powder daily for 35 years and was diagnosed with ovarian cancer three years back.
More cases will be filed soon and lawyers at several plaintiffs’ firms who have worked on the Fox case have confirmed of investigating thousands of additional claims. But then also, the talc cases represent a small portion of the tens of thousands of lawsuits J&J is facing over its many products.
To cite an example, the company is being targeted of more than 44,000 cases from women who say they have been affected by pelvic mesh devices made by its Ethicon unit. The next J&J talc trial has been set for April in St. Louis and additional trial dates have been set for later the year.
Attorney Danielle Mason of Beasley Allen, who was part of the team representing the Fox family at trial, said she expect the company would put up a strong fight to defend itself in the upcoming trials.
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Mesh Survivor on the FDA’s Oversight of Chinese Boston Scientific Mesh Controversy
Feb 29, 2016 | Mesh Medical Device News Deski
By Jane Akre
Jane,
I am a mesh victim. I follow your site regularly and receive your newsletter. Like many victims, I hesitate to reply due to litigation, and wish to remain anonymous. However, I felt compelled to forward my opinion on the BSC (Boston Scientific) litigation hold.
By sending this case to the FDA for review, Judge Goodwin has given all of us a voice within the FDA. Records pertaining to device compliance, medical, product safety and manufacturing for these devices could potentially be reviewed. This is a good thing.
By including them in this process, Judge Goodwin has given the FDA the charge to identify any infractions and to potentially fully investigate BSC medical device compliance. In their role of federal oversight, any ramifications from raw material safety violations fall under their jurisdiction. It is the FDA that has the authority and the expertise for this review.
Will the FDA examine the supply chain and production processes for BSC? Will they review the supply chain and safety precautions implemented by other pelvic mesh producers? Unknown, but the process of completing their investigation would include a paper trail that could provide a clearer picture of the manufacturers regarding product safety and regulatory control.
Manufacturers are required to establish procedures that identify and track product components throught the manufacturing process and guarantee their safety. Non-compliance could result in an audit or other regulatory event. Compliance to FDA standards is paramount to the device system. The FDA has the authority to evaluate whether these devices were produced in compliance with GMP (good manufacturing practices) and proceed accordingly.
Under the FDA regulations for GMP, manufacturers are required to track raw material purchases, production lots, and finished product quality and consumer safety information for every device. They are required to maintain these records in accordance to FDA policies and procedures…legal hold or not.
I think Judge Goodwin has opened the door for direct oversight of the supply chain and manufacturing processes, establishing accountability from the defendants in these cases. State and Federal policy makers, insurers and other stakeholders will be able to review the outcomes of any procedural review undertaken by the FDA. Any review will be an additional source of oversight and compliance. The attorneys and advocates will have additional references to apply to their review of each case. These are all good things.
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FDA panel recommends approval of Endo's mesh fecal incontinence device
Feb 26, 2016 | Fierce Medical Devices
By Varun Saxena
The first mesh device to treat fecal incontinence took a step closer to FDA's stringent PMA approval, winning the unanimous backing of the FDA's Gastroenterology-Urology Devices Panel on Feb. 25. The FDA is not obligated to follow the advice of its advisory panels, but typically it does.
The independent experts voted 8-0 that the Endo's ($ENDP) second-line Topas System demonstrated a reasonable assurance of safety and efficacy, and that its benefits outweighed its risks, meaning that they think it should be approved.
During the device's clinical trial, 105 of the 152 female patients (69%) who were implanted with the Topas experienced at least a 50% reduction in episodes of fecal incontinence. The median number of incidents per day fell from 18 per day to 5 per day as of the 36-month follow-up.
Patients in the trial had failed conservative therapies like dietary modification, medication and pelvic floor muscle training, in line with its proposed second-line indication.
According to Medscape, some panel members expressed concerned that the trial was on the small side for a PMA device and had a single-arm design. The FDA wrote in its executive summary of Endo's application that it approved the trial in 2009 because it did not think there was an appropriate control treatment available.
Regarding safety, 50 of 115 participants (43.5%) reported pelvic pain at the 3-year follow-up. But the panel members said the risk was acceptable given the debilitating nature of fecal incontinence. "I would trade off pain to having to wear a diaper," Barbara Berney, a consumer representative on the panel, said, according to Medscape.
In addition, 13 of 115 of the women (11%) in the trial reported de novo or worsening pelvic organ prolapse at the 3-year follow-up, but the panelists said it probably occurred due to disease progression and not the Topas device or implantation procedure.
Perhaps the biggest safety concern among the panelists is the spectacular failure of vaginal mesh implants, which have drowned their makers in lawsuits (including Endo, though most are now settled) and injured thousands of women.
"When mesh implants were approved, everything looked great. Now look where we are," panelist Dr. Terrell Hicks said, according to MedScape, who is concerned about long-term safety issues that weren't captured by the trial, due to its duration.
Endo wrote in its executive summary of the PMA application that "the Topas system's unique anatomical placement does not require transvaginal incision, or any incision or modifications to the pelvic floor muscle, and thus has a different safety profile than transvaginal mesh devices that are implanted in a different anatomical location to treat different disease states."
The Topas is implanted below the anorectum through two small incisions in the thigh and buttocks. It is believed to reduce fecal incontinence by providing anatomical support to the anorectum, thereby restoring the 90-degree angle between the axis of the rectum and the anal canal, according to FDA's executive summary.
Endo applied for approval of the Topas in April 2014, but FDA asked for more information, resetting its one-year clock for making a decision, MedScape reports. It is not available in any other country. A previous version of the device was 510(k)-cleared by the FDA for pelvic floor repair in 2007.
The Topas belongs to Endo's Astora Women's Health unit, which was previously named American Medical Systems, prior to Boston Scientific's ($BSX) acquisition of Endo's men's health devices for $1.6 billion in August 2015.
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FDA backs Endo’s Topas mesh to treat fecal incontinence
Feb 26, 2016 | Mass Device
By Fink Densford
The FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee this week voted unanimously to back approval of Endo Health Solutions (NSDQ:ENDP) subsidiary Astora Women’s Health’s Topas mesh designed to treat fecal incontinence.
The synthetic mesh does not require a transvaginal approach, according to a Medscape report, but is implanted using 4 small incisions in a procedure that takes less than 30 minutes.
“The safety issues are addressed within the confines of the study, but specific panel members have concerns about the applicability more generally…and over longer periods of time,” panel chairman Dr. Mark Talamini said, according to Medscape.
The panel said the device is effective at reducing fecal incontinence episodes by at least 50%.
Past issues with the safety of transvaginal mesh devices affected the panel’s judgement and discussion of the Topas system.
In January the FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review.
The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.
Astora said it will limit Topas procedures to surgeons who have previously implanted the device or those who are participating in a proposed postapproval study, and said it is developing a training program for the devices.
The committee said training would be necessary but it would be difficult to judge how many cases it takes to reach a competent level. The board called for a registry to follow surgeons and patient outcomes with the Topas mesh.
The company said it is still not clear when the Topas sytem will be approved.
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FDA Panel Backs Implant for Female Fecal Incontinence
Feb 26, 2016 | MedPage Today
By Shannon Firth
Members of the FDA's Gastroenterology and Urology Devices advisory committee voted 8-0 that the TOPAS treatment for fecal incontinence provides "a reasonable assurance of safety" and of effectiveness, and that the risks -- which are not insubstantial -- are tolerable given the relief seen in clinical trials.
The panel recommended postmarket studies, adequate training of surgeons, and labeling to indicate use in women 18 years or older who are not pregnant. (Some panelists suggested an additional warning for those who may become pregnant.)
While the mechanism of action is still unclear, the TOPAS system is thought to help support the puborectalis muscle, which appears to weaken in people with fecal incontinence. This weakening causes a change in the anorectal angle, which allows stool to move down the rectum involuntarily, a member of FDA's technical staff explained.
Agency briefing documents further clarified the theory that "the fixation of the mesh implant provides the physical support of the anatomy." In time, tissue growth around the device occurs, as the body heals, further enhancing this support.
In the product's main clinical trial, 52 of 80 participants completing the efficacy trialshowed at least a 50% reduction in fecal incontinence episodes over a 12-month period, the study's primary endpoint (65%, P=0.0048). The device also met several secondary endpoints, such as long-term effectiveness, a reduction in incontinent days, fecal incontinence episodes, and symptom severity.
However, 72 of the 152 patients in all who received the implant reported adverse events related to the device (47%). Of these, the most common was pain (45%) followed by infection (27%), and 12% reported new or worsening pelvic organ prolapse.
At the heart of the committee's decision were a few unknowns: how much pain is a woman willing to tolerate to improve her continence? Is pelvic organ prolapse worth the risk of gaining back continence?
Susan Kalota, MD, a urologist in Tucson, Ariz., said most women would agree to risk some pain in exchange for continence. "So it's just, how many are in the debilitating, God-awful pain?" she asked.
As for the second question, Kalota added, "The vast majority of women would easily trade prolapse for continence."
The committee's patient representative agreed. "Wetting your pants is not nearly as difficult as defecating in your pants," said Barbara Berney, from Rockford, Ill.
On the other hand, Jonathan Efron, PhD, a professor of urology and surgery at Johns Hopkins University in Baltimore, reminded the panel that a patient might have pain or prolapse without benefit from the surgery. Those patients "probably wouldn't be happy." Nevertheless, he agreed with other panel members that the benefits outweighed the risks overall.
In its presentations, the sponsor sought to distinguish the TOPAS system from transvaginal mesh devices, which have been associated with severe pelvic pain and organ perforation. The transvaginal mesh devices were also entrenched in countless lawsuits and a complex scam involving unscrupulous health plans who profited from their removal.
Unlike the transvaginal mesh devices which are inserted on top of the vagina, the TOPAS system is placed two centimeters from the anal rectum with a cushion of fat in between, the sponsor explained. The sponsor emphasized that to date none of its devices have required revisions or removal.
Asked if the device was possible to remove, the sponsor's representative said the device is intended to be permanent. But one of the firm's consultants later stated that it would be possible to explant the device, and that an ultrasound could be used to help locate the mesh.
Several panelists seemed skeptical about the possibility of complete removal because of in-growth around the device.
There also appeared to be a disparity in adverse events depending on who performed the surgery -- colorectal surgeons versus urogynecologists -- which favored the latter. But other factors, such as stretching regimens followed by participants prior to the surgery at some centers and not others, may have accounted for such differences.
Jason Connor, PhD, a statistician based in Orlando, Fla., recommended conducting more research on the effect of stretching on adverse events.
The committee spent some time discussing the lack of a control group in the pivotal study. At the time it was conducted, no other therapies or treatments were available to serve as a comparator and using a sham device as a comparator was considered "unreasonable," because it would require a control group to undergo anesthesia and receive incisions.
The committee did not reach consensus on whether studying new comparators was important. One panelist recommended a well-matched prospective cohort to gauge the rate of certain adverse events such as prolapse, without a procedure.
Cheryl Iglesia, MD, a urogynecologist based in Washington, D.C., recommended that a registry be used to conduct postmarket surveillance on surgical outcomes and to determine which surgeons may need additional training. She also suggested the possibility of using imaging to distinguish characteristics of responders and nonresponders.
The sponsor submitted its request for premarket approval in April 2014, received a deficiency letter in July 2014, and then submitted additional information to the FDA in July and October 2015.
The FDA could not say when a final approval decision would be made. It is not required to follow the advice of its advisory committees but it often does.
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FDA Advisers Back Mesh for Fecal Incontinence
Feb 26, 2016 | Medscape Medical News
By Alicia Ault
Women with fecal incontinence (FI) may soon have another treatment option if they do not respond to conservative therapies, such as a dietary change, medications, or exercises.
The US Food and Drug Administration's (FDA's) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted unanimously to back approval of the TOPAS system (Astora Women's Health LLC).
The FDA usually follows the advice of its panels.
The synthetic mesh does not require a transvaginal approach. It is implanted using four small incisions in a procedure that takes less than 30 minutes. The goal is to place the mesh inferior to and about 2 cm from the anorectum, parallel with the puborectalis.
The panel said TOPAS was effective in reducing FI episodes by at least 50%. The committee voted 8-0 that the device was safe, although there was some concern that the small, single-arm study — in which the implants were placed by highly skilled surgeons — might not be an indicator of long-term safety or of use in a broader patient population.
"The safety issues are addressed within the confines of the study, but specific panel members have concerns about the applicability more generally...and over longer periods of time," said Mark Talamini, MD, panel chairman and professor and chairman of surgery at Stony Brook University School of Medicine, in New York.
Transvaginal Mesh Haunts Panel
The specter of ongoing safety and litigation issues involving transvaginal mesh hung over the committee's discussion of TOPAS.
"When mesh implants were approved, everything looked great. Now look where we are," said panellist Terrell Hicks, MD, associate chairman of the Department of Colon and Rectal Surgery at the Ochsner Health System, in Jefferson Parish, Louisiana. Dr Hicks said he worried about safety problems arising in 5 or 10 years.
In January, after multiple safety alerts about the risk for severe pelvic pain, infection, painful intercourse, bleeding, organ perforation, and urinary problems with the use of previously approved products, the FDA reclassified transvaginal mesh for pelvic organ prolapse repair from a moderate-risk device (class II) to a high-risk device (class III) and gave manufacturers 30 months to prove safety and effectiveness.
Astora says it will limit performance of the TOPAS procedure initially to surgeons who have previously implanted the device or who are participating in a proposed postapproval study. The company also has developed a training program. To enter, physicians must be board certified in female pelvic medicine and reconstructive surgery or colon and rectal surgery; they must be currently treating patients who have FI; and they must have surgical experience implanting other FI devices or mesh in the pelvic floor. As part of the training, clinicians would be required to complete two proctored cases.
The committee members said the training was necessary but that it was difficult to say how many cases would indicate competency. Ashley Faulx, MD, a panelist and associate professor of medicine at Case Western Reserve University School of Medicine, in Cleveland, Ohio, said that quality of the completed proctored procedures was probably more important than the quantity.
Panel member Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, in Washington, DC, agreed and called for a registry to follow surgeon and patient outcomes. "I don't want to stifle innovation," she said. "At the same time, there is potential for harm."
Majority Had Reduction in Episodes
In Astora's pivotal trial, TRANSFORM, 152 patients received a TOPAS implant. The trial was a prospective, single-arm, open-label study. The procedure was conducted by colorectal surgeons at eight US clinical sites and by urogynecologists at seven US centers.
Patients had to have failed at least two conservative therapies and had to have had FI for more than 6 months. Those who were pregnant or who were planning a future pregnancy were excluded, as were patients with a history of inflammatory bowel disease, chronic watery diarrhea, or a recent gastroenterologic or gynecologic repair. For almost 60% of the particiants, obstetric trauma was the etiology of their FI; in 41%, the cause was unknown.
Overall, 69% of the 152 patients who received the implant exerienced a reduction in FI episodes of 50% or more. The number of episodes dropped from a median of 18 per day at baseline to five at the last 36-month follow-up. Patients improved on six of the seven quality-of-life scales that were used.
Forty-four percent of the women in the study reported pelvic pain, and 11% had de novo or worsening pelvic prolapse, according to the FDA. But committee members said they thought most women would trade pain for a decrease in FI and that the prolapse might not be caused by TOPAS.
"I would trade off pain to having to wear a diaper," said Barbara Berney, a consumer representative on the panel.
"The bottom line is, this is a terribly debilitating disease, and women would trade an awful lot," agreed Susan Kalota, MD, a panel member who practices at Urological Associates of Southern Arizona. "Many people would trade some pain for continence," she said.
Committee member John Efron, MD, said, however, that patients might not be happy if they were still incontinent and experienced an increase in pain. The prolapse seen in the trial was "probably more a continuation of the overall disease process taking place," said Dr Efron, who holds the Mark M. Ravitch, MD, Endowed Professorship in Gastrointestinal Surgery at Johns Hopkins University, in Baltimore, Maryland.
The panel said that if TOPAS is approved, it should not be used in pregnant women and that women who are expecting to become pregnant in the future who receive an implant should be counseled to undergo cesarean delivery.
It is not clear when the TOPAS system might be approved. Astora applied for approval in April 2014, and by law, a decision should have been made by April 2015. But the FDA asked for additional data, which reset the clock on that decision, Benjamin Fisher, PhD, director of the FDA's Division of Reproductive, Gastro-Renal, and Urological Devices, told Medscape Medical News.
TOPAS is not available in any country, said Thomas Rasmussen, senior director of Astora’s clinical and regulatory affairs.
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FDA Panel: Urogynecological Mesh Tools Need Higher Risk Level
Feb 26, 2016 | Medscape Medical News
By Alicia Ault
Instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling, according to US Food and Drug Administration (FDA) advisers.
The FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee today to seek its opinion on an agency proposal to reclassify the surgical instrumentation — from class I, which is for the lowest-risk devices, to class II, which designates intermediate risk of harm.
Some examples of the instrumentation include a Capio needle used for transvaginal pelvic organ prolapse (POP) procedure, instrumentation for retropubic sling placement, and instrumentation for transobturator sling placement.
The panel agreed that the surgical tools should be upgraded to class II. And, said the committee, the devices should be subject to special agency rules requiring manufacturers to provide reasonable assurance of the tools' safety and effectiveness. Manufacturers must prove a device is biocompatible and sterile, and must supply performance data showing that it functions over the length of its shelf life and that it performs as intended under anticipated conditions of use.
Labels will have to include instructions on which mesh design can be used with the tools, a detailed summary of the device's clinical evaluations, and an expiration date.
The FDA usually follows its panels' advice.
Hundreds of Devices Malfunctioned
The agency first proposed stricter requirements in May 2014. They were included in a proposal to also move surgical mesh for transvaginal POP repair from a class II to a class III device. The surgical meshwas reclassified in January 2016, giving manufacturers 30 months to submit a full premarket approval application with clinical data to the agency.
The mesh has been associated with numerous injuries and has been the subject of multiple lawsuits.
In many cases, surgical instruments are packaged together with mesh, which means that the FDA would be allowed to consider those particular instruments as class III, also, said Ben Fisher, PhD, director of the FDA's Division of Reproductive, Gastro-Renal, and Urological Devices. But manufacturers were not happy that some tools would be class III while others sold individually would remain class I.
Based on risks the agency identified with the tools, it decided that it would seek to put all of them under the rules governing class II devices, said Dr Fisher.
The FDA reviewed its Manufacturer and User Facility Device Experience (MAUDE) database for all medical device reports relating to urogynecological mesh tools submitted from January 2008 to December 2015 and found 463 such reports; 339 were for malfunctions and 124 for injuries. The vast majority — 186 — were related to placement of transvaginal mesh for POP.
Forty-five reports involved a device fragment in the patient; in 10 reports, a piece of nonresorbable material was left in a body. Just over 250 of the reports were about a detachment of a device, and 141 were for a tool breaking.
In almost all the reports — 231 — the manufacturers couldn't make a determination about the cause of a problem because the device was not returned for examination.
The FDA also reviewed published reports of problems with mesh instrumentation, finding a variety of issues from organ perforation to vascular and nerve injury.
Surgical Error
While the committee agreed that the surgical tools should receive stricter scrutiny from the FDA, they also said they believed the majority of patient injuries were due to poor surgical skill.
Panelist Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, in Washington, DC, called on the specialty societies to issue more clinical guidelines and education on mesh placement and use.
"That training component is going to be more important in mitigating these catastrophic injuries" than FDA requirements, said Dr Iglesia.
The FDA will make a final decision on moving the surgical tools to class II after weighing the panel's recommendations along with the available evidence, and public comments it has received, said Marjorie Shulman, director of the FDA's premarket notification program.
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Urinary Incontinence Risk Rises Slightly After Vaginal Birth, Study Finds
Feb 26, 2016 | HealthDay
By Robert Preidt
Women who give birth vaginally are slightly more likely to develop urinary incontinence afterward compared to women who have cesarean sections, according to Finnish researchers.
However, experts in the United States stressed that C-section deliveries come with their own risks, so the choice of how to deliver a child must be made between a woman and her doctor.
Urinary incontinence is a common problem among women, affecting hundreds of millions worldwide. It's known that aging, obesity and childbirth increase the risk, but the long-term effects of the type of childbirth have been unclear.
In its review, the Finnish team looked at data from 16 studies. The investigators found that vaginal delivery was associated with an 8 percent increased risk that the woman would later develop stress urinary incontinence, which was nearly two times higher than with cesarean delivery.
Stress incontinence involves involuntary leakage that occurs when a woman stresses her abdomen, such as in jumping, sneezing or coughing.
The link between vaginal delivery and stress incontinence was strongest in younger women and decreased the longer the time from childbirth, the research team found.
Vaginal delivery was also associated with a 3 percent increased risk of urge incontinence compared with C-section delivery, the Finnish researchers found. Urge incontinence involves a strong, sudden need to urinate.
The review "provides important information about the causes of urgency and stress urinary incontinence in women ... and [will] help women and their physicians make decisions regarding mode of delivery," said study co-authors Riikka Tahtinen, an obstetrics and gynecology consultant at Kuopio University Hospital, and Kari Tikkinen, adjunct professor at Helsinki University Hospital.
However, the authors also pointed out that the comparatively lower risk for incontinence seen after C-section may not outweigh other dangers linked to the surgical procedure.
"When choosing the mode of delivery, a variety of factors must be considered," Tahtinen said in a Helsinki University news release.
"A planned cesarean section increases the baby's risk of needing emergency care and the mother's risk of developing blood clot, bleeding as well as uterine rupture and placental adhesion disorders in subsequent pregnancies," Tahtinen explained.
The researchers noted that cesarean section rates in many countries have increased substantially since the 1970s and now account for 33 percent of births in the United States.
Two experts in the United States said that while the study findings were useful, C-section carries its own risks.
Dr. Jill Rabin is co-chief of ambulatory care for Women's Health Programs at Northwell Health in New Hyde Park, N.Y. She said the Finnish review had several limitations, and the "risks to both the mother and baby associated with delivery, while usually low, are nevertheless significantly higher for cesarean section."
Any decision over elective C-section "should therefore be based on a full understanding of the maternal and fetal issues, and a decision made in conjunction with a woman and with her physician," Rabin said.
Another medical expert agreed.
"It is important that women have all of the potential risks and complications of vaginal delivery versus C-section available, so that they and their physician can make the best decision for the mother and the baby," said Dr. Elizabeth Kavaler, a urology specialist at Lenox Hill Hospital in New York City.
The study results were published online recently in the journal European Urology.
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Welcome to Mesh Medical Device News Desk, aka Mesh News Desk
Feb 28, 2016 | Mesh Medical Device News Desk
By Jane Akre
If you are new to the mesh mess you have come to the right place.
There are about 100,000 lawsuits currently filed in the U.S. to address the injuries that come from pelvic mesh. You may know in 2008, after thousands of reports of complications came into the U.S. Food and Drug Administration (FDA), the FDA declared mesh complications were “rare.” By mid-2011 the FDA reversed that stance and said complications were “not rare.”
If you are one of the unlucky ones who has a complication, which can occur at any time, you may not agree that a pelvic mesh sling is the “Gold Standard” the term still used by some doctors to explain mesh slings.
What’s very disturbing is the doctors who have been advised not to use polypropylene mesh as a first-line repair, are still doing so. We have been told by women recently implanted that doctors say things like “it’s not the same mesh,” or the troublesome mesh “has been recalled.” Frankly, these things are not true. Polypropylene mesh remains on the market and besides manufacturers quietly removing some mesh from the market for “economic reasons,” most remain on the market.
If you are told you need polypropylene mesh to correct prolapse or incontinence, you will need to direct your own medical care and be a truly informed consumer. We hope these pages help you toward that goal.
For those of you considering having a pelvic mesh implant, or a hernia mesh implant for that matter, please ask your doctor if he or she knows how to do an alternative procedure. Unless and until one can predict who will react negatively, the Precautionary Principle is advised.
These pages will attest to that.
Onward Friends!
Jane Akre, Editor
Mesh News Desk
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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