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Astora lands FDA panel date for Topas incontinence device
Jan 8, 2016 | Mass Device
By Fink Densford
The FDA today scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device -
In light of FDA rules, pelvic mesh devices face uncertainty
Jan 9, 2016 | Star Tribune
By Joe Carlson
The Food and Drug Administration (FDA) decided not to impose an outright ban on sales of a widely used device for women with pelvic-organ prolapse, but new rules are clouding the future of pelvic mesh products used in a common gynecological surgery. -
Mesh News Desk Denied Access to Sherrer Pelvic Mesh Trial in Kansas City
Jan 8, 2016 | Mesh Medical Device News Desk
By Jane Akre
On Thursday, January 7, Mesh News Desk (MND), its editor and readers were denied access to the pool camera and coverage of the pelvic mesh trial of Eve Sherrer in Kansas City, Missouri. -
A workout to overcome incontinence — and look good too
Jan 9, 2016 | Corvallis Gazette-Times
By Wendy Donahue
Forceps helped bring Cristin Taylor's first child into the world, a joy that outweighed the pain of the fourth-degree tear Taylor suffered in her perineum during the birth. The wounds closed, but Taylor still struggled with urinary incontinence. She'd leak when she ran, coughed or brushed her teeth.
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Astora lands FDA panel date for Topas incontinence device
Jan 8, 2016 | Mass Device
By Fink Densford
The FDA today scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device.
The company and federal watchdog are slated to meet in late February to consider the company’s sling mesh device.
The Topas is designed to be implanted around the puborectalis muscle for treating women with fecal incontinence who’ve failed more conservative therapies.
The meeting will be split into multiple sessions, in which the company and members of the agency will discuss reclassification topics related to women’s health devices.
Topics range from reclassification of urogynecologic surgical mesh instrumentations from class I devices to class II, to shifting FDA classification product codes, according to an FDA release posted today.
The meeting comes shortly after 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 mesh products 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.
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In light of FDA rules, pelvic mesh devices face uncertainty
Jan 9, 2016 | Star Tribune
By Joe Carlson
The Food and Drug Administration (FDA) decided not to impose an outright ban on sales of a widely used device for women with pelvic-organ prolapse, but new rules are clouding the future of pelvic mesh products used in a common gynecological surgery.
At least 135,000 women and their families have filed personal-injury lawsuits against seven makers of pelvic mesh products.
That includes cases against devicemakers with Minnesota ties: American Medical Systems (46,600 claims), Boston Scientific Corp. (more than 30,000), Medtronic’s Covidien business (11,500), and Coloplast (at least 2,300), according to court records and securities filings.
Last week the FDA imposed stricter regulation on transvaginal mesh devices like those at issue in many of those lawsuits. The agency ordered transvaginal mesh-makers to submit new safety and effectiveness data on pelvic organ prolapse surgeries by the summer of 2018.
That order makes it likely some companies will stop selling mesh devices for the procedure, rather than go though a lengthy regulatory process with the FDA, said longtime Minneapolis regulatory lawyer Bob Klepinski.
“This will weed out some of the folks,” Klepinski said.
Regulating Mesh Safety
2008: A public health notification from the Food and Drug Administration warns of serious but rare complications with pelvic mesh implants.
2011: Following in-depth study, FDA announces mesh complications are not rare when used to treat pelvic organ prolapse (POP), and that mesh devices introduce new risks but may not be more effective than other treatments for POP.
2012: FDA orders device makers to monitor and report post-procedure complications from mesh devices.
2014: FDA proposes stricter regulation of mesh devices, including reclassifying them under the highest-risk category, Class III.
2016: The agency formally reclassifies mesh devices for POP as Class III, requiring companies to do new safety and effectiveness studies.
One in 10 women have a pelvic organ, like the bladder, drop or “prolapse” into the vagina following weakening of surrounding muscle tissue from childbirth or hysterectomy.
The stretched-thin muscle tissue can be reinforced surgically with a mesh, similar to hernia repair surgery. However, the FDA says implanting mesh through a vaginal incision introduces risks of infection, severe pain, bleeding and future re-operations while not consistently working more effectively than other prolapse surgeries, like native tissue repair or surgical approaches through the abdomen.
The manufacturers have vigorously defended the safety of their products in the handful of mesh lawsuits that have gone to trial so far, but they’re reluctant to make public comments about the devices amid ongoing litigation and settlement talks.
About 59,000 of the 135,000 mesh lawsuits are consolidated in a federal court in West Virginia. Taken together, they represent by far the largest group of ongoing multidistrict litigation cases related to health care, federal court records from December show. Only some of the lawsuits relate to the specific procedure of transvaginal prolapse repair.
The FDA has been evaluating the safety of various mesh devices since at least 2008. The FDA made a preliminary recommendation in 2011 to reclassify some mesh devices as Class III, the highest-risk category, and ordered devicemakers to study their use the following year.
In public comments to the agency, scores of women asked for a nationwide ban or recall of the devices. Some women told the agency that they were never told about the true risks of the surgery, and others said they didn’t find out about mesh until after it was used on them.
Last Tuesday, the FDA announced in the Federal Register that it “does not believe that there is sufficient evidence at this time to support the banning of this device. … The collection of additional clinical evidence on these devices is needed.”
Those conclusions applied only to transvaginal mesh surgery, not implants via abdominal surgery, nor to the similar mesh “slings” used to treat stress urinary incontinence.
Federal data show that doctors perform about 200,000 surgical repairs of prolapse each year, making it the most common inpatient procedure performed in women age 70 and older.
Some researchers have predicted that the rate of gynecological surgeries for prolapse will increase in coming decades, as the baby boomer population ages.
Last week, though, devicemakers did not use the FDA announcement as an occasion to affirm their future support for mesh devices.
“These rules are still new. We are evaluating what this means to Boston Scientific,” company spokesman Tom Keppeler said, noting that it would be typical for the company to announce product commentary during earnings reports. The company’s next report is scheduled for Feb. 4.
Minnetonka’s American Medical Systems, now operated as Astora Women’s Health and owned by Ireland-based Endo International, said it had been expecting the FDA actions and plans to continue its studies to meet the new requirements.
A Medtronic spokesman noted that the company does not make mesh devices. Covidien, which Medtronic acquired one year ago this month, was targeted by mesh litigation because two of its subsidiaries used to supply mesh products to another medical-device company, C.R. Bard. Medtronic is negotiating settlements of its cases.
The FDA order gives companies 30 months to submit premarket applications (PMAs) with new data on the safety and effectiveness.
“We cannot predict whether manufacturers will choose to submit PMAs for these devices,” spokeswoman Deborah Kotz said in an e-mail. “FDA is allowing manufacturers to submit clinical data in their PMA that was collected through 522 studies that we ordered them to conduct in 2012.”
At least 135,000 women and their families have filed personal-injury lawsuits against seven makers of pelvic mesh products.
That includes cases against devicemakers with Minnesota ties: American Medical Systems (46,600 claims), Boston Scientific Corp. (more than 30,000), Medtronic’s Covidien business (11,500), and Coloplast (at least 2,300), according to court records and securities filings.
Last week the FDA imposed stricter regulation on transvaginal mesh devices like those at issue in many of those lawsuits. The agency ordered transvaginal mesh-makers to submit new safety and effectiveness data on pelvic organ prolapse surgeries by the summer of 2018.
That order makes it likely some companies will stop selling mesh devices for the procedure, rather than go though a lengthy regulatory process with the FDA, said longtime Minneapolis regulatory lawyer Bob Klepinski.
“This will weed out some of the folks,” Klepinski said.
Regulating Mesh Safety
2008: A public health notification from the Food and Drug Administration warns of serious but rare complications with pelvic mesh implants.
2011: Following in-depth study, FDA announces mesh complications are not rare when used to treat pelvic organ prolapse (POP), and that mesh devices introduce new risks but may not be more effective than other treatments for POP.
2012: FDA orders device makers to monitor and report post-procedure complications from mesh devices.
2014: FDA proposes stricter regulation of mesh devices, including reclassifying them under the highest-risk category, Class III.
2016: The agency formally reclassifies mesh devices for POP as Class III, requiring companies to do new safety and effectiveness studies.
One in 10 women have a pelvic organ, like the bladder, drop or “prolapse” into the vagina following weakening of surrounding muscle tissue from childbirth or hysterectomy.
The stretched-thin muscle tissue can be reinforced surgically with a mesh, similar to hernia repair surgery. However, the FDA says implanting mesh through a vaginal incision introduces risks of infection, severe pain, bleeding and future re-operations while not consistently working more effectively than other prolapse surgeries, like native tissue repair or surgical approaches through the abdomen.
The manufacturers have vigorously defended the safety of their products in the handful of mesh lawsuits that have gone to trial so far, but they’re reluctant to make public comments about the devices amid ongoing litigation and settlement talks.
About 59,000 of the 135,000 mesh lawsuits are consolidated in a federal court in West Virginia. Taken together, they represent by far the largest group of ongoing multidistrict litigation cases related to health care, federal court records from December show. Only some of the lawsuits relate to the specific procedure of transvaginal prolapse repair.
The FDA has been evaluating the safety of various mesh devices since at least 2008. The FDA made a preliminary recommendation in 2011 to reclassify some mesh devices as Class III, the highest-risk category, and ordered devicemakers to study their use the following year.
In public comments to the agency, scores of women asked for a nationwide ban or recall of the devices. Some women told the agency that they were never told about the true risks of the surgery, and others said they didn’t find out about mesh until after it was used on them.
Last Tuesday, the FDA announced in the Federal Register that it “does not believe that there is sufficient evidence at this time to support the banning of this device. … The collection of additional clinical evidence on these devices is needed.”
Those conclusions applied only to transvaginal mesh surgery, not implants via abdominal surgery, nor to the similar mesh “slings” used to treat stress urinary incontinence.
Federal data show that doctors perform about 200,000 surgical repairs of prolapse each year, making it the most common inpatient procedure performed in women age 70 and older.
Some researchers have predicted that the rate of gynecological surgeries for prolapse will increase in coming decades, as the baby boomer population ages.
Last week, though, devicemakers did not use the FDA announcement as an occasion to affirm their future support for mesh devices.
“These rules are still new. We are evaluating what this means to Boston Scientific,” company spokesman Tom Keppeler said, noting that it would be typical for the company to announce product commentary during earnings reports. The company’s next report is scheduled for Feb. 4.
Minnetonka’s American Medical Systems, now operated as Astora Women’s Health and owned by Ireland-based Endo International, said it had been expecting the FDA actions and plans to continue its studies to meet the new requirements.
A Medtronic spokesman noted that the company does not make mesh devices. Covidien, which Medtronic acquired one year ago this month, was targeted by mesh litigation because two of its subsidiaries used to supply mesh products to another medical-device company, C.R. Bard. Medtronic is negotiating settlements of its cases.
The FDA order gives companies 30 months to submit premarket applications (PMAs) with new data on the safety and effectiveness.
“We cannot predict whether manufacturers will choose to submit PMAs for these devices,” spokeswoman Deborah Kotz said in an e-mail. “FDA is allowing manufacturers to submit clinical data in their PMA that was collected through 522 studies that we ordered them to conduct in 2012.”
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Mesh News Desk Denied Access to Sherrer Pelvic Mesh Trial in Kansas City
Jan 8, 2016 | Mesh Medical Device News Desk
By Jane Akre
Mesh News Desk, January 7, 2016~ On Thursday, January 7, Mesh News Desk (MND), its editor and readers were denied access to the pool camera and coverage of the pelvic mesh trial of Eve Sherrer in Kansas City, Missouri.
Sherrer v. Boston Scientific and C.R. Bard began December 2 but was interrupted for the holidays. It resumed Monday, January 4th.
Mesh News Desk had access to the pool camera and its daily feed until defense attorneys objected to a reader’s comment.
Jean Maneke, an attorney hired by Courtroom View Network (CVN), a for-profit business which operated the pool camera, argued before Judge Robert Schieber that many online media organizations accept comments from the public and it is the public’s right to comment, within reason. Maneke characterized the comment/ comments in question as “inflammatory” but not threatening.
The judge decided CVN could stay but MND was denied access.
Here is attorney Jean Maneke’s Motion for CVN, which clearly states the new reality of online news coverage and the public’s discourse.
As it now stands, interested parties can subscribe to Courtroom View Network to watch proceedings at a cost of $250 a day, according to their website here.
On Monday, January 4, an attorney representing Mesh News Desk, Jim Griffin, appealed to Judge Robert Schieber to resumeMDN’s access to the pool camera.
The transcripts and the MNDmotion are available to subscribers of the Mesh News Desk newsletter. Please make sure you are signed up to receive the newsletter on the right hand column here.
Also you can find the Judges final order Jan 7 2016 here.
While Lori Cohen, an attorney for defendant, C.R. Bard initially said to the Court, “It was not the coverage itself that was challenged, it was the reader comments and reaction…”
She then cites the headline “Mesh News Desk Files Brief to Stay in Court as Sheerer Pelvic Mesh Trial Resumes” as an example of inciting readers to “gin up activity,” a colorful reference to an undefined action.
Judge Schieber said reporting needs to be without an agenda and that his job is to make sure attorneys in his courtroom feel comfortable. He invited your editor or any members of the public to watch the proceedings in his courtroom.
Court Operating Rule #16 specifically forbids judges to “mediate any dispute as to the appropriate media representatives authorized to cover a particular judicial proceeding.” The Rule #16 does not provide authority to decide or direct the content of any stories produced on a particular proceeding.
The Sherrer trial is of particular interest because the plaintiff was implanted with two meshes, one made by Bard and the other by Boston Scientific. The plaintiffs case is in its fourth week but convened early Friday the 8th. It will reconvene Monday with the plaintiff’s case continuing.
MND had about 5,000 readers a day following the Sheerer trial. #
*Editors Note – The one commented cited was made by a reader calling herself “Maria.Garcia.” She stated the attorney for Bard, Lori Cohen (Greenberg Traurig), would lose the case, was on the wrong side of the issue, and was no better than an doctor who performs abortions. While offensive, it is not profane or particularly threatening, which would have it omitted. Your editor does not know the identity of Maria.Garcia who has failed to reply to many requests to contact me. Again, I would request she reach out to me, your editor, Jane Akre (janeakre@meshnewsdesk.com) to verify she is indeed a mesh-injured woman or associated with the issue in some way. #
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A workout to overcome incontinence — and look good too
Jan 9, 2016 | Corvallis Gazette-Times
By Wendy Donahue
Forceps helped bring Cristin Taylor's first child into the world, a joy that outweighed the pain of the fourth-degree tear Taylor suffered in her perineum during the birth. The wounds closed, but Taylor still struggled with urinary incontinence. She'd leak when she ran, coughed or brushed her teeth.
A decade-long battle with her bladder raged through Kegel exercises, the birth of another daughter and physical therapy (not with a pelvic floor specialist). Taylor resorted to surgery to insert mesh support, in hopes of correcting what had been diagnosed as a tilt in her bladder neck. After six weeks of recovery, the incontinence continued — now accompanied by numbness that dulled her sex life. "It was like a foot that had fallen asleep."
In 2011 Taylor and a friend tried a new fitness class at a gym near her home in Satellite Beach, Fla. Called Fluidity, the class uses an adjustable-height barre to strengthen all muscle groups but particularly the lowest and innermost structures of the core, what Fluidity founder Michelle Austin calls "the inner unit."
"Michelle talked a lot about the pelvic floor and alignment awareness," Taylor said. "They had three classes a week, and I came every time I could. Within six months, I was noticing huge changes in my life, including a wonderful, more connected sex life with my husband."
Women like Taylor were the original target for Austin's Fluidity regimen, which has been taught at gyms and rehabilitation centers around the country for over a decade. But in the last year Fluidity has been noticed and recommended by Microgate USA, a company that specializes in movement analytics to help everyone from professional athletes to the elderly and Parkinson's patients.
Anyone can benefit from the regimen, Austin said, which revolves around a barre with a backboard that rises from the floor. The ability to adjust the Fluidity barre to hip height is key, Austin said, because it reduces the tendency to perform exercises in a posterior tilt, which compromises alignment and effectiveness of some barre workouts.
Fluidity's goal: to correct pelvic instability that can contribute to chronic complaints such as incontinence, back pain, sexual dysfunction and loss of balance as we age.
The concept emerged from Austin's resolve to rehabilitate herself after cancer and a full hysterectomy at age 42, combined with her training in the Lotte Berk barre method, which Austin taught in the 1990s in New York City.
"In hysterectomies, they're taking out an organ, if not several, and there's no rehab," Austin said. "It's ridiculous."
Fluidity classes now are held at rehabilitation centers and gyms around the country. An at-home counterpart includes a collapsible barre, DVDs, mat, ball and bands.
The pelvic-floor muscles often become dysfunctional after childbirth, gynecological surgery, illness such as urinary tract infections, or just from disuse, says Cindy Neville, a physical therapist specializing in women's health who is on clinical faculty at the University of Northern Florida.
That dysfunction can contribute to pelvic organ prolapse, where the vaginal walls or cervix drop, as well as incontinence, estimated to affect 30 to 40 percent of middle-aged women and 30 to 50 percent of elderly women.
Many women suffer in silence. If they seek treatment, doctors sometimes recommend a surgery like Taylor's. Of the 400,000 pelvic floor surgeries annually in the U.S., 120,000 of those are repeats, Neville said, suggesting that surgery isn't solving the problem.
"But people are afraid to talk about the pelvic floor muscles; it's like breast cancer 20 years ago; to say the word breast was almost pornographic in our culture," she said.
Neville recommends Fluidity to some of her patients.
"In Fluidity there's not an emphasis on bending forward or rounding forward, it's more balanced with the front and back of the body, versus always being the front of the body, which so many things focus on," Neville said. "The neutral pelvis and engaging the deep core, including the pelvic floor, are very effective."
Peter Gorman, the president of Microgate USA who holds several patents on heart rate monitors, met Austin at a deli counter in Florida over Thanksgiving in 2014.
"I didn't know what Fluidity was, but she and I were speaking the same language," he said. "As you lose integrity in your core, especially your inner core, things happen; you can get physiological changes from anatomical deficiency."PauseCurrent Time0:00/Duration Time0:00Loaded: 0%Progress: 0%0:00Fullscreen00:00Unmute
He was curious enough about her method to observe her Fluidity class, where Austin guided participants into what she calls the "neutral pelvis" position: Wrap thumb and index finger around the right hip and around the left hip and tilt the pelvis all the way forward and all the way back. When you find the position where the wrist feels relaxed between those two places, that's neutral pelvis.
In that position, the muscles can contract and relax more effectively to not just tone the body but re-establish the stability of the inner core and pelvic floor.
Gorman thinks the Fluidity regimen has applications beyond fixing incontinence, which he views as an early warning sign for problems that become life-threatening as we age.
"As we march through life, we lose our balance control," Gorman said. "The average 53-year-old should be able to stand on one leg with eyes closed for 15 seconds. If she can't, she's at a higher risk (of deadly falls). So, what if we put her in a program where besides just feeling good and losing some pounds _ hey, let's all go to Ipanema together! _ but also, her balance, timing and coordination improved? By doing that she's basically learned to grow younger."
A year after starting Fluidity, Taylor visited a cranial sacral therapist who evaluated her muscle control.
"She reported I have 360 degrees of strength in my pelvic floor, which to her was phenomenal, regardless of what I recovered from," Taylor said.
Fluidity isn't a cheap or instant cure, she noted. When she is busy and goes on hiatus from her Fluidity workouts, she notices her bladder control starts to lapse. It's one reason she invested in the barre system for her home.
"I feel like I have this tool," Taylor said, "and I can always heal myself."
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