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FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks
Jan 4, 2016 | FDA Press Release
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. -
FDA Raises Approval Barrier For Some Pelvic Mesh Devices
Jan 4, 2016 | Law360
By Sindhu Sundar
Federal regulators finalized measures Monday to reclassify transvaginal mesh devices used to treat a pelvic condition common among older women as high-risk devices that need a safety evaluation by the U.S. Food and Drug Administration before they can be sold. -
FDA slaps PMA requirement on pelvic mesh
Jan 4, 2016 | Mass Device
By Brad Perriello
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 tightens clinical requirements for transvaginal devices
Jan 4, 2016 | Reuters
By Natalie Grover
The U.S. Food and Drug Administration said on Monday it had taken steps to strengthen the data requirements for surgical mesh devices when used to repair pelvic organ prolapse (POP) via the vagina. -
FDA increases risk level for surgical mesh to repair pelvic organ prolapse
Jan 4, 2016 | Examiner
By Robin Wulffson, M.D.
On January 4, citing problems such as severe pelvic pain and organ perforation, the Food and Drug Administration (FDA) issued two final orders to manufacturers and the public to beef up the data requirements for surgical mesh to repair pelvic organ prolapse transvaginally, or through the vagina. -
FDA labels pelvic mesh as
Jan 4, 2016 | CBS News
Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with the problem-prone devices. -
FDA Reclassifies Vaginal Mesh as a High-Risk Device
Jan 4, 2016 | Medscape
By Robert Lowes
The US Food and Drug Administration (FDA) today reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class ll) to a high-risk one (class lll) and gave manufacturers 30 months to prove that their products are safe and effective, the agency announced. -
FDA Issues High Risk Warning for Transvaginal Mesh
Jan 4, 2016 | MedPage
By Molly Walker
The FDA is warning transvaginal mesh products, a mainstay of pelvic organ prolapse repair, carries a high risk for adverse events and as result the mesh will now carry a class III warning. -
U.S. Watch
Jan 4, 2016 | The Wall Street Journal
By Shirley S. Wang
The Food and Drug Administration is tightening regulations for surgical mesh products used to repair a condition known as pelvic organ prolapse, after years of scrutiny by the regulator and many lawsuits by women who allege they have suffered harm. -
Just In- FDA Moves To Reclassify POP Vaginal Mesh as High Risk!
Jan 4, 2016 | Mesh Medical Device News Desk
By Jane Akre
An expert panel convened by the U.S. Food and Drug Administration (FDA) decided in September 2011 that mesh used to treat pelvic organ prolapse (POP) should be reclassified as high risk from its moderate risk (Class II) status.
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Jan 4, 2016 | FDA Press Release
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.
Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.
Doctors may perform surgery on women with POP who have significant symptoms, often using a minimally invasive transvaginal technique to reduce recuperation time. Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP, but over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:
Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP; and
Issued two proposed orders in May 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a PMA application.
Manufacturers may choose to submit a PMA before the 30-month deadline.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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FDA Raises Approval Barrier For Some Pelvic Mesh Devices
Jan 4, 2016 | Law360
By Sindhu Sundar
Federal regulators finalized measures Monday to reclassify transvaginal mesh devices used to treat a pelvic condition common among older women as high-risk devices that need a safety evaluation by the U.S. Food and Drug Administration before they can be sold.
The FDA finalized its proposals from April 2014 to heighten its scrutiny of surgical mesh devices for the transvaginal treatment of pelvic organ prolapse, in which pelvic muscles supporting organs including the bladder, bowel or uterus loosen and sag into the vagina. The move follows the agency's steps since 2008 to address "thousands" of complaints by patients that the procedure and device caused serious health problems including the perforation of organs caused by the mesh eroding within the implanted area, according to the agency.
The agency said Monday that it is reclassifying the products from Class II medical devices, for which the FDA only needs "reasonable assurance" of the products' safety. The devices will now be Class III devices, meant for high-risk products including pacemakers and breast implants, which are usually subject to the agency's premarket approval process, the strictest approval hurdle for medical devices. The new rules don't apply to mesh devices used to treat other conditions including stress urinary incontinence or for treating pelvic organ prolapse through abdominal surgery, according to the agency.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, said in a statement Monday. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
The devices are made by manufacturers including Johnson & Johnson unit Ethicon Inc.,Boston Scientific Corp. and C.R. Bard Inc. The manufacturers have been embroiled in multidistrict litigation in West Virginia federal court over mesh devices that allegedly caused injuries including severe pain or required follow-up surgeries.
The new rules allow companies that are already making the products about two and a half years to submit their premarket approval application. Companies making new transvaginal mesh devices for pelvic organ prolapse must submit a premarket approval application before marketing the products.
Mesh devices for the transvaginal treatment of pelvic organ prolapse were first cleared in 2002, and as a class II device, a category that includes most medical devices, according to the agency. Other class II medical devices including powered wheelchairs and contact lens care products, according to the FDA website.
Vaginal mesh products have generally been cleared through the less stringent 510k premarket notification program, in which companies don't have to show any clinical testing to support the safety of their products — they would need to show only that their products are "substantially equivalent" to a product the FDA has already approved.
Critics, including plaintiffs’ attorneys, have argued that this is a lax approval protocol for mesh devices, because it allows companies to win approval by showing their products are similar to approved products even if they are no longer on the market or have been voluntarily recalled by a manufacturer.
The MDL against Ethicon includes more than 23,000 cases, claiming that its mishandling of transvaginal surgical mesh devices caused serious injuries to patients. The cases also claim Ethicon didn't provide appropriate warnings and instructions regarding the risks and dangers posed by its devices, which are used to treat pelvic organ prolapse and stress urinary incontinence.
Bard faced the first jury trial in the seven MDLs assigned to U.S. District Judge Joseph R. Goodwin over the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. It was hit with a $2 million verdict in August 2013, in a case by Donna Cisson, who alleged that its Avaulta Plus Posterior BioSynthetic Support System caused her serious internal injuries. -
FDA slaps PMA requirement on pelvic mesh
Jan 4, 2016 | Mass Device
By Brad Perriello
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.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy science director & chief scientist for the agency’s Center for Devices & Radiological Health, said in prepared remarks. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
An estimated 100,000 product liability lawsuits have been filed in state and federal courts across the country against pelvic mesh makers, including Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon, Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR).
Companies that make pelvic mesh for transvaginal POP procedures have 30 months to file PMA applications with the FDA for devices already on the market. The agency warned about the risks of pelvic mesh in 2008 and 2011, but in 2014 refused to ban U.S. sales of the implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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FDA tightens clinical requirements for transvaginal devices
Jan 4, 2016 | Reuters
By Natalie Grover
The U.S. Food and Drug Administration said on Monday it had taken steps to strengthen the data requirements for surgical mesh devices when used to repair pelvic organ prolapse (POP) via the vagina.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs, leading to their prolapse into the vagina.
Over the past several years, the FDA has received thousands of reports of complications, including bleeding, organ perforation and urinary problems, involving the use of mesh for transvaginal POP repair, the agency said.
These devices have been used by surgeons since the 1950's to repair abdominal hernias. In the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990's, for the transvaginal repair of POP.
The FDA noted that an advisory panel of experts in 2011 recommended that more data was needed to establish their safety.
Boston Scientific Corp is among a handful of manufacturers that have collectively faced an estimated 100,000 lawsuits in state and federal courts over transvaginal mesh, alleging that poor design and substandard materials can cause side effects such as bleeding, infection and nerve damage.
Other major defendants include Johnson & Johnson's Ethicon unit and C.R. Bard.
The FDA on Monday issued an order to reclassify these medical devices from class II or moderate-risk devices, to class III, which encompasses high-risk devices. (1.usa.gov/1MPbStj)
In addition, the agency now also requires manufacturers to submit an application to support the safety and effectiveness of the surgical mesh, particularly for POP. These orders do not apply other indications, like stress urinary incontinence or abdominal repair of POP.
Manufacturers of already available surgical mesh used to treat POP transvaginally will have 30 months to submit an application for their devices. Makers of new devices must submit their application before they can be approved for marketing, the FDA said.
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FDA increases risk level for surgical mesh to repair pelvic organ prolapse
Jan 4, 2016 | Examiner
By Robin Wulffson, M.D.
On January 4, citing problems such as severe pelvic pain and organ perforation, the Food and Drug Administration (FDA) issued two final orders to manufacturers and the public to beef up the data requirements for surgical mesh to repair pelvic organ prolapse transvaginally, or through the vagina. One order reclassified the medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices; the second order requires manufacturers to submit a premarket approval application to support the safety and effectiveness of surgical mesh for the transvaginal repair of pelvic organ prolapse.
The orders mandate manufacturers to address safety concerns through a rigorous premarket approval pathway to demonstrate safety and effectiveness. They apply only to mesh devices marketed for the transvaginal repair of pelvic organ prolapse, and do not apply to surgical mesh for other indications, such as stress urinary incontinence or abdominal repair of pelvic organ prolapse.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” noted William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. He added, “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
Since the 1950s, surgical mesh has been used by surgeons to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of pelvic organ prolapse, and, in the 1990s, for the transvaginal repair of pelvic organ prolapse. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and, at present, there are five manufacturers who are marketing this product.
The FDA notes that over the past several years, it has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal pelvic organ prolapse repair, and in 2011, an advisory panel of experts recommended that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn physicians and patients regarding the use of surgical mesh for transvaginal pelvic organ prolapse repair.
Manufacturers of surgical mesh to treat pelvic organ prolapse transvaginally are allowed 30 months, as required by federal law, to submit a premarket approval for devices that are already on the market. Manufacturers of new devices must submit a premarket approval before those devices can be approved for marketing.
Pelvic organ prolapse is the result of damage to the muscles and tissue of the pelvic floor, usually through childbirth. The weakened pelvic floor can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs descend from their normal position and prolapse (bulge) into the vagina. The condition is not life-threatening; however, women with pelvic organ prolapse often experience symptoms such as low back pain, pelvic pressure, painful intercourse, constipation, or urinary problems such as leakage or a chronic urge to urinate.
Physicians may perform surgery on women with pelvic organ prolapse who have significant symptoms, often using a minimally invasive transvaginal technique to decrease the recovery period. Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair pelvic organ prolapse; however, over the past several years the FDA notes that it has received thousands of reports of complications involving the use of mesh for transvaginal pelvic organ prolapse repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from the mesh eroding into surrounding tissues.
To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:
Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of pelvic organ prolapse;
Issued two proposed orders in May 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a premarket approval application.
Manufacturers may choose to submit a premarket approval application before the 30-month deadline.
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Jan 4, 2016 | CBS News
Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with the problem-prone devices.
The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval applications demonstrating the safety and effectiveness of their products.
The change follows years of reports of pain, bleeding and infection among women who had the devices implanted to correct pelvic organ prolapse (POP). The condition occurs when when the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The new FDA requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.
Plastic mesh is often used to strengthen the pelvic wall and support internal organs in cases of prolapse. The mesh is often inserted through the vagina, using a small surgical incision. The Washington Post recently reported that as many as half of women may experience pelvic floor symptoms in their lifetime, and 200,000 undergo such operations each year.
Lateral view of the female pelvis FDA/COMMONS.WIKIMEDIA.ORG
The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repairin the 1990s and promoted as a way to speed patients' recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.
Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.
In a second rule, the FDA said vaginal mesh will now be classified as a "high-risk" medical device with a class III warning. Previously the implants were considered "moderate-risk" devices and carried a class II warning.
FDA recommends that women be aware of the risks associated with surgical mesh. On an advice page on the FDA website, the agency writes: "Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options."
Non-surgical options include pelvic floor exercises known as Kegels. There are also non-invasive devices such as the PeriCoach, a smartphone-connected pelvic floor muscle training device for incontinence.
The FDA first proposed the changes announced Monday in 2014 draft orders.
Like 90 percent of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products.
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FDA Reclassifies Vaginal Mesh as a High-Risk Device
Jan 4, 2016 | Medscape
By Robert Lowes
The US Food and Drug Administration (FDA) today reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class ll) to a high-risk one (class lll) and gave manufacturers 30 months to prove that their products are safe and effective, the agency announced.
First proposed in April 2014, the regulations top off FDA warnings in 2008 and 2011 about the risk for severe pelvic pain, infection, painful intercourse, bleeding, organ perforation, and urinary problems with the use of the mesh. A tsunami of lawsuits triggered by those warnings prompted one manufacturer, Johnson & Johnson, to stop marketing its product.
Five other companies continue to sell surgical mesh for transvaginal POP repair in the United States. Under today's regulations, they must submit a premarket approval (PMA) application for their products, which entails demonstrating their safety and effectiveness in the agency's most rigorous vetting process. The FDA previously had cleared these mesh devices through its 510(k) process, which bypasses clinical trials and requires manufacturers to show only that their product is substantially equivalent to one already on the market.
New mesh devices for this indication also must undergo PMA scrutiny.
The agency's decisions do not apply to surgical mesh for other indications, including stress urinary incontinence and abdominal repair of POP.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, in a news release. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures."
With POP, muscles and tissues of the pelvic floor are stretched, torn, or weakened to the point of no longer supporting organs such as the bladder, bowel, or uterus. Implanted surgical mesh can keep these organs from prolapsing into the vagina, but the FDA said it has received thousands of reports of adverse events over the past several years for this kind of POP repair.
More information on today's announcement is available on the FDA website.
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FDA Issues High Risk Warning for Transvaginal Mesh
Jan 4, 2016 | MedPage
By Molly Walker
The FDA is warning transvaginal mesh products, a mainstay of pelvic organ prolapse repair, carries a high risk for adverse events and as result the mesh will now carry a class III warning.
Prior to today's announcement, transvaginal mesh carried a class II or moderate risk warning.
In addition, manufacturers of the devices will also be required to submit to a premarket approval application to support the safety and efficacy of surgical mesh for the transvaginal repair of pelvic organ prolapse.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health said in a statement. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."
As part of the premarket approval application process, manufacturers will be required to address concerns about severe pelvic pain and organ perforation through a "rigorous PMA pathway."
Manufacturers of transvaginal mesh for the treatment of pelvic organ prolapse will have 30 months to submit a PMA for devices already on the market, although manufacturers may submit an application before this time.
The FDA initially proposed these changes in 2014, when the agency said that they had identified "clear risks" associated with surgical mesh for repairing prolapsetransvaginally. In 2011, the FDA's Obstetrics and Gynecology devices panel had recommended both of these changes to the agency. Transvaginal mesh manufacturers were ordered to conduct postmarket surveillance studies addressing concerns about the use of the device for transvaginal pelvic organ prolapse repair 3 years ago. In fact, the FDA has been increasing warnings for and conducting more research on the use of mesh for transvaginal POP repair, as far back as 2008.
In March 2015, Johnson & Johnson's Ethicon unit was ordered to pay out a $5.7 million settlement to a woman who sued the manufacturer over a transvaginal mesh implant(the judgement is currently under appeal). In August, an investigative report found several medical lenders linked to profit schemes and litigation over removal of transvaginal mesh.
The agency notes that these orders are not applicable to surgical mesh used for other indications, such as stress urinary incontinence or open (abdominal) repair of pelvic organ prolapse.
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Jan 4, 2016 | The Wall Street Journal
By Shirley S. Wang
Rules Tightened on Pelvic-Surgery MeshThe Food and Drug Administration is tightening regulations for surgical mesh products used to repair a condition known as pelvic organ prolapse, after years of scrutiny by the regulator and many lawsuits by women who allege they have suffered harm.
The products will be reclassified as high-risk rather than moderate-risk medical devices when used in procedures that go through the vagina to repair organ prolapse. The FDA will require manufacturers to submit data on the effectiveness and safety of such devices before they are allowed on the market.
Many of the available mesh kits were approved through an expedited review in which manufacturers need only demonstrate that a product is substantially similar to ones on the market.
The tightened regulations don’t apply to mesh used for other indications, such as stress urinary incontinence or treatment of pelvic organ prolapse through the abdomen, the FDA said.
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Just In- FDA Moves To Reclassify POP Vaginal Mesh as High Risk!
Jan 4, 2016 | Mesh Medical Device News Desk
By Jane Akre
An expert panel convened by the U.S. Food and Drug Administration (FDA) decided in September 2011 that mesh used to treat pelvic organ prolapse (POP) should be reclassified as high risk from its moderate risk (Class II) status.
Today, the FDA announced POP mesh would finally be reclassified as a high risk device.
The makers of POP pelvic meshes still on the market will have 30 months to submit proof their devices are safe and effective as proven by clinical trials. The FDA requires PMA or Premarket Approval of drugs and class III medical devices. It is considered a more stringent requirement to assure patient safety.
New POP meshes will require the manufacturer to submit a PMA before they receive FDA approval.
Whether manufacturers will be able to demonstrate safety and effectiveness through existing clinical trials remains to be seen since that was not previously a requirement for entering the market. Clinical trials to assure safety can run into the millions of dollars and are required of drug makers.
TVT Secur, Megamed Service, SUI tape or hammock
The order covers the larger pelvic meshes used for POP and not those used to treat stress urinary incontinence SUI.
Often called “hammocks” or “ribbons,” referring to their smaller amount of polypropylene mesh, SUI mesh remains in a Class II status or “moderate risk.” SUI mesh can continue to be introduced into the market once the manufacturer claims to the FDA it is the” substantial equivalent” of another mesh already being sold. The FDA’s 510(k) approval process, as it is known, relies on the integrity of the manufacturer to assure patient safety and does not require clinical trials to back up that assurance.
When MND reviewed FDA data in March 2013, SUI injury reports to the agency were up 36 percent. Reclassifying SUI mesh has not be proposed by the FDA. See the background story here.
FDA’s Dr. William Meisel
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, in a news release.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
The FDA says it has received thousands of reports of complications associated with pelvic mesh including mesh migration, erosion into other organs, chronic pain and infection, and autoimmune reactions to the polypropylene mesh.
This order does not include POP meshes implanted abdominally, just those that are implanted through the vagina or transvaginally.
The move to reclassify follows on the heels of two other FDA decisions regarding pelvic mesh.
In 2008, the agency said complications from all meshes were “rare” and that the benefits likely outweighed the risks. By July 2011, the FDA did an about face and announced POP complications with mesh were “not rare” and that the risks likely outweighed the benefits. That after the agency noted a five-fold increase in the number of reports of complications coming into the FDA representing thousands of complaints.
Between 2008 and 2010 there were seven reported deaths associated with pelvic organ prolapse mesh repairs. Two included towel perforations and one hemorrhage. Four deaths were due to post-operative medical complications, according to the FDA’s website.
There were approximately 300,000 POP repairs in the U.S. in 2010 with about 70,000 using polypropylene POP mesh. Additionally, thousands of POP repairs occur internationally. Many meshes taken off the market in the U.S., continue to be sold globally.
POP mesh, Elevate by AMS, still on the market
Pelvic organ prolapse meshes are generally larger and have arms that anchor them into deep tissues, muscles and ligaments. Mesh removal experts consider them particularly difficult to remove.
POP meshes include the Perigee, introduced by American Medical Systems in 2004; Prolift was introduced by Ethicon in 2005; the Elevate by AMS in 2008 and the Pinnacle/Uphold was introduced by Boston Scientific in 2007 and 2008.
Elevate and Apogee (AMS) are still on the market. Restorelle by Coloplast is still used for POP repair. Prolift was quietly removed by Ethicon (J&J) in June 2012. C.R. Bard took its Avaulta mesh off the market in 2012.
Manufacturers moved to remove their POP meshes from the market after a January 2012 mandate by the FDA that required three years of post-approval monitoring of the health of women implanted with POP mesh. By removing the mesh from the market, the manufacturers were relieved of the monitoring requirement, though the mesh remains in the women’s bodies.
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