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FDA Strengthens Rules For Using Mesh Implants In Pelvic Surgeries
Jan 7, 2016 | Tech Times
By Katrina Pascual
...Thousands of patients also filed lawsuits against mesh makers, including Johnson & Johnson, Boston Scientific, and Endo International. Ireland-based firm Endo announced in 2014 an $830 million settlement of over 20,000 personal injury cases in court... -
FDA Reclassifies Vaginal Mesh, Device Used For Prolapse, As ‘High Risk’
Jan 6, 2016 | WBUR Common Health
By Rachel Zimmerman
The U.S.Food and Drug Administration has moved to strengthen regulations on vaginal mesh, a controversial medical device used to treat pelvic organ prolapse, a condition that can occur after childbirth as a result of weakened pelvic muscles. -
FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair
Jan 6, 2016 | Renal & Urology News
By Brian L. Rini, MD
The US Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women, according to a news release issued by the agency.
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FDA Strengthens Rules For Using Mesh Implants In Pelvic Surgeries
Jan 7, 2016 | Tech Times
By Katrina Pascual
Tougher regulations have been slapped onto mesh surgical implants used for repairing pelvic organ prolapse (POP) in women, a condition that typically follows childbirth.
The U.S. Food and Drug Administration announced ont Monday that from being class II or moderate-risk, these medical devices will now be classified as class III or high-risk devices.
In a second order, it required manufacturers to submit a premarket approval application that vouches for the safety and effectiveness of these implants used transvaginally in patients.
The strengthened regulations followed an increased number of complaints and lawsuits associated with the use of these mesh implants.
Dr. William Maisel, chief scientist at the Center for Devices and Radiological Health of FDA, said these requirements will help address the issues associated with the said medical devices.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures,” he said in an official statement.
POP Symptoms And Treatment
POP occurs when the bladder, uterus, or other reproductive organs slip out of place and bulge or prolapse into the vagina. This happens when the pelvic floor’s muscles and tissues become stretched or torn and can no longer support the organs.
Symptoms include low back pain, constipation, painful sexual intercourse, or urinary issues such as a chronic urge to urinate.
Plastic mesh is typically implanted during POP surgery to support the weakened pelvic wall. Surgical mesh has been used for repairing abdominal hernias since the 1950s. In the 70s, gynecologists started to use it for abdominal POP repair, and in the 90s, it began to be implanted for transvaginal POP repair.
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Reported Problems And Complications
“[O]ver the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair,” warned the FDA announcement, citing severe pelvic pain, bleeding and infection, and organ perforation as among the most common complications.
Over four years ago, the agency concluded that patients with vaginal mesh implants suffer more complications than those undergoing traditional surgery involving stitches. It estimated that around 10 percent of women experienced side effects from mesh, even sometimes going through multiple surgeries for implant repositioning or removal.
In 2011, an expert panel said more data is necessary to prove these devices’ safety. In 2012, the FDA issued orders for manufacturers to conduct post-market surveillance research on plastic mesh for transvaginal POP surgery.
The FDA’s 2014 draft orders first contained the changes announced Monday.
Thousands of patients also filed lawsuits against mesh makers, including Johnson & Johnson, Boston Scientific, and Endo International. Ireland-based firm Endo announced in 2014 an $830 million settlement of over 20,000 personal injury cases in court.
Like 90 percent of medical devices marketed and sold in the country, pelvic mesh was cleared before under a streamlined FDA review process considered similar to products that preceded them.
Mesh makers for transvaginal implant surgery have 30 months to submit a premarket approval application for devices already sold to the public. Makers of new devices need to submit an application before their products can be marketed.
In December last year, a team of gynecologists urged the FDA to revise its 2014 ban on using morcellator, a device designed to remove uterine fibroids. They pinpointed the agency’s reliance on flawed data analysis, leading to banning such mechanical devices that chop fibroids into tiny pieces during surgery.
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FDA Reclassifies Vaginal Mesh, Device Used For Prolapse, As ‘High Risk’
Jan 6, 2016 | WBUR Common Health
By Rachel Zimmerman
The U.S.Food and Drug Administration has moved to strengthen regulations on vaginal mesh, a controversial medical device used to treat pelvic organ prolapse, a condition that can occur after childbirth as a result of weakened pelvic muscles.
Following reports of thousands of injuries related to the devices, FDA issued two orders this week: It reclassified the devices from Class II, generally considered to be a moderate-risk, to Class III, considered high-risk. Additionally, the agency will now require vaginal mesh manufacturers to submit “a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of” pelvic organ prolapse.
From the FDA statement:
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.
Prolapse occurs when pelvic muscles become stretched, torn or weakened, making it difficult to support the bladder, bowel or uterus; these organs can then drop and bulge 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,” according to the FDA.
This week’s move follows a series of actions by the FDA warning of potential dangers of vaginal mesh. Notably, the agency’s latest orders relates specifically to transvaginal surgery for prolapse, and not other conditions, such as stress urinary incontinence, which has also been treated with vaginal mesh.
For reaction, I reached out to several doctors and a woman who suffered from complications related to vaginal mesh.
Amy Gezon, who testified before an FDA advisory panel about her experience back in 2011, sent me this email: “I am disappointed that the FDA did not reclassify mesh kits for the treatment of [stress urinary incontinence]. The apparent disregard of the serious complications experienced by myself and countless other women is truly disheartening.”
Doctors’ comments were mixed.
Peter Rosenblatt, director of urogynecology at Mount Auburn Hospital in Cambridge, wrote:
Many urogynecologists like myself support the reclassification of transvaginal mesh to Class III devices. This will ensure that these devices undergo extensive clinical testing before they can be marketed to surgeons who perform prolapse surgery. It is important to note that the FDA did not pull these products off the market. They understand that when used properly, these devices are very useful and provide an important treatment option for some women with extensive or recurrent prolapse. It should also be noted that this reclassification does not affect other synthetic mesh products used in urogynecologic surgery; specifically slings, which have become the “gold standard” treatment for stress incontinence, and mesh used in abdominal prolapse repair, such as laparoscopic and robotic surgery.
Quoc Dien-Trinh, with the Division of Urology at Brigham and Women’s Hospital in Boston, added:
Notably, this reclassification does not apply to surgical mesh for other indications, including stress urinary incontinence. It is important to recognize that the right devices used by the wrong surgeons will almost always lead to poor outcomes.
And Jeannine Miranne, with the Division of Urogynecology at the Brigham, said the FDA’s move is “unfortunate”:
I think the FDA’s reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse is unfortunate and will only heighten the public’s concerns regarding the use of vaginal mesh. I do believe that vaginal mesh has a role to play in women’s health and is a reasonable option for a select patient population (i.e. older patients with recurrent prolapse who are not very sexually active and have no history of chronic pain) after careful consideration of the risks and benefits.
I also think that the reclassification will discourage companies from investing in products and conducting research that may benefit women’s health.
To help consumers sort through all of the conflicting opinions, the FDA also posted recommendations for patients considering vaginal mesh surgery for prolapse:
Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications. Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
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FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair
Jan 6, 2016 | Renal & Urology News
By Brian L. Rini, MD
The US Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women, according to a news release issued by the agency.
The devices were reclassified on Monday from a "moderate" to "high" risk category. Manufacturers must now submit pre-market approval applications to the FDA to help the agency better assess the implants' safety and effectiveness.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the 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 updated requirements apply to transvaginal placement of the mesh implants to treat pelvic organ prolapse. The new rules do not apply to other uses of surgical mesh. Makers of transvaginal mesh implants already on the market now have 30 months to submit pre-market approval applications, while makers of new devices must submit an application before their devices can be approved for sale in the United States, the FDA said.
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