Mesh Medical Device News Desk, February 11, 2019 ~ Today, February 11th, is the last day to submit comments to the Federal Register as the FDA convenes its Obstetrics and Gynecology Devices panel Tuesday to decide the future of transvaginal pelvic mesh used to treat pelvic organ prolapse (POP).
Industry and the anti-mesh community will testify to an expert panel gathered Tuesday as two mesh manufacturers attempt to convince the panel to keep three POP meshes on the market.
They include Boston Scientific’s Uphold LITE and Xenform, and Coloplast’s Restorelle DirectFix Anterior mesh.
Image: Rectocele, FDA
POP mesh is larger than mesh used to treat incontinence and is placed through the vagina to support the colon, uterus or bladder from prolapsing through the pelvic floor.
Transvaginal mesh, (placed through the vagina), to support the urethra to treat incontinence will not be the subject of this advisory committee made up of medical doctors, industry and patient reps. It is a smaller mesh, also sold in kits and referred to as the Gold Standard treatment by at least one medical society.
The FDA does not have to follow the advice of its expert panel but usually does.
Three years ago, POP mesh was reclassified by the U.S. Food and Drug Administration (FDA) as “High Risk” or class III due to the high numbers of complications being reported to the agency.
In response, the FDA required 33 companies to conduct post approval monitoring studies and industry quietly removed from the market three of the worst offending POP meshes including Ethicon’s Prolift, Boston Scientific’s Pinnacle and Bard’s Avaulta pelvic mesh kits. In doing so, they were relieved of conducting any post approval monitoring.
59 COMMENTS – THE FEDERAL REGISTER
View the comments from the Federal Register here.
With more than 104,000 product liability lawsuits consolidated in federal court in West Virginia, as of today there are only 59 comments. They include Dr. Vincent Lucente, MD, a preceptor for Ethicon who in court testimony has admitted to being paid at least $2 million by the company.
Here’s the link to the Federal Register to submit:
https://www.regulations.gov/comment?D=FDA-2018-N-4395-0001.The Meeting will be at the Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D
620 Perry Pkwy. Gaithersburg, MD 20877
Time: 8:00 am ET to 6:30 pm
The panel members are here. Here is a link to the Meeting Materials. Which includes the Agenda, and an Executive Report.
Note the proceedings will be called to order at 8 AM. At 8:30 AM the public will be invited to testify in 5 minute statements until approximately 10:00 AM. Then after lunch, manufacturers are given approximately one-half hour to present information on the particular meshes they would like to reintroduce into the marketplace.
After an afternoon break, the panel will deliberate at approximately 3 pm. Here are the questions the panel will consider. The meeting should adjourn at 6:15 PM.
The public can watch in a webcast with the meeting scheduled to start at 8:00 AM EST. The Webcast will be on-line at 7:00 AM EST so you can log on and check your system. Use Google Chrome as your browser. No password is required.
Login URL: http://fda.yorkcast.com/webcast/Play/31b27fb3fd4c46e9a6fe11fe2dfce7971d
BACKGROUND
Uphold Mesh, Boston Scientific
In September 2011, an FDA expert panel concluded mesh placed transvaginally to treat pelvic organ prolapse did not have a “well-established benefit/risk profile,”
“It is not clear that transvaginal POP repair with mesh is more effective than tradition non-mesh repair,” said the FDA on July 13, 2011.
After counting the growing numbers of complication reports, the FDA concluded POP mesh complications were “not rare.”
By 2016, the FDA moved to reclassify POP mesh from Class II or moderate risk, to Class III or high risk. Incontinence mesh remains a moderate risk Class II even though at least half of the defective product lawsuits are due to incontinence pelvic mesh, also known as slings.
The agency also gave industry 30 months before it had to submit safety studies or remove its mesh from the market. Earlier the FDA ordered 34 mesh makers to conduct post approval studies, called 522 studies to assess the health of women who had received a mesh medical device. Instead, most POP meshes were removed from the market, relieving the company of the 522 study requirement.
The 30 month time frame concluded in July 2018. See story here.
Four of the postmarket surveillance studies for five surgical meshes are currently ongoing.
TESTIFYING
Madris Tomes, Device Events
Among those testifying are Madris Tomes of Device Events. Formerly an IT project manager in its adverse event reporting program, she created her own more user-friendly database after leaving the FDA. Today, she investigates under-reported or mis-reported entries to the complication databases of the FDA to look for patterns of injury or death.
Tomes will testify that through January of this year there have been more than 139,000 adverse events reports for mesh products with 1,107 patient dying. The rest of her report is embargoed until after her presentation. MND will report its contents then.
Mesh injured women have vowed to have their voices heard before the FDA panel, but some tell Mesh News Desk, they are too sick to travel or are unable to afford the trip.
POLYPROPYLENE MESH
Uphold LITE, pore size 2.8 mm
While polypropylene (PP) mesh works for some people, at least in the short run, one of the world’s experts in mesh removal, UCLA urologist, Dr. Shlomo Raz, has stated he stopped putting it in when he saw complications up to a decade later.
Mesh trials have proven that traditional polypropylene mesh had a small pore size of less than 1 mm which caused bridging fibrosis or a scar plate that would cause the mesh and surrounding tissue to shrink, causing pain. That with injuries during placement, chronic infections, nerve damage, mesh erosion have led to personal injury trials yielding millions in awards to injured plaintiffs.
Interestingly, the meshes that industry will try to keep marketing have a larger pore size.
Uphold LITE Boston Scientific – A light weight PP mesh with a pore size of 2.8 mm smaller mesh footprint is used for anterior and apical compartments with a trocar-free approach. Boston Scientific has upgraded its warning to physicians here.
Xenform by Boston Scientific is a bovine (cow) dermis xenograft used for POP repair.
Coloplast Restorelle DirectFix Anterior is called a “Smartmesh technology” in an “ultra-lightweight mesh.” It too is polypropylene.
LEARN MORE:
FDA Announcement, November 20, 2018
https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel
https://wayback.archive-it.org/7993/20170403223431/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm262488.htmDecember 2015, Orders Federal Register, PMA required by July 5, 2018 for POP mesh, Class III
https://www.federalregister.gov/documents/2016/01/05/2015-33163/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organMesh News Desk, July 10, 2018, 30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many
https://www.meshmedicaldevicenewsdesk.com/30-months-is-up-pop-mesh-is-officially-high-risk-too-late-for-many/Federal Register, January 5, 2016, Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use with Urogynecologic Surgical Mesh (here)
FDA Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, July 2011 (here)
FDA, Concerns about Surgical Mesh for POP, July 13, 2011 (here)
MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders (here)
MND, March 2013, SUI Injury Reports to FDA up 36 Percent (here)
FDA Final Order – Letter to mesh makers for 522 studies, January 2012 (here)
MND, January 9, 2012, Mesh Makers who Received FDA Letter Requiring Postmarket Surveillance (here)
MND, AUGS Prolapse Consensus Conference Announced with Patient Advocates, October 16, 2016 (here)
Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” from the Pelvic Surgeons Network, January 2012 (here)
MND, What Happened to the FDA Request for Transvaginal Mesh Studies? September 19, 2012 (here)
June 4, 2012, Ethicon letter to Judge Goodwin, it plans to stop commercialization of four meshes (here)
MND Mesh-Injured Patient Researches ProteGen Mesh Predicate, November 8, 2011 (here)
News Release, April 4, 2018, Female Pelvic Implants Market to reach a value of over US $300 Mn by the End of 2027 (here)
BMJ, December 2017, Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process (here)
I had my mesh put in when I was38 now Im 53 and my life is over All I got to say to you people🙄
Actually sorry Im late could have a before when I had a Life and a good one and now🤗Would be an eye opener people donts even no me😶
I had mine in 2004 I was 41 years old and I`m now 56 and can`t have any kind of social life struggle every day some days good some days bad. Can`t have a relationship so that`s very troublesome. I am meshed up til I die.Struggle with UTI`s pelvic pain bladder is small incontinence irregular bleeding in the bladder vaginal area bacteria infections leg and back pain etc. The FDA should of woke up years ago. I will never have a normal life but I try every day to be more positive than negative and make the best of whats left. Keep your head up Heather we are warriors of mesh I don`t want to be painted a victim. Amen! God Bless every one of my meshed up sisters.
Shirley, I’m so sorry you are suffering so much. Your pain sounds similar to what I experienced. My mesh was in 2008, posterior and anterior mesh for organ prolapses. I was fortunate enough to be able to gather a good medical team but it was an effort. The important word here is team. The complications are complex and they need the expertise of many different experts. Just managing one of your pain generators can make a big difference in your experience of pain. My healers were a urogynecologist, pelvic floor physical therapist, a psychologist, a holistic physician, myofascial nassage therapist, a nutritionist, and chocolate. This fall I added colorectal surgery, GI, and Urogynecology at Mayo Clinic. The mesh had so invaded my pelvic structure that I had my rectum, two feet of my colon and vagina removed in a brutal surgery. I had 8 other major surgeries prior to this one.
Do you have a physician who is trying to help you at all? If not, please keep trying. There are some things that can help. UTIs are much more than just infection. They are pain generators as well. It causes you to brace your pelvic floor because of the pain. This tenses your muscles, then you brace some more and a cycle of pain ensues because tight muscles are painful and they keep getting tighter. This can also cause bladder spasms that lead to incontinence and things just fall like dominoes from there.
I know this sounds simplistic and it isn’t but there is not unlimited space here. But I do want to share a few things that helped me.
1. Break the UTI cycle. I had 8-10 a year after mesh because the urethra was shortened by all the scarring. My holistic doctor told me to take D-Mannose, a supplement that literally coats the bladder wall so bacteria won’t adhere to it. Jane has it on this site to order. It is cheap. I take one a day and have not had a UTI since 2015 when I started taking it. It was a lifesaver. Another cause of UTI is lack of estrogen. Vagina dryness promotes UTI infection because it provides less natural protection against bacteria. I use Estrace three times a week. Make sure your doctor is taking a clean catch specimen instead of a pee in the cup one. Sometimes you feel that it is an infection but pelvic pain instead causing the symptoms.
2. Muscle relaxers can help a lot to stop vagina and bladder spasms, either orally or vaginal suppositories. Common suppositories can be Valium, diazapam or combinations.
3. Pelvic floor therapy by a certified therapist can also help pain. It is painful at first, but no more than the pain I already had. She became a great source of support for me.
4. There are also some soft stretches you can do daily that loosen muscles and release your hips so that you can move with less pain. It is hard to move when you have so much pain, but motion is lotion and stretching , walking will not make you any worse. The book Ending Female Pain by Isa Herrera is wonderful.
5. Heat and ice are good tools but be careful with heat and it can be too much of a good thing. I had so much vagina pain and finally froze filled water bottles, put a sock on it then used it between my legs. It really helped.
6. Pacing is important. My doctor told me he wanted me to rest one hour for every two hours up. Hard for me to do because I’m kind of am not a good rester.
7. Of course, you know the power of mind over body. Focusing on positive instead of negative is a powerful pain tool as you have stated. There were many days it was hard to do but it can make a tremendous difference in how you move through your day.
Please don’t accept what is. Be a vocal advocate and insist on better comprehensive care. I thought I would never have a pain free moment. Then a physician referred me to Mayo for severe constipation which started after mesh. Thanks to 3D ultrasound, which is the only imaging that can pick up mesh and few facilities have it, they found that it had concreted my bowel to my pelvic wall, invaded my rectum and vagina, concreted around my rectum. They had to remove everything en bloc and I have a permanent colostomy. But, it was a price I was willing to pay. I can bend over, crouch down, walk, ride in a car, sit, breathe, do most of those things I took for granted before mesh. There are things I can’t do of course, but it’s ok. The surgeons I had at Mayo were unbelievable and never once discounted my pain or tried to explain it away as anything but mesh. The surgery was brutal and I ended up in ICU with blood transfusions but I’m still standing and giving thanks for my Mayo Miracle. Hang in there. I believe miracles are possible. I am one.
Keep fighting and always aggressively advocate for yourself and for interventions that will help you. The medical community owes that to each of us.
In 2007 I was also all meshed up !! 2 full sheets , what i’m told is 50/50 Chance I WOULD BLEED TO DEATH before they could even get close to fixing the mess ..Life sure changed 4 me .. and doctors don’t care they made their cash and the market made their profits .. I say all medical staff whom used that on us !! earned the right to also get messed up and live what we have had to ..