Mesh / Medical Device News DeskOct 19th, 2011 | By Jane Akre | Category: Welcome- Why We're Here
Many years from now the public will probably look back and say “They put permanently implanted medical devices in people without any scientific review for safety? ” By then it may seem a perfectly normal question, but for now, Mesh/Medical Device News Desk (MDND) is devoted to telling the stories of the Faces Behind the Adverse Events, complications, injuries and deaths from the implantation of synthetic medical mesh for hernias, pelvic organ prolapse and incontinence.
The truth is- no one really knows what the complication rate is. That’s because there is no tracking after surgery. It’s only when you put a face on the growing number of folks with “adverse events” that the enormity of the problem becomes apparent. Injured patients are tired of suffering in silence and with the July 13th FDA notification as backing they’re finally joining a chorus of voices of others with complications asking How did this happen? and crying out for both information and regulation.
What’s the problem?
Whether a systemic reaction – a sort of host response, a materials breakdown, or the biokinetics of having a hard piece of plastic implanted in soft tissue and bone, all sorts of adverse events are being felt by mesh patients, both women and men. If you haven’t had a negative reaction- congratulations! No one wishes that upon you but the fact that a) there is no premarket scientific review for mesh and b) no one really knows the adverse event rate since followup is not required and c) mesh has been aggressively marketed to doctors and patients as a new and improved solution, and you have the perfect storm of an ideal population group, large profits, and little to no regulation.
And while injured citizens have brought about two FDA public health notifications about adverse events, the FDA continues to be bashed about the head by the medical device industry that says get off my back, by venture capitalists who say they will launch new devices overseas first because of a restrictive regulatory environment in the U.S., and lately by some in Congress who hope to “reduce regulatory burdens” on medical device makers.
How will the FDA respond to this pressure?
Given the industry influence will it be able to increase much-needed patient protections? An expert panel that gathered in early September 2011 to try and understand a five-fold spike in devastating complications will decide whether or not to make surgical mesh a Class III device, which means finally some premarket testing and regulation.
I appreciate the conversations and the intelligence of the readers have become very smart out of necessity and pain. The passion and commitment many bring to this perfect storm of patient injury is amazing!
Thank you for joining in the conversation! Your email addresses will not be visible and I WILL NOT share them with anyone unless I ask you first!! Promise!!
Information contained is not intended to substitute for a conversation with your doctor or lawyer. Information belongs to Independent News Group LLC and permission is needed to reproduce but certainly not to link!
Jane Akre, News Editor MDND
THE READING ROOM
Resources – Where to Start and What you need to advance your knowledge about surgical mesh
Support Groups/ guidance to lawyers, doctors- The following are groups of mesh injured patients who share a tremendous amount of information out of necessity and pain.
TVTNo.org, a newly formed nonprofit organization to help women find resources. Donations are welcome! Established by Teresa Sawyer, a mesh victim, and her husband David.
Mesh Medical Device News Desk
MDND FB group
Medical Mesh Legal Support
TVT-No Mesh Survivors
National Meshoma Foundation – Bruce Rosenberg 1-954-701-5094- Rosenberg patient advocate advocating for men injured by mesh for hernia repair
TVT Mum- UK site for mesh injured patients
Meshies United Group – UK
Meshed Up- European Union site for mesh sufferers in The Netherlands
Change.org- Petition for Accountability by Mesh Device Companies
Earl’s View – Earl Stevens Blog on Artificial Hip Medical Devices
Australian Woman’s Facebook page on Mesh
*! Be Aware of any Health Resource that may be solely sponsored by industry alone
October 2008- Medical Device Alert and Notice, October 20, 2008 – This was the first FDA Public Health Notification about complications associated with surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
July 2011- Alerts and Notice, July 13, 2011 – This was the second notice – FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical mesh for Pelvic Organ Prolapse,
This is a much more strongly worded caution about surgical mesh questioning whether benefit is worth the risk, but falls short of a recall. See symptoms the FDA has received from its adverse event database here.
FDA White Paper on Mesh, July 2011, an excellent summary
How to Post an Adverse Event with the FDA
Institute of Medicine, July 29, 2011 – One hour briefing public discussion following a special independent report on the FDA’s 510(k) approval process
The IOM Report, July 29,2011 – The report calls the 510(k) process which allows high-risk medical devices onto the market with no clinical trials “fatally flawed” www.iom.edu/510kprocess
American College of Obstetrics and Gynecology (ACOG) & American Urogynecological Society (AUGS) – Both professional societies issued a Joint Recommendations, November 21, 2011, that the use of synthetic mesh placed vaginally for the treatment of pelvic organ prolapse “should be reserved for high-risk women for whom the benefit may justify the risk.” The groups urge a national registry to track outcomes after placement.
Reporter Laura Newman reports on the medical industry from the patient point-of-view.
Public Citizen- issued a petition July 2011 to have synthetic surgical mesh recalled from the market.
Dr. Lewis Wall- Washington University
Dr. Daniel Elliott – Mayo Clinic
Consumers Union- November 15, 2011, In a letter to Congress, Consumers Union urges medical device oversight and a rigorous review by the FDA for implantable medical devices so they do NOT get approved by the 510(k) process. Also calls for a issued a call for a patient registry and removal from the predicate list any device that has been recalled.
Consumers Union – Safe Patient Project
WEB SUPPORT/ DISCUSSIONS
Topix- Hernia Mesh Patch Recall
Topix- Marlex Hernia Mesh Patch
Topix- Lawsuit filed GyneCare TVT
Topix- Injured by Ethicon’s Prolene Hernia/ Bladder Mesh?
Topix- Ethicon Suture Recall
Earl Stevens Blog on Artificial Hip Medical Devices
Diane Fichter’s Blog