Med Device Expert LLC

(c) 2005-2014 Lana C. Keeton. All rights reserved.

While there is no mandate to label medical devices for patient consumption and information, the HHS/FDA have an ongoing "FDA Label Man" Campaign, complete with mascot, to make sure Americans know what the ingredients are in their cereal.

The Unique Device Indentifier (UDI) regulations will not be mandatory, nor reported by patients. It is for doctor/hospital/FDA knowledge. Patients need to know what is permanently implanted in their bodies, certainly more than their morning cereal.

 Lana Keeton and Chef at Health & Human Services (HHS) headquarters in the Hubert Humphrey Bldg in Washington, D.C. 03-28-2012. (pic above)























 Synthetic Surgical Mesh: Life-Threatening Medical Device

By Lana C. Keeton, Medical Device Expert

Legal Consultant/Research Analyst

1602 Alton Road, #423, Miami Beach, FL 33130

(all rights reserved 03-06-2010)


            Synthetic Surgical Mesh is a life-threatening medical device. It is frequently described as the “new gold standard” because it is popular, not because it has been proven safe and effective. Short term complications include infection and urinary retention, while long term complications are de novo urgency and urethral and vaginal erosions.


            “Using a transverse vaginal incision for the TVT procedure can be another risk factor for vaginal erosion, as the sling material contacts with the suture line for a longer distance compared with vertical vaginal incisions. The incidence of vaginal erosion in our patients decreased significantly after we decided to use vertical vaginal incision, as originally described by Ulmsten, in the TVT procedure.”


            Doctors are misled by rosy medical marketing showing high cure rates and very low complications. (There are no randomized controlled trials to support these numbers, just press releases from the makers of the mesh.) Patients are told nothing. Frequently they do not even know mesh has been implanted in them. If the patient does know the doctor has used mesh, there is no readily available information telling them exactly what mesh has been permanently surgically implanted or how to deal with the complications. Patients are left in the dark.


            Future medical treatment for the serious complications of mesh becomes a mine field. The body’s own natural inflammation process, by which the surgical mesh adheres to internal tissues, never reaches the healing phase. A cascade of complications follow as chronic inflammation sets in. Autoimmune diseases multiply as the body fights the chemicals leached by the foreign body polymer(s), polypropylene, polyethylene terephthalate, etc. All petroleum-based synthetic surgical meshes create havoc in the body as each leaches its own proprietary blend of chemicals.


Synthetic Surgical Mesh must be taken off the market (except for the rare cases when there is no human tissue available to close the defect). Long term consequences, including autoimmune disease, have never been studied and many complications are not recognized as related to surgical mesh.


Patients suffer permanent, long term debilitating complications including chronic pain, nerve damage, inability to sit, to walk, to have sex, to work and perform daily tasks in their own lives. Some become pelvic cripples, bedridden and/or wheel chair bound, all because of a filthy piece of petroleum waste by-product. This has to stop.