“PELVIC MESH” - WHAT’S CHANGED SINCE JANUARY 2016? HAS THE FDA LOOKED CLOSER AT THE THOUSANDS OF FILED ADVERSE EVENTS? MESH IS NOW A CLASS III HIGH RISK MEDICAL DEVICE

Who’s Telling Who About The High Risk Of Synthetic Surgical Mesh?

By Mark A. York (February 21, 2018)

Do you want polypropylene “fishing line” in your body? That’s what surgical mesh is made of.

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) FDA labels pelvic mesh as a “High Risk Medical Device” yet minimal review, investigation or action has been undertaken regarding the thousands of annual adverse events that are recognized in the medical industry as caused by “plastic or synthetic mesh” which is comparative to high quality polypropylene fishing line, which in both mesh and fishing line is available in various strengths. Is this something that’s either disclosed by your doctor and would it have an affect on your surgical decision?

WHO DISCLOSES RISK?

In January 2016, 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. Are healthcare professionals and surgical mesh manufacturers making sure this is a known factor in pre-surgical decisions? If notice to the public of the high risk designation of surgical mesh devices follows historical medical device manufacturers standards, that answer is an emphatic “NO”- medical device makers and their sales and marketing staff do not advertise or declare FDA and other regulatory defined risks to the public unless forced to, which includes patients undergoing surgeries. You physician may disclose whatever minimal product warning or risk statements that they’ve been provided by the medical product manufacturer.

DOES THIS HELP PATIENTS?

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 these 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 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.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

WHAT IS MESH?

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

MESH REPAIR VERSUS SUTURES

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 repair in 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.

50,000+ MESH LAWSUITS FILED

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.  For more information see Mesh Litigation Briefcase -50,000 Cases Pending and More Each Day along with TVM mesh cases there are now two more “hernia mesh” multidistrict litigation cases , designated as “Ethicon Physiomesh MDL 2782 (Ethicon Physiomesh MDL 2782 Briefcase Re: Hernia-Mesh-Litigation) and the Atrium Medical C-Qur Hernia Mesh MDL 2753 (ATRIUM MDL 2753 Re: C-QUR-HERNIA-PATCH Briefcase) these case apply to synthetic hernia mesh complication with adverse systems and long term medical complications, being the same as those alleged in the massive TVM litigation, which are pending in federal court across the country.

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.

WHY WAS THERE AN FDA DELAY?

The FDA first proposed the 2016 changes in 2014 draft orders, why would a regulatory safety agency wait two years to announce the high risk designation of a product being used over 200 thousand times a year in the USA? This reflects the back office control and influence of the medical manufacturing industry as a whole and how they use influence to defer and often stop disclosure of adverse risk s related to the medical products they sell to consumers. Profits before patient in the general rule in most device manufacturer boardrooms..

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. This has resulted in billions of dollars in profits for major medical manufacturers and the medical field as a whole, while thousands and thousands of patients have been afflicted with life changing post-surgical complications and until the FDA or other parties make the high risks known, many thousands more patients will have plastic products surgically implanted into their bodies, without knowing the true risks.


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