Mesh Medical Device News Desk, January 21, 2019~In an effort to keep alive the mid-urethral sling (MUS) as an option for women experiencing incontinence, a medical society has written a letter to oppose the upcoming trial of Washington State v. Ethicon.   Mesh News Desk now has the letter.   

Subscribers to MND can obtain a copy. Contact:  janeakre@meshnewsdesk.com.  Click here to subscribe @ $52 yr.

Here is a summary.

The letter is dated December 9, 2018.It was written by Jeffrey L. Clemons, MD, a urogynecologist from Tacoma, Washington, and it claims to represent 63 surgeons who object to the Attorney General of Washington’s lawsuit against Ethicon.

Their concern – That the mid-urethral polypropylene mesh sling will be eliminated as a treatment option for women in Washington State as a result of the lawsuit.

Mesh News Desk has obtained a copy of the letter after requests to AUGS and the AG’s office were denied.

State of Washington v. Johnson & Johnson, Ethicon, filed May 24, 2016, is set to be heard in Kings County Superior Court April 22, 2019. The state wants to be reimbursed upward of $24 million alleging that Johnson & Johnson deceptively marketed its pelvic mesh to women living in the state and the state advanced the costs to care for these injured women.

The state estimates J&J sold more than 12,000 of its polypropylene devices in Washington State between 2002 and 2015 in violation of the Consumer Protection Act in Washington. Devices include polypropylene mesh used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Kentucky, California and Mississippi soon followed with their own AG-generated lawsuits against Ethicon, also seeking reimbursement for dollars spent on treating injured women and alleging violations of the state consumer protection laws.

 

THE LETTER – WHAT AUGS WANTS 

Dr. Jeffrey Clemons, ABC News

The letter, advanced by AUGS, the medical society representing about 1,900 members of the American Urogynecology Society, was placed in the hands of the media which generated a number of stories at the time, among them an AP and ABC News story (here and here).

Among the 63 surgeons who signed onto the letter, Clemons admits three have been retained by lawyers for Johnson & Johnson, in connection with the state lawsuit, however, “this letter was physician generated, and was written without any assistance or payment from Ethicon.”

“Some of us have done research that raised awareness of the complications from transvaginal mesh for POP that led to the FDA notification in 2011.  We also advocate for women suffering from SUI whose quality of life is improved by the mid urethral sling. With its high efficacy rates, low complication rates, and minimally invasive approach, the mid urethral sling revolutionized treatment for SUI. Millions of women worldwide have been safely and successfully treated for SUI since the advent of the mid urethral sling.”

The lawsuit alleges physicians treating women were “deceived or misled by Ethicon when we made treatment decision related to these devices” because the Instructions for Use (IFU) were inadequate.

Dr. Clemons replies that doctors do not rely on the IFU to counsel patients.  Instead they rely on their medical education, medical journals, conferences and medical society guidelines.

AUGS receives about half of its support from industry as its annual breakdown shows, and leadership is often called in as company consultants or “preceptors” as has been revealed at many product liability trials.

“It is astonishing that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group.”

Clemons says the state is mixing the problems with prolapse mesh, a much larger mesh, with mid urethral slings, a smaller mesh used to support the urethra.

“These issues need to be viewed separately.”


INFORMED CONSENT

Art by Jay Lee

The letter says sling complication rate includes 2% for mesh exposure, ie erosion, and urinary retention at 1% with a higher exposure rate for POP mesh. But he notes it “varies with surgeon experience and technique; similarly, mesh erosion and chronic pain rates are higher for transvaginal mesh than for slings.”

The letter says unwarranted fear is caused for patients when the AG complaint states that polypropylene mesh is linked to cancer and should not be implanted in the human body.

Interestingly a 60 Minutes story from May 2018 also featured a polymer expert who echoed the same sentiments, that polypropylene should never be implanted in the human body. Read it here.

The loss of the mid urethral sling would be a “setback of 20 years of surgical progress for women’s health,” he writes.

“Our patients are appropriately counseled” on the use of slings, he writes, though there is no consensus at the present time on the actual injury rate following a mesh implant. Dr. Shlomo Raz, of UCLA, a world renowned mesh removal surgeon, no longer uses mesh because he sees complications ten years after an implant.  Most studies attempting to quantify the complication rate are short-term.

The most recent, done in the UK, an English National Health Service database study notes the mesh sling removal rate of “only 1.4% at one year in over 90,000 women 2.7% at 5 years in over 52,000 women, and 3.3% at 9 years in almost 7,000 women.”

POP mesh, Elevate by AMS

Six years after the Food and Drug Administration ordered mesh makers to undergo studies to reveal how women with POP implanted mesh are faring. The information contained in the post-approval 522 studies has not been made public.

The studies are ongoing” the letter states, but a look at the FDA’s 522 database finds most mesh makers have dropped their POP mesh from the market.

Of the 33 POP mesh makers who were ordered to conduct 522 studies, only ACell (here), Coloplast, Boston Scientific are still looking at the patients implanted with their mesh medical devices.  Dropping a mesh from the market allowed a manufacturer to curtail its 522 study, despite the fact that the mesh remains in the patient.

In an email, an FDA spokeswoman would not reveal to Mesh News Desk, which of the POP meshes are presently cleared for market.

See the 522 orders here.

Polypropylene does not cause cancer nor does it cause autoimmune disease, write the authors in this letter to Washington State. Anecdotally, many women report the onset of an autoimmune response to their mesh including Lupus, fibromyalgia, rashes, loss of hair and teeth.  Studies are underway to determine the link.

Complication rates are within the accepted norms, it states.

“We are neither pro-mesh nor anti-mesh. We are pro-science, and science and evidence must lead the way,” says the letter, in lockstep with a recent statement by AUGS.

 

LEARN MORE:

[PLEASE SUPPORT REPORTING IN THE PUBLIC INTEREST **  Subscribers to Mesh News Desk can receive the letter, the Washington State and California Complaint, along with links to many stories and additional content!   Contact:  janeakre@meshnewsdesk.com

MND, Surgical Mesh Crisis: Regulatory Action & Inaction Here

MND, Kentucky AG Files Deceptive Marketing Lawsuit Against Johnson & Johnson Over Surgical Mesh, August 16, 2016, Here

Washington State AG Office PRESS Release Here

New York Times, April 14, 2018, AUGS often cites the New York Times article “How Profiteers Lure Women Into Oft-Unneeded Surgery”.