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Study: Insufficient Science to FDA Allows Med Devices On the Market

Power morcellator, Contemporary ObGyn

Power morcellator, Contemporary ObGyn

Mesh Medical Device News Desk, May 22, 2016 ~  The U.S. Food and Drug Administration (FDA) has put safety in the back seat in approving several high risk devices for obstetric and gynecological procedures, according to a study by researchers at Northwestern University.

Citing the problems with transvaginal mesh, power morcellators, and the Essure birth control device, researchers reviewed the 18 medical devices approved  by the obstetrics and gynecology advisory committees of the FDA between January 2000 and December 2015.

Focusing on the devices with the highest potential risk to patients, they found many made it to market based on flawed data from studies that were either too small or too short.  They conclude they should have undergone more rigorous pre-approval and post-approval scrutiny.

Devices include those for Endometrial Ablation (33%), where menstrual flow is reduced;   contraception (28%), such as Essure, a permanent sterilization device was approved after short-term evidence and insufficient post-market follow-up; and 17% were for fetal monitoring.

Northwestern Researchers Steve Xu MD and Jessica Walters MD

Northwestern Researchers Steve Xu MD and Jessica Walter MD

Transvaginal meshes and laparoscopic morcellators are two devices cleared through the less stringent 510(k) pathway of the FDA which requires little to no additional clinical evidence or postmarketing surveillance before clearance. Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with both devices, it may have provided earlier warning of patient safety risks.”

The information comes at a time the 21st Century Cures Act is under consideration by the Senate after passing the U.S. House of Representatives this month. It contains provision that would further reduce medical device regulation by widening what is considered “valid scientific evidence.”

 

BACKGROUND

Dalkon Shield was approved in the 1970’s had a string that was a pathway for bacteria leading to infertility and infection, septic abortions and death.  The dangerous device was the basis of passage of the 1976 Medical Device Amendment which granted the FDA authority to regulate medical devices.

Unlike drugs, the approval process for the majority of medical devices, even those permanently implanted, do not require clinical trials, randomized controlled trials or even post-market surveillance.

Meanwhile, drugs must undergo premarket approval which includes clinical trials involving humans.

 

Essure birth control device removed

Essure birth control device removed

THE FDA DEVICE REVIEW

Since approval of the 18 devices, the Northwestern researchers found three have been withdrawn from the market, two of which had failed to show efficacy in their clinical trials (fetal monitors, noninvasive). One was not required to be monitored after approval and removed from market because of patient safety concerns.

During this review, one-third of the 18 devices were not required to undergo postmarket review or studies.  Of the devices, 42% were approved based on nonrandomized controlled trials ranging from three to 48 months.

Four devices were approved even though they failed to demonstrate efficacy in clinical trials.

The advisory committee recommended 9 devices for approval and recommended three devices not be approved.   The committee recommended against approval of both the Stan S31 Fetal Heart Monitor and the LUMA Cervical Imaging system.

The median approval time was 290 days from application to market.

Intergel, made by Gynecare Worldwide (J&J), was an adhesion prevention gel solution put in an open abdominal cavity to keep tissues from sticking together during the healing process. After two years on the market, Gynecare Intergel was withdrawn April 16, 2003 here  due to reports of serious foreign body reactions and postprocedure pain.

The committee recommended against approval of Intergel which did not demonstrate significant differences compared with its control.  During its review, Intergel required no additional postmarketing studies outside of adverse event reporting.

Essure, a permanent birth control device, is currently undergoing increased regulatory scrutiny as a result of complications reported to the Manufacturer and User Facility Device Experience database (MAUDE).

Essure’s approval was based on a prospective single arm study with a primary outcome of pregnancy at one year.  It was approved through the premarket approval pathway “with insufficient long-term evidence and postmarket surveillance requirements” say researchers.

The researchers conclude there are “significant weaknesses” in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices. They recommend more rigorous clinical studies before and after devices make it to market.

“The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” says Dr. Steve Xu the lead researcher.

The study is published in the journal Obstetrics and Gynecology, May 4, 2016, here.

While industry argues that more regulation will slow innovation, the researchers say there is limited evidence to support that assertion.

 

LEARN MORE:

Northwestern Press Release here

J. of Obstetrics/Gynecology, May 4, 2016, Abstract here

 

6 Comments

  1. Kitty says:

    It’s gruesome and painful when the eroding mesh pulls on the sacral nerve all the way down….somtimes passing the lower leg and then settles into the feet

  2. Bejah Blue says:

    As a species we are losing our humanity, failing our obligation as one of the most sentient creatures on the planet, an obligation to hold life as sacred. With regard to this medical devices industry…it has long been said that like Shelly’s Frankenstein (A portent of what was to come) in the name of science we create monsters, not so much of the pieces of others lives, the lives of other mammals and even other homo sapiens, but in the case of these devices, those who bear our children ensuring the continuation of humanity as “Frankenstein weeps”. It seems that increasingly we have no sense of the sacred, and the “mad scientists” and their business partners as it were, have conjured a way to legally (sort of, through influence peddling and promises of the Golden Fleece) use women and men as experimental animals with impunity and w/o meaningful punishment, motivated by golden riches and the promise of a throne in the “Devil’s Garden”. So where is our humanity? I think we all know of many other mammals and other creatures that exhibit far more humanity than we do and this outside of instinctual response. So what are we evolving into? And remember, fair warning, other life forms on this and other worlds is evolving as well. Truly, it is and always has been, “A brave new world” perhaps not in the way we imagined in our innocence, long passed.

    No myth, no cautionary tale, no warnings from the visionaries passes through the armor of lust for fame an fortune, and so humanity (And I say that because we are our brother’s keeper, and one species, ) can save us from what seems a very bleak future as a species.We butcher our own people and then present an appalled front when we see genocide in other nations.

    It is also said that the mentally ill, and specifically those “suffering from Narcissism” deny that they are unwell and like vampires continue to feed on their own people.

    Bejah

  3. Elizabeth says:

    Hi, I had a Coloplast transvaginal mesh implanted back in October of 2015. It was implanted laproscopiclly. I have had nothing but problems, excruciating pain from this surgery. I cannot live my day to day life as I use to. I am having this reevaluated by another doctor. I know all these lawsuits are for women that had the implant done vaginally, but what about the women that had the surgery done thru their abdomen? My pain in a daily basis is a 9-10. The symptoms are the same as the women that have had this procedure done vaginally. I am going to physical therapy as well, and it is not working. I am at a loss, and am coming close to quitting my job, because I just cannot perform my duties fully. Any advice would be helpful. Thank you, Elizabeth.

    • Jane Akre says:

      Elizabeth I know there are some law firms taking the abdominal placement cases. You might try the lawyer evaluation on page one of this website. I’m not up to date on who those law firms are, but David Moyer who runs Sundown Marketing does! I would ask for several referrals to see who I like best.

      • Elizabeth says:

        Thank you very much.

        • Still Standing says:

          Elizabeth, I’m so sorry you were implanted and so recently. A pain level of 9 on a daily basis is not something you can sustain physically or emotionally. Have you explained it in detail to your physician? How long have you been going to physical therapy. Are they doing any internal work? Are you able to do some work at home in between your PT? PT helped me a lot, but that was done in conjunction with some pretty specific medications..amitriptyline, zanaflex, baclofen vaginal suppositories( these help me a lot) , gabapentin, trigger point injections, lots and lots of rest, estrace. I had to quit my job, couldnt sit, couldnt ride in a car, couldnt even think. I remember those “10” pain days. Have them still on occassion but please know there is some hope. I had no consistent relief until I had removal surgery. It took several surgeries to get it out, but I had posterier and anterior mesh placed at the same time and it really did some damage. I will be glad to talk with you via phone if you need some moral support. Jane has my contact info and has my permission to share it with you. Hang in there. I know that is hard to do on many days.

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