Category: Gynecologic

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A Big Hot Mesh Mess

On Tuesday, April 16, The Food and Drug Administration (FDA) officially forced the two remaining companies that sell medical mesh for transvaginal pelvic organ prolapse repair surgeries, Boston Scientific and Coloplast, to discontinue all sales in the United States. This bold and powerful move is one that many pelvic floor therapists have been long awaiting. For years, we have witnessed the deleterious effects that mesh has on our patients, and we have seen the extent of the damage it can cause. Finally, the FDA has gotten the memo, and they are prohibiting doctors from further usage of this product. Pelvic floor therapists around the world are breathing a sigh of relief and saying, “It’s about time.”

But let’s rewind a bit and provide some historical background. Gynecologists have been utilizing mesh since the 1970s to correct pelvic organ prolapse, also known as descent of one (or more) of the pelvic organs (bladder, uterus, and/or rectum). When the suspensory ligaments that attach to the organs or the supportive muscles beneath the organs weaken, the organs may descend lower than they should. Mesh is a device that provides additional support to the weakened tissue. Surgical mesh is typically comprised of either synthetic material or animal tissue. Mesh repair surgeries have been performed transabdominally as well as transvaginally. Both approaches have been deemed “controversial” in the past decade, especially after complaints began pouring in by the dozen. In fact, the 2016, the FDA acknowledged increasing concern by changing the former classification of transvaginal POP mesh from a “moderate-risk device” to a “high-risk device.” However, it wasn’t until last month that the product was recalled altogether…for treatment of POP.

But…mesh has also been used to treat stress urinary incontinence. It has been implanted transvaginally to support the bladder neck or urethra (also referred to as sling procedures). And yet, the FDA has NOT banned usage of mesh for these procedures because…your guess is as good as mine.

According to the FDA, approximately 10-15% of the 10 million women worldwide who have undergone these surgeries have experienced serious complications. Within the United States, more than 10,000 reported complaints of severe injury and eighty deaths as of last year. More than 100,000 people have filed complaints against mesh manufacturers at both the state and federal levels.

These statistics include both prolapse repair and urinary incontinence related surgeries. Shockingly, the FDA has only recalled mesh within the context of prolapse related surgeries. How many more women who have undergone sling surgeries will need to suffer before the FDA gets another wake up call? How many more reports will need to be filed?

Please allow me to be clear- my goal is NOT to frighten women who have undergone successful mesh repairs. If you have had a surgery involving mesh and are feeling better, mazal tov! I am thrilled to hear that, and I hope you continue to feel wonderful for many happy and healthy years. My very strong opinions are being expressed from the perspective of a therapist who has worked with the minority of mesh recipients who are struggling, of the ones who have experienced complications that include pain, infection, dyspareunia (pain during intercourse), urinary complications, bleeding, and/or organ perforation. So yes, I am extremely biased. And I am also biased against surgery altogether as a pelvic floor specialist.

Why are thousands of women being operated on, undergoing invasive and often unnecessary surgical procedures, for POP and urinary incontinence, both of which can be significantly improved with conservative pelvic floor physical therapy? Kate Haranis, a spokeswoman for Boston Scientific, foolishly stated that “the inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives.” (Oh yeah, by the way, she also admitted that transvaginal mesh accounts for $25 million in annual sales for the company.) I counter that the inaccessibility of these products will prevent further harm to suffering women who are given misinformation by their doctors. I also would wager money on the fact that Haranis has not done her homework on the benefits of pelvic floor physical therapy. She is not aware that studies have revealed that on average, pelvic floor physical therapy has been shown to reduce prolapse by one grade (out of four). I wonder if she has ever even heard of a pessary, another alternative to surgery.

Ladies, granted, we have won a big battle, but we are still fighting a war. The road ahead of us may be long and arduous, but we won’t quit. We pelvic floor physical therapists will continue to fight alongside you, and we will educate as many medical practitioners as possible about the benefits of pelvic floor physical therapy as the first line of defense against POP and incontinence.

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The Endometriosis Summit

Dr. Iris Orbuch sharing knowledge at The Endometriosis Summit
 

Mandie and other participants raise their hands while raising awareness during Endometriosis Awareness Month!

 

There are no words to describe how incredible The Endometriosis Summit was this past Sunday. “Mind-blowing,” “informative,” and “collaborative” don’t even begin to do it justice. Thanks to the extensive efforts of event co-chairs Dr. Sallie Sarrel, a pelvic floor physical therapist who specializes in endometriosis, and Dr. Andrea Vidali, a specialist in endometriosis excision surgeries and fertility preservation, close to 350 patients and practitioners gathered for this groundbreaking town hall meeting.

The keynote speaker was Heather Guidone, Surgical Program Director of the Center for Endometriosis Care in Atlanta, Georgia. Other speakers included a variety of surgical specialists, physical therapists, and individuals who have endometriosis.

Many important topics were discussed, and I would like to share several of the salient points that emerged from the conversation.

Dr. Iris Orbuch, a minimally invasive surgeon, emphasized the importance of early detection. She described the long, painful medical path endured by most young women with endometriosis. This nightmare of chronic pain coupled with failed medical interventions lasts an average of ten years before a proper diagnosis is made. Symptoms worsen while the endometriosis continues to grow and spread. Therefore, in order to prevent years of needless suffering and to optimize fertility, it is our duty as medical care providers to be familiar with the symptoms of endometriosis and to refer patients to endometriosis specialists immediately.

The mission of early detection is being spearheaded by Shannon Cohn, filmmaker, attorney, and endometriosis activist. Cohn, who was featured in a previous blog entitled “The Most Common Disease You Never Heard Of” (link to blog), has produced Endo What, a documentary about endometriosis. In addition, she educates school nurses about endometriosis in order to help them detect it in their students. They are often the first health care providers with whom symptoms are shared. The more knowledgeable they are about the disease, the more equipped they will be to suspect its presence and refer appropriately.

Dr. Allyson Shrikhande, a pelvic pain physiatrist who performs pelvic floor muscle injections to address overactivity, shared two red-flag signs for endometriosis. Namely, a history of difficulty inserting tampons and difficulty tolerating speculum examinations. She strongly encouraged using these indicators as guides.

Occult inguinal hernias may be a co-morbidity of endometriosis, and they can be a hidden source of pain. Dr. Mark Zoland is a general surgeon who has specialized in treatment of such hernias. He explained that many radiologists are focused solely on herniation of organs, not fatty tissue. However, fatty tissue which has herniated through the abdominal wall can compress nerves and result in pain the same way an organ might. Therefore, he emphasized the importance of having diagnostic studies read by doctors who will be on the lookout for fatty tissue herniation in addition to organ herniation.

Last but certainly not least, we had the privilege of hearing from one of my favorite pelvic floor physical therapists, Dr. Holly Herman. Dr. Herman has been practicing for over thirty-five years, and she is one of the founders and pioneers of pelvic floor physical therapy. On a personal note, she co-taught the first pelvic floor continuing education class that I ever took, and it is in part thanks to her that I fell in love with the specialty. In addition to her many contributions as a pelvic floor specialist, she is also a certified sexuality counselor, and she moderated a panel entitled “Safety, Sexuality, and Gender Inclusivity.” This discussion was eye-opening on many levels. The importance of avoiding binary language and respecting patients’ preferred titles was emphasized. Dr. Herman shared that one of the ways she does so is by asking her patients, “Do you have any sexual concerns or preferences that if I knew about, I could treat you better?” She reported that this open-ended question creates a safe environment for the patient, and that she has found it to be encouraging to individuals who may have had prior negative heteronormative experiences.

I would like to highlight one of the panel members, Cori Smith. Cori is a transgender endometriosis advocate and “Endo brother.” He explained to us that endometriosis is not only a “woman’s problem,” and that people should be aware that there are men who suffer as well. He encouraged the audience to reconsider the typical ways that we quote statistics and discuss the disease. For example, Cori aptly pointed out that the commonly quoted statistic, “On average, it takes over ten years for a woman to be properly diagnosed with endometriosis” could just as easily be stated with the more generic “it takes over ten years for endometriosis to be properly diagnosed.” It only takes a modicum of thought and sensitivity for ALL patients to feel comfortable.

There you have a small sampling of the information shared at the summit. I am so grateful that Mandie and I were able to experience this together and to learn more about this topic. We both look forward to applying what we learned at the summit to our patients and having the opportunity to help those suffering.