“What Insect repellents are safe during pregnancy?”

ANUSHKA CHELLIAH, MD, AND PATRICK DUFF, MD (JUNE 2016)

Alternatives to DEET

Picaridin is not mentioned in this brief report from Drs. Chelliah and Duff. I suggest reviewing the July 2015 Consumer Reports article on repellents; picaridin is a likely safer alternative to DEET, with the highest efficacy of all those tested, at least in Sawyer Fisherman’s Formula Picaridin Insect Repellent and Natrapel 8 Hour Insect Repellent. Products that have little or no efficacy also were not mentioned, including Avon Skin So Soft, Coleman Naturals Insect Repellent Snap Band, and SuperBand Wristband. In addition, the concentration of products is very important, as is the precise formulation within brands. For example, Off! Deep Woods VIII (with DEET 25%) is very effective versus Off! FamilyCare II Clean Feel (with picaridin 5%), which has very little benefit.

David H. Janowitz, MD
Houston, Texas

Drs. Chelliah and Duff respond

In our short discussion of mosquito repellents, we based our recommendations on publications from the Centers for Disease Control and Prevention (CDC) and the Florida Department of Health. Those publications presented DEET (N,N-diethyl-m-toluamide) at the top of the list for preferred repellents. A recent publication from the Organization of Teratology Information Specialists (MotherToBaby, September 2013) indicated that, in a concentration of 20% to 30%, DEET was safe in pregnancy and was effective in protecting against 90% of all mosquito bites and tick attachments. Increasing the concentration of DEET above 30% does not enhance the product’s effectiveness or prolong its duration of action.

However, Dr. Janowitz is correct in stating that other agents are also highly effective and safe in pregnancy. These agents include picaridin (20%) and oil of lemon/eucalyptus (30%). We thank Dr. Janowitz for directing us to the most recent testing program conducted by Consumer Reports.¹ That testing program demonstrated that Sawyer Fisherman’s Formula Picaridin and Natrapel 8 Hour, which each contain 20% picaridin, and Off! Deep Woods VIII, which contains 25% DEET, kept Aedes mosquitoes from biting for approximately 8 hours. The Sawyer product was also effective in preventing bites from the Culex mosquitoes, which carry West Nile virus, and deer ticks, which can transmit Lyme disease. Repel Lemon Eucalyptus (30%) stopped Aedes mosquito bites for 7 hours.

In the Consumer Reports testing program, IR3535 products, which we recommended in our article, did not perform well, nor did repellents that contained only 7% DEET or less than 20% picaridin. Moreover, products made from natural plant oils—such as citronella, lemongrass oil, cedar oil, geraniol, rosemary oil, and cinnamon oil—were not particularly effective. Some did not last for more than 1 hour; some failed immediately.

When applying any of these products, individuals should observe the following guidelines:

apply insect repellents only to exposed skin or clothing
do not apply repellents on cuts, wounds, or abraded skin or immediately after shaving
avoid the eyes and mouth when applying repellent to the face
after exposure is over, wash the skin with soap and water
clothing that has been treated with one of these agents or with permethrin should be washed separately before it is worn again.

Reference

Byrne S. Mosquito repellents that best protect against Zika. Consumer Reports. http://www.consumerreports.org/insect-repellents/mosquito-repellents-that-best-protect-against-zika/. Updated April 16, 2016. Accessed July 25, 2016.

“Tissue extraction: Can the pendulum change direction?”

ARNOLD P. ADVINCULA, MD (JUNE 2016)

We have met the enemy and he is us

While I share the optimism Dr. Advincula expressed in his recent guest editorial regarding a change in the direction of the pendulum that swung away from use of the power morcellator, I feel compelled to express the opinion that this entire fiasco has been nothing other than an outrageous regulatory overreach.

Shortly after the US Food and Drug Administration (FDA) issued its proclamation in April 2014, the Society of Gynecologic Oncology repudiated the bogus statistics that were being used to describe the incidence of leiomyosarcoma and, further, stated that it would not matter how someone’s uterus containing this rare tumor was removed because the outcome would be poor. Similarly, the American Journal of Obstetrics and Gynecology published an article enumerating the expected significant increase in complications and the resulting misery that could be expected for patients whose management was diverted from minimally invasive to open hysterectomy.¹ The AAGL also expressed opinions that this was an unnecessary, and counterproductive, policy—all to no avail.

My optimism, however, is tempered by a number of questions: 1) Why did it take more than a year for 36 nationally recognized gynecologic surgeons to write a letter to the FDA denouncing the warning, yet again, and reiterating the errors in analysis used to establish the policy? 2) Why are gynecologic surgeons only now being asked to serve in the FDA’s Network of Experts? Should not that have been the case before the warning was issued? 3) If the perioperative outcomes are similar using a containment bag compared with open morcellation, what is the benefit of using the containment system? I, for one, think that prolonging a procedure another half hour is significant.

The FDA’s egregious policy clearly has had a net negative impact on the welfare of our patients. The gynecologic surgeon community should have pushed back more forcefully and effectively. I hope the next time something like this happens (and it will) we can be better advocates for our patients.

Mark S. Finkelston, DO
Shawnee Mission, Kansas

Reference

Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1−e8.

Dr. Advincula responds

I thank Dr. Finkelston for his thoughts regarding my editorial. There is no doubt that the issues surrounding tissue extraction have been heated. Although I do not have definitive answers that explain all of the various reactions, whether immediate or delayed, to the cascade of events surrounding morcellation, I do believe that much of it was a response to N-of-1 policy-making, as very nicely discussed in a New England Journal of Medicine article by Lisa Rosenbaum.¹ We must continue to foster constructive dialogues with our regulatory bodies and cultivate the spirit of innovation that has brought so many advances to the field of surgery. Ultimately, going forward, it will be important for clinicians and other health care providers to speak up and not remain silent for fear of being vilified.

Reference

Rosenbaum L. N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation. N Engl J Med. 2016;374(10):986−990.

Vaginal hysterectomy solves the tissue morcellation dilemma

Dr. Advincula starts his guest editorial with the statement, “With practical, evidence-based, sound clinical judgement, I believe that it can.”

In fact, what “practical, evidence-based, sound clinical judgement” supports is a return to vaginal hysterectomy with transvaginal extracorporeal morcellation techniques. As Dr. Carl Zimmerman said in a recent debate at the Society of Gynecologic Surgeons (SGS annual meeting), “There is no recorded case of a vaginal hysterectomy with morcellation upgrading a patient with leiomyosarcoma.” In addition, the majority of cases in which Dr. Advincula and others are performing robot-assisted laparoscopic hysterectomy or total laparoscopic hysterectomy have this clinical and demographic profile: average age, 42; average parity, G2; average body mass index, 30; most common diagnosis, abnormal uterine bleeding, fibroids; most common pathology, fibroids; average uterine weight, 165 g. The majority of these can be performed much more safely, quickly, and cost effectively by transvaginal hysterectomy/morcellation. Please see an excellent commentary by Dr. Andrew Walter, immediate past president of SGS, on “Why we should strive for a vaginal hysterectomy rate of 40%.”¹

But the main reason Dr. Advincula should not be given a voice on this issue is because he has significant financial conflict of interest with the medical device industry. Should he even be on the OBG <scaps>Management</scaps> board of editors? I do not believe the rest of your editors have anywhere near his level of conflict of interest. Should he not be asked to recuse himself in this debate or abandon his financial connections with the medical device industry? Is this not the whole purpose of the Sunshine Act? Please, should you not be supporting what is in the best interest of our patients and payers?

R. Bruce Councell, MD
Asheville, North Carolina

Reference

Walter AJ. Why we should strive for a vaginal hysterectomy rate of 40%. ObGyn News. http://www.obgynnews.com/?id=11146&tx_ttnews[tt_news]=505393&cHash=d0dd4348213d571a2dd0f7c6a6873091. Published May 6, 2016. Accessed July 27, 2016.

Dr. Barbieri responds

At OBG Management, we wholeheartedly agree with Dr. Councell that vaginal hysterectomy is an excellent approach to removing the uterus in most women with noncancer indications for surgery. Our recently featured articles focused on vaginal hysterectomy include: “Transforming vaginal hysterectomy: 7 solutions to the most daunting challenges,” “Is energy-based vessel sealing safer than suturing for vaginal hysterectomy?,” Is same-day discharge feasible and safe for women undergoing vaginal hysterectomy?,” and “Can we reduce the use of abdominal hysterectomy and increase the use of vaginal and laparoscopic approaches?” We plan to publish more content on advances in both vaginal and laparoscopic surgery.

We are proud to have Dr. Advincula, an internationally recognized leader in gynecologic surgery, serve on the OBG Management Editorial Board. His expertise and perspective is of great value to our readers. It is true that many leading surgeons, including Dr. Advincula, serve as consultants with manufacturers of surgical devices. Working together, clinical experts and device manufacturers help to advance medical care. In his editorial, Dr. Advincula did disclose these relationships. As a check on the quality and balance in our editorial material, I personally review all content and I have no financial relationships with any pharmaceutical or device manufacturer.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Letters to the Editor: Alternatives to DEET for pregnant patients; Tissue extraction