UPDATE: On May 26, 2023, the FDA issued the final guidance: Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures. This final guidance provides recommendations to help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general use laparoscopic power morcellation containment systems (tissue containment systems), as well as other non-clinical testing recommendations to support a 510(k) submission. This final guidance document is focused on non-clinical performance testing; additional information, such as clinical data, may be needed to demonstrate substantial equivalence.
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Laparoscopic power morcellators are Class II medical devices used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or less).
These devices are commonly used in hysterectomy (surgical procedure to remove a woman's uterus) and myomectomy (surgical procedure to remove uterine fibroids which are noncancerous growths in a woman's uterus).
Laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to a hysterectomy or myomectomy done through an abdominal incision.
Uterine sarcoma (a type of cancer) is more common in women undergoing surgery for uterine fibroids (noncancerous growths in a woman's uterus) than previously thought, and it can be hard to distinguish between a uterine sarcoma and a uterine fibroid before surgery with available tests. When laparoscopic power morcellators are used for myomectomy or hysterectomy in women with presumed uterine fibroids that are actually uterine sarcomas, the surgical procedure poses a risk of spreading cancerous tissue beyond the uterus, worsening a woman's chance of long-term survival.
The FDA estimates that a hidden uterine sarcoma may be present in approximately 1 in 225 to 1 in 580 women undergoing surgery for uterine fibroids based on published literature. The FDA also estimates that a leiomyosarcoma (a specific type of uterine sarcoma) may be present in approximately 1 in 495 to 1 in 1,100 women undergoing surgery for uterine fibroids based on recent studies. Before 2014, the clinical community estimated uterine sarcomas to be present much less often, in as few as 1 in 10,000 women undergoing surgery for uterine fibroids.
Several studies show that using a laparoscopic power morcellator during gynecologic surgery in women with hidden uterine sarcomas is associated with lowering their chances of long-term survival without cancer. While these studies have limitations, women who have had fibroid surgery with a laparoscopic power morcellator later found to have a hidden uterine sarcoma, have lower disease-free survival (less time without any sign or symptom of cancer after surgery), when compared to women who were treated with manual morcellation or without morcellation. In addition, there are data to suggest an increase in rate of occult sarcoma (cancer that cannot be identified during pretreatment evaluation) for women undergoing surgery for presumed fibroids.
The FDA recommends health care providers share this information with patients and warn against using laparoscopic power morcellators in gynecologic surgeries to treat patients with suspected or confirmed cancer and in women over 50 years of age having a myomectomy or hysterectomy for uterine fibroids.
Uterine sarcomas and uterine fibroids may have similar signs and symptoms, so it may be difficult to determine whether cells are cancerous. At this time, there is no reliable method for predicting or determining whether a woman with fibroids may have a uterine sarcoma. Patients should talk with their health care provider about preoperative screening and whether using a laparoscopic power morcellator for their gynecologic surgery is appropriate for them.
Health care providers and informed patients can work together to choose the best treatment approach based on known risk factors for uterine sarcoma (for example, age, exposure to pelvic radiation therapy, prior use of the drug Tamoxifen, and race). For some patients, the benefits of minimally invasive surgery with a laparoscopic power morcellator may outweigh the risks. These patients may include some younger women who wish to maintain their fertility.
The FDA recommends that health care providers use tissue containment systems when using laparoscopic power morcellators, and that they ensure the laparoscopic power morcellator and tissue containment system are compatible. The FDA previously issued the guidance, Product Labeling for Laparoscopic Power Morcellators recommending that laparoscopic power morcellator labeling include a statement that the device should only be used with a containment system.
The FDA granted marketing authorization for tissue containment systems that are intended for use during gynecologic laparoscopic surgery and tissue containment systems that are intended for use during general laparoscopic surgery. The FDA issued the final guidance on Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures to provide recommendations on non-clinical testing information to include in a premarket submissions. Laparoscopic power morcellation tissue containment systems are intended to isolate and contain tissue that is considered benign (noncancerous). Based on non-clinical testing, use of a tissue containment system confines morcellated tissue within the containment system.
Use of laparoscopic power morcellators allows for minimally invasive surgical procedures, which, when compared to open abdominal surgery, typically reduce the risk of infection and shorten the post-operative recovery period. However, when used in myomectomy or hysterectomy procedures, there is an increased risk of spreading unsuspected cancer and benign tissue within the abdomen and pelvis. The risk of unsuspected cancer increases with age, particularly in women over 50 years of age.
Because of this increased risk, the FDA recommends use of laparoscopic power morcellation only in appropriately selected women undergoing myomectomy or hysterectomy and only if a tissue containment system is used. See the UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication for more patient and health care provider recommendations.
To find more information about FDA-cleared tissue containment systems for gynecologic or general laparoscopic surgery, go to the De Novo database or the 510(k) Premarket Notification database, type PMU or PZQ in the Product Code field and click Search.
The FDA encourages patients, health care providers, and manufacturers to continue to report events associated with laparoscopic power morcellators and laparoscopic power morcellator tissue containment systems to the Agency. This information helps the FDA monitor the safety of marketed medical devices.
If you suspect a problem resulting from the use of a laparoscopic power morcellator or a laparoscopic power morcellator tissue containment system, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
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If you have questions about this issue, please contact the Center for Devices and Radiological Health's Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
Since introduction of laparoscopy in the 1980s, the field of surgery has rapidly transitioned toward minimal access techniques and procedures. Along with this shift, many new surgical devices and instruments have been developed. The design and implementation of these devices is complex and expensive, yet vital to advancing surgery. Medical device companies frequently employ human factors engineers and key opinion leaders to help guide the design of these devices and to understand how to make them useful for physicians. Unfortunately, because surgery has traditionally been a male dominated field, most instruments have been built and designed with the male user in mind.
Biomechanics and anthropometry are integral, related components of device development. Biomechanics refers to the structure and function of mechanical aspects of individuals, such as joint function, while anthropometry refers to measurements of the human body. The design of these devices involves incorporating these inherently intertwined dimensions to make them effective for users. These measurements are highly variable among the differing demographics of surgeons. For example, females have less grip strength, grip span and different hand anthropometry compared with male counterparts1 and a recent commentary by Hallbeck and Lal underscores the fact these measures vary by ethnicity as well.2 A 2001 medical device ergonomics paper defined the goal of designing laparoscopic instruments: to design a handle that accommodates 95% of the defined user population.3 This begs the question, who comprises the aforementioned ‘user population’?
The field surgery is continuing to diversify and recruit women. This has been a welcome change. But, as the change in the population of surgeons occurs, design of laparoscopic devices has not seen parallel change. An ergonomics paper by van Veelen et al defined the population of laparoscopic surgeons as 90% male and 10% female.3 While this may have been previously true, this is no longer the case and will continue to change and evolve. Data from the AAMC reports that 44.8% of current general surgery residents are female as of 2021.4 Further, an overwhelming 85.2% of obstetrics and gynecology residents, a subspecialty which frequently uses laparoscopy, are women.4 Since it is obvious that the population of people using laparoscopic instruments has changed and will continue to change, the design of these instruments must also start to adapt. These key points are summarized in box 1.
Box 1
The user population drives surgical device design.
Ergonomic factors vary across both sex and ethnicity.
The user population of laparoscopic surgical instruments has changed and will continue to change, particularly to include more women.
Laparoscopic device design should be revisited for the current diversity in the population of surgeons.
While most women and small-handed surgeons can probably agree that palming bowel graspers and Marylands during laparoscopic cases is feasible, where the ergonomic difference is particularly pronounced is with disposable laparoscopic instruments. These devices are made mostly of plastic and then disposed of as medical waste at the end of cases. In the current world of injection moulds and three-dimensional (3D) printers, it seems easy enough to allow for these to be designed in multiple sizes. In fact, a 2020 ergonomics study 3D printed ergonomic handles in multiple sizes and found that surgeons had decreased execution time when using the correct sized handle.5
Why does all of this matter? Many will argue that women surgeons have been able to effectively and proficiently use laparoscopic instruments and operate at a level comparable to male counterparts. Electromyography data during real-time operations found that women surgeons had increased muscle activation and higher fatigue levels compared with men6 and women and users with smaller hand sizes are more likely to experience injury after using laparoscopic instruments.7 8 Beyond physical implications, instrument size also has the potential to be a source of stress for trainees as it pertains to their education. Surgical residents are now required to pass two simulation examinations: the fundamentals of laparoscopic surgery and the fundaments of endoscopic surgery but data show women and small-handed surgeons are at a significant disadvantage when it comes to passing.9 Additionally, a study found that correlations between perceived hand size and ability to learn how to use instruments and their ability to learn a particular operation.10 Table 1 summarizes previous studies examining gender-based ergonomic differences with surgical instrumentation.
Table 1|
Summary of previous literature regarding gender based ergonomic disparities in laparoscopic and endoscopic surgery
It has been over 30 years since the adoption of laparoscopic surgery. The trend toward minimally invasive techniques only continues to increase. Since the benefits of minimally invasive surgery to the patient are obvious, decreased infection risk, faster recovery, increased cosmesis, perhaps it is time to start considering the effects of minimally invasive surgery on the surgeon and the surgeon’s ability to safely and comfortably use the instruments. Considering surgeon’s ergonomics and health is imperative. These factors ultimately affect the longevity of surgeons’ careers and their ability to use the instruments correctly and with the most benefit to patients. More importantly, a lack of properly sized instruments for women alludes to the larger, systemic issue: that women and diversity are not always welcome in surgery.
An easy and straightforward way to do this would be to increase the diversity of engineers and key opinion leaders who have a large hand in influencing device design. Increasing the representation of women in the group of people who directly influence the device development will undoubtedly lead to change that will result in devices which benefit all surgeons ergonomically. Additionally, having devices available in multiple sizes or adjustable devices could allow for each surgeon to choose the appropriated size tools. Societies such as the Association of Women Surgeons (AWS), the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Society of Surgical Ergonomics all have an interest in working with devices companies in order to improve device design. Working more closely with companies such as these could help to improve the ergonomics of surgical devices for all users. It is time to urge medical device companies, engineers and key opinion leaders who influence the design of new medical devices to re-examine the design of laparoscopic instruments for the current user population.
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