FDA Issues A Safety Communication About Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries

Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication

Date Issued

February 28, 2019

Audience

• People with breast cancer or those at high risk for breast cancer who are considering the surgical removal of one or both breasts (mastectomy) using robotically-assisted surgery
• People considering robotically-assisted surgery for the prevention or treatment of other cancers
• Health care providers who perform robotically-assisted procedures as part of cancer prevention or treatment
• Health care providers who advise patients on the need for mastectomy

Medical Specialties

Breast Surgery, Obstetrics and Gynecology, Gynecological Oncology, General Surgery, Surgical Oncology, Endocrine Surgery, Hepatobiliary Surgery, Thoracic Surgery, Urology, Colorectal Surgery, Medical Oncology, Radiation Oncology, Oncology Nurses, Primary Care.

Device

Robotically-assisted surgical devices enable surgeons to perform a variety of surgical procedures through small cuts (incisions) in a patient's body. This type of surgery may help reduce pain, blood loss, scarring, infection, and recovery time after surgery in comparison to traditional surgical procedures.

Computer and software technology allow a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in three-dimensional high definition.

Purpose

The FDA takes women's health issues very seriously. The FDA is issuing this safety communication because it is important for health care providers and patients to understand that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. There is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival. Health care providers and patients should consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider this information to make informed treatment decisions.

Summary of Problem and Scope

Since robotically-assisted surgical devices became available in the US, robotically-assisted surgical procedures were widely adopted because they may allow for quicker recovery and could improve surgical precision. However, the FDA is concerned that health care providers and patients may not be aware that the safety and effectiveness of these devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer. Patients and health care providers should also be aware that the FDA encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.

Current evidence on use of robotically-assisted surgical devices

The safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established. However, the FDA is aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.

To date, the FDA's evaluation of robotically-assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques. To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.

The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established. The FDA is aware of peer-reviewed literature reporting clinical outcomes for the use of robotically-assisted surgical devices in cancer treatment including one limited report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery). In this report minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared (New England Journal of Medicine, November 2018).

To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer. The labeling for robotically-assisted surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by the FDA.

Recommendations for Patients

Before you have robotically assisted surgery to prevent or treat cancer:

• Be aware that that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established.
• Discuss the benefits, risks, and alternatives of all available treatment options with your health care provider to make the most informed treatment decisions.
• Before choosing your surgeon, we recommend asking the following questions:
  • Ask your surgeon about his or her training, experience, and patient outcomes with robotically-assisted surgical device procedures.
  • Ask how many robotically-assisted surgical procedures like yours he or she has performed.
  • Ask your surgeon about possible complications and how often they happen.

If you had treatment with a robotically-assisted surgical device for any cancerous condition and experienced a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Recommendations for Health Care Providers

• Understand that the FDA has not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
• Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.
• The FDA recommends that you take training for the specific robotically-assisted surgical device procedures you perform.
• Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically-assisted surgical devices.
• Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
• Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight. For further information, please refer to the FDA's Investigational Device Exemption website.
• If any of your patients experience adverse effects or complications with a robotically-assisted surgical device, we encouraged you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

FDA Actions

• Robotically-assisted surgical devices are novel and complex systems and the FDA reviews each robotically-assisted surgical device system individually, based on the complexity of the technology and its intended use.
• The FDA is monitoring adverse events in the literature and reported to the FDA to inform our understanding of the benefits and risks of robotically-assisted surgical devices when used for specific indications.
• The FDA encourages academic and research institutions, professional societies, robotically-assisted surgical device experts, and manufacturers to establish patient registries to gather data on the use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeon's learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.
• The FDA will update this communication if significant new information becomes available.

Happy Strawberry Day! February 27

Happy Strawberry Day! DYK It’s important to rinse produce to remove any lingering dirt & bacteria before eating? It’s important to wash them first because bacteria can spread from the outside to the inside as you cut or peel them!

National Strawberry Day is on February 27. These juicy, sweet berries can brighten up any dish and are delicious all on their own.

Teva Finalizes Settlement patent litigation settlements.

Teva Finalizes Settlement with Federal Trade Commission to Resolve All Outstanding Litigation between the Parties

Published: Feb 19, 2019

Feb. 19, 2019 23:24 UTC

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced a settlement with the Federal Trade Commission (FTC) that will resolve all outstanding litigation between the parties. Under the terms of the settlement, which is subject to court approval, the FTC will dismiss its claims against Teva and its affiliates in three outstanding cases, and the parties will modify certain terms in their 2015 consent decree. Teva will not pay any additional money to the FTC as part of this settlement.

"We are very pleased to put these litigations against the FTC behind us," said Brendan O’Grady, EVP and Head of North America Commercial at Teva. "We also appreciate the FTC's willingness to modify our consent decree to eliminate certain administrative burdens that will make it easier for us to navigate the patent issues that are critical to our business."

Originally entered in 2015 in FTC v. Cephalon, Inc., the consent decree provides clear guidance on the types of patent litigation settlements that are appropriate from the FTC’s perspective. This clarity helps Teva manage the complex antitrust and other related issues inherent in the pharmaceutical business environment. The three outstanding cases that will be dismissed against Teva and its affiliates as a part of the settlement are FTC v. AbbVie Inc., Nos. 18-2621, 18-2748, 18-2758 (3d Cir.); FTC v. Actavis, Inc., Civ. Action No. 09-955 (N.D. Ga.); and FTC v. Allergan PLC, Civ. Action No. 17-00312 (N.D. Cal.).

Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication

 

FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication

Date Issued

February 25, 2019

Audience

• Women
• People recommended for breast cancer screening
• Health care providers
• Cancer treatment advocacy organizations

Medical Specialties

Radiology, Pathology, Internal Medicine, Obstetrics/Gynecology, Oncology, Nursing, General Practice, Breast Surgery, Acupuncture, Osteopathy, Chiropractic, Naturopath

Product

Thermography is a noninvasive tool that uses an infrared camera to produce images (thermograms) that show the patterns of heat and blood flow on or near the surface of the body. Thermography devices, also known as digital infrared imaging devices, have been cleared for marketing by the FDA only for use with another screening or diagnostic test like mammography, not for use as a standalone diagnostic tool.

Purpose

The FDA is alerting women, health care providers, and people getting breast cancer screening, that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis.

There is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition including the early detection of breast cancer or other diseases and health conditions.

Mammography (taking X-ray pictures of the breasts) is the most effective breast cancer screening method and the only method proven to increase the chance of survival through earlier detection.

Summary of Problem and Scope

The FDA is aware that health spas, homeopathic clinics, mobile health units, and other health care facilities are using thermography inappropriately as a standalone tool for breast cancer screening or diagnosis.

The FDA has received reports that these types of facilities provide false information that can mislead patients into believing that thermography is an alternative or better option than mammography. Some facilities make inaccurate, unsupported, and misleading claims, such as thermography can find breast cancer years before it would be detected through other methods or thermography improves detection of cancer in dense breasts.

None of these claims are true or have any valid scientific evidence to support them. In addition, the Society for Breast Imaging notes a lack of evidence that thermography has any effective role in breast cancer screening.  Mammography is the most safe and effective tool for screening and diagnosis of breast cancer, and the only method proven to increase the chance of survival through earlier detection.

The FDA is concerned that people will believe the misleading claims about thermography and not get mammograms to screen for breast cancer.  People who choose thermography instead of mammograms may miss the chance to detect cancer at its earliest and most treatable stages. The agency is taking steps to stop the false advertising of thermography—see the FDA Actions section below for more information.

Recommendations for People Getting Breast Cancer Screening  

• Be aware that thermography is not a substitute for regular mammograms and should not be used in place of mammography for breast cancer screening or diagnosis.
• Have regular mammograms according to screening guidelines or as recommended by your health care provider.
  • You can learn more about what to expect during a mammogram on the FDA's Mammograms webpage.
• Follow your health care provider's recommendations for additional steps to diagnose breast cancer such as a clinical breast exam, other breast imaging (for example, breast ultrasound or MRI), or breast tissue biopsy.

Recommendations for Health Care Providers

• Educate patients about the limitations of thermography. For example, the high false negative and false positive rates of thermography can provide misleading information that could result in a delayed diagnosis or unnecessary medical follow up.
• Discourage the use of thermography to diagnose or screen for breast cancer.
• Talk to patients or caregivers about safe and effective ways to screen for breast cancer including the benefits and risks of available testing options.

FDA Actions

On February 22, 2019, the FDA issued a Warning Letter to Total Thermal Imaging, Inc., in La Mesa, California, for marketing and promoting thermography devices for uses that have not received marketing clearance or approval.

The FDA has also issued Warning Letters to the following facilities:

• Warning Letter to Thermogram Assessment Services (November 10, 2016)
• Warning Letter to Nature's Treasures (April 17, 2017)
• Warning Letter to Meditherm, Inc (April 4, 2011)
• Warning Letter to Dr. Joseph Mercola, Dr. Mercola's Natural Health Center (March 22, 2011)
• Warning Letter to Central Coast Thermography (January 6, 2011)

In these Warning Letters, the FDA instructed the providers to immediately stop making inappropriate claims about thermography devices.

The FDA is closely monitoring adverse event reports associated with thermography and will take additional steps necessary to address the risks associated with use of these products. We are committed to protecting and promoting access to safe and effective breast screening devices. 

Flu Map 2018-19 Influenza Season Week 7

2018-19 Influenza Season Week 7 ending Feb 16, 2019

*This map uses the proportion of outpatient visits to healthcare providers for influenza-like illness to measure the ILI activity level within a state. It does not, however, measure the extent of geographic spread of flu within a state. Therefore, outbreaks occurring in a single city could cause the state to display high activity levels.
*Data collected in ILINet may disproportionately represent certain populations within a state, and therefore may not accurately depict the full picture of influenza activity for the whole state.
*Data displayed in this map are based on data collected in ILINet, whereas the State and Territorial flu activity map are based on reports from state and territorial epidemiologists. The data presented in this map is preliminary and may change as more data is received.
*Differences in the data presented by CDC and state health departments likely represent differing levels of data completeness with data presented by the state likely being the more complete.
*For the data download you can use Activity Level for the number and Activity Level Label for the text description.

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For more information, please see CDC's Exit Notification and Disclaimer policy.