FDA Issues Warning to Women Needing a Mastectomy.

August 25, 2021 – San Diego, CA. Women who need a mastectomy should consult their doctors about all the options available for their operation.  On August 20, 2021 the FDA has issued an alert for those who may need a mastectomy.

The heart of the matter is the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or treatment of breast cancer has not been established by the FDA. 

The FDA has also noted that it’s aware that some companies that manufacture these robots have started doing clinical studies on RAS devices to perform mastectomies without the FDA’s oversight that is required for all risk studies. Are these manufacturers skirting the laws? We’ve seen it before with some medical device makers.

FDA has Approved RAS for some surgeries, but not all.

FDA has cleared RAS devices for some cancer surgeries including hysterectomy, prostatectomy, and colectomy. Those clearances were based on the short term, 30 day, patient follow up.

RAS Manufacturers must obtain an IDE

According to the FDA; an investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.

Clinical studies are most often conducted to support a PMA (premarket application). Only a small percentage of 510(k)s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

FDA offers Guidance to Patients

Women who are considering undergoing a mastectomy should ask whether the surgeon expects to use robotically-assisted surgery, and if so should:

• Be aware that the safety and effectiveness of using RAS devices in mastectomy procedures or in the prevention or treatment of breast cancer have 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 a surgeon for robotically-assisted surgery, the FDA recommends you ask the surgeon about:
  • Their training, experience, and patient outcomes with RAS device procedures.
  • The number of robotically-assisted surgical procedures like yours they have performed.
  • Potential short-term and long-term complications, and whether they are due to the mastectomy procedure, cancer prevention, cancer treatment, or an associated breast reconstruction-and how often they happen.

Did you have a robotically-assisted mastectomy?

Even though the FDA has made clear that that they don’t condone the use of RAS for mastectomies, it is aware that some women may have undergone RAS mastectomies, and is asking for those women to report any side effects or complications to the FDA’s MedWatch Adverse Event Reporting System.

The attorneys at Schmidt National Law Group are concerned about the health and safety of women needing mastectomies and asking those to seek medical advice from their doctors before having a robotically-assisted mastectomy.

Since the FDA has made clear that these devices are not cleared for mastectomies we will continue to keep up-to-date on any injuries or complications from those device markers.

If you’ve had a RAS mastectomy and suffered any complications please contact us today at 1-800-631-5656.  

Sources:

https://www.fda.gov/medical-devices/safety-communications/update-caution-robotically-assisted-surgical-devices-mastectomy-fda-safety-communication

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

FDA Issues Warning to Women Needing a Mastectomy page updated on August 25, 2021.