Medical Device: Breast Cancer Recovery

In In The News by Barbara Jacoby

After a mastectomy, sentinel node biopsy, or breast reconstruction for breast cancer, survivors suffer with scars of surgery, hair loss and sickness from chemo, red skin from radiotherapy and menopausal symptoms from endocrine treatments. And then they are sent home with drains.

Post-surgical grenade and Jackson-Pratt drains have tubes and bulbs that hang outside the skin near the surgical incision. Part of the drainage tube extends inside the surgical area where it collects blood and lymphatic fluid. The tube is held in place with a suture so it doesn’t accidentally slip out. The only real answer to date has been recovery shirts with pouches for the bulbs hanging outside patients’ armpits.

At last, a post-surgical device has been designed to replace the manual pumps that have seen little to no innovation in 40 years.

The SOMAVAC® 100 is a low-profile, user friendly, wearable medical device that applies sustained vacuum to a closed wound following surgery to remove fluid effectively and reduce the risk of seroma, and is the only patient-centric, value-based alternative to the suction bulbs used in closed suction drains. It is designed to replace the legacy technology of using suction bulbs with surgical drains, which has seen little innovation or advancements since the bulbs’ conception in 1970’s. In addition to its health benefits, the drain and pump can be discretely worn under clothing which aids in helping patients return to normal activities while recovering.

The old manually operated closed-suction systems, such as Jackson-Pratt (JP) drains or Hemovacs, are designed to draw fluid out with manual suction generated by a flexible, suction bulb attached to the end of the drain. Surgical drains are worn by patients anywhere from days to several months depending on the self-reported fluid volume. The inability of the flexible suction bulb to generate continuous suction is a major factor in prolonged drain indwelling times which increases opportunities for complications. Bulbs are also fraught with issues such as leakage, clogging and spillage, and patients struggle to follow instructions which may lead to inaccurate use of drains.

One breast cancer survivor was quoted as saying, “Doctors should consider quality of life with drains as part of their decision-making criteria. If they were walking around with uncomfortable hoses and bulbs hanging out of their armpits with blisters and chafing all over, I’m sure they’d rethink their opinions about them in a hurry.”

The SOMAVAC 100 is indicated for use in a range of surgeries which lead to large surgical flaps requiring drains, such as abdominal surgery, mastectomy, cosmetic surgery, hernia surgery, orthopedic procedures, etc. SOMAVAC 100 was cleared by the U.S. FDA last month.