Essure is a birth control device that is marketed as a form of permanent birth control with no surgery required. Instead of going under the knife, which tubal ligation requires, Essure is inserted during an outpatient procedure in which a doctor inserts it by catheter. No anesthesia or incision is required. The device is made …
The Food and Drug Administration (FDA) has just announced that they received a report that a St. Jude Durata cardiac defibrillator lead conductor became externalized; meaning the wire carrying electricity from the heart defibrillator to the heart was exposed through its insulation, a potentially dangerous and life-threatening defect.
HeartSine sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery.
More than half of the high-risk cardiovascular devices approved in the past decade had no supporting active control data.
St. Jude Medical Inc. said it received a FDA warning about manufacturing and quality-control problems at its Sylmar, California, plant.
Hospira has sent out 11 device notifications so far in 2013, including recall and device corrections. The company also said it sent notices to customers about some of its infusion pumps that had to either be recalled, fixed or adjusted.
Doctors traditionally believed the larger the size of the implant, the more protective it was against failure, according to Sedrakyan. However, he said his study found regardless of size, women had a higher rate of revision occurrence, so some other factor besides the actual implants may be leading to this effect.
For some women a pelvic transvaginal mesh product has been a god sent. To be able to resume a full active life, without the worry of a leaky bladder, is a true miracle for some women. And, this only became possible with the help of pelvic mesh. The mesh is most commonly used after pelvic …
Hip joint deterioration can lead to pain, stiffness or difficulty walking. When these symptoms do not respond to conservative treatment, such as physical therapy, patients may be advised to undergo total hip replacement or hip resurfacing. As part of this treatment, they may receive a “metal-on-metal” hip implant in which the “ball and socket” of …
The FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient. An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced …