According to the LA Times for the first time, the Food and Drug Administration on Friday approved a drug to reduce the risk of premature delivery, although it required the manufacturer to conduct more studies to demonstrate the drug’s efficacy.
The agency gave the nod to a synthetic form of the hormone progesterone, which is normally produced during pregnancy, that can be injected into women who have already had a spontaneous preterm birth. The weekly injections, to be marketed under the name Makena, are for use only in women who are carrying a single fetus and who have no other risk factors for an early delivery.
The approval comes under the FDA’s accelerated approval program in which drugs are allowed on the market because they produce a result — in this case, preventing premature births — that is assumed to correlate with a clinical benefit as yet unproven by studies.
Patients who have delivered their babies prematurely are sometimes disappointed to see that their body has changed considerably even though their pregnancy may have been shorter than anticipated. It is not uncommon for patients to have sagging in the breast as well as a loss of breast volume. Patients may also find that the skin on the abdomen is loose and lax even after losing the weight from the pregnancy. Dr. O’Toole recommends a breast augmentation combined with an abdominoplasty for women who desire to improve the shape of their body following childbirth. Patients are thrilled with the results as many of them look better than they did prior to having the baby.
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