Irvine-based Allergan Inc. has come a long way from its early days with breast implants, a line of business that once gave Chief Executive David Pyott pause.
“I literally sat in my office thinking, ‘No, no, no, no, you really can’t be thinking this,’ ” he said in a 2006 Business Journal story.
Allergan eventually moved full steam ahead into implants.
The Food and Drug Administration last month approved Allergan’s request to market its Natrelle 410 Highly Cohesive Anatomically Shaped silicone breast implants for use in reconstruction, augmentation and revision surgeries.
Natrelle is sold in Canada and Europe.
Breast implant sales accounted for about 7% of Allergan’s $5.7 billion in 2012 product sales (which are slightly less than total sales).
Pyott said in a release that Natrelle 410 “provides an important new alternative to traditional round implants” for breast surgeries.
Natrelle 410 is designed to mimic the slope of the breast and is filled with what Allergan calls a “highly cohesive silicone gel” that’s intended to enable the implant to “hold its shape over time while remaining soft to the touch.”
Allergan said that the FDA conducted an extensive review of various clinical studies and data.
Regulators have put various conditions on the approval, including continued follow-up on a number of patients for five years in a pair of studies. The company also must participate in developing the National Breast Implant Registry as a data center, as well as a separate study of newly enrolled implant patients who will be tracked for a decade.
Allergan got into the implant market some seven years ago after acquiring Santa Barbara-based Inamed Corp. for $3 billion.
The company’s Inamed buy pushed it deeper into the medical-cosmetic business. Juvéderm, a popular lower-face filler, and the Lap-Band weight-loss device came with that deal.
The cosmetic form of Allergan’s flagship Botox drug is also part of that lineup.
Lap-Band’s sales have declined in recent quarters, and Allergan has said that it hopes to find a buyer for the business sometime this year (see related Board Profile, page 1).
New EMR, CMIO for Kareo
Kareo Inc., an Irvine-based healthcare software maker, has introduced a new cloud-based electronic medical record.
Kareo caters to small, group medical practices. It based its new cloud-based offering on technology acquired from Epocrates Inc. in San Mateo, which is in the process of being sold to Athenahealth Inc., a Watertown, Mass.-based healthcare information technology company.
Kareo said in a release that it acquired electronic health record technology from Epocrates and combined it with its existing medical office software.
The company also said that Dr. Tom Giannulli is its chief medical information officer, a new position.
Giannulli was previously chief medical information officer at Epocrates, and he also served as chief executive of Westlake Village-based Caretools, a software company he founded.
Kareo, a venture-backed company, now serves more than 17,000 doctors offices.
St. Joe’s Appoints Chiefs of Staff
Orange-based St. Joseph Health appointed new chiefs of staff at two its three OC hospitals: St. Jude Medical Center in Fullerton and Mission Hospital, which has campuses in Mission Viejo and Laguna Beach.
St. Joseph Health also operates St. Joseph Hospital in Orange.
Dr. James Benoit is the new chief of staff at 384-bed St. Jude. The family physician succeeds Dr. Timothy Greco.
Benoit also is vice president of St. Jude Heritage Medical Group, an affiliated group practice. He’s also served on the St. Jude Medical Center board and chaired the hospital’s department of medicine.
Dr. Todd Lempert is the new chief of staff at Mission, which has 552 beds between its two facilities. Lempert succeeds Dr. Rudy Marquez.
Lempert has served on the hospital’s board of directors. He will continue his role as a radiologist specializing in neurointerventional radiology, neuroradiology and interventional radiology.
Bits and Pieces
UCI Medical Center in Orange is now linked to the Orange County Partnership Regional Health Information Organization Inc., which also is based in Orange and connects providers’ electronic health records with users in a bid to improve care. … MemorialCare Heart & Vascular Institute at Saddleback Memorial Medical Center in Laguna Hills recently introduced a less-invasive fenestrated graft medical device to treat abdominal aortic aneurysms, or a ballooning of the body’s main artery. … The work of Dr. John Lipham, an upper-gastrointestinal and general surgeon who practices at Hoag Memorial Hospital Presbyterian, was recently featured in the New England Journal of Medicine. The journal was looking at safety and evidence of a medical device to treat gastroesophageal reflux disease.
