About Boston Scientific
Boston Scientific Corporation (BSX) is a Massachusetts-based medical device manufacturer. The company employs 36 thousand people worldwide with representation in 120 countries and on 6 continents. Boston Scientific manufactures diagnostic and treatment devices for a wide variety of health specialties including endoscopy, surgery, cardiology, gynecology, peripheral vascular disease, and urology.
Boston Scientific had estimated global revenue of about $11.9 billion in 2021 and about half of of which is generated in the U.S. The company has developed more than 15,000 medical devices and products including a number of “firsts” such as the first angioplasty balloon in the 1970s.
Boston Scientific History
Boston Scientific was founded in 1979 as a holding company intended to purchase Medi-Tech, an interventional medicine company. The first Boston Scientific product was a polyethylene (flexible plastic) balloon used for peripheral angioplasty to open clogged arteries.
Within two years, the device was the “industry standard” and led to the development of several later generation cardiac interventional devices including the adult aortic valvuloplasty balloon. The device was listed as one of the nine most important regulatory approvals of 1990 by the FDA and was the first of many cardiology products. The company has since developed additional interventional cardiology devices including the wildly successful “TAXUS Express” drug-eluting coronary stent.
Through the 1980’s and 90’s, the company acquired several medical device manufacturers to expand its presence in cardiology and reach into other therapeutic areas such as urology, neurology, and surgery. The company went public in May of 1992 and was producing an estimate $1.8 billion in annual revenue by 1997.
In 2003, Boston Scientific introduced TAXUS Express, a drug-eluting stent which contained the drug paclitaxel and was used for coronary artery disease. It was only the second of its kind and though the company had high hopes for the product, of the original 100,000 units shipped, 85,000 had to be recalled in Europe and the U.S.
In 2004, the company also acquired Advanced Bionics, a neuromodulation company and acquired Guidant, a manufacturer of implantable defibrillation devices for $27 billion in 2006 in a bidding war with the pharmaceutical giant, Johnson & Johnson. It was the largest company acquisition to date, but analysts believed it was overpriced and later resulted in a $5.5 billion antitrust lawsuit and a $1.3 billion tax dispute with the IRS which was settled by an agreement to pay $275 million. As part of the anti-trust agreement, the vascular business was portioned off to Abbott Labs and the claim was dismissed.
During the same time period, the U.S. Department of Justice (DOJ) was investigating Guidant for sales of defective defibrillators to Medicare patients which may have been hidden by Guidant executives. In 2011, Guidant (as assumed by Boston Scientific) pled guilty to federal charges and paid $254 million in DOJ fines. Cases regarding the defective defibrillator devices were settled in 2013 with a $30 million payment by BSX to patients and their families.
In 2010, the company was fined $600 thousand by the DOJ after paying kickbacks to an Army physician for using Boston Scientific devices and recommending them to other doctors BSX has also been involved in patent litigation with a Chinese device manufacturer, OrbusNeich which claimed that BSX could not sell their products in certain markets. The claim of territory infringement resulted in the police being called to Boston Scientific German headquarters for product seizure, but the dispute was mutually settled in 2013 under undisclosed terms.
In the same year, the company paid $1.73 billion to Johnson and Johnson to settle a patent infringement lawsuit over heart stents. Abbott Labs also accused Boston Scientific of employee poaching with the hiring of a former Vice President and several sales directors in Abbott’s cardiac division, resulting in a federal lawsuit.
In addition to troubles over its business practices, Boston Scientific has faced thousands of lawsuits regarding its transvaginal mesh products used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. Many of these lawsuits have been settled, as have thousands from other companies, however some may remain in court systems.
Boston Scientific Acquisitions from 2007
From 2007 forward, Boston Scientific has acquired, divested, and reorganized a number of companies and divisions including:
- 2007 – divested Fluid Management and Venous Access business to Avista Capital Partners
- 2008 – acquired CryoCor
- 2009 – acquired Labcoat Limited
- 2010 – acquired Asthmatix
- 2011 – acquired Atritech, Intellect Medical, and Sadra Medical. Divested neurovascular division to Stryker Corporation
- 2012 – acquired Cameron Health, BridgePoint Medical, Rhythmia Medical, and Vessix Vascular
- 2013 – acquired Bard EP
- 2014 – acquired IoGyn, and interventional division from Bayer
- 2015 – acquired American Medical Systems urology business unit from Endo International and Xluma
- 2016 – acquired Cosman Medical, EncoChoice Holdings, gynecology and urology portfolio of Distal Access and a fraction of Neovasc
- 2017 – acquired Symetis and Apama Medical
- 2018 – acquired nVision Medical Corporation, NxThera, Securis Medical Group, Cryterian Medical, Veniti, Augmenix, Claret Medical, BTG, and Millipede
- 2019 – acquired Vertiflex
- 2021 – acquired Preventice Solutions, Lumenis, Faripulse, Devoro Medical, Baylis Medical Company
- 2022 – acquired M.I. Tech Co., and Obsidio
Boston Scientific has been listed as one of the Top 100 places to work in Glassdoor’s annual listing since 2018 and is noted for its progressive hiring practices by publications and organizations including Forbes, Bloomberg, Human Rights Campaign, US Black Engineer & Information Technology and Working Mother magazine.
Boston Scientific and Transvaginal Mesh
Introduced in the 1990’s, transvaginal mesh was modeled after mesh that was in use for tissue stabilization in hernia and other surgical repair procedures. The first transvaginal mesh product, the ProtoGen Sling by Boston Scientific was approved in 1996 but was recalled just three years later due to safety concerns.
Transvaginal mesh was approved to treat pelvic organ prolapse and stress urinary incontinence in women. It was implanted “transvaginally” or through the vagina, rather than requiring a more invasive abdominal surgery. It was intended to improve the safety and efficacy of surgical treatments but has been shown to cause a number of serious adverse events which can result in permanent injury or even, death.
Boston Scientific transvaginal mesh products that may have caused injury include:
- Advantage Transvaginal Mid-Urethral Sling System
- Arise Vaginal Support System
- Lynx Suprapubic Mid-Urethral Sling System
- Obtryx Sling Systems
- Pinnacle Pelvic Floor Repair Kit
- Polyform Synthetic Mesh
- Prefyx PPS System
- ProtoGen Sling
- Uphold Vaginal Support System
Many patients have been injured by transvaginal mesh products and several have died due to the devices. Some of the Boston Scientific transvaginal mesh products have been recalled, including the ProtoGen in 1999 and the Pinnacle Pelvic Floor Repair Kit in 2011. The FDA has also reversed a prior statement and says that transvaginal mesh products may pose greater risk to patients than traditional surgeries.
Boston Scientific has faced over 54,000 lawsuits regarding injury caused by transvaginal mesh products. Many of these lawsuits have been settled and by November of 2016, BSX announced that they had settled about half of the lawsuits for undisclosed amounts with total legal costs reaching to more than $2.9 billion but some may still remain in court systems.
In 2019, Boston Scientific, along with Coloplast, was ordered by the FDA to remove vaginal mesh products from the U.S. market.
Boston Scientific Cardiac Devices
Boston Scientific has also faced a number of issues with its cardiac devices including the Guidant implantable defibrillators. In 2007, shortly after Guidant was acquired, the company shipped 100,000 new defibrillators but had to recall about 73,000 of them due to draining batteries caused by faulty capacitors.
In 2014 and 2016, after several patients had died, Boston Scientific was forced to recall some of its Lotus heart valve systems. The line of devices was also recalled in 2017 due to a manufacturing defect.
No lawsuits regarding those devices have resulted in large-scale litigation but the company has hundreds of devices, some of which are used in critical therapeutic areas and high medical risk diseases.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.