Medical device and MedTech insights, news, tips and more

Allergan Recalls Textured Breast Implants Linked to Rare Type of Cancer

July 25, 2019


The FDA said today that it asked Allergan to recall its Biocell breast implants after concluding that they are six times as likely as other textured breast implants to cause an uncommon form of lymphoma.

The federal safety watchdog said that nearly 84% of the 573 cases of breast implant-associated anaplastic large cell lymphoma reported worldwide – including 33 deaths – involved patients implanted with the Allergan implants; of the 13 deaths in which the manufacturer was known, 12 involved Allergan (the implant maker is unknown in the other 20 deaths, the FDA said).

“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.,” the agency said, noting that “continued distribution of Allergan’s Biocell textured breast products implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”

Although the FDA this year declined to impose a ban on the implants, despite a surge in adverse event reports, regulators in severalforeignjurisdictions are considering or have already enacted bans on textured implants. In March the bureau warned breast implant manufacturers Sientra and Johnson & Johnson subsidiary Mentor Worldwide over failures to conduct appropriate post-approval studies of the devices.

Allergan, which pulled Biocell from the European market last December, said it’s doing the same worldwide as a precaution based on the newly reported BIA-ALCL risk.

See Full Article at the Source: UPDATE: FDA asks Allergan to recall textured breast implants – MassDevice

Article Written by: Brad Perriello

A Speciality Recruiting Firm Exclusively Servicing The Medical Device Industry

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?

Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.