SANTA BARBARA, Calif., Oct 09, 2015 (GLOBE NEWSWIRE via COMTEX) --
Sientra, Inc. SIEN, -2.77%(link is external) a medical aesthetics company, today announced that it has sent a letter to plastic surgeons regarding products manufactured by Silimed, one of Sientra's contract manufacturers.
Among other things, the letter updates plastic surgeons on actions Sientra is taking:
Sientra has been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding Brazilian regulatory inquiries into Silimed products, and is conducting its own review of the matter.
Out of an abundance of caution, Sientra is voluntarily placing on temporary hold the sale in the United States of all Sientra devices manufactured by Silimed and also recommending that plastic surgeons discontinue implanting these devices until further notice.
Brazilian and other regulatory agencies have reiterated that no reports of adverse events and no risks to patient health have been identified in connection with implanting Silimed-manufactured products, and, accordingly, there is no need to explant or adopt any specific procedure or action for those patients who have received them.
The full text of the letter is below:
October 9, 2015
Dear Valued Plastic Surgeon,
As a valued partner to Sientra, we want to ensure we are communicating with you in a timely fashion about the latest information regarding our products.
As we previously announced, we learned that Brazilian regulatory agencies have temporarily suspended the manufacturing of all medical devices made by Silimed, including products manufactured for Sientra, as they continue to review technical compliance issues related to Good Manufacturing Practices (GMP) at Silimed's manufacturing facility.
We have been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding this matter and out of an abundance of caution, we are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed. We are also voluntarily placing on temporary hold, the sale in the United States of all Sientra devices manufactured by Silimed, and we ask that you set aside all such devices in a secure location and not use them until further notice.
Let me emphasize that we are taking these steps as a precautionary measure. It is important to note that no reports of adverse events and no risks to patient health have been identified in connection with implanting these Silimed-manufactured products. Furthermore, neither Brazilian regulatory agencies nor any other regulatory authority has found that there is a need to explant these devices or adopt any specific procedure or action for patients who have received them. This finding has been reiterated by the foreign regulators reviewing this matter in their public announcements.
In the meantime, you can continue to reassure your patients as needed by informing them that there has been no indication that these issues would pose a threat to their safety. Furthermore, you should continue to advise your patients who have received Sientra implants to contact you if they experience any complications, consistent with standard patient follow up.
We value the relationships we have built with you, and the safety of your patients is of the utmost importance to us. We are providing this update to ensure that you have all the relevant facts about the steps we are taking now and are committed to taking moving forward. In addition to our discussions with the FDA, we are conducting our own review of this matter. Once we have completed our review, we will make sure you are apprised of any pertinent, additional information. Rest assured that this is a top priority for our company and we are committed to completing our review expeditiously, but thoroughly.
In addition to reaching out to you directly, we will also be posting updates to our website, www.sientra.com(link is external). As always, I am available along with my team to address your needs and inquiries. Please do not hesitate to contact us via our information request line at info@sientra.com(link sends e-mail), or by calling us at 888.708.0808.
Thank you for your patience, understanding and support throughout this process.
Sientra’s troubles started with a review of Silimed’s Brazilian factory by TUEV SUED AG, a company empowered by German regulators to inspect the manufacturing of products destined for export to the continent. The inspection concluded that there were particles on implants in the factory. In a statement, TUEV SUED said Silimed wasn’t able to adequately explain the source of the impurities or to provide sufficient measures to remedy the situation.
A spokesman for TUEV SUED said the company suspended three quality-management certificates at the Silimed factory through Dec. 17. That led U.K and European Union health authorities to suspend(link is external) Silimed’s marketing certificate, according to a Sept. 23 statement, and other regulators took note. Australia’s Therapeutic Goods Administration issued a statement Sept. 25 identifying the particles as silica and cotton(link is external) and saying that the distribution of Silimed products in Australia would remain on hold until an investigation is complete.
Under den senaste revisionen av våra tillverkningsprocesser för silikonimplantat av den europeiska tillsynsmyndighet TÜV SÜD hittat mikroskopiska partiklar på ytan av vissa bröstimplantat.
Som en försiktighetsåtgärd, avbröt SILIMED försäljningen och marknadsföringen av sina produkter i Europa och den 17 september blev CE märkningen tillbakadragen.
Under hela processen har SILIMED varit i regelbunden kontakt med relevanta europeiska myndigheter och samarbetar fullt ut med dem i deras undersökningar.
Som en försiktighetsåtgärd, avbröt SILIMED frivilligt försäljning i Europa medan det genomförs en rigorös utredning i samarbete med de europeiska myndigheterna. Denna process är inte ett återkallande utan en ytterligare åtgärd för att hjälpa oss att bibehålla högsta kvalitet.
SILIMED har en 37-årig historia och har producerat och sålt mer än en miljon implantat. Under denna tid har bolaget inte haft ett enda fall där mikroorganismer har återfunnits på dess implantat. Patientsäkerheten är av största vikt för oss och vi tar alla nödvändiga steg för att säkerställa att våra produkter är säkra att använda och att vår tillverkningsprocess är robust.
För att ge perspektiv av de första resultaten som nämns ovan så refererar TÜV SÜDs preliminära rapporter till partiklar på implantaten, som vanligtvis återfinns på många medicinska produkter. Även om det inte finns någon standard eller index som avgör en acceptabel nivå av partiklar på medicinska produkter så visar litteratur och forskning inom området att partiklar inte visar några tecken på risker för patienterna.
Det är också värt att notera de senaste kommentarerna från brittiska tillsynsmyndighetens (MHRA) direktör för medicintekniska produkter, John Wilkinson; "Det har hitintills inte funnits några indikationer på att dessa frågor skulle utgöra ett hot mot patientsäkerheten."
Denna uppfattning stöds ytterligare av kommentarer från den brasilianska plastikkirurgiska föreningen, den brasilianska bröstkirurgiska föreningen och den amerikanska plastikkirurgiska föreningen.
Därför säger SILIMED följande:
Detta är inte ett återkallande.
SILIMED garanterar att alla sina produkter vederbörligen steriliserats i enlighet med de högsta kraven på säkerhet och följaktligen, de är helt fria från mikroorganismer, vilket innebär att patienter är säkra.
SILIMED, har under sin 37-åriga historia, aldrig haft några fall där det fanns några bevis på mikroorganismer i sina implantat, vare sig i membranet eller i silikongelen. Under årens lopp har företaget tillverkat och sålt miljontals implantat och aldrig haft ett enda fall av förorening av mikroorganismer.
litteratur, riskanalyser och uppföljande vaksamhet under de senaste 37 åren visar att förekomsten av sterila partiklar, som är vanliga på alla medicinska produkter, även andra implantat på marknaden, inte har påvisat några belägg för hälsorisker.
SILIMED var det första utländska bolaget att få sina silikonimplantat godkända enligt CE-märkning 1995.
FDA har granskat SILIMED många gånger för att säkerställa bolagets efterlevnad av kvalitetssystemen föreskrifterna och det har aldrig gett ett formulär 483 (bristande efterlevnad) hittills.
SILIMED genomför rutinmässigt interna granskningar av sitt kvalitetssystem för kontinuerlig förbättring av kvaliteten och säkerheten på sina produkter.
En officiell teknisk rapport kommer att överlämnas till de europeiska myndigheterna och certifieringsorganet med alla nödvändiga uppgifter och information.
Företaget har frivilligt avbrutit försäljningen av sina produkter till dess att den officiella tekniska analysen är slutförd.
SILIMED har alltid varit ett riktmärke för den globala marknaden när det gäller innovation, kvalitet och säkerhet. Bolaget upprepar att dess produkter erbjuder någon som helst hot mot sina kunder i alla 75 länder där SILIMED produkterna finns tillgängliga.
This communique has been prepared to bring you up to date regarding what is being done by Silimed since the latest events in October. As everyone knows, one of our manufacturing plants – factory F2 – had a fire on October 22. We want to highlight some of the steps that are underway to normalize the entire situation:
- We are making every effort to resume production in Factory 1, as soon as possible, and, for that reason, we are working 24x7, including weekends and holidays.
- At the same time, we will build a new factory to replace the one that burned. The new unit will have cutting edge technology, as is the tradition at Silimed.
- Our inventories, which were not affected by the fire, will be made available as soon as they are released by the regulatory agencies, with which we have been working very closely.
- Technical reports are currently reviewed by the European and other authorities, in full collaboration.
Regarding the temporary suspension of the CE Certificate and the precautionary suspension by ANVISA, we are moving forward with our action plan for normalizing everything. Silimed, which only achieved the position it holds in the market due to the partnership it has had with the entire medical profession, while always seeking to jointly develop solutions and products according to the highest standards of quality, diversity, and innovation, knows that this is a challenging moment. But we are fully confident in a quick recovery of our company and we are certain that we will come out of this much stronger. We are immensely thankful for all of the support that we have received.
MHRA has issued the following statement today to UK distributors of Silimed implants reiterating the existing advice that implants should continue to be quarantined:
* We are contacting you to reiterate our previous advice about the harmonized European Competent Authorities’ position on the distribution of Silimed products. EU health experts are evaluating test results to establish if there are potential health risks associated with particles on the surface of these implants.
* We are aware that Silimed have issued communications to suggest that there is no risk to patients however this is yet to be determined through our evaluation of testing. We will communicate the conclusions shortly. In the meantime our previous advice that devices should be quarantined continues to apply.
* The CE suspension by Tüv Süd has been prolonged until the end of June 2016 due to the exceptional circumstances and occurrences in particular the fire in the main manufacturing site.
Sientra made three major announcements on Jan. 7: It is not yet resuming production at its factory in Rio de Janeiro, it is looking for a new manufacturer of its implants and the existing inventory could be back on the market within weeks.
On Jan. 8, the British Medicines and Healthcare Products Regulatory Agency also gave an update and said Sientra’s current manufacturer, Silimed, had its European quality management certificate, known as a CE-mark, suspended until June.
The announcement by the Medicines and Healthcare Products Regulatory Agency explains why Sientra is not resuming manufacturing yet. Sientra CEO Jeffrey Nugent made the announcement in a letter to plastic surgeons at about 5 p.m. on Jan. 7. For days, investors and plastic surgeons have been excited, saying they thought the Goleta based breast implant manufacturer would resume production or start selling its remaining inventory any day.
Sientra stock was up five days in a row from Dec. 30 to Jan. 5. The stock acted like investors knew an announcement of some kind about manufacturing or product sales was imminent. On Jan. 5, it even hit a peak of $7.09 before closing at $6.73.
A Sientra spokesman told the Business Times on Jan. 5 an announcement of some kind would come before Jan. 8.
Sientra traded down on Jan. 6 to $6.62 and closed Jan. 7 at $5.90 per share.
Bill Baum in an investment manager at Great American Investors in Kansas City, Kan. and a Sientra investor who bought stock on Nov. 18. He was excited on Jan. 5 about the possibility of Sientra selling its products and resuming production again.
“We hit a high today of $7.09, so there’s clearly some good, solid buying,” said Baum said. “But right now your run rate is just about five times normal volume, so, clearly — who knows.”
While Baum was excited at the time, his optimism was guarded. He still had questions about how manufacturing might resume because of a fire that burned down the biggest building at the factory of Silimed on Oct. 22. Sientra officials said several times since that manufacturing at a smaller Silimed plant is possible, but would require significant renovations.
In the letter to plastic surgeons, Nugent said Sientra finished an internal review of the safety of its products. The company then sent data from those tests to the FDA by the end of 2015 as planned.
“Over the last few months, we’ve been making important progress,” Nugent said in the letter. This is an important component of our return-to-market strategy, and we look forward to providing you with further updates as we move forward. In our view, the data has concluded that all Sientra products are safe and represent no significant risk to your patients.”
Nugent also hinted Sientra implants might return to the market in just a few weeks.
Nugent may have hinted at when Sientra products will return to the market. Near the end of the letter, he gave a vague timeline of when Sientra will re-enter the market for the first time.
“I look forward to communicating with you further in the coming weeks and on a continuing basis as we re-enter the market,” Nugent said. “We are also continuing to aggressively develop a variety of alternatives for a high quality, stable manufacturing solution.”
Nugent may make a handsome profit off the announcement. He exercised a stock option on Jan. 1 to buy 241,753 shares at the Dec. 31 closing price of $5.92 per share. That increased Nugent’s stake in the company to 879,811 shares.
German inspection agency TUV SUD found implants contaminated by microscopic particles of silica and cotton during April and July inspections of Silimed’s factory. Silimed’s CE-mark was suspended on Sept. 17 and Silimed sales were suspended in Europe on Sept. 23. Sientra products were voluntarily pulled from U.S. shelves on Oct. 9.
Sientra has maintained its products are safe ever since. While Sientra is working with the FDA to bring its breast implants back to market, the FDA has not taken any regulatory action and has not initiated its own review.
During a conference call with investors on Oct. 30, Sientra said it had about a year’s supply of implants already produced and waiting to be sold. At the time, Sientra also had cash reserves of about $148.9 million.
Silimed’s CE-mark suspension expired on Dec. 17, raising the possibility the company could re-start manufacturing Sientra implants. A spokesman for the MHRA said at the time the CE-mark suspension would be continued because of the Silimed factory fire.
In a statement issued on the morning of Jan. 8, the Medicines and Healthcare Products Regulatory Agency said European Union officials are still conducting tests to see if the 20 nanometer in diameter particles pose any health risks to patients. In the meantime, it reiterated its previous position that there is no risk to patient safety.
“The CE suspension by TUV SUD has been prolonged until the end of June 2016 due to the exceptional circumstances and occurrences in particular the fire in the main manufacturing site,” the agency said in a statement.
Sientra’s stock spiked in early-morning trading in reaction to both the announcements. In pre-market trading the morning of Jan. 8. Sientra’s stock hit $7 per share at 5 a.m. At 5:30 a.m. it peaked at $8.85 per share. By the time markets opened at 6:30 a.m., the stock settled to $7.58 per share.
http://www.marketwatch.com/story/sientra-sends-letter-to-plastic-surgeons-regarding-silimed-manufactured-products-2015-10-09(link is external)
SANTA BARBARA, Calif., Oct 09, 2015 (GLOBE NEWSWIRE via COMTEX) --
Sientra, Inc. SIEN, -2.77%(link is external) a medical aesthetics company, today announced that it has sent a letter to plastic surgeons regarding products manufactured by Silimed, one of Sientra's contract manufacturers.
Among other things, the letter updates plastic surgeons on actions Sientra is taking:
The full text of the letter is below:
October 9, 2015
Dear Valued Plastic Surgeon,
As a valued partner to Sientra, we want to ensure we are communicating with you in a timely fashion about the latest information regarding our products.
As we previously announced, we learned that Brazilian regulatory agencies have temporarily suspended the manufacturing of all medical devices made by Silimed, including products manufactured for Sientra, as they continue to review technical compliance issues related to Good Manufacturing Practices (GMP) at Silimed's manufacturing facility.
We have been in ongoing discussions with the United States Food and Drug Administration (FDA) regarding this matter and out of an abundance of caution, we are voluntarily recommending that you temporarily discontinue implanting all Sientra devices manufactured by Silimed. We are also voluntarily placing on temporary hold, the sale in the United States of all Sientra devices manufactured by Silimed, and we ask that you set aside all such devices in a secure location and not use them until further notice.
Let me emphasize that we are taking these steps as a precautionary measure. It is important to note that no reports of adverse events and no risks to patient health have been identified in connection with implanting these Silimed-manufactured products. Furthermore, neither Brazilian regulatory agencies nor any other regulatory authority has found that there is a need to explant these devices or adopt any specific procedure or action for patients who have received them. This finding has been reiterated by the foreign regulators reviewing this matter in their public announcements.
In the meantime, you can continue to reassure your patients as needed by informing them that there has been no indication that these issues would pose a threat to their safety. Furthermore, you should continue to advise your patients who have received Sientra implants to contact you if they experience any complications, consistent with standard patient follow up.
We value the relationships we have built with you, and the safety of your patients is of the utmost importance to us. We are providing this update to ensure that you have all the relevant facts about the steps we are taking now and are committed to taking moving forward. In addition to our discussions with the FDA, we are conducting our own review of this matter. Once we have completed our review, we will make sure you are apprised of any pertinent, additional information. Rest assured that this is a top priority for our company and we are committed to completing our review expeditiously, but thoroughly.
In addition to reaching out to you directly, we will also be posting updates to our website, www.sientra.com(link is external). As always, I am available along with my team to address your needs and inquiries. Please do not hesitate to contact us via our information request line at info@sientra.com(link sends e-mail), or by calling us at 888.708.0808.
Thank you for your patience, understanding and support throughout this process.
Respectfully,
Hani Zeini
Founder and Chief Executive Officer
Sientra, Inc.
Sientra’s troubles started with a review of Silimed’s Brazilian factory by TUEV SUED AG, a company empowered by German regulators to inspect the manufacturing of products destined for export to the continent. The inspection concluded that there were particles on implants in the factory. In a statement, TUEV SUED said Silimed wasn’t able to adequately explain the source of the impurities or to provide sufficient measures to remedy the situation.
A spokesman for TUEV SUED said the company suspended three quality-management certificates at the Silimed factory through Dec. 17. That led U.K and European Union health authorities to suspend(link is external) Silimed’s marketing certificate, according to a Sept. 23 statement, and other regulators took note. Australia’s Therapeutic Goods Administration issued a statement Sept. 25 identifying the particles as silica and cotton(link is external) and saying that the distribution of Silimed products in Australia would remain on hold until an investigation is complete.
http://www.bloomberg.com/news/articles/2015-10-16/sientra-breast-implants-stuck-in-limbo-after-supplier-s-setbacks(link is external)
http://plastikoperationsforum.se/plastikoperationer-plastikkirurgi-forum/information-fran-kliniker/pressreleaser/silimed-information
Detta är informationen som Silimed via svenska generalagenten (Human Tech Medica(link is external)) gått ut med till läkare.
Under den senaste revisionen av våra tillverkningsprocesser för silikonimplantat av den europeiska tillsynsmyndighet TÜV SÜD hittat mikroskopiska partiklar på ytan av vissa bröstimplantat.
Som en försiktighetsåtgärd, avbröt SILIMED försäljningen och marknadsföringen av sina produkter i Europa och den 17 september blev CE märkningen tillbakadragen.
Under hela processen har SILIMED varit i regelbunden kontakt med relevanta europeiska myndigheter och samarbetar fullt ut med dem i deras undersökningar.
Som en försiktighetsåtgärd, avbröt SILIMED frivilligt försäljning i Europa medan det genomförs en rigorös utredning i samarbete med de europeiska myndigheterna. Denna process är inte ett återkallande utan en ytterligare åtgärd för att hjälpa oss att bibehålla högsta kvalitet.
SILIMED har en 37-årig historia och har producerat och sålt mer än en miljon implantat. Under denna tid har bolaget inte haft ett enda fall där mikroorganismer har återfunnits på dess implantat. Patientsäkerheten är av största vikt för oss och vi tar alla nödvändiga steg för att säkerställa att våra produkter är säkra att använda och att vår tillverkningsprocess är robust.
För att ge perspektiv av de första resultaten som nämns ovan så refererar TÜV SÜDs preliminära rapporter till partiklar på implantaten, som vanligtvis återfinns på många medicinska produkter. Även om det inte finns någon standard eller index som avgör en acceptabel nivå av partiklar på medicinska produkter så visar litteratur och forskning inom området att partiklar inte visar några tecken på risker för patienterna.
Det är också värt att notera de senaste kommentarerna från brittiska tillsynsmyndighetens (MHRA) direktör för medicintekniska produkter, John Wilkinson; "Det har hitintills inte funnits några indikationer på att dessa frågor skulle utgöra ett hot mot patientsäkerheten."
Denna uppfattning stöds ytterligare av kommentarer från den brasilianska plastikkirurgiska föreningen, den brasilianska bröstkirurgiska föreningen och den amerikanska plastikkirurgiska föreningen.
Därför säger SILIMED följande:
MHRA has issued the following statement today to UK distributors of Silimed implants reiterating the existing advice that implants should continue to be quarantined:
* We are contacting you to reiterate our previous advice about the harmonized European Competent Authorities’ position on the distribution of Silimed products. EU health experts are evaluating test results to establish if there are potential health risks associated with particles on the surface of these implants.
* We are aware that Silimed have issued communications to suggest that there is no risk to patients however this is yet to be determined through our evaluation of testing. We will communicate the conclusions shortly. In the meantime our previous advice that devices should be quarantined continues to apply.
* The CE suspension by Tüv Süd has been prolonged until the end of June 2016 due to the exceptional circumstances and occurrences in particular the fire in the main manufacturing site.
https://www.gov.uk/government/publications/devices-made-by-silimed/latest-update-8-january-2016(link is external)
--------------------------------------------
Sientra made three major announcements on Jan. 7: It is not yet resuming production at its factory in Rio de Janeiro, it is looking for a new manufacturer of its implants and the existing inventory could be back on the market within weeks.
On Jan. 8, the British Medicines and Healthcare Products Regulatory Agency also gave an update and said Sientra’s current manufacturer, Silimed, had its European quality management certificate, known as a CE-mark, suspended until June.
The announcement by the Medicines and Healthcare Products Regulatory Agency explains why Sientra is not resuming manufacturing yet. Sientra CEO Jeffrey Nugent made the announcement in a letter to plastic surgeons at about 5 p.m. on Jan. 7. For days, investors and plastic surgeons have been excited, saying they thought the Goleta based breast implant manufacturer would resume production or start selling its remaining inventory any day.
Sientra stock was up five days in a row from Dec. 30 to Jan. 5. The stock acted like investors knew an announcement of some kind about manufacturing or product sales was imminent. On Jan. 5, it even hit a peak of $7.09 before closing at $6.73.
A Sientra spokesman told the Business Times on Jan. 5 an announcement of some kind would come before Jan. 8.
Sientra traded down on Jan. 6 to $6.62 and closed Jan. 7 at $5.90 per share.
Bill Baum in an investment manager at Great American Investors in Kansas City, Kan. and a Sientra investor who bought stock on Nov. 18. He was excited on Jan. 5 about the possibility of Sientra selling its products and resuming production again.
“We hit a high today of $7.09, so there’s clearly some good, solid buying,” said Baum said. “But right now your run rate is just about five times normal volume, so, clearly — who knows.”
While Baum was excited at the time, his optimism was guarded. He still had questions about how manufacturing might resume because of a fire that burned down the biggest building at the factory of Silimed on Oct. 22. Sientra officials said several times since that manufacturing at a smaller Silimed plant is possible, but would require significant renovations.
In the letter to plastic surgeons, Nugent said Sientra finished an internal review of the safety of its products. The company then sent data from those tests to the FDA by the end of 2015 as planned.
“Over the last few months, we’ve been making important progress,” Nugent said in the letter. This is an important component of our return-to-market strategy, and we look forward to providing you with further updates as we move forward. In our view, the data has concluded that all Sientra products are safe and represent no significant risk to your patients.”
Nugent also hinted Sientra implants might return to the market in just a few weeks.
Nugent may have hinted at when Sientra products will return to the market. Near the end of the letter, he gave a vague timeline of when Sientra will re-enter the market for the first time.
“I look forward to communicating with you further in the coming weeks and on a continuing basis as we re-enter the market,” Nugent said. “We are also continuing to aggressively develop a variety of alternatives for a high quality, stable manufacturing solution.”
Nugent may make a handsome profit off the announcement. He exercised a stock option on Jan. 1 to buy 241,753 shares at the Dec. 31 closing price of $5.92 per share. That increased Nugent’s stake in the company to 879,811 shares.
German inspection agency TUV SUD found implants contaminated by microscopic particles of silica and cotton during April and July inspections of Silimed’s factory. Silimed’s CE-mark was suspended on Sept. 17 and Silimed sales were suspended in Europe on Sept. 23. Sientra products were voluntarily pulled from U.S. shelves on Oct. 9.
Sientra has maintained its products are safe ever since. While Sientra is working with the FDA to bring its breast implants back to market, the FDA has not taken any regulatory action and has not initiated its own review.
During a conference call with investors on Oct. 30, Sientra said it had about a year’s supply of implants already produced and waiting to be sold. At the time, Sientra also had cash reserves of about $148.9 million.
Silimed’s CE-mark suspension expired on Dec. 17, raising the possibility the company could re-start manufacturing Sientra implants. A spokesman for the MHRA said at the time the CE-mark suspension would be continued because of the Silimed factory fire.
In a statement issued on the morning of Jan. 8, the Medicines and Healthcare Products Regulatory Agency said European Union officials are still conducting tests to see if the 20 nanometer in diameter particles pose any health risks to patients. In the meantime, it reiterated its previous position that there is no risk to patient safety.
“The CE suspension by TUV SUD has been prolonged until the end of June 2016 due to the exceptional circumstances and occurrences in particular the fire in the main manufacturing site,” the agency said in a statement.
Sientra’s stock spiked in early-morning trading in reaction to both the announcements. In pre-market trading the morning of Jan. 8. Sientra’s stock hit $7 per share at 5 a.m. At 5:30 a.m. it peaked at $8.85 per share. By the time markets opened at 6:30 a.m., the stock settled to $7.58 per share.
http://www.pacbiztimes.com/2016/01/08/sientra-implants-could-be-back-on-the-market-in-weeks/(link is external)